The document provides details about an in-plant training report submitted by 5 students from Southeast University at ACME Laboratories Ltd. It includes: 1) An introduction to the in-plant training and about ACME Laboratories which produces over 500 pharmaceutical products across various dosage forms and therapeutic categories. 2) Descriptions of the different production units at ACME including the General Unit, Solid Dosage Unit, Cephalosporin Unit, and the BFS, Liquid & Semisolid Unit. 3) Overviews of other departments visited including Quality Assurance, Quality Control, Warehouse, Engineering, and Research & Development.

1. REPORT
ON
IN PLANT TRAINING
ACME LABORATORIES LTD.
REPORT SUBMITTED BY:
Name of the trainee Student ID Number Name of the Institution
Md. Maruf Hossen 2015000300002 Southeast University
Ali Asraf Sohel 2015000300008 Southeast University
Ibrahim Habib 2015000300015 Southeast University
Al-Amin 2015000300017 Southeast University
Md. Mamunur Rashid 2015000300052 Southeast University

2. In Plant Training Report
Submitted By:
Sl. No. Name of the trainee Student ID Number University
1 Md. Maruf Hossen 2015000300002 Southeast University
2 Ali Asraf Sohel 2015000300008 Southeast University
3 Ibrahim Habib 2015000300015 Southeast University
4 Al-Amin 2015000300017 Southeast University
5 Md. Mamunur Rashid 2015000300052 Southeast University
We would like to express our special thanks of gratitude to:
Mr. Modhusudan Shome, Head of QO, CPU, GNU & HSU.
Mr. Md. Mazaharul Islam, Deputy Manager, Admin& HR (Plant).
Ms. Sheuli Das, Asst. Manager, QA Department, CPU.
Mr. Md. Ataur Rahman, Asst. Manager, QC Department, CPU.
Mr. Bashir Ahmed, Head of Production - Cephalosporin Unit.
Mr. Md. Ziaul Haque, Head of Production- GNU.
Mr. Foyez Ahmed, Head of PPIC.
Mr. Swapan Kr. Gain, Head of Production, SDU.
Mr. Md. Ziaul Huq, Sr. Manager
Mr. Nur Ahmed Bhuiyan, Sr. AGM, Engineering Division- GNU, CPU, Herbal &
Ayurvedic
Mr. Md. Zahidul Islam, Head of production- BLS.
Mr. Khondakar Amirul Islam, Manager, QA Department, GNU.
Mr. Md. Kamal Uddin, Manager, QC, GNU.
Mr. Kazi Akramuddaula, Sr. Manager, R & D.
And finally, we want to thank our in-plant training Co-ordinator, Mr. Shamim Ahmed,
AGM, QOD, who guided us with all effort and responsibility.

3. Table of contents:
SL NO Content Page
1 Introduction 1
2 ABOUT ACME 1-3
3 HR & Admin(Factory) 3
4 General Unit(GNU) 4
5 Solid Unit(SDU) 5
6 Cephalosporin Unit (CPU) 6
7 Production Division- (GNU,SDU,CPU) 7-13
8 Production Division(BLS)-LVP,SVP, Suppository, Oral 13-18
liquid, Cream
9 Quality Assurance (QA) Department(GNU & CPU) 18-23
10 Quality Control(QC) Department(GNU & CPU) 23-39
11 Warehouse Department 40-47
12 Engineering Division(SDU& BLS, GNU, Herbal & 47-51
Ayurvedic)
13 Research & Development Department 51-54
14 Conclusion 55

4. INTRODUCTION
An in-plant training (IPT) is a short duration training course which is provided to the students for
help them to correlate between theoretical knowledge and their practical knowledge. We have
choose ACME Laboratories Ltd for our in-plant training which is perceived as one of the
prestigious Pharmaceutical Company in Bangladesh who ensures manufacturing and marketing
of essential medicines with the highest quality by following cGMP, and ISO 9001:2015 by all
modern technologies. We have visited general unit (GNU), solid unit (SDU), cephalosporin unit
(CPU), quality assurance (QA) & quality control (QC) department, Production department,
warehouse division, engineering division, research & development division.
The main dosage forms manufacturing by the respective company are solid such as tablet,
capsule and dry syrup, Semisolid preparations such as ointments, creams and suppository &
sterile products include ophthalmic, injectable product. According to GMP, every procedure and
equipment has its own Standard Operating Procedure (SOP). Our training period was 05
th
February to 20
th
February 2019. During this period, we have visited every section under the
direct supervision of assigned management staffs. In this report, we have discussed about our bits
of knowledge into the structure, functioning of The ACME Laboratories Ltd.
ABOUT ACME
The ACME Laboratories Ltd. is a leading company for manufacturing world-class and top-
quality pharmaceutical products in Bangladesh. We are currently producing more than 500
products in different dosage forms covering broader therapeutic categories which include anti-
infective, cardiovascular, anti-diabetics, gastrointestinal, CNS, respiratory disease etc. among
many others. The success in local market prompted us to explore the international market and
over the years we gained a firm presence in South East Asia, Africa and Central America and
continuously discovering new horizons to improve the quality of life for patients, to further the
success of our customers and to help meet global challenges. Through the outstanding
knowledge, professionalism and commitment of more than 7000 employees, we are consistently
building upon our facilities, capabilities and also portfolio to meet the growing health care needs.
We are united, inspired and fueled by our mission to ensure health, vigour and happiness for all.
Since our founding in 1954 by Mr. Hamidur Rahman Sinha, an entrepreneur and philanthropist
in this region of the British divided Indian sub-continent, we have been committed to offering
1

5. solutions to our most pressing health care needs. More than half a century later, we remain true
to our founder’s vision and values – to produce high quality medicines with integrity, customer
focus, pro-activity, team spirit, excellence and desire to win and responding to social and
environmental needs. Over the past few decades, we have seen an amazing growth and success
in pharmaceutical sector. With more than 60 years of expertise in medicine and science, our
company draws upon a rich legacy of high quality formulations and a robust pipeline of
promising generic medicines at affordable price to meet the health care needs.
Since 1954 ACME has been stood for quality, business success and responsible
entrepreneurship. Our heritage and our values are the foundation of our mission to ensure health,
vigour and happiness for mankind.
We are an ISO 9001:2015 certified company. “Perpetual Quest for Excellence” is our quality
slogan.
Mission Statement, Vision & Core Values
MissionStatement
Our holistic approach is to ensure Health, Vigour and Happiness for all by manufacturing ethical
drugs and medicines of the highest quality at affordable price and expanding in the local and
global market.
We view ourselves as partners with the doctors, healthcare professionals, all other customers, our
employees and harmonize with environmental issues.
Our Vision
To ensure Health, Vigour and Happiness for all.
Core Values
Our company values are the measure for our thinking and actions. They are the core of what ties
us together in the past, present and future. We do business on the basis of common values. Our
success is based on customer focus, team spirit, desire to win, pro-activity, integrity and
excellence. These values determine our actions in our daily dealing with customers and business
partners as well as in our teamwork and our collaboration with each other.
2

6. QUALITY POLICY

Quality slogan of The ACME Laboratories Ltd. is “Perpetual Quest For


Excellence”



The ACME Laboratories Ltd. is committed to maintain state of art manufacturing
facilities for ensuring best quality products to the customers.


The company is devoted to—



Increase sales growth



Increase productivity



Increase profit margin



Improve company image and customer satisfaction



Ensure continual improvement



ACME is committed to achieve excellence by proper execution of



ISO 9001-2008 Standard



WHO, cGMP Standard



Best practices that are proven effective.

HR& Admin
Mr. Md. Mazaharul Islam, in charge-FAD (plant) told us about ACME that how
employees are recruited, rewarded and given opportunities in the organization, purely
based on their merits. The backbone of this culture is the Performance Management
System, the aim of which is to evaluate employees performance in a fair and transparent
manner .He informed us that more than 7,000 full time qualified, trained and skilled
professionals, including a good number of white and gold collar employees such as
pharmacists, chemists, doctors, microbiologists, scientists, engineers, accountants and
business administration graduates and/or post-graduates are currently working at ACME.
We are appreciative of the effort of admin & HR team.
3

7. General Unit
General unit is the oldest unit of the ACME laboratories limited which is designed and
constructed to provide proper air circulation and air handling, particle-free finishes, equipment
layout, process flow, hygiene and safety.
Dosage forms manufactured:
Tablet, Capsule, Powder for Suspension, Cream, Ointment, Suppository, Eye, Ear & Nasal drops
are manufactured.
4

8. Solid Dosage Unit
Solid Dosage Unit is an innovative and vision-driven manufacturing unit, designed to conform
global standards like WHO-cGMP and UK-MHRA. The finest and one of largest manufacturing
facility in Bangladesh has been established by active guidance of European Consultants.
Facilities and Processes are of the highest quality which has been designed to achieve quality
products with vision to meet the growing demand of home market and also to meet the cGMP of
Stringent Regulatory Authority (SRA) in global market.
Dosage forms manufactured:
Tablet, Capsule, Pellets/ Powder for Suspension, Sachets, Liquid in Hard Gelatin Capsule
5

9. Cephalosporin Unit
Separate manufacturing facilities are designed ,constructed and established to produce
cephalosporin drugs which have separate and dedicated self-contained areas with separate air
handling facilities to prevent cross-contamination between Cephalosporin drugs (non-beta
lactum antibiotic) and penicillin drugs ( beta lactum antibiotic).
In ACME Pharmaceuticals Ltd, there is a separate facility for cephalosporin drugs which is
situated far from the main facility and also far from the main road. It is facilitated with separate
warehouse, HVAC system, water processing unit and also a separate R & D department.
Dosage forms manufactured:
Tablet, Capsule, Dry syrup, Injection
6

10. Production Division
Instrument found in cephalosporin unit (CPU)
Machine Origin
Tablet Compression Machine Cadmach, India
Coating Machine Gansons, India
Capsule Filling Machine Dr. Pharm, China
Blister Packing Machine Buchon, Korea
Integrated Powder Filling Machine Brothers, India
Integrated Vial Washing Machine MACOFAR, Italy
Autoclave De LAMA, Italy
Instrument found in general unit (GNU)
Machine Function Number
High speed granulator (RMG) Granulation 2
Planetary mixture Mixing 3
Fluid bed dryer Drying 4
Coating Machine Coating 4
Compression machine Compression 7
Instrument found in solid unit (SDU)
Machine Origin Manufacturer Number
Granulation Machine India, Taiwan GANSONS, 7
YENCHEN
Blender PMS Thailand 5
Compression Machine Korea, England, SEGON, PTK, 12
Germany MANESTY, FATTE
Coating Machine Taiwan, India YENCHEN, 5
NEOCOTE
Blistering Machine Germany, Korea NOAK, HOONGA 11
Capsule filling & sealing machine India ACG pump, ROTO 2
7

11. In the production process to start the production the changeover need to be completed and the
line clearance is required to prevent contamination.
Process of dispensing:
The production unit sends requisition for the raw material and packaging material according to
the BMR and BPR arrived from QA department. The warehouse sends the whole containers
containing the required material (usually excess amount) to the production division via pass box
and after rechecking, the materials is dispensing in the dispensing area which has laminar air
flow and the temperature and the pressure is controlled in this area. After dispensing, the
materials are kept in post dispensing area.
The production process depends on the type of dosage form.
For tablet manufacturing 3 processes can be used:
1. Direct Compression
2. Dry Granulation
3. Wet Granulation
Direct compression method:
API & direct compression enhancer excipients measurement
Mixing
Compression
Blistering
Packaging
8

12. Wet granulation:
Material rechecking
Sieving
Accurate weighing of active ingredients & necessary additives
Dry Mixing of materials by RMG (Rapid mixing granulator)
Moistening with paste preparation
Wet Mixing
Wet Milling
Drying (FBD)
Final (dry) Milling
Lubrication
Compression
Tablets
(Coating if needed)
9

13. Dry granulation:
Material rechecking
Sieving
Accurate weighing of active ingredients & necessary additives
Mixing
Slugging
Crushing
Blending
Compression
Tablet
(Coating if needed)
Coating
1. Materials used for film coating:

Hydroxy propyl methyl cellulose



Polyethyleneglycol



Methylenechloride.


2. Materials used for enteric coating:

Cellulose acetate phthalate.



Hydroxy propylmethylcellulose phthalate



Diethylphthalate

10

14. For capsule manufacturing Process:
Developing and preparing the formulation and selecting the size capsule.
The raw materials (active and excipients) are blended
Fill the capsule shells.
Capsule sealing
Cleaning and polishing the filled capsules.
Packaging
Packaging is the process by which the pharmaceuticals are suitably packed so that they should
retain therapeutic effectiveness from the time of their packaging till they are consumed.
Packing can be defined as an economical means of providing, presentation, protection,
identification, information, convenience, and compliance for a product during storage, carriage,
display and use until such time as the product is used.
After manufacturing of tablets and capsule they are packed either in blister pack or in the strip.
Classification of Packaging:
Primary Packaging: When the product contents are directly in contact with the packaging
materials then the packaging is called Primary Packaging.
Examples:
1. Strip Packaging
2. Blister Packaging
Secondary Packaging: When the product contents are directly not in touched with the
packaging materials then the packaging is called Secondary Packaging.
11

15. It is three types:
1. Inner Carton
2. Master Carton
3. Shipper’s Carton
Purpose of Packaging:

To increase the acceptability of the drug



To increase thestability of the drug



To minimize thetransport/shippinghazards



To improve patients compliance



To improve the pharmaceutical elegance by use of special color or contrasting printing

Packaging Information:
Following Information are generally provide by primary packaging:
1. Product name
2. Materials name.
3. Batch size & batch number.
4. Manufacturing date and expiry date.
5. Packaging systems.
6. Logo of the company.
7. DAR No. of the product etc.
Following Information are generally provided by secondary packaging:
1. Product name
2. Materials name.
3. Batch size & batch number.
4. Manufacturing date and expiry date.
5. Packaging systems.
6. Logo of the company.
7. Storage condition of the product
8. Name of the manufacturing company
9. MRP. Of the product etc.
12

16. Materials used in blister packaging:

PVC (Polyvinyl chloride)



Polyethylenelaminated aluminum foil.



PVDC



Alu-Alu foil.

Striping materials: Polyethylene laminated aluminum foil.
BFS, Liquid & Semisolid Unit (BLS)
Figure: BFS, Liquid & Semisolid Unit (BLS)
BFS Department:
Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL)
and large volume, (500mL +) liquid-filled containers. The ACME Laboratories Ltd. enters into
13

17. the era of BFS (Blow-Fill-Seal) technology. The technology is provided by Rommelag,
Germany, the most renowned innovator of BFS technology in the world. ACME is
manufacturing Large Volume Parenteral (LVP) fluid products (ACME’s Dextrose – DA 5%,
ACME’s Dextrose DS - DA 10%, ACME’s Normal Saline - NS, ACME’s Cholera Saline - CS)
through BFS technology with the State of the Art Manufacturing Facilities in a dedicated plant.
The basic concept of BFS is that a container is formed, filled, and sealed in a continuous process
without human intervention, in a sterile enclosed area inside a machine. Thus this technology can
be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
The process is multi-stepped: first, pharmaceutical-grade plastic granules (polypropyl) is
vertically heated (2100C) extruded through a circular throat to form a hanging tube called the
prison. This extruded tube is then enclosed within a two-part mould, and the tube is cut above the
mould. The mould is transferred to the filling zone, or sterile filling space, where filling needles
(mandrels) are lowered and used to inflate the plastic to form the container within the mould.
Following the formation of the container, the mandrel is used to fill the container with liquid.
Following filling the mandrels are retracted and a secondary top mould seals the container. All
actions take place inside a sterile shrouded chamber inside the machine. The product is then
discharged to a non-sterile area for labeling, packaging and distribution.
BFS equipment:
Name of The Machine Origin
BFS Technology Rommelag, Germany
Liquid Department:
The oral use of liquid pharmaceuticals has generally been justified on the bases of ease of
administration to those who have difficulty swallowing solid dosage forms. A drug administrated
in solution is immediately available for absorption and in most case, is more rapidly and
efficiently absorbed than the same amount of drug administered in a tablet or capsules. In liquid
section Temperature is below 28°C at the production area.
14

18. Manufacturing Process of Syrup:
Collection of required amount of water & sugar
When temperature goes to 100⁰ C preservatives are added
After 20 minutes, cooling starts
Addition of wetting agent when temperature below 45⁰ C
Addition of ingredient
Addition of co-solvent, buffering agent
Addition of sweetening agent
Addition of color & flavor
Volume adjustment
Filling & sealing
Packaging
15

19. General manufacturing process of oral liquid:
Weighing of API along with Excipients
Mixing of excipients with certain amount of demineralized water as specified in BPR
By the aid of a mechanical stirrer
Addition of active ingredient
Passing through a pump to the storage vessel
Transfer of the solution to the filing vessel through 0.2-micron cartridge filter
Manufacturing process of suppositories:
Compounding vessel
Melting 50⁰C
Overnight cooling (40⁰C)
Compounding vessel (40⁰C)
Addition of active ingredient
Sieving 40 mesh
Per foil 1.15 g liquid products filling
Cutting
Packaging
16

20. Injection
The ACME Laboratories Ltd. produces various injectable in vials and ampoules meant for
administration in the body through IV or IM routes. The ACME Laboratories Ltd. has separate
for injectable which consists of several sub units

Compounding area



Asepticrooms for filling and sealing



Sterilization room (autoclaving and terminal sterilization)



Vials and ampoules washing and sterilizing room



Packaging and packing room.

Aseptic condition:

Room temperature: 20-25oC



Room humidity : >50%



Pressure difference: 10-15pascle



Clothes, utensils and removable parts of themachine: autoclave at 121oC for 15

Manufacturing process ofinjectable products:
Empty ampoule washing
Sterilization & cooling
Solution preparation
Filtration
Visual inspection
Terminal sterilization
Filling & Sealing
Blister sealing Packing
17

21. Quality Assurance Department
Quality assurance is the sum total of the organized arrangements made with the object
of QA = Product design + GMP + QC + Quality goal activities.
QA has 3 major sections:
1. Quality compliance
2. GMP Implementation
3. Process validation & Qualification
These sections have several sub-sections:
Quality Compliance:

Document control & management.



Change control & monitoring.



Environmental monitoring.



Customer compliance.



Risk assessment.



Change control.



Batch Release.

GMP Assurance:

CAPA.



Deviation.



Training.



IPQA.



Internal Audit.

Validation:

Process Validation.



Cleaning validation.



Facility.

Documentation Control & Management:
They approve, control, distribute, maintain archive and ensure superseding of documents. They
deal with SOP, BMR. They are responsible for the change control system.
18

22. Change Control System:
If any type of change is needed at any stage of production process, facility, utility or material
usages, change control is must. The corresponding person or department must have to submit
written request as a change control form to QA for approval for the change. QA will analyte
whole system & consequences that will appear after the change & if satisfied with quality &
safety then they will give approval. Without change control, no change at any situation is
accepted.
Risk Assessment:
It is related to change control. If any formulation is being modified, QA do a risk assessment for
ensuring that the new formulation or process would not create any severe negative impact on the
quality of product.
Risk assessment is done with Failure Mode Effect Analysis (FMEA) model. Risk Priority
Number (RPN) is concerned with it.
RPN = S * P * D (range 1-125)
Where, S= Severity (range: 1-5)
P= Probability (1-5)
D= Detectability (1-5)
If RPN ranges 1-11 = Low risk
12- 27= Medium risk
28 – 125 = High risk
Training:
QA arrange & manage all different types of training programs of the pharmaceutical factory.
There are 3 levels of training:
Level 1: It’s like an orientation program for new personnel recruited by the company.
Level 2: Departmental training
Level 3: For job training.
Deviation Management:
Deviation from standard may arise while processing products. QA does deviation control
program.
19

23. Steps:
Team formation in QA.
Observation will occur after evaluating several critical parameters & effects.
Cause identification.

CAPA is provided.



CAPA implementation.



Continuous monitoring.

CAPA:
CAPA stands for Corrective and Preventive Actions. If any change is needed in any system or
deviation happens, QA analyzer team points out the problems & provides a report as CAPA. The
changes are done according to CAPA.
CAPA is also issued for development purpose. More effective processes are
implemented. Deviation
Change Control
Approval
Monitoring
Internal Audit:
The departments in a pharmaceutical company do internal audits to ensure the working quality.
Personnel from other several departments form the audit team for any particular department.
Qualification:
Qualification is the planning, carrying out and recording of test on equipment and systems,
which form part of the validated process, to demonstrate that it will perform as intended.
20

24. URS ( User
DQ ( Design
requirement
FAT
specification)
Qualification)
IQ OQ ( PQ (
(Installation Operational Performance
Qualification) Qualification) Qualification)
PV
(Performance BMR/ BPR
Validation )
Validation:
Validation is establishing documented evidence that provides a high degree of assurance that a
specific process, method or system will consistently produce a result meeting its predetermined
acceptance criteria.
Divisions of validation:
1. Cleaning validation.
2. Process validation.
Process Validation:
1. Prospective: It is carried out during the development stage by means of a risk analysis of the
production process for 3 consecutive batches.
2. Retrospective: Involves the examination of past experience & documents. This process is not
used in pharmaceuticals.
3. Concurrent: This process is carried out during normal production process for consecutive
batches.
4. Re-validation: Provides the evidence that changes in a process and/ or process environment
do not adversely affect process characteristics & product quality.
Cleaning Validation:
Cleaning validation is done for sharing equipment, not for dedicated ones. 2 types of cleaning is
done in pharmaceutical plants:
1. Type A.
2. Type B.
21

25. Type A cleaning is done with suitable disinfectants & cleaning agents when different product is
to be manufactured or processed on same equipment.
Type B cleaning is done with PW when same product of different batch is to be prepared.
APQR:
APQR stands for Annual Product Quality Review.
It is a report prepared by analyzing & taking data from the documents (BMR, BPR etc) regarding
all the batches released in a year. It includes info about certain product from raw material buying
to market release of finished product & also the review 7 monitoring information. So, APQR can
provide full info about a product concerning all the batches of a particular year. It includes
several appendixes, such as:
Appendix A:

Name



Active, Excipient.



Primary packaging material.



Raw material code.



Vendor information.



Reference no. for identification.

Appendix B:

Actual yield.



Intended amount.



Actual amount.



Lost amount.



Causes of loss.



Reconciliations.



Packaging material

Appendix C:

In-process test information: LOD, Thickness, Hardness, DT, Appearance, pH, weight etc



Certificate of analysis

Appendix F:

Stability information

22

26. Appendix G:

Summary; if there is any problem



Different numbers, like license no.



Other information

Appendix D & E are used for liquid products.
IPQA:
IPQA stands for In Process Quality Assurance.
IPQA is an important department for ensuring the quality of the product. They test all physical
parameters under specific condition (temp: 22±2°C, humidity: 45±5).

Test the product during start-middle-end when the duration of the production is within 4
hrs. If the duration is more than 4 hrs. Then test should be performed every 2 hrs.



Appearance test, hardness, thickness, DT, pH, leak test, friability test are done in IPQC
lab.


They provide machine approval to production



Check cleaning procedures.

QUALITY CONTROL
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured
product or performed service adheres to a defined set of quality criteria or meets the
requirements of the client or customer.
Major responsibilities of QC:

They collect raw materials from ware house along with material name, batch no, batch
size.



They perform various tests of raw materials and keep records and provide the analytical
record sheet to the concerned departments which are later included with BMR.


They ensure precision and accuracy of all testing method.



They calibrate and standardize laboratory instruments.



They follow BP, USP, NF to perform various analytical tests as specified.

23

27. GMP requirements for the Quality Control Areas:

Normally QC laboratories should be separated from the production areas.



Sufficient space should be given to avoid the mix-up and cross contamination. There
should be adequate suitable storage space for samples and records.



Separate rooms may be necessary to protect the sensitive instruments from the vibration,
electrical interference, humidity etc.



Special requirements are needed in laboratories handling particular substances such as
biological or radioactive samples

The QC department has 6 sections
1. Raw material analysis
2. Packaging material analysis
3. Finished product analysis
4. Calibration
5. Microbiology test
6. Stability testing
1. Raw material analysis:
Raw material section of QC department performs all the activities required to ensure the quality
of the raw material. They test the raw material from the new vendor for vendor approval. They
test the raw material received by the warehouse from approved vendor before giving release for
the production
24

28. The tests performed on the raw materials are:
Solid Raw materials:

Identification



% of LOD



Sulfated Ash



Bulk density



Heavy Metaltesting



Impurities



Melting point



Bulk density



Specific Optical Rotation



Water content test

Liquid Raw Materials:

Maximum tests for solid



Refractive Index



pH



Weight per ml



Viscosity

Raw material testing procedures are given below:

Raw materials are received by warehouse.



The material will be ready for use for theproduction purpose.



GRI is sent to the QC department by warehouse.



Then theQC department collect sample to perform the test.



Depending on thetesting result, release or pass tag will be attached.



After the testing the materials will receive the release tag.

2. Packaging materials analysis:
This subsection is concerned with good quality packaging materials import. They have major
two functions like vendor approval for packaging materials and quality check for commercial
packaging materials which are provided by selective vendor.
25

29. Vendor approval process
1) Materials requirements are sending to vendor.
2) The vendor sends a dummy for testing.
3) Then specimen sample are tested for approval.
4) If the sample passed the assessment, then it will be approved.
5) Otherwise it will be rejected and another vendor will be searching.
Sampling is done by military standard stated in ISO guideline. Appearance and identification
is done by comparing with Shade Card which is send by vendor itself. Parameters which are
checked with Shade Card:

Upperlimit



Standard limit



Lower limit

Specification parameters for Packaging materials are:

Appearance



Measurement



Locking teeth



Paper quality: Duplex board and Chroma board

Machine trial with packaging material is done by production department
Chemical test of packaging materials:
Alu-PVC, Alu-PVDC foils are deeped into NaOH or HCl solution for about 1 to 1.5 hours.
Alu layer is dissolved and HSL (Heat Soluble Leaker) is separated from the foil as a result the
remaining part is PVC layer. The thickness of PVC layer is measured by calibrated slides
Calipers. After receiving the GRI from the warehouse, the released tag should be passed within
15 days.
GSM calculation for packaging materials:
GSM is the unit to measure the strength of the fabrics, paper, corrugated fiber board, foils,
leather, rexine, etc. It stands for Grams per Meter Square or Grams per Square Meter. It is a very
simple to perform test but tells a lot about the basic properties of the material which are very
26

30. important to decide the quality of the fabric. For the best quality analysis of packaging materials,
the accurate GSM of the products must be known.
Sampling procedure:
Sampling comprises the operations designed to select a portion of pharmaceutical products for a
defined purpose. When sampling starting materials proper consideration has to be given to
decide on a sampling plan.
The following sampling plans could be used:
A. The n plan
B. The r plan
C. The p plan
In ACME Pharmaceutical Limited the n plan is used for starting materials. In case of API, there
will be 100% sampling that means sample will be collected from every container for
API. But in case of excipients, the sampling will be based on the n plan. The n plan is based on
the formula n= √ +1
Where, N= the number of sampling units in the consignment.
The value of n is obtained by simple rounding. A minimum number of container needs to be
sampled, e.g. if N is less than or equal to 4 then ever container is sampled.
When lot of API is more than 200 then 100% sampling for the purpose of identification and
assay test and for the remaining containers only identification test is performed.
Re sampling is done only for the purpose of identification.
3. Finished product analysis
Finished product analysis is an important thing to ensure the quality of the product. It is
mandatory in pharmaceutical to analyze finished goods according to GMP specifications & tests.
We were taken to the finished product testing area. The QC department begins its work after
completion of compression process, sample form the batch is sent to the QC for testing. Then the
analytical tests are performed on the sample. The most common performing tests are given
below:
27

31. Description: This test is often called appearance on a specification and is a qualitative
description of the pharmaceutical products. For example, the description of a tablet on a
specification may white to off-white colored.
Identification: The purpose of an identification or identity test is to verify the identity of the API
in the pharmaceutical tablets.
Average weight: 15-20 tablets are weighed and average is determined. 20 tablets are taken and
weight individually to determine the average weight of 20 tablets. Then it is compared with
individual tablet weight to average weight.
The following parameters are done for finished product testing-
Solid Preparation:

Description



Dissolution & Disintegration time



Weight Variation



Assay



Content uniformity



Hardness



Thickness



Friability test



Average weight

Liquid Preparation:

Appearance



Suspendibility



Potency



Weight per ml



Microbiological Limit Test



pH

28

32. Semi-solid Preparation:

Microscopic Examination



Assay

Nasal Spray:

pH



Identification



Assay



Totalno. of spray per container



Uniformity of delivered dose



Particle size



Deposited amount size



Leak test

Tests for Gel/Dry syrup/pediatric drop:

Identification of active ingredient



Microbial contamination (satisfactory/unsatisfactory)



pH value



Water per ml at 20±C, gm.



Viscosity



Sedimentation test



Totalsolid



Color content



Alcohol content



Assay (Spectrophotometric/Titrimetric/HPLC)

29

33. Tests for WFI:

Contents of vial/bottle



Sterility test



pH value test



Ammonia test



Nitrates test



Chlorides test



Sulphate test



Acidity/alkalinity test



Oxydizable substances test



Heavy metals test



Ca & Mgtest



Residue on evaporation



Conductivity test



Water content

For Packaging Materials:

Description



Text



Color



Dimension



Weight (gm/m2)


Visual inspection for defects



Opacity &chemical test glass pack



Adaptability

30

34. Control of Bulk Products:
Each lot of bulk product is tested to ensure

Identity



Quality



Potency



Purity

Bulk products are tested following their MCP. Some products require compendia (BP/USP)
procedures for testing.
4. Calibration:
To ensure the high quality of the end products, ACME must ensure that all of their equipment is
well calibrated. At the same time, they must have confidence in the performance and results of
the instruments they use to calibrate their manufacturing equipment. It is the technique of
correcting or setting a measuring device by adjusting it to match a dependably known and
unvarying measure. Calibration is primarily done to achieve 5 main purposes which are:

To make sure that the readings of equipment or instruments are consistent with other
measurements and display the correct readings every single time



To determine the accuracy, precision, reliability and deviation of the measurements
produced by all the instruments



To establish the reliability of the instrument being used and whether it can be trusted
to deliver repeatable results each time



To map the ‘drift’ as documented. Instruments have a tendency to produce inaccurate
measurements over a period of time, following repeated use.



Ensuring that the industry standards, quality assurance benchmarks such as current
good manufacturing practice (cGMP) and government regulations are adhered to.

HPLC calibration:
Frequency: Once in a year.
31

35. Procedure:

Operate the instrument according to SOP.



Pump calibration.



Wavelength accuracy of detector.



Reproducibility of results.



Program files check.



Linearity test.



Carry over test.



Quaternary gradient accuracy test.



Temperatureaccuracy test for column oven & Sample cooler tray.

Balance calibration
Frequency: Once in 6 months.
IR calibration:
Frequency: Once in 6 months.
Procedure:

Operate the instrument according to SOP.



Put the reference polystyrene filmon the sample holder & scan.



Compare the obtained spectrumwith the standard spectrum.

AAS calibration:
Frequency: Once in a year.
Procedure:

Operate the instrument according to SOP.



Use Cu standard for radiation.



Measurethe absorbance of some standard solution.



Calculate the correlation coefficient by the instrument.



Correlation coefficient should not less than 0.9900%

32

36. UV calibration:
Frequency: Once in 6 months.
Procedure:

Operate the instrument according to SOP.



Control thewavelength.



Control of absorbance.



Limit of spray light.



Resolution power.

Viscometer calibration:
Frequency: Once in a year.
Procedure:

Operate the instrument according to SOP.



Calibrate the instrument with standard viscosity solution of 10, 100, 500, 5000 & 12500
cps using respective spindles & record the result.

PH meter calibration:
Frequency: Once daily.
Procedure:

Operate the instrument according to SOP.



Key function of pH meter.



Operation of pH meter to determine pH of solution.



3 buffer solutions are used for PH meter calibration. They
are I. Buffer solution of PH
4.00

II. Buffer solution of PH
7.00
III. Buffer solution of PH
10.00

Determination of pH
electrode slope.


Electrode rejuvenation.

Disintegration testercalibration:
Frequency: Once in a year.
33

37. Procedure:

Operate the instrument according to SOP.



Measure the temperature of individual beaker,when indicator displays 370C.


Record thenumber of up down cycles per minute.



Measurethe oscillation & record the result.

Dissolution testercalibration:
Frequency: Once in a year.

RPM check with tachometer.



Temperaturecheck.



Calibration for disintegrating typeprednisonetablets 50 mg.



Checking all physicalparameters: Basket, paddle.



Checking of wobbling, rotations & distance parameters.

5. Microbiology Section
Microbiology department plays a great role for the safety & quality of the product. Here
We noticed different type of instruments that is necessary for microbiological tests. Some of
them are given below:

Waterbath,Clifton



Liquid born particle counter,APSS-2000



Double door autoclave



Universal oven, Memmert, Germany Incubator, Memmert, Germany



Laminar flow cabinet, Air tech, Malaysia



LAL analyzer, Biotek, US.

We noticed several rooms in microbiology department. Different tested were conducting those
rooms respectively. They are:

Media preparationroom



Autoclave room



LAL test room



Incubation room



Wash room for disposing materials

34

38. Microbiology section also perform the continuous monitoring of microbial and particle count in
production and different controlled area to ensure that the environment of those area is within the
specification of required clean room class. They also take part in cleaning validation. They test
the sterility of the finished products and raw materials. Finished products sterility also
determined. For this purpose direct incubation method or membrane filter method is used. For
injectable liquid borne particle count is also determined.
Environmental monitoring is done by collecting sample from different part of the
area. The sample number,
N = VA (Where the N is the sample number and the area in m2
)
The samples are collected by different method:
1. Settle Plate
2. Air Sampling
3. Contact plate
All the equipment used is sterilized first. Then the samples are cultured to determine the
microbial count of the monitored area. In case of raw material, they perform the following tests:
1. Limit test
2. Bacterial Endo-toxin test
3. Pathogen tests
Those tests are performed on:
4. WFI
5. Raw materials
6. Packaging material
7. Sterile product
8. Medical device.
35

39. Sterility Test according to SOP:
Equipment & reagent
Sampling
Preparation microbiological culture media
Growth promotion test
Preparation of sample dilution
Member filtration
Sample preparation
Test for sterility
Direct inoculation technique
Incubation (14days)
Interpretations of results
Method suitability test
Incubation (5days)
Investigate fluid result
Maintain logbook
36

40. 6. Long time stability testing:
This subsection of QC department performs the stability test on both raw and finished products.
The purpose of stability testing is to provide evidence on how the quality of an active
pharmaceutical ingredient or medicinal product varies with time under the influence of a variety
of environmental factors such as temperature, humidity, and light, and to establish a retest period
for the active pharmaceutical ingredient or a shelf life for the medicinal product and
recommended storage conditions.
Four climatic zones can be distinguished for the purpose of world wide. Stability testing by ICH
guidelines:
ICH Stability Zones
Zone Type of climate
Zone I Temperate zone
Zone II Mediterranean/subtropical zone
Zone III Hot dry zone
Zone IV Hot humid/tropical zone
Long term stability testing frequency are 0, 3, 6, 9, 12, 18, 24 months and annually through the
proposed shelf-life. Accelerated stability testing frequency are 0, 3 and 6 months.
Study Storage condition Minimum time period
covered by data at
submission
Long –term 30°C ± 2°C. RH 60% ± 5% 12 months or
or Six months
30°C ± 2°C. RH 65% ± 5%
or
30°C ± 2°C. RH 75% ± 5%
Intermediate 30°C ± 2°C .RH 65% ± 5% Six months
Accelerated 40°C ± 2°C. RH 75% ± 5% Six months
37

41. Instruments
1) Particle size analyzer .Brand name: Malvern
2) Dissolution tester
3) ICP (Inductivity Couple Plasma)
INSTRUMENTATION OF QUALITY CONTROL SECTION
INSTRUMENTS ORIGIN FUNCTION
HPLC Waters, USA For separation, identification & assay
Shimadzu, Japan
Dionex, Germany
PerkinElmer, USA
Gas Chromatography(GC) Shimadzu, Japan Product identification, separation &
assay
UV-Visible Spectrophotometer Shimadzu, Japan Product identification, assay
Fourier Transform Infrared Shimadzu, Japan Product identification, mainly for raw
Spectrophotometer (FTIR) materials
Atomic Absorption Shimadzu, Japan For identification/ detection of metal
Spectrophotometer (AAS) (elemental analysis).
Dissolution Testing Apparatus Erweka, Germany Dissolution rate determination.
Hanson,USA
Disintegration Testing Erweka, Germany Disintegration time determination
Logan, USA
Phamatest,
Germany
Melting Temperature Testing Optical acivity, Melting point determination
Apparatus UK.
38

42. pH Meter Mettler-Toledo, Disintegration of pH.
Switzerland.
Metrohm,
Switzerland
Moisture Analyzer OHAUS, USA. Disintegration of moisture& bound
Shimadzu, Japan water.
Potentiometer Titrator Metrohm, Used for titration & voltage change, pH
Switzerland. Change.
Visometer Brookfied, USA Determination of Viscosity
Conductivity meter Mettler-Toledo, Determination of conductivity in solvent
Switzerland.
39

43. Warehouse department
Warehouse is the area where the initially received incoming materials stored and issued for
production after necessary quality activities. Warehouse activities considered as one of the major
part of any manufacturing industry. Usually the warehouse operations are large in volume.
The warehouse department of the ACME Laboratories Ltd. includes the following sections:
1. Raw materials warehouse
2. Packaging materials warehouse and
3. Finished goods warehouse
Besides there are some common areas which are using by all the sections; like as-
4. Cold and cool room
5. Rejected materials room
6. Non-confirming materials room
7. Loading / unloading area
40

44. Working procedures:

The Standard Operating Procedures are available which covers the working process of
warehouse. At present there are 22 standard operating procedures and the warehouse
personnel maintaining strict adherence with the standard operating procedures during
performing their job.


As per organization policy the warehouse material management following ‘Periodic


Inventory Method’ by using both software and manual documentation in some cases.


Company goals, Quality objectives and Role Profiles are available and well described.



There are flow charts for all the major activities which describe the working methods in
line with standard operating procedures as well as ISO 9001:2008 guidelines.

Some important and major activities:
a. Ensure the reception of right materials.
b. Issue required materials for production within the limit.
c. Reception of Finished Goods from production & timely distribution.
d. Monitoring of temperature & relative humidity.
e. Overall cleanliness of both materials & areas. Materials management
(Segregation, QC formalities, Disposition, etc
Section / Storage areas of warehouse
1. Raw material warehouse
Location: Level 02 (1
st
floor) of warehousing building
Facilities: Quarantine area, release area, sampling booth. Dispensing booth is place in
separate area for Cephalosporin materials, Penicillin materials and Narcotic materials.
Storage temperature: Below 25ºc and ambient
Activities: The major activity includes receiving of raw materials and issue of raw materials
to production.
41

45. Raw Material Receive
Checking ofvehicle with Receiving chalan/Invoice (Exact product, volume/amount)
Unloading vehicles,sorting and palletization
Cleaning ofincoming materials
Checking for damage/loss/excess
Information entry in “Material Receiving Register” (MRR)
Preparation of “Goods Receive Information” (GRI) & Quarantined Label
Affixing of “Quarantined Label” & transfer ofmaterials to the quarantine area ofwarehouse.
Sending out ofGRI to QC department
Result: Released Result: Reject
Affixing of release label, transfer of Affixing of reject label & transfer of
material to released area & software entry material to reject store
Informing PPIC about rejection of
materials.
42

46. Raw material Issue to Production
Receiving of “Batch Manufacturing Record” (BMR) from Production
Checking ofmaterials “Bin Card”
Information entry in the required field ofBMR
Arranging of required released materials as per FIFO/FEFO system
Information entry in “Bin Card”
Issuing materials to the materials dispensing both
Dispensing of Raw Materials & issue to production
Returning the access materials to Warehouse & information entry in “Inventory
software”
Storing of returned excessmaterials in the respictive location/area ofwarehouse.
Dispensing Booth: There are 04 dispensing booth in warehouse. Each and every booth is
equipped with laminar air flow facility. There are sufficient calibrated electronic balance and
other dispensing apparatus. Inside the dispensing boots cleaning activities found satisfactory.
The people are working here trained and using all the necessary protective garments and
equipment’s.
2. Packaging Material Warehouse
Location: Level 03 to level 06 (2
nd
floor to 5
th
floor) of warehousing building.
Facilities: Quarantine area, Release Area, Separate area for primary and secondary packaging
materials, under lock and key facilities for printed and dedicated area for exportable items.
Storage temperature: Below 25ºc and ambient
Activities: The major activity receiving of packaging materials and issue of packaging materials
to production.
43

47. Packaging Material receive
Checking of vehicle with Receiving challan/Invoice (Exact product, volume/amount)
Unloading vehicles, sorting and palletization
Cleaning of incoming materials
Checking for damage/loss/excess
Information entry in “Material Receiving Register” (MRR)
Preparation of “Goods Receive Information” (GRI) & Quarantined Label
Affixing of “Quarantined Label” & transfer of materials to the quarantine area of
warehouse.
Sending out of GRI to QC department
Result: Released Result: Reject
Affixing of release label, transfer of Affixing of reject label & transfer of
material to released area & sotware entry material to reject store
Informing PPIC about rejection of
materials.
44

48. Packaging MaterialIssue to Production
Receiving of “Batch Manufacturing Record” (BMR) from Production
Checking of materials “Bin Card”
Information entry in the required field of BPR
Arranging of required released materials as per FIFO/FEFO system
Information entry in Bin Card
Issuing materials to Production information entry in Inventory software
Storing of returned excess materials in the respictive location/area of warehouse
3. Finished Goods Warehouse
Location: Level 01 to level 03(ground floor to 2nd
floor) of warehouse building
Facilities: Quarantine area, Release Area, separate area for products need to be stored under
controlled temperature.
Storage Temperature: 15ºC to 20ºC and ambient
Activities: The major activity includes reception of finished goods in warehouse after
production and distribution of the same.
45

49. Finished Goods receive
Delivery of finished goods from production to warehouse with goods receiving note
Checking of quantity of finished goods with the quantity mentioned in the good receiving
note
Transfer of finished goods to the quarantine area of warehouse
Information entry in the finshed good receiving register
Result: Released Result: Reject
Affixing of release label, transfer of Affixing of reject label & transfer of
material to released area & sotware entry finshed goods to reject store
Informing PPIC about rejection of
materials.
Finished Goods Dispatch
Receiving of “Requisition of Finished Goods” from Central Sales Centre.
Checking of availability of Finished Goods
Sending request to Quality Assurance for release (if required)
Arranging covered van for loading Finished goods
Preparation of Delivery Challan, Issue voucher & gate pass
46

50. Important Aspects of Warehouse Department:
Storage Condition Maintenance: Materials or products are stored according to their
required storage conditions. ACME Laboratories Ltd. uses HVAC system to maintain these
storage conditions. Such as
Temperature: The facility has three special room of different temperature-
1. Cold Room (2-8) °C
2. Cool Room (8-15) °C
3. Ambient Room (15-25) °C
Air pressure: The cold and cool room has negative air pressure to prevent materials from
coming to the outside corridors. But all the corridors have positive air pressure. The air
pressure is controlled by megnehelic gauge.
Relative Humidity: Maintained by the HVAC system.
In order to control the temperature and RH the facility uses thermo-hygrometers. Each storage
room has at least two of this device that are checked daily for two times at 10.30-12.00 a.m.
and 3.30-4.30p.m.
Locked/Fenced area: These areas are locked as confidential materials such as printed labels or
packaging materials are kept here. Only authorized people have access to it. One-way door
system: Important for safety management.
Pest control: Pest control system include-
1. Rodent trap
2. Crawling insect’s gum trap.
47

51. Engineering Department
The Engineering department divided into two sections
Operation
Maintinance
Project
management
• Utility
• Production Machine
• New building design
• machine setup
Steam Generation:
There are four steam generation unit:
1.Two boiler that convert 6 tons water into steam per hour.
2. One boiler converts 6.6 tons water into steam.
3. One boiler converts 7.8 tons water into steam.
Power Sources
REB
Generator
48

52. HVAC SYSTEM
This section maintains the required environment at different area. Control environmental
conditions like temperature, humidity, air bone particle number, air pressure are controlled by
HVAC system. ACME has 63 HVAC systems in total. The HVAC system has three functions:
ventilation
Heating
Air
conditioning
HVAC
system
HVAC consists of different parts such as
Air handling unit (AHU):
Ducts
Chiller
Heater
Dehumidifier
Filter
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53. Water Treatment Plant
Purified water treatment is divided into three units:
Pre-treatment Unit: The purpose of pre-treatment is described below.
Portable water was transported from deep tube well to the tank and
filtered bythe 25μ filter
Again water was filtered by multimedia filter. Multimedia filtrate was added
withsodium hypo chloride to kill bacteria and transferred to the break tank.
Thenthe water transferredtothe softenerthroughthe feedwaterpump
The water then passed through the activated carbon filter and through the
heat exchanger it was transferred to the Generation Unit with the help of a lubricating
liquid Antiscalant for free movement of water through the RO membrane filter.
Generation Unit:
From the pre-treatment unit the water filtered through a 1μ filter and filled in a feed
water tank of 125 litter.
Through primary pump the water passed through primary RO membrane (where
theconductivity of the water becomes 5)
Through secondary pump the water passed through secondary RO membrane
(where the conductivity of the water becomes 4.8)
Then it passed through the Degasser where it became free from CO2 gas.
Thenit passedthroughthe CEDI-A where the conductivitybecomes0.08which
wasscreenbyUV detectorandfilledinthe DistributionTank(capacity10000L).
50

54. Distribution Unit:
From the Distribution Tank the water went to the cooling section through a pump.
Then it passed through the UV detector.
It is distributed into 32 units. The draining valve opened automatically for water.
Calibration:
Pre-treatment unit: Multi-media filter were backwashed one by one after 20 minutes by Salt
water (where ACME salt was used)
Generation Unit: When Sanitation button is clicked water is heated into 85 degree
Celsius and after washing the lines it is cooled in 24 degree Celsius.
Distribution Unit: Sanitation starts with 85 degree Celsius steam and after cleaning it is cooled
with chilled water (24 degree Celsius)
It is done Two times a year. The name of the Machine is GENESYS (origin UK and capacity
2000L) It has two multimedia filter, two softener and two activated carbon filter.
There are one water treatment plant
General Unit whereas there are
7000L/hour).
in SDU (capacity 2000L/per hour), Cephalosporin unit &
two water treatment units in BLS (capacity 5000L&
RESEARCH AND DEVELOPMENT DEPARTMENT (R&D)
R&D has 2 sections.
These are:
1. Formulation development section: This department is responsible for product development
and stability study.
2. Analytical development section: Method development and validation is the prime concern of
this section.
51

55. Product Development:
Functions of PDD:

New product formulation.



SOP development for new product.



Troubleshooting for existing product.



Modification of an existing formulation for cost reduction.



Development of formulation of new products.



Preparation of B.M.R & B.P.R. for a new product.



Development of existing product.

New product development:

Selection of new product is done by PMD for product development, according to the demand
of the market.


Collection of raw material (both excipient & active drug) for new product development.



Pre-formulation study.

Checking of following parameters for active drug or excipients:

Solubility.



Water content.



Particle size.



Bulk / tapped density.



Flow properties.



Melting point.



Crystalproperties.



Biological properties.



Recipe Preparation.



Lab scale trial batch production.



Analytical method development & validation.



Preparation of stability study protocol&stability study as per ICH guidelines.



Evaluation of stability study test result after 1 month, 3 months & 6 months interval.

52

56. 
Preparation of BMR (Batch Manufacturing Record) & BPR (Batch Packaging Record) for
small scale commercial batch, i.e., pilot batch.


Pilot batch production (at least 3 consecutive successful batches).



Preparation of BMR & BPR for routine commercial production.

Documentation:

Preparation of product dossier for regulatory purpose.



Preparation of export document (e.g. manufacturing process, batch formula, and stability
data) as per requirement of respective countries.

Method validation:
R&D also develops and validates method. During method development, some parameters are to
be considered. Those are

Accuracy



Precision



Linearity



Standard deviation (SD)



Relative standard deviation (RSD)



Robustness

Lab Batch A lab batch is produced to see if the formulation is effective. The recipe of the lab
batch is sent to the DRA. It is also done for a feasibility study. The lab batch recipe undergoes
various corrections.
Pilot Batch The manufacturing procedure should be validated on at least three pilot lots to
identify the critical parameters in the product and process.
53

57. Commonly used machines in the product development department:
Machine Name Company Country of origin
Compression Machine Manesty Machines Liverpool, England
Film Coating Machine New Cota, Thailand
High Speed Mixer Granulator Pharmaceuticals & Medical Supply Thailand
Ltd.
Fluid Bed Dryer (FBD) Sapphire Machines Mumbai, India
Friability Tester Erweka Germany
Moisture Analyzer Sartorius Japan
HPLC Shimadzu Japan
Hardness tester Comply UK
Viscometer Brookfield UK
Particle Size Analyzer Malvern UK
Dissolution Machine ERWEKA, Handson Germany, USA
Disintegration Tester Erweka Germany
Weighing Machine Sartorius Japan
54

58. CONCLUSION
For a pharmacy student a learning combination of theory and practice is an invaluable asset
which helps in understanding the core meaning of pharmacy by way of first-stand experience.
Subject like pharmacy demands practical knowledge of its own field. Thus industrial training
program is one of most important parts of a student studying in a subject like pharmacy. This
training is the bridge between the theories and principles in other word between the institute &
commercial organization.
This in plant training in The Acme Laboratories Ltd has given me such a great experience about
all Quality Operation Division, Production Division, Marketing & Sales Division and Warehouse
Department also, which is going on the company.
It is also help me to understand the exact mechanism of working of the various department. So,
this help me well to establish myself in the corporate world after completing my academic
session.
Appraisal for all the officers & employees of this industry who give their intellectual thinking
and labor for this industry and make this industry going upwards.
I have learned many other things from here; one of them was discipline The Acme Laboratories
Ltd. Strictly follows the discipline, which is the key to their success and also important in any
organization level. The officer try heard and soul to lead the company forward.
During this in-plant training in The Acme Laboratories Ltd, I have got lots of friendly
cooperation from every people in each section starting from the Executive to the workers.
Thanks to all for their very friendly cooperation of The Acme Laboratories Ltd.
Our heartiest wishes to The Acme Laboratories Ltd
55