Objectives and policies of cGMP & inventory management and control

1. OBJECTIVES AND POLICIES OF CGMP
INVENTORY MANAGEMENT AND
CONTROL
PRESENTED BY
SWEETY KURIAKOSE
M PHARM 1ST SEMESTER
DEPARTMENT OF PHARMACEUTICS

2. CONTENTS
 INTRODUCTION
 IMPORTANCE OF CGMP
 OBJECTIVES
 POLICIES OF CGMP
 INVENTORY CONTROL
 OBJECTIVES
 FUNCTIONS
 INVENTORY COST
 ECONOMIC ORDER QUANTITY
 IMPORTANT TERMS RELATED TO THE
INVENTORY CONTROL
 TECHNIQUES OF INVENTORY CONTROL

3. CURRENT GOOD MANUFACTURING
PRACTICES
 CGMP refers to the regulations given by the USFDA under
the authority of Food Drug and Cosmetic act
 CGMPs provides the system that assure proper design,
monitoring, and control of manufacturing processes and
facilities.
 This assures the identity strength, quality and purity of drug
products by requiring that manufactures of medications
adequately control manufacturing operations.

4. TITLE 21 of Code of federal regulations (CFR) -
Food Drug and Cosmetic Act
Current good
manufacturing practices
in manufacturing
process is packing and
holding of drug.
21CFR210
• Current GMP for
finished
pharmaceuticals.21CFR211

5. IMPORTANCE OF CGMP
 It prevents the incidents of product mix up, contamination,
deviations, failures, and errors which assures that the drug
products meet the required quality standards.
 It assures that the drugs are manufactured under good
conditions, equipment is properly maintained and
calibrated, by who are qualified and fully trained and
processes that are reliable and reproducible

6. OBJECTIVES OF THE CGMP
 Ensure that products are consistently manufactured and
controlled to the specified quality.
 Concerned with all aspects of production and quality
control
 In the manufacture of cosmetic products of specified
quality
 Ensure that the consumer receives products of specified
quality.
 CGMP regulations assures the identity, strength, quality,
and purity of drug products

7. CURRENT GMP POLICIES
Section 1: PERSONNEL
 There shall be an adequate number of personnel at all levels
having knowledge, skills and capabilities relevant to their
assigned functions, in good mental and physical health to be
able to execute their duties.
 The organizational structure of the company shall be such
that the production and the quality assurance are headed by
different managers like quality control manager, production
control manager etc.
 All employees who are engaged in the manufacturing
activities shall be trained properly that the employees
perform in accordance with the principles of Current Good
Manufacturing

8. Section 2: PREMISES
 The premises for manufacturing shall be of suitable size,
design, construction and location to facilitate proper
operation, cleaning and maintenance.
 The individual working areas shall be adequate so that
any risk of confusion, cross-contamination will
adversely affect the quality of drugs and devices will be
avoided.
 Production areas shall be ventilated with air control
facilities
 Avoid exposed overhead roof joints, pipes and ducts.
 The condition of buildings shall be reviewed regularly,
and repaired where necessary

9. Section 3: EQUIPMENT
 Equipment used in the manufacturing of drug products
shall be of appropriate design and construction, adequate
size
 It should be properly installed in order to assure product
quality and process reproducibility and to facilitate its
cleaning and maintenance
 Equipment shall be subjected to regular maintenance
checks at appropriate intervals to prevent malfunctions or
contamination
 Written procedures shall be established and followed for
maintenance of equipment.
 Validation shall be conducted following a Validation
Protocol

10. Section 4: SANITATION AND HYGIENE
 The sanitation and hygiene program cover personnel,
premises, equipment and apparatus, production materials
and containers and anything that could become a source
of contamination to the product.
 It should be validated and periodically assessed to ensure
that the effectiveness of the operation
 Direct contact shall be avoided between the operator and
raw materials, intermediate or bulk products.
 Records of cleaning, sanitizing, sterilization and
inspection shall be maintained.

11. Section 5: STORAGE OF STARTING AND PACKAGING
MATERIALS AND FINISHED PRODUCTS
 Materials shall be stored in an order to prevent any risk of
mix-up or contamination and to facilitate inspection and
maintenance
 The materials shall be stored under suitable environmental
condition
 All raw materials, packaging materials, intermediate and
bulk products returned to storage areas shall be properly
documented and reconciled.
 Rejected raw materials and packaging materials shall not
be stored together with approved materials
 The First Expiry First Out system (FEFO) on approved raw
materials shall be used.

12. Section 6: PRODUCTION
 Production shall follow defined procedures capable to
provide assurance that drug products to conform their
specification
 Manufacturing facilities and methods shall be designed
to prevent cross-contamination.
 Process Validation
 The presence in a drug product of any contaminant is
unacceptable
 A batch and/or lot numbering system applied to a
processing state and finished product

13. Section 7: PACKAGING
 Packaging operations shall be performed under strict
control to protect the identity, integrity and quality of the
final package.
 All packaging operations shall proceed in accordance
with a SOP.
 Coding of components shall take place in an area
isolated from other packaging operations
 Written in-process control procedures shall be followed.

14. Section 8: FINISHED PRODUCT QUARANTINE AND
DELIVERY TO WAREHOUSE
 Finished product quarantine is the last point of control
before the product enters the warehouse and available
for distribution to the market.
 Strict controls shall be maintained to ensure that the
product and its packaging records meet all specified
requirements before release to the warehouse.
 Written procedures should be maintained for the transfer
of finished product into the quarantined area, and
subsequent transfer to the finished goods warehouse.

15. Section 9: QUALITY CONTROL
 Quality Control is an essential part of Good
Manufacturing Practices to provide assurance that the
products will be consistently of a quality appropriate to
their intended use
 An independent quality control unit shall be established.
 A quality control system shall be developed to ensure
that finished products contain the correct materials of
specified quality and quantity and are manufactured
under proper conditions following standard procedures.
 Quality control involves all analytical functions
conducted in the laboratory, including sampling,
inspecting and testing of starting materials, intermediate,
bulk and finished products

16. Section 10: DOCUMENTATION
 Documents shall be prepared and designed carefully for
easy, correct and effective use.
 Documents shall contain records of activities within
production, quality control, equipment maintenance,
warehouse, distribution and other specific activities
related to Good Manufacturing Practice
 A master production document should include the
product name, dosage form, strength and description,
the writer’s name and department, name of verifier and
list of document distribution.
 Batch Processing Record
 Master packaging procedure

17. Section 11: SELF INSPECTION
 The purpose of self-inspection is to evaluate the
manufacturer’s compliance with Good Manufacturing
Practices on all aspects of production and quality control.
 Self-inspection shall be performed routinely and corrective
actions shall be implemented.
 A team consisting of personnel who can evaluate the
implementation of Good Manufacturing Practices
objectively shall be appointed.
 The procedure and record for self-inspection shall be
documented

18. Section 12: GUIDELINES FOR HANDLING OF
PRODUCT COMPLAINT, PRODUCT RECALL AND
OR RETURNED PRODUCT
 A product complaint and report may relate to the
quality, adverse reaction or other therapeutic effect of
the product
 A follow-up action shall be taken after investigation and
evaluation of the product complaint and report
 A product recall is a process of withdrawing one or
more batches or all of a certain product from market
distribution
 A returned product is a finished product which is
already in distribution and returned to the manufacturer
due to complaint, damage, expiration, validity or other
reasons.

19. INVENTORY MANAGEMENT AND
CONTROL
 Inventory control is the process by which inventory is
measured and regulated according to predetermined norms
such as economic lot size for order or production, safety
stock, minimum level, maximum level, order level etc..
 Inventory means all the raw materials, semi processed
materials, semi processed materials and finished goods
etc.
 Inventory management is essential to maintain a large
size inventory for smooth and efficient production and
also for sales operation

20.  To minimise the possibility of disruption in the production
schedule for want of raw materials, consumables, spares and
other store items.
 To keep down the capital investment in inventories.
 To ensure adequate stock of finished product to meet the
deliver requirement of the customer.
 To reduce the loss due to changes in prices of inventory
items.
 To facilitate the intermittent production of several products on
the same facility.
 To stabilize employment and improve labour relations by
inventory of human resources and machine efforts.
OBJECTIVES OF INVENTORY
CONTROL

21.  Minimise the carrying cost of the materials.
 Maintenance of sufficient stock of materials to take care of
the requirement during the period of short supply
 Maintenance of sufficient stock of finished goods for smooth
sales operations.
 Protect the inventory against deterioration, obsolescence and
unauthorized use.
 To keep the inventories as low as possible which leads to
consistent price of market conditions.
 Maintain the proper records and assess the stock position of
the materials.
FUNCTIONS OF INVENTORY
CONTROL

22. INVENTORY COSTS
ORDERING
COST
• cost of ordering the item
 Expenses from raising the indent, Purchase
requisition by user department till the execution
of order
INVENTORY
CARRYING
COST
• Costs incurred for holding the volume of
inventory
 Obsolescence cost, Deterioration cost, Taxes on
inventory, Capital cost
OUT OF
STOCK COST
• Loss due to non availability of material
• Break down/delay in production, lost sales, loss
of service to custom

23. ECONOMIC ORDER QUANTIY(EOQ)
 It is the technique of ordering materials whenever stock
reaches the reorder point.
 It deals when the cost of procurement and handling of
inventory are at optimum level and total cost is minimum.
 In this technique, the order quantity is larger than a single
period’s requirement so that ordering cost and holding cost
balance out.
 EOQ=√2DS/H
D- demand
S- cost of placing the order
H- annual holding and storage cost per unit of inventory

24. Minimum stock level
Maximum Stock Level
Reorder Level
Safety Stock
Lead Time(servicing lead time, Supplier’s lead time)
Reserve Stock
TERMINOLOGIES RELATED TO
INVENTORY CONTROL

25. TECHNIQUES OF INVENTORY CONTROL

26. ABC ANALYSIS
Always Better Control
Based on the annual inventory values

27. PROCEDURE FOR ABC ANALYSIS
List of all materials used in the
company
Work out their annual
consumption value and money
value
Multiply each item’s annual value
by its money value
Arrange the items in the
descending order
find out each item’s percentage of
the total inventory

28.  It ensures the better control over costly items
 It helps in developing scientific method of controlling
inventories
 It helps in maintaining the stock in a better way
 It helps in reducing the storage cost
 It helps in maintaining enough stocks of group A, B, and
C items
ADVANTAGES OF ABC ANALYSIS

29.  Inconvenient to compute when items are in large
numbers
 More chance of deterioration of item of class C when
it is purchased in bulk
 Loose control on C items causes shortages
 Focuses on money value and not on functional
importance causing shortage of critical items
 Does not consider variation of prices with time
DISADVANTAGES OF ABC ANALYSIS

30. VED ANALYSIS
 Based on the utility of the materials.
VITAL
• Ventilator
• Morphine
• Adrenaline
injection
• V belts
• bearings
ESSENTIAL
• Anti malarial
• Sedatives
• Thermometer
• Flow meters
• Stand by
powerset
DESIRABLE
• Cetrizine
• Syringes
• Vitamins
• Analgesics
• Other
equipments

31. COMBINATION OF ABC AND VED ANALYSIS
CATEGORY V- ITEMS E- ITEMS D- ITEMS
A. ITEMS Constant
control and
regular follow
up, AV
Moderate
stocks, AE
nil stocks, AD
B ITEMS Moderate
stocks, BV
Moderate
stocks, BE
Low stocks,
BD
C ITEMS High stocks,
CV
Moderate
stocks, CE
Very low
stocks, CD

32. FSN ANAYSIS
 Based on the quantity, the rate of consumption, pattern of
issues from stores
FAST
MOVING
SLOW
MOVING
NON-
MOVING
• Crocin
• Digene
• Becosules
• Cifran
• Brufen
• Actilase injection
• Terlipressin

33. HML ANALYSIS
 Based on their unit cost
HIGH VALUE
MEDIUM VALUE
LOW VALUE

34. XYZ ANALYSIS
 Based on the value of inventory of materials
X
• High stock value
• X ray film, blood bag
Y
• Medium stock value
• ECG recording paper, fistula needle
Z
• Low stock value
• ECG jelly, syringes

35. GOLF ANALYSIS
 Based on the availability and nature of
suppliers
GOLF
govern
ment
ordinary
local
foreign

36. SDE ANALYSIS
 Based on their availability of the item or the length of its
lead time
DIFFICULT

37. SOS ANALYSIS
 Based on the seasonality of items
SEASONAL
OFF- SEASONAL

38. REFERENCE
 www.fda .gov.in
 How to practice GMPs by P.P Sharma, pageno.105-284
 Current Good Manufacturing Practice Guidelines for
drugs available at https: www.wipo.int>laws
 Inventory control and management by C. D. J waters.
 Methods of inventory control available at http://www.
Yourarticlelibrary.com
 Tom Jose V, Akhilesh Jayakumar, et.al , analysis of
inventory control techniques, International Journal Of
Scientific And Research Publications, Volume 3