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GMP
Good Manufacturing Practice
        What is it ?
       Why Bother ?
              Mr.Rajendra Sadare
      Senior Software Engineer-Testing And
                   Validation
           Arisglogal Software Pvt.Ltd
Today’s Agenda
Medicines - why should they be
any different to other products ?


     Regulations & Guidelines
         - History & Current


                GMP
                QA
                          - What do they
                QC           mean ?
Quality Choices
                 Engine size
Make and model                    Age /
                               registration




  Colour                         Documents /
                  Condition    previous history


      You can tell by looking
Quality Choices
                       Engine size
Make and model       Right strength
                                       Age / registration
 Right product
                                      Right expiry date


   Colour
    right
 appearance                              Documents /
                                       previous history
                     Condition          Batch Record
                  No contamination


 You can’t tell just by looking
THE TRUST CHAIN

PATIENT



 TRUSTS   DOCTOR/
           PHARMACIST

              TRUSTS
                        MANUFACTURER
GMP - THE HISTORY

1960   THALIDOMIDE marketed in West Germany then
       Canada & Britain as sleeping tablet, treatment for colds,
       flu etc. Pregnant women used for nausea.
1961   Alarm at the sudden increase in the birth of deformed
       infants ESTIMATED 10,000 INFANTS DEFORMED
1961   Withdrawal of Thalidomide


   DEMONSTRATED THAT SAFETY REQUIREMENTS OF
         NEW DRUGS HAD TO BE TIGHTENED
GMP - THE HISTORY

1962     World Health Assembly set out resolutions on drug
         safety and monitoring


1968    The Medicines Act

       introduced systems for
       • Product Licencing covering old (pre1968)
          and new medicines
       • Licencing of manufacturing sites
       • Licencing of Clinical Trials
GMP - Rules & Guidance

• The Rules Governing Medicinal Products in
  the European Union
• “Rules & Guidance for Pharmaceutical
  Manufacturers and Distributors 1997
  (Orange Guide)
• Annex 13 : Manufacture of Investigational
  Medicinal Products
                               Guide only
                          - no legal standing for
                               clinical trials
EU Clinical Trials Directive
• Directive 2001/20/EC
• Implemented by 01May 2004
• Makes GMP & GCP a legal requirement
• Requirement for QP to certify IMPs
• Requires that IMP has been manufactured,
  packaged and distributed according to standards of
  GMP at least equivalent to 91/356/EEC
• Audit of facility by MCA
Why GMP ?

   Consistency

 Control



Quality Product
To achieve a quality product we must
       BUILD QUALITY
   into our systems and processes
                 Q
             U       A

             L   IT      Y



   We can’t TEST QUALITY into a
        product at the end
Building Blocks of GMP
                            GMP

   Controlling                              Controlling
    Quality                   +             Processes
 Quality Control    Well trained staff   Quality Assurance
  (QC) is about             +              (QA) is about
testing materials                        testing processes
                      Documentation
                            +
                           Good
                    Premises/Equipment



                 High Quality Product
Quality Standards

GMP
      QA
QC
            practice
 theory                   Q

                       Quality
                       Product
GMP - Why bother ?
Mid 1980s

• Several patients being treated for shock
  probably
• Given Hydrocortisone Injection
• Patients stops breathing and die
• Warning issued on national news
• Immediate MCA Investigation
Potential for Disaster

      Norcuron                      Hydrocortisone
(Vecuronium Bromide)                • Steroid
• Musle relaxant used in            • Anti inflammatory
                                    • Can help breathing
  surgery
• relaxes respiratory
  muscles
• patient can’t breathe
  unaided
       Both products filled into identical ampoules
GMP - Why ?
• Both products were manufactured at same site
                     ( Holland)
 • Batch of product dosed to baby was labelled
           at a different site in the UK



         Long, difficult investigation
           manufacturing problem ?
              labelling mix up ?
GMP - Why ?
• Ampoules segregated on different tables but
  inspected in the same room
• Samples of Norcuron, removed for in-process
  sample, were returned ( to save product /
  cost) to the batch
• Samples returned to the wrong table
• Appeared identical so not visually identified
• Norcuron labelled as Hydrocortisone
• Life saving drug mixed up with potentially
  life threatening drug
GMP - Why ?
• Design of area for inspection (Not one
  product in area at one time)
• Insufficient reconciliation ?
• Documented evidence of sampling ?
• Ampoules not differentiated ?
• No investment in facilities ?
• Management attitude to GMP
Quality Standards


      GMP
  is everyone’s
  responsibility
Mistakes - The Cost !



    In House         After Supply

Waste materials    Product Recall

Labour costs       Lawsuits

Back orders        Reputation
Q   How do we build a quality product ?
A    By completing the jigsaw
                          Pro
                              c   ess
                                      es
      Product
                           s&
                        ise t
                  P rem men
                   Eq uip

                         Documentation
           nnel
      Perso
GMP - The Jigsaw

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GMP Introduction

  • 1. GMP Good Manufacturing Practice What is it ? Why Bother ? Mr.Rajendra Sadare Senior Software Engineer-Testing And Validation Arisglogal Software Pvt.Ltd
  • 2. Today’s Agenda Medicines - why should they be any different to other products ? Regulations & Guidelines - History & Current GMP QA - What do they QC mean ?
  • 3. Quality Choices Engine size Make and model Age / registration Colour Documents / Condition previous history You can tell by looking
  • 4. Quality Choices Engine size Make and model Right strength Age / registration Right product Right expiry date Colour right appearance Documents / previous history Condition Batch Record No contamination You can’t tell just by looking
  • 5. THE TRUST CHAIN PATIENT TRUSTS DOCTOR/ PHARMACIST TRUSTS MANUFACTURER
  • 6. GMP - THE HISTORY 1960 THALIDOMIDE marketed in West Germany then Canada & Britain as sleeping tablet, treatment for colds, flu etc. Pregnant women used for nausea. 1961 Alarm at the sudden increase in the birth of deformed infants ESTIMATED 10,000 INFANTS DEFORMED 1961 Withdrawal of Thalidomide DEMONSTRATED THAT SAFETY REQUIREMENTS OF NEW DRUGS HAD TO BE TIGHTENED
  • 7. GMP - THE HISTORY 1962 World Health Assembly set out resolutions on drug safety and monitoring 1968 The Medicines Act introduced systems for • Product Licencing covering old (pre1968) and new medicines • Licencing of manufacturing sites • Licencing of Clinical Trials
  • 8. GMP - Rules & Guidance • The Rules Governing Medicinal Products in the European Union • “Rules & Guidance for Pharmaceutical Manufacturers and Distributors 1997 (Orange Guide) • Annex 13 : Manufacture of Investigational Medicinal Products Guide only - no legal standing for clinical trials
  • 9. EU Clinical Trials Directive • Directive 2001/20/EC • Implemented by 01May 2004 • Makes GMP & GCP a legal requirement • Requirement for QP to certify IMPs • Requires that IMP has been manufactured, packaged and distributed according to standards of GMP at least equivalent to 91/356/EEC • Audit of facility by MCA
  • 10. Why GMP ?  Consistency  Control Quality Product
  • 11. To achieve a quality product we must BUILD QUALITY into our systems and processes Q U A L IT Y We can’t TEST QUALITY into a product at the end
  • 12. Building Blocks of GMP GMP Controlling Controlling Quality + Processes Quality Control Well trained staff Quality Assurance (QC) is about + (QA) is about testing materials testing processes Documentation + Good Premises/Equipment High Quality Product
  • 13. Quality Standards GMP QA QC practice theory Q Quality Product
  • 14. GMP - Why bother ? Mid 1980s • Several patients being treated for shock probably • Given Hydrocortisone Injection • Patients stops breathing and die • Warning issued on national news • Immediate MCA Investigation
  • 15. Potential for Disaster Norcuron Hydrocortisone (Vecuronium Bromide) • Steroid • Musle relaxant used in • Anti inflammatory • Can help breathing surgery • relaxes respiratory muscles • patient can’t breathe unaided Both products filled into identical ampoules
  • 16. GMP - Why ? • Both products were manufactured at same site ( Holland) • Batch of product dosed to baby was labelled at a different site in the UK Long, difficult investigation  manufacturing problem ?  labelling mix up ?
  • 17. GMP - Why ? • Ampoules segregated on different tables but inspected in the same room • Samples of Norcuron, removed for in-process sample, were returned ( to save product / cost) to the batch • Samples returned to the wrong table • Appeared identical so not visually identified • Norcuron labelled as Hydrocortisone • Life saving drug mixed up with potentially life threatening drug
  • 18. GMP - Why ? • Design of area for inspection (Not one product in area at one time) • Insufficient reconciliation ? • Documented evidence of sampling ? • Ampoules not differentiated ? • No investment in facilities ? • Management attitude to GMP
  • 19. Quality Standards GMP is everyone’s responsibility
  • 20. Mistakes - The Cost ! In House After Supply Waste materials  Product Recall Labour costs  Lawsuits Back orders  Reputation
  • 21. Q How do we build a quality product ? A By completing the jigsaw Pro c ess es Product s& ise t P rem men Eq uip Documentation nnel Perso
  • 22. GMP - The Jigsaw