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GMP Introduction

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Introduction to GMP

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GMP Introduction

  1. 1. GMP Good Manufacturing Practice What is it ? Why Bother ? Mr.Rajendra Sadare Senior Software Engineer-Testing And Validation Arisglogal Software Pvt.Ltd
  2. 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. 3. Quality Choices Engine size Make and model Age / registration Colour Documents / Condition previous history You can tell by looking
  4. 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
  6. 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. 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. 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. 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. 10. Why GMP ?  Consistency  Control Quality Product
  11. 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. 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. 13. Quality Standards GMP QA QC practice theory Q Quality Product
  14. 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. 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. 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. 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. 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. 19. Quality Standards GMP is everyone’s responsibility
  20. 20. Mistakes - The Cost ! In House After Supply Waste materials  Product Recall Labour costs  Lawsuits Back orders  Reputation
  21. 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. 22. GMP - The Jigsaw