Module 14Slide 1 of 23 WHO - EDM Basic Principles of GMP Active Pharmaceutical Ingredients Part...
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Transcript of Module 14Slide 1 of 23 WHO - EDM Basic Principles of GMP Active Pharmaceutical Ingredients Part...
Module 14 Slide 1 of 23 WHO - EDM
Basic Principles of GMP
Active Pharmaceutical Ingredients
Part Three, 18
Module 14 Slide 2 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Objectives To discuss the GMP guidelines for the manufacture
of Active Pharmaceutical Ingredients (APIs) To examine key problems experienced during
inspections of the manufacturers of APIs and to seek possible solutions
Part Three, 18.1–18.59
Module 14 Slide 3 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Areas to be Covered General considerations Personnel Premises Equipment Sanitation Documentation Retention of records and samples Production Part Three, 18.1–18.59
Module 14 Slide 4 of 23 WHO - EDM
Active Pharmaceutical Ingredients
General Considerations Overall control Consistent uniform batches Compliance with GMP
production quality control
General guidelines Co-operation in production Human and veterinary preparations
Part Three, 18.1–18.6
Module 14 Slide 5 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Personnel Qualified and competent
production and quality control sufficient number education, knowledge, experience
Organizational chart with responsibilities Written job description or instructions Trained Health
diseases open lesions
Part Three, 18.7–18.10
Module 14 Slide 6 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Premises General
suitable construction and environment adequately adapted and sufficient size mix-ups or contamination logical work flow
Special purposes antibiotics, hormones, cytostatic substances separate specifically designed enclosed areas separate air handling systems
Part Three, 18.11–18.13
Module 14 Slide 7 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Premises
Hygiene clothes, washing, toilets eating, drinking, smoking
Part Three, 18.11–18.13
Module 14 Slide 8 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Equipment Design, construction, location and maintenance
intended use, cleaning, contamination validated operation
Cleaning sterilised, used, maintained: SOPs, records and
checks
Part Three, 18.14–18.18
Module 14 Slide 9 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Equipment Process monitoring and control
calibrated, checked records
Defective equipment removed or labelled repaired, documented
Part Three, 18.14–18.18
Module 14 Slide 10 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Sanitation Written programmes
validated for premises and equipment quality standard for water hygiene , health and clothing practices waste disposal
Implementation and training Practices not permitted:
eating, smoking unhygienic practices Part Three, 18.19–18.22
Module 14 Slide 11 of 23 WHO - EDM
Active Pharmaceutical IngredientsDocumentation
Master formulae written instructions master formula contents authorisation outdated documents amendments
Batch documentation batch manufacturing record contents contract production data recording Part Three, 18.23–18.30
Module 14 Slide 12 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Record and reference sample retention Activities are traceable
production and quality control Retention of records and samples
retention period
Part Three, 18.31–18.32
Module 14 Slide 13 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Production Processing procedures
master formula critical steps defined and validated supervision labelling
– vessels, containers, equipment daily activities - information
Part Three, 18.33–18.37
Module 14 Slide 14 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Production (continued) Starting materials
receiving, quarantine, sampling testing release, reject, storage, labelling dispensing SOP exceptions for hazardous materials
Intermediates testing labelling storage Part Three, 18.38–18.40
Module 14 Slide 15 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Production (continued) Active pharmaceutical ingredients
meet specifications limits for residue and reactants sterile APIs
Part Three, 18.41–18.42
Module 14 Slide 16 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Production (continued) Packaging
packaging material selection procedures to prevent error labelling, including:
– Product name– Quality– Batch number– Expiry or retest date– Warnings, if required– Storage conditions– Names of manufacturers and suppliers Part Three, 18.43–18.45
Module 14 Slide 17 of 23 WHO - EDM
Active Pharmaceutical IngredientsQuality Control
Independent unit Duties: Approve, reject or release
specifications and methods sampling, sanitation and hygiene reprocessing stability complaints
Laboratory access and requirements Contract laboratories Part Three, 18.46–18.51
Module 14 Slide 18 of 23 WHO - EDM
Active Pharmaceutical IngredientsStability Studies
Written programme stability indicating methods
Samples containers storage conditions
Expiry or retest date
Part Three, 18.46–18.51
Module 14 Slide 19 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Self-Inspection and Quality Audits Regular independent inspection
expert or team of experts production and quality control
RecordsStorage
Suitable conditions based on stability studies Distribution records for each batch
written SOP facilitate recalls Part Three, 18.52–18.55
Module 14 Slide 20 of 23 WHO - EDM
Active Pharmaceutical Ingredients
Complaints and Defects Written instructions Prompt action and investigation
record facts Product review system
Reject materials Written procedures
starting materials, intermediates, packaging materials identified storage pending fate Part Three, 18.56–18.59
Module 14 Slide 21 of 23 WHO - EDM
Active Pharmaceutical IngredientsGroup Session
Identify major deficiencies experienced in GMP in active pharmaceutical ingredients manufacture.
Are there any deficiencies that should prevent material being released?
Within what timescale should these deficiencies be corrected?
What are the implications for bulk active supply to your country?
Module 14 Slide 22 of 23 WHO - EDM
Active Pharmaceutical IngredientsPossible Issues
Manufacturers supplying various types of industries Imports through brokers Hazardous processes Commercial secrecy Unsatisfactory final facilities
Module 14 Slide 23 of 23 WHO - EDM
Active Pharmaceutical IngredientsPossible Issues
The interpretation of the meanings of expiry dates and re-test dates
The use of APIs close to their expiry date Blending of rejected APIs Reprocessing, recovery and/or reworking of APIs Recycling and treatment of solvents Addition of impurities to batches of APIs Trace-ability, repacking and re-labelling