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Guide to Good Manufacturing Practice for Medicinal Products

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Sections

INTRODUCTION
QUALITY ASSURANCE
GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS (GMP)
QUALITY CONTROL
PRODUCT QUALITY REVIEW
GENERAL
KEY PERSONNEL
TRAINING
PERSONAL HYGIENE
General
Production Area
Storage Areas
Quality Control Areas
Ancillary Areas
EQUIPMENT
DOCUMENTS REQUIRED
Specifications
Specifications for starting and packaging materials
Specifications for intermediate and bulk products
Specifications for finished products
MANUFACTURING FORMULA AND PROCESSING INSTRUCTIONS
PACKAGING INSTRUCTIONS
BATCH PROCESSING RECORDS
BATCH PACKAGING RECORDS
PROCEDURES AND RECORDS
Receipt
Sampling
Testing
Other
PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION
VALIDATION
STARTING MATERIALS
PROCESSING OPERATIONS - INTERMEDIATE AND BULK PRODUCTS
PACKAGING MATERIALS
PACKAGING OPERATIONS
FINISHED PRODUCTS
REJECTED, RECOVERED AND RETURNED MATERIALS
GOOD QUALITY CONTROL LABORATORY PRACTICE
DOCUMENTATION
SAMPLING
TESTING
ON-GOING STABILITY PROGRAMME
THE CONTRACT GIVER
THE CONTRACT ACCEPTOR
THE CONTRACT
Chapter 8 Complaints and product recall
COMPLAINTS
RECALLS
Chapter 9 Self inspection
PRINCIPLE
BLOW/FILL/SEAL TECHNOLOGY
TERMINALLY STERILISED PRODUCTS
ASEPTIC PREPARATION
PERSONNEL
PREMISES
SANITATION
STERILISATION
STERILISATION BY HEAT
MOIST HEAT
DRY HEAT
STERILISATION BY RADIATION
STERILISATION WITH ETHYLENE OXIDE
FINISHING OF STERILE PRODUCTS
MANUFACTURE OF BIOLOGICAL MEDICINAL PRODUCTS FOR HUMAN USE
SCOPE
PREMISES AND EQUIPMENT
ANIMAL QUARTERS AND CARE
Starting materials
Seed lot and cell bank system
Operating principles
MANUFACTURE OF RADIOPHARMACEUTICALS
PRODUCTION
DISTRIBUTION AND RECALLS
MANUFACTURE OF PREMIXES FOR MEDICATED FEEDING STUFFS
THE MANUFACTURE OF ECTOPARASITICIDES
THE MANUFACTURE OF VETERINARY MEDICINAL PRODUCTS CONTAINING PENICILLINS
STERILE VETERINARY MEDICINAL PRODUCTS
MANUFACTURE OF IMMUNOLOGICAL VETERINARY MEDICAL PRODUCTS
ANIMALS AND ANIMAL HOUSES
DISINFECTION - WASTE DISPOSAL
MANUFACTURE OF MEDICINAL GASES
2. PERSONNEL
3. PREMISES AND EQUIPMENT
4. DOCUMENTATION
5. PRODUCTION
6. QUALITY CONTROL
7. STORAGE AND RELEASE
GLOSSARY
MANUFACTURE OF HERBAL MEDICINAL PRODUCTS
Storage areas
Production area
Specifications for starting materials
Processing instructions
PACKAGING MATERIAL
PRODUCTION AND QUALITY CONTROL
SYSTEM
USE OF IONISING RADIATION IN THE MANUFACTURE OF MEDICINAL PRODUCTS
RESPONSIBILITIES
DOSIMETRY
VALIDATION OF THE PROCESS
COMMISSIONING OF THE PLANT
Gamma irradiators
Electron Beam Irradiators
Re-commissioning
PROCESSING
MICROBIOLOGICAL MONITORING
QUALITY MANAGEMENT
Specifications and instructions
Order
Product specification file
Manufacturing Formulae and Processing Instructions
Packaging Instructions
Processing, testing and packaging batch records
Packaging materials
Manufacturing operations
Principles applicable to comparator product
Blinding operations
Randomisation code
Packaging
Labelling
RELEASE OF BATCHES
SHIPPING
RECALLS AND RETURNS
Recalls
Returns
DESTRUCTION
BLOOD AND PLASMA COLLECTION
TRACEABILITY AND POST COLLECTION MEASURES
RETENTION OF SAMPLES
DISPOSAL OF REJECTED BLOOD, PLASMA OR INTERMEDIATES
PLANNING FOR VALIDATION
QUALIFICATION
Design qualification
Installation qualification
Operational qualification
Performance qualification
Qualification of established (in-use) facilities, systems and equipment
PROCESS VALIDATION
Prospective validation
Concurrent validation
Retrospective validation
CLEANING VALIDATION
CHANGE CONTROL
REVALIDATION
Change Control
Annex 16 Qualified person and batch release
[QUALIFIED PERSON AND BATCH RELEASE]*
PARAMETRIC RELEASE
1. PRINCIPLE
2. PARAMETRIC RELEASE
3. PARAMETRIC RELEASE FOR STERILE PRODUCTS
4. GLOSSARY
Annex 18 GMP Guide for active pharmaceutical ingredients

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Category:	Uncategorized.
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Upload Date:	10/31/2010
Copyright:	Attribution Non-commercial
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