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Sections

Background to the review
Interpretation of the Code
PART 1 CORE ELEMENTS OF THE CODE
Important information
CHAPTER 1 QUALITY MANAGEMENT
Quality management guidelines
Management of quality
Quality assurance
Quality control
Quality and production nominees
Process control and change control
CHAPTER 2 PERSONNEL AND TRAINING
Personnel and training guidelines
General
Key personnel
Qualifcations and experience
Training and competency assessment
Personal hygiene and health issues
CHAPTER 3 BUILDINGS AND GROUNDS
Manufacturing principles
Buildings and grounds guidelines
Cleaning and sanitation
Storage areas (including receipt and despatch)
Production areas
Quality control areas
Ancillary areas
Animal houses
CHAPTER 4 EQUIPMENT
Equipment guidelines
Equipment qualifcation and validation
Maintenance
Calibration
Cleaning
CHAPTER 5 DOCUMENTATION
Documentation guidelines
Document control
Records
Documents required
Specifcations
Materials control (stores receipt, storage and disposal)
Master packaging and labelling instructions
Batch manufacturing/processing records
Batch packaging records
Quality control sampling and testing
Release/rejection and distribution of fnished product
Complaints, recalls and returns
Computer records
Laboratory records
Validation records
Other
CHAPTER 6 COMPUTER SYSTEMS
Computer systems guidelines
CHAPTER 7 PRODUCTION
Production guidelines
Materials control (including storage)
Receipt, storage and quality assurance of raw materials
Receipt, storage and quality assurance of packaging materials
Cross-contamination control
Process validation
Production procedure
Dispensing of raw materials
Processing operations
Intermediate and bulk products
Process water
Primary (flling) and secondary packaging operations
Release of fnished products
Residual, rejected, recovered and returned materials
CHAPTER 8 QUALITY CONTROL
Quality control guidelines
Documentation
Sampling
Sampling plans
Sampling Procedures
Retention samples
Product release
CHAPTER 9 CONTRACT MANUFACTURE
Contract manufacture guidelines
The GMP Agreement
The contract giver
The contract acceptor
Inspection of contract manufacturers
CHAPTER 10 INTERNAL AUDITS
Manufacturing principle
Internal audit guidelines
CHAPTER 11 COMPLAINTS AND PRODUCT RECALLS
Complaint and product recall guidelines
Complaints
Suspected product defects
Recalls
PART 2 ANNEXES
ANNEX 1 MANUFACTURE OF STERILE PRODUCTS
Introduction
Sanitation and hygiene
Environmental control
Air quality
Environmental monitoring
Specifcation for materials
Processing
Sterilisation by heat—general
Sterilisation by moist heat
Sterilisation by dry heat
Sterilisation by radiation
Sterilisation by ethylene oxide
Sterilisation by fltration
Finishing (primary packaging)
Aseptic processing
ANNEX 2 IMMUNOBIOLOGICALS AND OTHER PRODUCTS OF BIOLOGICAL ORIGIN
Essential information
Premises
Segregation and containment
Sanitation, disinfection and waste disposal
Personnel
Equipment
Animals and animal houses
Production
Starting materials
Media
Seed lot and cell bank system
Operating techniques
Powders and tablets
Products containing penicillins and other highly sensitising antibiotics
Electrolytes
Bloat oils
Slow-release intra-ruminal devices
Premises and equipment

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Category:	Uncategorized.
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Upload Date:	12/15/2010
Copyright:	Attribution Non-commercial
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