WHO - PSM Premises Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4 March 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: [email protected]Basic Principles of GMP Part One, 12
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WHO - PSM Premises Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4 March 2005 Maija Hietava M.Sci.Pharm Quality Assurance.
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WHO - PSM
PremisesWorkshop on
GMP and Quality Assurance of HIV products
Shanghai, China28 Feb - 4 March 2005
Maija Hietava M.Sci.Pharm
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster
Tel: +41.22.791.3598 Fax: +41.22.791.4730World Health Organization
Logical flows of materials and people Adequacy of working space and orderly and
logical positioning of equipment Interior surfaces smooth/crack-free/easy to clean
WHO - PSM
Premises
Other Areas Personnel rest areas/cafeterias/changing rooms
away from operating areas prevention of cross-contamination prevention of operators going outside in work clothes provision of access control prevention of visitors access to operating areas
Maintenance service areas separated from production areas whenever possible
WHO - PSM
Premises
Finish of Floors, Walls and Ceilings
Difficult but not impossible to get right
Smooth, impervious, hard-wearing, easy to clean
Resistant to operations and materials in use
Windows not opening to the outside
Avoid sliding doors
WHO - PSM
Part One 16.12 (a)–(i)
Premises
Cross-contamination1. Segregated areas
2. Campaign production
3. Airlocks and pressure differentials
4. Treatment of recirculated air
5. Protective clothing
6. Effective cleaning procedures
7. Closed production systems
8. Residue testing
9. Status labelling
WHO - PSM
Part One 12.28 – 12.30
Premises
Manufacturing and Packaging – I Pipework and other fittings sited to avoid recesses
Drain design: equipped to prevent backflow open channels avoided
Effective air handling to suit product temperature humidity filtration monitoring
WHO - PSM
Part One 12.31 – 12.32
Premises
Manufacturing and Packaging – II Specifically designed and laid out to avoid mix-ups
and cross-contamination Changing facilities to provide segregated access
Prevention of cross-contamination
Suitable lighting levels
WHO - PSM
Part One 12.33 – 12.36
Premises
In-Process and QC laboratories
Located separate from but near manufacturing
prevention of cross-contamination separate biological , microbiological,