WHO - PSM Premises Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4...
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Transcript of WHO - PSM Premises Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28 Feb - 4...
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
E-mail: [email protected]
Basic Principles of GMP
Part One, 12
WHO - PSM
Premises
Objectives
1. To review general requirements
WHO - PSM
Part One, 12.1
Premises
Principle
Premises must be located, designed, constructed, adapted and maintained for the operations:
Minimize risks of errors and cross-contamination
Permit effective cleaning
Permit effective maintenance
Minimize build-up of dirt and dust
Eliminate any adverse effects on quality
WHO - PSM
Part One, 12.1, 12.4
Premises
Principle Premises must be
located to minimize risks of cross-contamination; e.g. not located next to a malting factory with high airborne levels of yeast
WHO - PSM
Part One, 12.4
Premises
Location Geography, climate, noise and economic factors
Neighbours What do they do? What impact can they have on the business?
Pollution/effluent control
WHO - PSM
Part One, 12.3 – 12.9
Premises
Premises should be built to:
Facilitate sanitation.
Be maintained and cleaned easily
Services availability
Protection against entry of insects or other animals
WHO - PSM
Part One 12.11 – 12.14
Premises
Ancillary Areas
Rest and refreshment rooms
Changing, washing and toilet areas
Maintenance workshops
Animal houses - isolated
WHO - PSM
Premises
Design Principles
Process flow
Material flow
People flow
WHO - PSM
Q C
Offices Gowning
Canteen
Incoming goods
Corridor
Corridor
Shipping
Corridor
Packaging
Weighing Processing
Filling
Raw Materials
& Packaging Storage
Washing
Machine
Shop
Finished Products Storage
Corridor Utilities and Services Waste Treatment
PremisesExample of Materials and People Flow
Arrival of goods Entrance for visitors Entrance for Workers Shipment of goods
Material Flow
People Flow
Zone: Clean
Zone: Secondary
Packaging
Zone: Controlled
WHO - PSM
Premises
Part two
Basic Principles of GMP
Part One, 12
WHO - PSM
Part One 12.15 – 12.16
Premises
Warehouse – I
Importance sometimes underestimated!
Storage areas of sufficient capacity for all the material
Clean, dry and maintained within acceptable temperature limits
Area under cover, protection from heat, dirt, and rain
WHO - PSM
Part One 12.18 –12.22
Premises
Warehouse – II Areas clearly marked and access limited for
quarantine status goods.
QC sampling area with GMP standards
Segregated areas for rejected, recalled and returned materials
Separate areas for highly active, hazardous, narcotic materials – safety issues/national legislation
Printed materials storage – security essential
WHO - PSM
Part One 12.23
Premises
Weighing areas Control systems: right product, right quantity
Environmental controls, dust control
Segregation
Smooth, impervious, durable, easy to clean finishes
Cleaning
Documentation
AVOID CROSS-CONTAMINATION
WHO - PSM
Part One 12.24 – 12.23
Premises
Manufacturing and Packaging – I
Dedicated and self-contained facilities for: Highly sensitizing materials (penicillins) Biological preparations (live microorganisms)
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,
radioisotopic areas
Designed for the operations being carried out
suitable storage space