WHO - PSM Water –part 3 Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28...
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WHO - PSM Water –part 3 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]
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Transcript of WHO - PSM Water –part 3 Workshop on GMP and Quality Assurance of HIV products Shanghai, China 28...
WHO - PSM
Water –part 3
Workshop onGMP 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]
WHO - PSM
Inspection on
Water systems
WHO - PSM
Objectives
To understand:
1.The specific requirements for inspecting water systems, including
the need for a Water Quality Manual
validation of water treatment systems
2.Water system inspection techniques
WHO - PSM
Review
What is the water to be used for?
sterile products non-sterile products liquid products solid dose products washing and rinsing
Check specifications and trends
WHO - PSM
WHO water treatment guidance
(1)
All water-treatment systems should be
subject to:
planned maintenance
validation
monitoring
Maintenance work should be documented
WHO - PSM
WHO water treatment guidance (2)
For reliable production, water treatment plants
should be:
1. Designed
2. Constructed
3. Maintained
4. Operated within design limits
5. Controlled to prevent microbial growth
WHO - PSM
Prepare a checklist or an aide-memoire
and review:
1. Water Quality Manual
2. Water system drawing
3. Validation
4. Sampling procedures, locations and plan
5. Records of testing
6. Sanitation and maintenance
7. Schedules of maintenance
WHO - PSM
Review water quality manual (1)
1. A water quality manual is advisable but
prepare it
2. A brief description of water systems is
required
3. Include drawings of the purification,
storage distribution system (P&ID)
WHO - PSM
Review of water quality manual (2)
The water quality manual should show:
pipelines non-return (or check) valves breather points couplings pipe slopes velocities
valves sampling points drain points instrumentation flow rates
s
WHO - PSM
Review water quality manual (3)The manual should contain:
1. Specification for each system element
2. Standard procedures for use
3. System changes
4. Routine and non-routine maintenance
5. Investigations and corrective action
6. Validation studies
WHO - PSM
Review water quality manual (4)
The manual should contain
1. Chemical and microbiological specifications
2. Sampling instructions
3. Test procedures
4. Responsible persons
5. Training requirements
WHO - PSM
Review validation (1)
Validation for water systems consists of three phases
Phase 1: 2 – 4 weeks
Phase 2: 4 weeks
Phase 3: 1 year
WHO - PSM
Review validation (2)
Phase 1 – Investigational Phase (2 – 4 weeks)
DQ, IQ and OQ
Develop operational parameters cleaning and sanitization procedures and
frequencies Sample daily at each point of use
End of Phase I, develop SOPs for the water system
WHO - PSM
Review validation (3)
Phase 2 – verifying control (4 - 5 weeks)
Demonstrate the system is in control
Same sampling as in phase 1
Phase 3 – verifying long-term control (1 year)
PQ
Demonstrate the system in control over a long period of time
Weekly sampling once from each point of use/sampling point
WHO - PSM
Conducting the inspection (1) Take the drawing and walk around the entire system Check:
dead legs filter pipes and fittings DI storage tanks Maintenance andCalibrations/documents Inline measuring/analysis Results of analysisOOS/corrective action
pumps UV lights sample points RO non return valves heat exchangers normal use of water/sampling
WHO - PSM
Conducting the inspection (2)
Check: Stainless steel - PVC and most plastics not
recommended Weld quality Hygienic couplings Passivation
WHO - PSM
Conducting the inspection (3) Check pipes and pumps
hygienic couplings welded pipes hygienic pumps hygienic
sampling points acceptable floor no leaks
WHO - PSM
Staining on water storage tanks
Corrosion on plates of heat exchangers indicates possible contamination
Conducting the inspection (4)Check condition of equipment
WHO - PSM
Conducting the inspection (5) Check maintenance records
Check maintenance of pump seals and O rings
WHO - PSM
Check air filters
Check integrity testing, sterilization and replacement frequency
Conducting the inspection (6)
WHO - PSM
Conducting the inspection (8)
Further points to check:
1. Activated carbon bed sanitization
2. Temperature-compensated conductivity
meters
3. Influence of plastic pipe adhesive on TOC
4. Specifications of the pure steam/Non-
condensable gases in pure steam
WHO - PSM
Conducting the inspection (9)
Further points to check: (Contd.)
1. Polypropylene welding inspection
checking pin holes
2. Retrospective validation of WFI system
3. WFI storage systems
4. Spray ball efficacy
WHO - PSM
Conducting the inspection (10)
Further points to check (Contd.)
1. UV light – monitoring performance and lamp life and intensity
1. Validating ozone dosage
2. Specifications for acids, alkalis for DI and sodium chloride for water softener
3. “Normally open” and “normally closed” valves
WHO - PSM
Conclusions
• Water is a very important raw material in pharmaceutical industry
• Water system should be well maintained
• There should be a responsible person for the system
• The function of the system should be well described and well documented
• Inspectors are very interested and exited about water systems …. Be aware well in advance!
WHO - PSM
Thank you very much for your
Kindness
and
Hospitality
