Supplementary Training Modules on Water for Pharmaceutical Use

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Supplementary Training Modules on Water for Pharmaceutical Use Good Manufacturing Practice Water for Pharmaceutical

Supplementary Training Modules on Water for Pharmaceutical Use Good Manufacturing Practice Water for Pharmaceutical Use Part 3: Inspection of water systems Module 2, Part 3: Inspection of water systems Slide 1 of 25 WHO - EDM

Water for Pharmaceutical Use Objectives To understand: The specific requirements for inspecting water systems,

Water for Pharmaceutical Use Objectives To understand: The specific requirements for inspecting water systems, including l l ä the need for a Water Quality Manual ä validation of water treatment systems Water system inspection techniques Module 2, Part 3: Inspection of water systems Slide 2 of 25 WHO - EDM

Water for Pharmaceutical Use Review l l What is the water to be used

Water for Pharmaceutical Use Review l l What is the water to be used for? ä sterile products ä non-sterile products ä liquid products ä solid dose products ä washing and rinsing Check specifications and trends Module 2, Part 3: Inspection of water systems Slide 3 of 25 WHO - EDM

Water for Pharmaceutical Use WHO water treatment guidance (1) l All water-treatment systems should

Water for Pharmaceutical Use WHO water treatment guidance (1) l All water-treatment systems should be subject to: ä planned maintenance ä validation ä monitoring l Maintenance work should be documented Annex 1, 17. 32 Module 2, Part 3: Inspection of water systems Slide 4 of 25 WHO - EDM

Water for Pharmaceutical Use WHO water treatment guidance (2) For reliable production, water treatment

Water for Pharmaceutical Use 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 Annex 1, 17. 33 Module 2, Part 3: Inspection of water systems Slide 5 of 25 WHO - EDM

Water for Pharmaceutical Use Prepare a checklist or an aide-memoire and review: 1. Water

Water for Pharmaceutical Use 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 Module 2, Part 3: Inspection of water systems Slide 6 of 25 WHO - EDM

Water for Pharmaceutical Use Review water quality manual (1) 1. A water quality manual

Water for Pharmaceutical Use Review water quality manual (1) 1. A water quality manual is advisable 2. A brief description of water systems is required 3. Include drawings of the purification, storage distribution system (P&ID) Module 2, Part 3: Inspection of water systems Slide 7 of 25 WHO - EDM

Water for Pharmaceutical Use Review of water quality manual (2) l The water quality

Water for Pharmaceutical Use Review of water quality manual (2) l The water quality manual should show: ä pipelines non-return (or check) valves breather points couplings pipe slopes ä ä ä velocities Module 2, Part 3: Inspection of water systems valves sampling points drain points instrumentation flow rates Slide 8 of 25 WHO - EDM

Water for Pharmaceutical Use Review water quality manual (3) The manual should contain: 1.

Water for Pharmaceutical Use 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 l Investigations and corrective action l Validation studies Module 2, Part 3: Inspection of water systems Slide 9 of 25 WHO - EDM

Water for Pharmaceutical Use Review water quality manual (4) The manual should contain l

Water for Pharmaceutical Use Review water quality manual (4) The manual should contain l Chemical and microbiological specifications l Sampling instructions 1. Test procedures 2. Responsible persons 3. Training requirements Module 2, Part 3: Inspection of water systems Slide 10 of 25 WHO - EDM

Water for Pharmaceutical Use Review validation (1) Validation for water systems consists of three

Water for Pharmaceutical Use Review validation (1) Validation for water systems consists of three phases l Phase 1: 2 – 4 weeks l Phase 2: 4 weeks l Phase 3: 1 year Module 2, Part 3: Inspection of water systems Slide 11 of 25 WHO - EDM

Water for Pharmaceutical Use Review validation (2) Phase 1 – Investigational Phase (2 –

Water for Pharmaceutical Use Review validation (2) Phase 1 – Investigational Phase (2 – 4 weeks) l DQ, IQ and OQ l Develop ä operational parameters ä cleaning and sanitization procedures and frequencies l Sample daily at each point of use l End of Phase I, develop SOPs for the water system Module 2, Part 3: Inspection of water systems Slide 12 of 25 WHO - EDM

Water for Pharmaceutical Use Review validation (3) Phase 2 – verifying control (4 -

Water for Pharmaceutical Use Review validation (3) Phase 2 – verifying control (4 - 5 weeks) l Demonstrate the system is in control l Same sampling as in phase 1 Phase 3 – verifying long-term control (1 year) l PQ l Demonstrate the system in control over a long period of time l Weekly sampling Module 2, Part 3: Inspection of water systems Slide 13 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (1) l l Take the drawing and

Water for Pharmaceutical Use Conducting the inspection (1) l l Take the drawing and walk around the entire system Check: ä dead legs pumps ä filter UV lights ä pipes and fittings sample points ä DI RO ä storage tanks non return valves ä by-pass lines heat exchangers Module 2, Part 3: Inspection of water systems Slide 14 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (2) Check: l Stainless steel - PVC

Water for Pharmaceutical Use Conducting the inspection (2) Check: l Stainless steel - PVC and most plastics not recommended l Weld quality l Hygienic couplings l Passivation Air breaks or “Tundish” l Module 2, Part 3: Inspection of water systems Slide 15 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (3) l Check pipes and pumps ä

Water for Pharmaceutical Use Conducting the inspection (3) l Check pipes and pumps ä hygienic couplings ä welded pipes ä hygienic pumps ä hygienic sampling points ä acceptable floor ä no leaks Module 2, Part 3: Inspection of water systems Slide 16 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (4) Check condition of equipment Staining on

Water for Pharmaceutical Use Conducting the inspection (4) Check condition of equipment Staining on water storage tanks Corrosion on plates of heat exchangers indicates possible contamination Module 2, Part 3: Inspection of water systems Slide 17 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (5) l Check maintenance records l Check

Water for Pharmaceutical Use Conducting the inspection (5) l Check maintenance records l Check maintenance of pump seals and O rings Module 2, Part 3: Inspection of water systems Slide 18 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (6) l Check air filters l Check

Water for Pharmaceutical Use Conducting the inspection (6) l Check air filters l Check integrity testing, sterilization and replacement frequency l Check burst discs Module 2, Part 3: Inspection of water systems Slide 19 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (7) Softened water out to deionizer By-pass

Water for Pharmaceutical Use Conducting the inspection (7) Softened water out to deionizer By-pass lines By-pass valve • Carefully check by-pass valves and lines • These sometimes leak or are inadvertently left open • A blanking piece is better during operation phase Zeolite water softener exchanges Ca and Mg for Na Module 2, Part 3: Inspection of water systems Slide 20 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (8) Further points to check: 1. Activated

Water for Pharmaceutical Use 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. Non-condensable gases in pure steam Module 2, Part 3: Inspection of water systems Slide 21 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (9) Further points to check: (Contd. )

Water for Pharmaceutical Use Conducting the inspection (9) Further points to check: (Contd. ) 1. Polypropylene welding inspection ä checking pin holes 2. Retrospective validation of WFI system 3. Rouging of WFI storage systems 4. Spray ball efficacy Module 2, Part 3: Inspection of water systems Slide 22 of 25 WHO - EDM

Water for Pharmaceutical Use Conducting the inspection (10) Further points to check (Contd. )

Water for Pharmaceutical Use 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 Module 2, Part 3: Inspection of water systems Slide 23 of 25 WHO - EDM

Water for Pharmaceutical Use Group Session l You are given a schematic drawing of

Water for Pharmaceutical Use Group Session l You are given a schematic drawing of a water system to discuss l List any problems and their solutions. Module 2, Part 3: Inspection of water systems Slide 24 of 25 WHO - EDM

Water for Pharmaceutical Use Group Session Module 2, Part 3: Inspection of water systems

Water for Pharmaceutical Use Group Session Module 2, Part 3: Inspection of water systems Slide 25 of 25 WHO - EDM