Pharmaceutical validation of water system

In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur

1. Validation of Pharmaceutical Water System A Seminar as a part of curricular requirement for M. Pharm I year II semester Presented by K.VenkataSai Prasad (20L81S0402). Department of Pharmaceutical Quality Assurance. 1

2. Content Table 2 S.No Content 1 Introduction 2 Grades of Water 3 Different Techniques and Equipments 4 System Qualification 5 Design Qualification 6 Installation Qualification 7 Operation Qualification 8 Performance Qualification 9 Complete Documentation 10 References

3. Introduction 3 High-quality water is essential for the manufacturing of pharmaceuticals. Water is the most commonly used raw material in pharmaceutical manufacturing. Water is directly or indirectly used in pharmaceutical manufacturing such as major component in injectable products and in cleaning of manufacturing equipment. Water is thus an important raw material in GMP and in validating the manufacturing process.

4. 4 Validation of Pharmaceutical Water System

5. Validation of Pharmaceutical Water System Water is a component of every pharmaceutical product, so Water system must be validated to ensure the consistent production of high quality water. The pharmaceutical industry places a high priority on the quality of water used in the production of finished product, intermediate reagent preparation and analytical processes and especially in case of parenteral products where quality of water must be as per pharmacopoeia.

6. Grades of water Specified in the USP are classified as 1. P otable water 2.Purified water 3.Water for injection 4.sterile water for injection 5.sterile water for inhalation 6.sterile water for irrigation 7.sterile bacterial static water for injection.

7. The quality attributes of water for a particular application are dictated by the requirement of its usage. Sequential steps that are used for treating water for different pharmaceutical purposes are shown in the figure below.

8. Different Techniques used for Water Treatment De-chlorination Filtration Ultra Filtration Softening Demineralization Reverse Osmosis UV Treatment Deionization Ozonization 8

9. Different Equipments & Components for Water System Piping Valves Pumps Pressure gauges Heat exchangers Distillation Filters Sensors Auxiliary equipments 9

10. Steps of Validation Establishing standards for quality attributes. Defining system and subsystem. Designing equipment, control, & monitoring technologies. Establishing standards for operating parameters. Developing an IQ stage & OQ stage. Establishing alert and action levels Developing a prospective PQ stage. Completing protocols and documenting each steps. 10

11. System Qualification Validation Master Plan User Requirements Specifications Design Qualification Installation Qualification Operation Qualification Performance Qualification Re-Qualification 11

12. Design qualification (DQ ) Based on the URS supplier designs the equipment This is the 1 st step in the qualification of new water supply system. It is documented the design of the system & will include : - Functional Specifications. (storage, Purification, etc ) - Technical/ Performance specification for equipment. (requirements for water volume and flow, define pumps and pipe sizes) - Detailed layout of the system Preliminary preventive maintenance procedures. Design must be in compliance with GMPs and other regulatory requirements.

13. Installation Qualification IQ is in the form of check list and it should include Instrumentation checked against current engineering drawings and specifications. Review of P&ID. Verification of materials of construction. Installation of equipment with piping. Calibration of measuring instruments. Collection and collation of supplier operating and working instructions and maintenance requirements.

14. Conti... Installation of system as per Design requirements. Installation verification- -System range of adjustments, measurments and tests should be carried out to ensure proper installation. Documentation include details of completed installation.

15. Conti... IQ Documents should contain Instrument name, model, I.D. No, Personal responsible for activities and Date. A fully verified installation that complies with the documented design. All equipments documentation and maintenance requirements would be documented. Completed calibration of measuring instruments. Verification of Materials of construction.

16. 16 Definition : The purpose of OQ is to establish, through documented testing, that all critical components are capable of operating within establibshed limits and tolerances. It is the functional testing of system components mainly the critical components. Operation Qualification

17. Conti... 17 Operation Qualification Checks- Ability to provide water of sufficient quality and quantity to ensure achievement of specifications. Ability to maintain general parameters like temperature, pressure, flow at set points. Includes the tests that have been developed from knowledge of processes, systems and equipment. Tests include a conditionor a set of condition with upper and lower operating limits, sometimes referred to as ‘worst case’ conditions.

18. Performance Qualification The purpose of PQ is to verify and document that water supply system provides acceptable control under ‘Full Operational’ conditions. PQ should follow successful completion of IQ and OQ. According to FDA’s advice “ The observed variability of the eqipment between and within runs can be used as a basis for determining the total number of trails selected for the subsequent PQ studies of the process”

19. Three phases approach recommended according to WHO Technical Report series 929 to prove reliability and robustness. Phase 1 (Investigational Phase) Test shall be 2-4 weeks (14 days minimum) for monitoring the system intensively. During this period The system should operate continuously without failure and performance deviation. 19 Qualification Phases

20. Phase 2 (Verification Step) A further test period of 2-4 weeks (30 days) should be spent carrying out further intensive monitoring, while developing all the refined SOP’s after the satisfactory completion of phase 1. water can be used for manufacturing purpose during this phase. Phase 3 Phase 3 typically runs for one year after the satisfactory completion of phase 2. Water can be used for manufacturing purpose during this phase. After the completion of phase three of the qualification programme of water system a routine plan should be established based on the results on phase three.

21. Validation Report Written at the conclusion of the eqipment IQ, OQ and at completion of process validation. Will serve as primary documentation for FDA regulatory inspection. Will serve as reference documet when changes to the system are occured and revalidation is needed. 21

22. Complete Documentation Verification of design documentation, including -Description of installation and functions -Specification of the requirements Instructions for performance control Operating procedures Maintenance instructions Maintenance records Training of Personnel Environmental records Inspection of plant Finally certificate (Sign Off) by Engineering, User (Production) and QA Heads.

23. REFERENCES Nash R. A. and Wachter A. H. "Pharmaceuticals Process Validation"; An international 3rd edition page no. 401-442. Quality Assurance of Pharmaceuticals volume-II GMP & Inspection WHO. https://bharathpharmacist/water-system-validation . 23

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