Validation master plan

In this slide contains details about Validation master plan.
Presented by: HIMA BINDHU (Department of pharmaceutical analysis).RIPER, anantapur

1. 1 Validation Master Plan A Seminar as a part of curricular requirement for I year M.Pharm II Semester Presented by G.HIMABINDU (Reg.no:20L81S0703) Pharmaceutical analysis Under the guidance of Dr. P.Ramalingam M.Pharm , Ph.D. Director – R&D Division, Professor of pharmaceutical analysis and medical chemisry President – IPA local branch - anantapuramu

2. 2 Validation Validation master plan Who perform the validation master plan Contents of validation master plan Contents

3. 3 Validation Validation is an essential part of Good manufacturing practices(GMP). It is therefore, an element of quality assurance programme associated with particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.

4. 4 Quality, safety, efficacy must be designed and can be built in to the product. Quality cannot be inspected or tested in to the product. Each critical step of manufacturing process must be validated. The concept of validation was first proposed by two Food and drug administration officials. Tedbyers and Bud loftus , in 1979 in USA to improve the quality of pharmaceuticals. Principles as follows:

5. 5 US-FDA : Confirmation by examination and Provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. WHO: Validation is defined as the documented evidence that provides high degree assurance that specific method or process or systems will consistently produce results meeting the predetermined acceptance criteria. Definitions

6. 6 Schedule M The defined process, materials and equipment specified shall be demonstrated yield a product consistently of the required quality. US FDA included Some form of validation around 1970s (process validation under 21 CFR Parts 210 and 211).

7. 7 Definition: The VMP is a high-level document that establishes an umbrella validation plan for the entire project and summarizes the manufacturer’s overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer’s validation work programme and defines details of and time scales for the validation work to be performed, including a statement of the responsibilities of those implementing the plan. Validation Master Plan

8. 8 VMP

9. Key elements: A validation policy Organizational structure of validation activities Summary of facilities, systems, equipment, process validated and to be validated. Documentation format (e.g. Protocol and report format) Planning and scheduling Change control References to existing documents.

10. 10 Who perform the VMP? Members: Validation manager, Quality Assurance department Member from production Member from Engineering (utilities) Member from QC lab Member from HVAC department Member from product development lab

11. 11 V M O D E L

12. 12 Introduction Methodology Qualification: Design qualification (DQ) Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ) Personnel Schedule Preventive maintenance Change control Documentation Contents of VMP:

13. 13 The introduction of a VMP should include following details: A description of facility, its premises and equipment, and its purpose. Intension and scope of validation. Other relevant site policies and plans, like factory or corporate policy statements on GMP, QA, etc., Introduction:

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15. 15 The VMP document serves as a guide with company’s overall approach towards performing validation and qualification activities, in accordance with: WHO cGMP cGLP Objective:

16. 16 Validation master plan ensures that: To demonstrate that the facility is capable of meeting process or product parameters in repeatable manner. The critical programs for utilities, qualification, process validation have been established, in accordance with the product requirements.

17. 17 This section should address the predetermined requirements by identifying the standards that are applied to the facility. It also involves planning and execution of documents such as, protocols, records, or other. The standards will involve three elements: Regulatory and guidance documents National standards Company standards. Methodology:

18. 18 This section encompasses all aspects of the design, procurement, installation, and commissioning process. The extent of qualification and re-qualification shall be decided based on critical nature of equipment and system. Qualification:

19. 19 The very first part of the validation of any new equipment Site, system or facilities could be the design qualification. It comprises the documented verification of equipment and manufacturing facilities. Design Qualification :

20. 20 The objective of this qualification is to establish evidence that all key factors of the process equipment. It should be coherent to the manufacturers approved specification along with recommendation of supplier of the equipment. Installation Qualification:

21. 21 The objective of this qualification is to establish the evidence that process control limits and action levels as per predetermined requirements. Operational Qualification:

22. 22 The objective of this qualification is to establish evidence that the process, under anticipated conditions, consistently meets the specified requirements. Performance Qualification:

23. 23 The CFR 21 states that each person engaged in and each person responsible for supervising the manufacturing, processing and holding a drug product. All employees shall be trained on good manufacturing practices (GMP). Training evaluation should be carried out with proper training records as per standard operating procedures. The training includes validation activities and calibration as per international regulations. Personnel:

24. 24 The work programme is essential and should be prepared at an early stage. A good plan will contain all necessary features which are to be considered during execution of a plan. It ensures that all the personnel involved in the VMP are not only aware of engineering targets but also the validation targets. Schedule:

25. 25 This is the responsibility of site maintenance and operation department. It embodies all maintenance and support activities necessary to ensure the validated status of the systems. For standard procedure refer SOP for preventive maintenance of equipments. Part of review process must conclude and examination of any change recording. Preventive maintenance:

26. 26 A strict change control procedure should be followed as per the standard procedure. All changes shall be formally requested, documented and accepted by the representatives of quality assurance. Change control format comprises of the following: Detail of change requested Reason for proposed change Impact and risk assessment of change. Change control:

27. 27 Some of the major and minor changes are: Major changes: For a substance of microbiological and chemical quality evaluation. Addition or deletion of step in manufacturing process. Change in quality of raw materials used in formulation manufacturing process. Change in input quantities of formulation manufacturing process.

28. 28 Minor changes: Change in references( name/company name/address) of manufacturing site. Change or updating the method of analysis used to test the substance. Change in supplier of starting and packaging material. Change in batch size.

29. 29 Each change control contains 7 digits. CC-001/18 First 2 digits represent change control code (CC). 3,4,5 digits represent sequential change control number (001). 6,7 digits represent the current year (18).

30. 30 For effective use of documents they should be designed and prepared with utmost care. As per SOP it shall: Have a clear title Have a particular identification number Have the effective date Be approved by authorized persons. Documentation:

31. 31 In case of any additional information added to the existing protocol addendum or supplement should be prepared. Supplement or addendum shall be retained along with the existing protocol.

32. 32 U.S. Food and drug administration, 21CFR 601.12 (a), April 1, 2000. International pharmacopoeia. Pandey m.a.g. Validation technology in pharmaceutical industry. A Review Journal of drug discovery and development -2018,2(1), (30-34). B.t. Loftus and nash, pharmaceutical process validation, drugs and pharmaceutical sciences, vol-129, 3 edition, 2003 pg no. 144-155. References

33. 33 THANK YOU