Pharmaceutical process validation (PV)
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This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
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Pharmaceutical process validation (PV)
- 1. Process validation Guru Balaji.S Global product development (R&D) s.gurubalaji@gmail.com
- 2. Process
- 3. Process validation (PV) Quality, safety, efficacy Global regulatory agencies History of validation Definition Why process validation Overview of process validation Importance of validation Process validation team PV: Types of documentation PV documents and support documents PV flowchart PV team PV – Types of documentation Prospective validation Retrospective validation Concurrent validation Revalidation Phases of process validation
- 4. Process validation is established documented evidence which give high degree of assurance that a specific process will consistently produce a product meeting its quality characteristics and pre-determined specifications
- 7. Validation details are described in the current good manufacturing practice (cGMP) for finished pharmaceuticals in 21 CFR parts 210 and 211 of USA Concept of validation - first proposed by two FDA officials, Ted Byers and Bud Loftus, in the mid 1970’s in order to improve the quality of pharmaceuticals It was proposed in direct response to several problems in the sterility of LVP (.Large volume parentals) The first validation activities were focused on the processes involved in making these products, but quickly spread to associated process of pharmaceutical. U.S.F.D.A. was the pioneer in advocating the concept of process validation, but till 29th September 1978 the definition did not appear any where. History of validation
- 8. US FDA Definition “Process validation is establishing documented evidence which provides a high degree of assurance that a specified process will consistently produce a product meeting its pre-determined specifications and quality characteristics.” ICH Definition “Process Validation is the means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of the required quality.” WHO Definition “The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to expected result.” Definition
- 9. Why process validation Why ? Need of process validation: • To obtain consistent, reliable and accurate data • Act as proof in decision making • To get assurance of quality product • To demonstrate the process remains in control • To demonstrate the process works as intended
- 11. Importance of Validation Assures the repeatability of the process Decreases the risk of manufacturing problems Minimal batch failures, improved efficiently and productivity Reduction in rejections Increased output Avoidance of capital expenditures Fewer complaints about process related failures Reduced testing in process and in finished goods More rapid and reliable start-up of new equipment's Easier scale-up form development work Improved employee awareness of processes More rapid automation Government regulation (compliance with validation requirements is necessary for obtaining approval to manufacture and to introduce new products)
- 13. Process validation: Types of documentation
- 14. Change control 1. Process understan ding 2. Process design 3 qualification 3. Process qualification 4. Commercial manufacture 5.Monitorin g & improvemen t Based on product quality and patient safety Know the process Know the variables Have the confidence vigilance
- 17. The particular type of process validation is normally carried out in connection with the introduction of new drug products and their mfg. process Carried out prior to distribution of new product or existing product made under a revised manufacturing processes where such revision may affect product specification or quality Also called as premarket validation An experimental plan called the validation protocol is executed before the process is put into commercial use
- 18. Conducted for a product already being marketed, and is based on extensive historical data accumulated over several lots and over time. Some essential elements of retrospective validation - Batches mfg. for a defined period - Batch size/strength/mfg./year - Master manufacturing/packaging documents - Current specifications for active materials/finished products - List of process deviations, corrective actions and change to mfg. documents - Data for stability testing for several batches - Trend analysis including those for quality related compliants
- 19. • This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control. • Study is carried out under a protocol during a course of normal production • This may be a practical approach under certain circumstances (a) When previously validated process is being transferred to a third party contract manufacturer or to another manufacturing site (b) Where the product is a different strength of a previously validated product with the same ratio of active /inactive ingredients
- 20. It is repeating/ part of the original validation activity. It is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for doing : (1) The transfer of a product from one plant to another. (2) Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality. (3) Change - equipment (type,function,location,control system,major repairs) (4) Periodic revision (5) Significant (usually order of magnitude) increase or decrease in batch size. (4) Sequential batches that fail to meet product and process specifications. It depends on the extent of the changes and the effect upon the product.
- 21. Phases of process validation Process design /process development1 Process qualification a) Design of facility b) Qualification of utilities & equipment c) Process performance qualification(PPQ) d) PPQ protocol e) Process execution and report 2 Process verification3
- 22. Process development Process development activities begin after the formulation has been developed. It meets the following objectives Develop a suitable process to produce a product which meets all a) Product specification b) Current good manufacturing practice's Identify the key process parameter that affect the product attribute Identify in process specification
- 23. Process Objective Variable (Monitor) Test (response) Solution preparation To ensure a colorless/specified color solution with specified pH and % assay(specified % of labelled amount) • Load • Mixing time • Mixing speed Assay Clarity pH Filtration To comply the sterility test • Filtration rate • Pressure Sterility Filling & partial stoppering To ensure uniformity in filled volume and % assay • Filling rate • pressure Sterility Lyophilisati on & stoppering To ensure uniformity in appearance of lyophilized cake and reconstitution time • Load • Vacuum • time • temperature Water content Scale formation reconstitution time pH weight Appearance Sealing To ensure integrity of seal - Leak test seal integrated Lyophilized formulation process with monitor and test
- 24. Process Objective Test (response) Pre blending To ensure uniformity % assay (specified % of labeled amount) Description Assay Dissolution Water content Weight variation Related substances Granulation To comply the granulation parameters Drying To ensure the granules drying parameters and PSD Sizing To ensure uniformity in appearance of lyophilized cake and reconstitution time Blending To ensure uniformity % assay (specified % of labeled amount) Tableting Ensure tableting parameters Film coating Ensure film coating parameters Tablet formulation process with monitor and test
- 25. Knowledge…… is proud that he has learnt so much Wisdom… Is humble that he knows no more William cowper
- 26. Guru Balaji.S Global product development(R&D) 91-99 44 33 08 34 s.gurubalaji@gmail.com