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Process validation
- 1. Process Validation Prepared By: Ms. Navdha N. Soni Assistant Professor L.J Institute of Pharmacy Ahmedabad
- 2. Introduction • Validation is establishing documented evidence which provides a high degree of assurance that a specific process, procedure or activity carried out in testing and then production maintains desired level of compliance at all stages. • Validation is a key process for effective Quality Assurance its simple meaning is “ACTION OF PROVING”
- 3. Types of validation 1 Analytical Method Validation 2 Process Validation o Prospective Validation o Concurrent Validation o Retrospective Validation o Revalidation 3 Equipment Validation o DQ o IQ o OQ o PQ 4Cleaning Validation 5 Calibration 6 Raw Material Validation
- 4. Process Validation • It is defined as a documented programme which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality characteristics. • Effective process validation contributes significantly to assuring drug quality. • The basic principle of quality assurance is that a drug should be produced that is fit for its intended use.
- 5. • This principle incorporates the understanding that the following conditions exist: 1. Quality, safety, and efficacy are designed or built into the product. 2. Quality cannot be adequately assured merely by in-process and finished- product inspection or testing. • The goal is to create a robust manufacturing process that consistently produces a drug product with minimal variation that adheres to quality criteria of purity, identity, and potency. Process Validation
- 7. • The guidelines on general principles of process validation mentions four types of validation: 1. Prospective validation (or premarket validation) 2. Retrospective validation 3. Concurrent validation 4. Revalidation Types of Process validation
- 8. Prospective validation • In Prospective Validation, the validation protocol is executed before the process is put into commercial use. • This approach to validation is normally undertaken whenever the process for a new formula (or within a new facility) must be validated before routine pharmaceutical production. • In fact, validation of a process by this approach often leads to transfer of the manufacturing process from the development function to production.
- 9. • During the product development phase the production process should be broken down into individual steps. • Each step should be evaluated based on experience or theoretical considerations to determine the critical parameters that may affect the quality of the finished product. • A series of experiments should be designed to determine the criticality of these factors. Each experiment should be planned and documented fully in an authorized protocol. Prospective validation
- 10. • Using this defined process a series of batches should be produced and observations made should be sufficient to allow the normal extent of variation and trends to be established to provide sufficient data for evaluation. • Upon completion of the review, recommendations should be made on the extent of monitoring and the in- process controls necessary for routine production. Prospective validation
- 11. • It is generally considered acceptable that three consecutive batches within the finally agreed parameters, giving product of the desired quality would constitute a proper validation of the process. • During this step the input resources are selected and clearly specified. E.g. v Material specification is clearly defined. v Equipment & process parameter are defined. v Operating condition if any specified. v Level of training of people can also be defined Prospective validation
- 12. Retrospective Validation • In many establishments, processes that are stable and in routine use have not undergone a formally documented validation process. Historical data may be utilized to provide necessary documentary evidence that the processes are validated. • Retrospective validation is only acceptable for well established detailed processes that include operational limits for each critical step of the process and will be inappropriate where there have been recent changes in the formulation of the product, operating procedures, equipment and facility
- 13. • It is generally considered acceptable that three consecutive batches within the finally agreed parameters, giving product of the desired quality would constitute a proper validation of the process. • This approach is rarely been used today because it’s very unlikely that any existing product hasn’t been subjected to the Prospective validation process. • It is used only for the audit of a validated process. Retrospective Validation
- 14. • The source of data for retrospective validation should include amongst others, batch documents, process control charts, maintenance logbooks, finished product test results, and stability results. • For the purpose of retrospective validation studies, it is considered acceptable that data from a minimum of ten consecutive batches produced be utilized. Retrospective Validation
- 15. • When less than ten batches are available, it is considered that the data are not sufficient to demonstrate retrospectively that the process is fully under control. • In such cases the study should be supplemented with data generated with concurrent validation. Retrospective Validation
- 16. • Concurrent validation is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process. • This approach involves monitoring of critical processing steps and product testing of current production, to show that the manufacturing process is in a state of control Concurrent Validation
- 17. • In using this approach there is always the risk of having to modify process parameters or specifications over a period. • This situation often leads to questions regarding disposition of the batches that had already been released for sale, subsequently known to have undesired quality characteristics. Concurrent Validation
- 18. Revalidation • Revalidation means repeating the original validation effort or any part of it and includes investigative review of existing performance data. • This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. • Re-validation provides the evidence that changes in a process and /or the process environment that are introduced do not adversely affect process characteristics and product quality.
- 20. Example • VALIDATION OF WET GRANULATION PROCESS: Parameters to be considered during development & validation are: BINDER CONCENTRATION & ADDITION: The optimal binder conc. will be need to be determined for the formulation. If the binder solution is sprayed, it is needed to be diluted enough so that it can be pumped through the nozzle. It should also be sufficiently concentrated to form granules without over wetting the materials.
- 21. Example AMOUNT OF BINDER SOLUTION: Too much binder or solvent solution will over wet the materials and prolong the drying time. BINDER SOLUTION ADDITION RATE: Define the rate at which the binder solution can be added to the material. MIXING RATE: It is the rate required to ensure the proper formation of granules. Over mixing of the granules can lead to harder granules and a lower dissolution rate.
- 22. Reference 1. Jain N.K. “Pharmaceutical Product Development” , CBS Publishers & Distributors, 2008. Page no. 524-549. 2. Nash R.A. “Pharmaceutical Process Validation” 3 edition, Marcel & Dekker publication, Page no. 20-47. 3. Guidance for Pharmaceutical Industry on Process Validation, USFDA, January 2011.
- 23. Questions Expected Questions § Explain Process Validation in detail.