What are the different type of validation
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The document outlines various types of validation in pharmaceuticals, including process, cleaning, equipment, and analytical validation. It details the definitions, purposes, and requirements for prospective, retrospective, concurrent, and revalidation, highlighting the importance of ensuring product quality and compliance with FDA standards. Key aspects of analytical validation, such as accuracy, precision, specificity, and robustness are also discussed to ascertain the reliability of testing methods.
What are the different type of validation
- 1. TYPES OF VALIDATION -Joan Vijetha R (M.pharm) Asst.Prof(Pharmaceutics)-MSAJ College of Pharmacy
- 2. VALIDATION…
- 3. •TPYES OF VALIDATION •Process validation •Cleaning validation •Equipment validation •Analytical Validation
- 4. Process validation • FDA has mentioned the requirements for process validation in Section 820.75 of the Quality System Regulation (QSR). • Performance of the process is inspected to obtain documented assurance that the manufacturing process successfully meets the pre-defined acceptance criteria. • The activities in process validation that focus on machines, systems and equipments are called “qualifications”. They include: design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification.
- 5. •Types of Process validation •Prospective validation. •Retrospective validation. • Concurrent validation. •Revalidation.
- 6. Prospective Validation • It is defined as the established documented evidence that a system does what it purports to do based on a pre-planned protocol. • This validation usually carried out prior to distribution either of a new product or a product made under a revised manufacturing process. • Performed on at least three successive production-size (Consecutive batches).
- 7. Prospective validation should include, but not be limited to the following: • Short description of the process. • Summary of the critical processing steps to be investigated. • List of the equipment/facilities to be used (including measuring, monitoring/recording equipment) together with its calibration status. • Finished product specifications for release. • List of analytical methods, as appropriate. • Proposed in-process controls with acceptance criteria. • Additional testing to be carried out, with acceptance criteria and analytical validation, as appropriate. • Sampling plan. • Methods for recording and evaluating results. • Functions and responsibilities. • Proposed timetable.
- 8. Retrospective validation. • Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process. • Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence. • Therefore, this type of validation is only acceptable for well-established processes and will be inappropriate where there have been recent changes in the composition of product, operating processes, or equipment. • 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.
- 9. Some of the essential elements for Retrospective Validation are: • Batches manufactured for a defined period (minimum of 10 last consecutive batches). • Number of lots released per year. • Batch size/strength/manufacturer/year/period. • Master manufacturing/packaging documents. • Current specifications for active materials/finished products. • List of process deviations, corrective actions and changes to manufacturing documents. • Data for stability testing for several batches.
- 10. Concurrent Validation • It is similar to prospective, except the operating firm will sell the product during the qualification runs, to the public at its market price, and also similar to retrospective validation. • This validation involves in-process monitoring of critical processing steps and product testing. This helps to generate and documented evidence to show that the production process is in a state of control.
- 11. REVALIDATION • 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.
- 12. Cleaning validation • Definition: ▫ “A process of attaining and documenting sufficient evidence to give reasonable assurance, given the current state of Science and Technology, that the cleaning process under consideration does, and / or will do, what it purpose to do.”
- 13. • Objective. ▫ To minimize cross contamination. ▫ To determine efficiency of cleaning process. ▫ To do troubleshooting in case problem identified in the cleaning process and give suggestions to improve the process
- 14. Steps
- 15. Equipment validation • As per FDA, May 1987,‘Action of proving that any equipment works correctly and leads to the expected result is equipment qualification. • It is not a single step activity but instead result from many discrete activities.
- 17. Analytical Validation • Definition : “The process by, which it is established, by laboratory studies, that the performance characteristics of the method meet the requirements for the intended analytical application”.
- 18. • Accuracy : ▫ “The closeness of test results obtained by that method to the true value. This accuracy should be established across its range.” • Precision: ▫ “The degree of agreement among individual test results when the method is applied repeatedly to multiple sampling of a homogenous sample.”
- 19. • Specificity : ▫ “The ability to assess unequivocally the analyte in the presence of components that may be expected to be present, such as impurities degradation products and matrix components.” • Limit of Quantization : ▫ “A characteristic of quantitative assays for low levels of compounds in sample matrices such as impurities in bulk substances and degradation products in finished pharmaceuticals. It is the lowest amount of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions.”
- 20. • Range : ▫ “Interval between the upper and lower of analyte (including these levels) that have been demonstrated to be determined with a suitable level of precision , accuracy and linearity using the method as written. The range is normal expressed in the same units as test results. ( e.g. Percentage , parts per million, etc.) obtained by the analytical method.” • Ruggedness: ▫ The degree of reproducibility of test results obtained by the analysis of the same sample under a variety of conditions such as different laboratories, different analysts, different instruments , different lots of reagents, different elapsed assay times, different assay temperatures, different days, etc.
- 21. • Robustness: ▫ "A measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provides an indication of its reliability during normal usage.” • Linearity : ▫ “Its ability to elicit tests that are directly or by a well defined mathematical transformations proportional to the concentration of analyte in samples within a given range.” • Limit of Detection : ▫ The lowest amount of analyte in a sample that can be detected but not necessarily quantitated, under the stated experimental conditions.”
- 22. Thank You…