types of validation

types of validation

1. MODERN PHARMACEUTICS Presented by- ABDUL NAIM M – Pharm – Pharmaceutics 1-st semester

2. Validation:- validation is confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled TYPES OF VALIDATION THE MAJOR TYPES OF VALIDATION Process validation Cleaning validation Equipment validation (Qualification ) Validation of analytical method

3. Process validation Definition As per FDA Nov,2008, ‘the collection of data from the process design state throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Types of process validation: Prospective validation Retrospective validation Concurrent validation Revalidation

4. a . Prospective validation Carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps. These are then evaluated on the basis of past experience to determine whether they might lead to critical situations.

5. b . Concurrent validation Concurrent validation is validation which is carried out during normal production. It is appropriate when:- it is more appropriate to validate process during routine production due to well understanding of process. Extensive testing and monitoring ensure the desired quality characteristics of product with high degree of confidence

6. C. Retrospective validation Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged Such experience and the results of in-process and the final control tests are then evaluated Recorded difficulties and failure in production are analysis to determine the limit of process parameters

7. d. Revalidation Revalidation is needed to ensure that changes in the process and/or in the process environment , do not adversely affect process characteristics and product quality . Revalidation may be divided into two broad categories: Revalidation after any change having a bearing on product quality. Periodic revalidation carried out at scheduled intervals.

8. 2. Cleaning validation Definition “A process of attaining and document in 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.” 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

9. 3. Equipment validation Definition :- As per FDA, May 1987, ‘Action of proving of providing that any equipment works correctly and leads to the expected results is equipment qualification. It is not single step activity but instead result from many activities.

10. 4. Validation of analytical method 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.” 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

11. VALIDATION OF SOLID DOSAGE FORMS The objective of the design and manufacture of the solid dosage form(tablet, capsule) is to deliver orally by correct amount of drug in the proper from, over a period of time and in the desired location and to have its chemical integrity protected to that point. The prime objective of any pharmaceutical plant is to manufacture product of high quality consistently at the lowest possible cost. Through a careful design & validation of both the process and controls, the manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable.

12. The product quality can be ensured by, Chemical and physical stability Preservation against microbial contamination Uniformity of dose of drug Acceptability to users(prescriber & patient) Suitable packaging and labelling Validation Tablets as a dosage form comprises a mixture of active substances and excipients, usually in powder form, pressed (or) compact in to solid The excipients include Binder, glidants and lubricant- to ensure efficient tabletting Disintegrant - to promote tablet break up in the GIT

13. 3. Sweetener/flavour – to enhance taste 4. Pigment – to make the tablet visually attractive Polymer coating is often applied to make the tablet :- Smoother Easy to swallow Control the release rate of active ingredients More resistant to environment Extending its shelf life To enhance appearance of the tablet

14. The manufacturing of tablet includes extensive powder handling The powder must blended for uniformity and converted in to the dosage from through compression. The typical requirement include Weight Blending Mixing/ granulation areas Compression Coating

15. GOVERNMENT REGULATION This emphasis on validation began in the late 1970 s, the requirement has been set at 1963 as cGMP for finished pharmaceuticals. There shall be return procedures for production and process control designed to assure that the drug products have the identity strength, quality, purity. Validation is considered to be integral part of GMPs essentially worldwide, compliances with validation requirements is necessary for obtaining approval to manufacture and to introduce new products. The FDA’s cGMP refer to the concepts of the validation in both sections.

16. They state that such control procedure shall be established to monitor output and to validate the performance of those manufacturing process that may be responsible for causing variability in the characteristics of in process materials and drug materials. The accuracy, sensitivity, specificity and reproducibility of test methods employed by the firm shall be established and documented. A generally stated requirement for process validation is contained in the medicinal device GMP regulations. Where deviations from device specification could occur as result of manufacturing process itself . There shall be written procedures describing any process controls necessary to assure conformance to specifications.

17. Manufacturing process model

18. Facilities Facilities for URS(user requirement specification ):- User requirement specifications may be define as the ,user department will raise the indent for his requirement regarding machine ,equipment or software. He will give his requirement in a one format is called the URS which including the functional and technical specification for the machine ,equipment or software ,these specification written is called the URS.

19. General format for URS : Name of organization (URS ) Date …. Name of your department ……. Location ……. Name of machine , or software …… Purpose of machine …. software………. Other area impact …..(AHU space )

20. SL.NO Parameter Specification 1 Name 2 Model 3 Make 4 Capacity 5 Calibration 6 Spare 7 Change part 8 others

21. Facilities For Design qualification-( DQ) Once the URS is finalized the Engineering department, R&D ,user, QA department will prepare the design qualification ,which including drawing ,calculation ,sample & other design document .¨ Manufacturer will study the design ,if the design is ok from the construction point of view manufacturer will quote to the user . if the design is not ok from the construction ,national & international point of view. machine manufacture will prepare new drawing from the construction as well as legal & user point of view .than these drawing is send to user for approval .

22. 1 -General 2 -Document approval 3 -Version control 4 -Abbreviation 5 -Objective 6 -Responsibility 7 -URS 8 Equipment 9- DQ review and approval ,etc.

23. Facilities Of Installation qualification (IQ) Installation qualification is the documented verification that the system is installed satisfactory & is compliance with other appropriate engineering code, manufacturing and approval specification and that instrument is calibrated & all service are available & of adequate .

24. IQ protocol • ¨ Validation file • ¨ Security access • ¨ Environment • ¨ System diagnostics • ¨ hardware component • ¨ Instrument installation & calibration ¨ Electric power & circuit protection • ¨ Instrument air supply • ¨ Loop wiring

25. • ¨ Hardware configuration • ¨ Software backup and restoration • ¨ General system inspection Facilities Of Operational qualification(OQ): The computer must be power backup & check to ensure it functioning correctly .This may be involve observing & recording system status lamp & rerunning diagnostic check

26. OQ protocol Operator interface & screen display ¨ Input/ output signal ¨ Data storage ,backup & restore ¨ Electrical record &electrical signature ¨ System report printout ¨ Trend display ¨ Alarm event & massages

27. ¨ Safety interlocks ¨ Control & Monitoring loop wiring ¨ Software process logic ¨ SOP preparation & approval ¨ Power failure & data recovery

28. Performance qualification(PQ) Performance qualification is an documented verification that computerized operation consistently perform as intended in the URS throughout all the anticipated operating range . Performance qualification are a collection of test cases used to verify that a system perform as expected under simulated real world Condition The performance and equipment for its routine analytical use is check to ensure that complies with its specification .

29. THANK YOU