Process validation

Process validation is one of the important topic of Pharmaceutical Validation subject.

1. Process Validation By Shifa A. Sheikh, M. Pharm I st year ( QA) Roll No. 10 Institute of Pharmaceutical Education & Research, Wardha ( Meghe ) Borgaon .

2. Contents Introduction Stages of process validation Objectives Process Documentation Types of validation Revalidation criteria Reference

3. What is Process Validation? USFDA defines, Process Validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

4. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describe process validation in three stages.

5. Stage 1 Process Design : During this stage the commercial manufacturing process is defined based on knowledge gained through development and scale-up activities. S tage 2 Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Stage 3 Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

6. Objectives To establish a record keeping system that considers all concept of manufacturing process which includes controlled testing. To evaluate all possible sources of variation in process. To identify all sources of variation those are possible from the materials, machines, methods and men. To evaluate the requirement for in-process testing and evaluation. To document everything that is done to follow establish procedures and protocols as closely as possible. Quality must be assured.

7. Process

8. Documentation A written protocol should be established that specifies how qualification and validation will be conducted. The protocol should be reviewed and approved. The protocol should specify critical steps and acceptance criteria. A report that summarizes the results obtained, commenting on any deviations observed and drawing the necessary conclusions, including changes necessary to correct deficiencies. Any changes to the plan as defined in the protocol should be documented with appropriate justification.

9. Types of Process Validation 1. PROSPECTIVE VALIDATION It is defined as establishing documented evidence that a system does what it purports to do based on a preplanned protocol. This validation usually carried out prior to development of new product, new process or a product made under a revised manufacturing process. Performed on at least three successive production-size batches. In prospective validation, the validation protocol is executed before the process is put into commercial use. During the product development phase, the production process should be categorized into individual steps.

10. Requirements: - 1. Equipment/facilities should meet cGMP requirements. 2. Personnel have an awakeness about the requirements. 3. Critical processing stages and process variables are identified. 4. At least one qualification trial (size x 100) made which shows that there is no significant deviation from expected performance of process. 5. Batches should be run at different days, shifts and different quantities.

11. 2. 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. This validation involves in-process monitoring of critical processing steps and product testing. This helps to generate, documented evidence to show that the production process is in a state of control. 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.

12. 3. RETROSPECTIVE VALIDATION : The 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 that the process is doing what it is believed to do. For retrospective validation, data from ten to thirty consecutive batches should be examined to access process consistency.

13. Requirement :- 1. Gather all historical data of process/product in chronological sequence according to batch manufactured. 2. Data should consists of at least last 20-30 manufactured batches for analysis. 3. Trim data by eliminating results of non-critical steps. 4. Subject the resultant data to statistical analysis and evaluation. 5. Draw the control charting & go for conclusion.

14. Revalidation Criteria Revalidation indicates that the process must be validated once again. It may not necessarily mean that the original program must be repeated, however. Re-validation provides the evidence that changes in a process and/or the process environment do not adversely affect process characteristics and product quality. Facilities, systems, equipment and processes including cleaning should be periodically evaluated to confirm that they remain valid. Revalidation becomes necessary in certain situations. Changes in raw materials Changes in the process Changes in the equipment.

15. Reference www.pharmaguideline.com www.slideshare.com

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