Periodic validation reviews

Periodic Review. Periodic validation reviews should be conducted at approximately 12-month intervals. The periodic review has a number of objectives ... 

A formal validation review should be carried out periodically to determine the necessity for revalidation. 

Finally, utility and equipment revalidation or validation review may be structured differently than techniques typically used in the manufacturing environment. Unlike the production facility, the pilot plant may not use every piece of equipment or system on a routine basis. In fact, some equipment may remain idle for significant periods of time. Revalidation may need to be scheduled based on hours in use rather than a program designed for periodic review. It should be pointed out that some equipment or systems might need more frequent revalidation activities because of lack of use. No matter what basis is chosen, it is imperative that a formal revalidation program be established in the pilot plant environment. 

ASTM (American Society for Testing and Materials) methods are proposed for testing because they embody the above principles. Use of ASTM procedures ensures that periodic peer review of the methods will maintain their validity, currency, and reproducibility. 

On July 20, 1995 the reactor was shutdown and the reactor core was unloaded. Because of the lengthening of the re-licensing period and review of the SAR, TAEK (Turkish Atomic Energy Authority) gave permission for limited operation to maintain the system s operability and the validity of the operators license. By the end of 2000 the core was unloaded again. 

Changes to methods will occur due to changes in applications and technological developments and these changes need to be formally implemented and recorded, after appropriate validation. A periodic review (commonly every two years) and, where necessary, revision is considered to be good practice . 

Approaches to Process Validation Process Validation Program Periodic Review of Validated Systems Cleaning Validation Validation of Analytical methods Change Control, Rejection, and Reuse of Materials Rejection Reprocessing Reworking... 

Documentation comprises procedures, instructions, test methods,batch records, and so on that are documented and controlled. Documentation is prepared, reviewed, and approved by qualified personnel. Approved copies of documents are distributed to relevant departments and superseded copies are retrieved and archived. The retention period for each type of document is specified. Documents are issued with document and version numbers for ease of identification and reference. Master copies of documents are filed at secured locations with authorized access. Master copies stored in electronic media require validation in accordance with FDA regulation 21 CFR Part 11 (see Section 9.6.3) to assess the security of access and data integrity. Operators are trained and retrained to only apply the latest approved documents. 

Risk assessment is the first critical step in the validation of a computer system. After risk assessment, the validation protocol must be created, including all the points referred in the VMP. The procedures to be executed in a computer system should be defined, in addition to the specifications and tests to be performed. These tests could be trials for IQ, OQ, and PQ. After the test procedure and data evaluation, a validation report must be available. Therefore, a very well written and periodically reviewed (e.g., every year) VMP, validation protocol, and validation report are always necessary. 

Validation Team A well-defined validation team with a well-written description of responsibilities is required and assures the adequate realization of the validation tasks. A validation team should be composed by different responsibilities responsible-of-validation team, team leader, archive manager, test coordinator, quality assurance member, tester, and witness. The responsible-for-validation team elaborates and approves the VMP, protocols, and reports. The team leader should be responsible for the computer system validation and utilization. An archive manager is responsible for the management of all computer system validation documents. The test coordinator is responsible for the computer system test and coordinates the elaboration and operation of tests for evaluating the performance of the computer system. A quality assurance member is required to periodically inspect and train the personnel and review all the validation documents. The tester is responsible for the execution of the tests required to perform the validation protocol. The witness is responsible for observing and reviewing the operations of the tester. 

Validation will include items 18.3.2, Requirements, to 18.3.9, Periodic Review (see relevant sections of this chapter). 

All other validation sections, such as Design, Test, Security, Documentation for User and Training, Changes and Version Control, Archiving, Periodic Review, and Review and Approval, can be taken from the content uniformity example described earlier in the chapter. 

Validation (policy, documentation, qualifications, approaches to process validation, periodic review of validated systems, cleaning validation, and analytical methods validation)... 

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