Validation files

The project validation plan is a live document that should be reviewed against each life-cycle step and any other validation milestones (as a minimum). Any changes to the plan should be identified on a revision history section within the document. The plan should be retained in the validation file and should be easily accessible. 

A formal agreement that references all relevant tender documents and clearly identifies responsibilities and document deliverables should be prepared by the pharmaceutical manufacturer. The purchase order should include the final agreement and identify any associated contractual documentation. A copy of the signed final agreement and purchase order should be retained in the pharmaceutical manufacturer s validation file, together with evaluation records applicable... 

Supplier acceptance test records and reports for both FAT and SAT should be approved and kept in the validation file. 

Test records should be kept in the validation file and used in preparing each qualification summary report. 

Each qualification must be formally reported to ensure an approved and audit-able transition to subsequent life-cycle phases. Qualification summary reports for the system must be prepared by the pharmaceutical manufacturer and should be kept in the validation file. Each qualification report should confirm the qualification test acceptance and review associated change control records. The report must present a documented record that clearly states the basis for concluding that the qualification is acceptable, particularly if there are any minor conditions or actions outstanding. 

The documentation for system design and development activities complete with development test results is normally prepared by the supplier. At a minimum, copies of the document reviews and a listing of the application development records should be provided for appending to the pharmaceutical manufacturer s DQ report. The pharmaceutical manufacturer may request copies of the supplier s application development and test records for inclusion in the validation file or arrange for the supplier to maintain and store all system application development records. 

The report should also preview the validation file documentation, control procedures, and support programs that are vital to the ongoing validation program and must be used as the basis for maintaining the validation status of the computer system. At this time a review of the GMP risk assessment should be undertaken and included as a section in the validation report. 

The pharmaceutical manufacturer is responsible for maintaining the validation file and must ensure the computer system supplier(s) documentation is also up to date. The validation file document set must be under document control at all times, and is normally located in the pharmaceutical manufacturer s quality system to ensure controlled and expedient access at all times. 

The validation file should have a file reference name and number and contain a document schedule or index with individual document titles, reference numbers, and version numbers. The file may also include electronic copies of documents (e.g., floppy discs, CD-ROM). Consideration should be given to... 

Documents that cannot easily fit into the validation file or may be required on a day-to-day basis (e.g., supplier system manuals, calibration schedule, and records) may be filed elsewhere, and these should be identified on the document schedule stating where they are located and identifying who is responsible for them. All documentation provided by the supplier must be suitably marked to easily identify its location in the validation file. It is acceptable to have the system development records archived by the supplier. If the pharmaceutical manufacturer requires the supplier to store and maintain the documents there needs to be a formal agreement on the retention period. 

Consideration should be given to periodic revalidation to ensure the computerized operation remains capable of achieving the intended results. The extent of revalidation will depend upon the nature of the changes and how they affect the different aspects of the previously validated computerized operation. Unless circumstances demand, revalidation does not necessarily mean a full repeat of the validation life cycle. As appropriate, partial requalification may be acceptable. For instances in which new qualification testing is undertaken it is advisable to retain the original qualification summary reports in the validation file or quality system archives, marked superseded with cross-reference to the new documents. 

For the life-cycle validation documents and any associated support documents that make up the validation file the periodic review must verify that these are approved and auditable, and maintain traceability between related documents. 

All revised documentation must be checked and approved by designated personnel and placed in the validation file. All superseded documentation must be marked as such and dealt with in accordance with site quality procedures. 

The procedure should include review of all the collective information in the validation file to confirm the validated status of the system and ensure data records that are to be retained in support of released product are available. The requirements necessary to conduct and report the archiving of GMP records need to be defined, and should identify all life-cycle documents, electronic raw data, electronic records (including associated audit trail information), and system application/operating software that are to be archived. 

The periodic review report(s) should be retained in the validation file as a record of the computer system validation of the validation status and the validation plan should be updated with a date for the next review. 

Provide for retention of archived validation files for required periods following last commercial lot expiration date. 

Following the successful conversion of the electronic records, and QA acceptance of the validity of the conversion, the new system may be authorized for use. The results of the validation must be fully documented and added to the validation file of the system that is being retired. 

In addition to the retention of operating data in electronic format, the following list shows the supporting documentation that should be archived along with the data. The integrity of archived data is assured when the systems on which the data was produced have been validated, and the documentation relating to these systems has been assembled, as part of the validation file. 

A new concept Flexibibilization of scope of accreditation or Accreditation of types of tests or Scope in testing has emerged [11] in microbiology. It has been used by German and Swiss accreditation bodies for nearly ten years in other fields. Under this concept, an accredited laboratory, which has shown solid technical competence in the past, could, after establishment of a validation file, directly incorporate the new developed test method or application inside its scope of accreditation without a separate specific inspection. This laboratory could also at any moment retry new test methods or application. Surveillance audits then confirm (or fail to con-... 

A program to ensure control of critical system documentation will be established. The files will be controlled by QA. Validation and centralized for easy retrieval. Equipment validation data such as operating and service manuals, purchase orders, manufacturer specifications, as-built drawings and schematics, spare parts lists, and any other information pertaining to the system will be included in the file. Separate validation files for Facility, Systems, and Process validation of each product, including all related data, will be maintained. Procedures will be developed to create files for new equipment, update information for existing equipment, control, removal, and return of information, etc. 

Equipment logbooks, status tags, and room clearance Validation files Drawings/Layouts... 

The master plan is finalized during detail engineering. The protocols prepared (IQ s, OQ s and PQ s) and the validation files started during construction. The IQ s (Installation Qualifications) are performable as construction is completing and can be completed by the constructor under supervision. The OQ s (Operational Qualifications) can be performed during the earlier parts of start-up as verification of mechanical completion. The PQ s (Process Qualifications) are performed as start-up completes and continue through the operating life of the plant. For maximum schedule... 

The results of the validation are archived in a validation file. A validation file of equipment may consist of the following chapters URS, functional/technical specification, DQ, IQ, OQ, PQ, re-validation(s) (see Sect. 34.15). 

---