The use of Validation protocol interactive template makes it easy and foolproof to present documentation to the regulators that is carefully prepared, with all statements worded to preclude ambiguous and incorrect interpretations of the meaning of the statement. In addition there are specific requirements stipulated by the regulatory authorities. Documents presented to regulators during inspections that fail to satisfy these requirements; indicate to the regulator a lack of care and commitment on the part of the company. The exact opposite to what is required.
The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance is being driven by evidence that the industry is failing to match the standards set by other regulated industries.
Process qualification requires the establishment of scientific evidence that the process is capable of consistently delivering product that satisfies all the applicable requirements documented in the User Requirements Specification (URS).
Further to this the process verification should not be viewed as a one-time event, but should be viewed as an ongoing lifecycle requirement. Sampling methodology should become a key factor in carrying out ongoing process qualification.
Current good manufacturing processes (cGMP) regulations specify that samples must: represent the batch under analysis and meet specifications and statistical quality control criteria as conditions of approval and release. Furthermore, the batch must meet its predetermined specifications.
The importance of pharmaceutical process qualification is emphasized by the way the regulators relate all other activities relative to it. Calibration, maintenance, documented procedures, operator training, utility and ancillary service requirements are all defined by the “process”.
Since testing for conformity will usually destroy or damage the product, we are often totally reliant on replicating the process so precisely that the product is produced to the exact efficacy specified.
Process verification ensures that all aspects of the process execution have been subjected to rigorous verification procedures verifying that the product is consistently manufactured to specification.
Company approved Project Quality Plan (VP) details the actions, deliverables, responsibilities and scope of qualification activities required for each of the identified VRA ratings. This definition and scope must be built into each Installation Qualification and Operational qualification protocol.
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The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. It must mandate the production of all Practices and Procedure manuals and SOP's.
The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.
When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities. This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.
During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated