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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This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. Resulting in the document becoming notably easier to use and quicker to review and amend. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.
This new 4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the these four protocols and carefully weaving them into one notably easy to use protocol, we have made significant progress in reducing validation paperwork. Reductions of up to 75% have been quoted as the likely total. Integrating the old style DQ/IQ/OQ/PQ protocols into one 4Q document will be an enormous savings in man hours in the authoring, reviewing, updating and approving tasks. With the simultaneous introduction of the new Validation risk & Requirements Plan (VrrP) which integrates the VP, VRA & URS into one document - equipment validation has been reduced to two document.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
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