FDA COMPLIANT DOCUMENTATION
FDA Compliant Quality Manual.
The Corporate Quality Manual is the start of all compliant documentation. The policies container in it, dictate what documents must be raised and details the scopes and responsibilities in raising, approving and executing them. Here our CQM goes a great deal further, in containing interactive downloadable templates for,
Validation Master Plan (VMP),
Design Qualification (DQ),
Installation Qualification (IQ),
Operational Qualification (OQ),
Performance Qualification (PQ), User Requirements Specification (URS), and many more documents, all of which are compliant with Good Manufacturing Procedures GMP, GAMP 4, Food and Drug Authority (FDA) and Medicines and Healthcare Regulatory Agency
(MHRA), rules and regulations.
Authoring and publishing a Corporate Validation Manual is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing.
Our FDA Compliant, manual preface is constructed in the format of an Standard Operation Procedure - SOP - as an SOP. This SOP takes you through the simple stage of populating the Corporate Validation Manual. This standard manual is now your new company bespoke manual.
If you have a validation requirement, then make certain the validation flow of documements is complete and thorough. Validation documentation should cascade chronologically from the URS to the PQ.
VP – URS – DQ - VRA – IQ – OQ – PQ,
for equipment systems "
The Wall Street Journal published an article informing all; that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were still not being achieved.
Computer System Validation - CSV - encompasses the largest range of validation tasks that the validation specialist has to cope with. Ranging from relatively simple data loggers up to facility wide Distributive Control Systems - DCS -, the variation in complexity, is at times, challenging. Very often you are dealing with new or extended programs, leading to glitches in the field, and vendor fixes. What a horrible word that is – Vendor Fixes. Then of course you get vendor fixes for vendor fixes, then you arrive at the state that the vendor looses control, of what fix is where. Result one - 8000 i/o system, 9 months late, result two - 18,000 i/o system 16 months late. The next requirement was for a green field site in Asia, a 25,000 expandable to 35,000 i/o point system. We decided it was essential to audit the vendor (yes eventually). The audit (the same VA document that is available from Validation Online) revealed a whole host of digressions from the software design life cycle advocated by the FDA and other quality organizations. It became obvious why their software was so disconnected. It was also very apparent that if you wanted trouble free software, then planning and open management of software design, were the most important phases of the whole software production cycle. The development and execution of a quality DQ, prior to commencement of coding was the paramount feature found missing in our audit. There were many things missing, but most of these would have been caught, directly or indirectly, if the DQ had been properly authored and executed.
So FDA Compliant along with Validation Online has authored a very detailed Computer Validation Master Plan, a document that although subservient to the site VMP, takes it’s place along side, the site VMP. It details all aspects of the company’s validation of computers. To complement this document, Computer Installation Qualification (CSV-IQ) and Computer Operational Qualification (CSV-OQ) are also available from the site. To cater for the smaller systems a combined computer IQ and OQ has been produced, the CSV-IO/OQ. Thsse are fully referenced, interactive formated documents, which at the IQ stage verifies whether 21 CFR Part 11 is applicable to the equipment/system, and if it it is, at the OQ stage has all the test scripts built in to verify compliance with the requirement.
All regulatory required FDA Compliant documentation must be carefully prepared, with statements worded to preclude ambiguous and incorrect interpretations of the purpose
of the statement. In addition there are quite separate 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 driven by evidence that the industry is failing to match the standards set by other regulated industries.
FDA Compliant, and Validation Online, have designed unique interactive documents for all validation activities such as
VMP, URS, IQ, OQ, PQ, and many others. These documents have all been designed to be cGMP,
compliant, along with incorporating the structures the regulators look for. These documents are realistically priced to ensure it is much more cost effective for companies to download documents as they require them, than individually author them.
FDA Compliant, have an existing data base of many hundreds of protocols written for a bewildering range of equipment, facilities and utilities.
Autoclave, Autoclaves cat 3 & 4, freeze dryers, mixers, tabletizers, blast freezers, cryogenic freezers, fillers, bottle washers, ovens, isolators, laminar flow systems, particle count, pure water, WFI, clean steam, foil presses, packing machines, refrigerators, low humidity dryers, nitrogen, storage & use, oxygen storage & use, carbon dioxide storage & use, micronizers, laboratory equipment, filter integrity testers, HVAC, Category 4 HVAC systems, Incubator, Clean rooms to all ISO 14644 standards, and many, many more protocols for production and laboratory use.
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This definitive manual arrives with you in DVD format, complete with a search facility that enables you at any time to have the benefit of over thirty years of validation experience and wisdom, right beside you. Enabling you to access references, instantly down load test scripts, and above all, have access to the best FDA Compliant document templates available anywhere.
If you have background knowledge in pharmaceuticals and are reasonably competent, the Definitive Validation Manual will do the rest for you. If you are in the Pharmaceutical / Biotechnological / API / Medical Device, industries or whether your in any of the engineering streams that are involved with these industries, the Definitive Validation Manual will enable you to:-
- Get started in pharmaceutical validation.
- Gain promotion in the industry.
- Become dual skilled.
- Get into the highest paid section of the industry.
The cost of the FDA Compliant, Definitive Validation Manual, will be recouped in the first few weeks, it will then go on to show a massive return on your original investment.