The FDA Quality Plan must start with Primary Requirements (PR). However these PR’s inevitably will have Support Requirements (SR) and further along the line Ancillary Requirements (AR). It is essential that all these requirements are identified as early in the procurement stage as is possible. Failure to identify and consequently not provision for; SR’s and ER’s, has and still is one of the main causes of validation program delays and cost overruns. We always recommend that companies involved in URS authoring develop their own exhaustive check list of all possible SR’s and AR’s. This check list can then be used by all persons involved in authoring FDA Quality Plan and User Requirements Specification documents; as an infallible aid de memoir.
The Validation task ends with the PQ; which is required to verify that all the requirements as detailed in the URS have been challenged, inspected and or tested in accordance with and results obtained confirm complete compliance with their respective documented acceptance criteria.
(i.e. no URS; equates to no content for your PQ = flawed validation). In between are the FDA Quality Plan (Validation Plan) (VP or QP), Validation Risk Assessment (VRA) and the Design Qualification (DQ). The regulatory authorities require these documents to be in place with the dates for content approval and execution of running consecutively.
The devil is in the detail: The User Requirements Specification (URS) must be fully detailed and include all aspects of procurement; such as usage, maintainability, calibration, cleaning, utility requirements, facility requirements, user training, support documentation, support engineering drawings, software programs and all the attendant SOP’s that are required in the execution of the these and all other GMP specified tasks. There must be no surprises or shocks when the machine / software arrives, all requirements (yes even the most obscure details) must be anticipated and engineered for.
If you tackle the URS in a professional manor with your colleague’s and peers, you should develop a sound company reviewed and approved document that will guide, develop and produce a comprehensive User Requirements Specification (URS); that will prove to be worth its weight in gold.
The FDA Quality Plan
have stated that over 70% of validation problems stem from the procurement not being properly detailed and or managed. Get the URS correct and you are well set to execute your validation task smoothly, compliantly, on time and on cost. The execution of your VRA defines and authorizes your whole approach to the validation of any software used in the or system undergoing qualification. Software used in this type of equipment can normally be validated by testing its functionality against the requirements documented in the URS document along with verification that the software was developed using an approved FDA quality plan appropriate for the GMP requirements for this class of software.
It must be getting rather obvious now that the documentation required for compliant validation does indeed form a chain, with each link firmly supported by the previous link and forming a sound footing for the next link in the progress towards qualification.
The FDA Quality Plan is defined in the manual which 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 Quality Plan document templates available anywhere.
If you have background knowledge in pharmaceuticals and are reasonably competent, the Definitive Validation Requirements Manual will do the rest for you by detailing all validation requirements. 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 Requirements Manual, will be recouped in the first few weeks, it will then go on to show a massive return on your original investment. An investment that you will never ever regret.
June 2015, The FDA is to Create a New Drug Quality Office: The agency said the new office will publish a 'dashboard' of quality findings that will show the range of metrics, good and bad, achieved by the industry.........In September 2003, 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 FDA quality plan problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were still not being achieved.
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. 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 Risk Mitigation in Validation template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.