FACILITIES QUALIFICATION.



Facilities qualification (FQ).

Facilities Qualification validates the overall manufacturing / testing / production environment. The requirement is as usual driven from the product processes. Where the product process calls for specific room condition, as defined in ISO 14644 and was in FS209E, the engineers must design the respective process area to enable these conditions to be achieved and maintained.

Good engineering principles and practice must be used to protect this conditions as required, using the appropriate quality of air filtration, temperature control, humidity control, air flows control, and differential air pressures controls.

All equipment and utilities used in the process area must be listed in the Facilities Qualification, along with reference to the validation documents generated during their qualification.



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Referencing all Standards.

Knowing what standards are acceptable and what is not is the key. Experience shows that the more referenced your protocols are, they better they are for execution. When you allow authors to insert unreferenced and unqualified inspections into documents such as; DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP , then you are close to being out of control.

Validation authors are there to raise protocols to verify that equipment is install, in accordance with an engineering drawing. They must use the drawing and should not call up any inspections that are nor referenced on the drawing. This way the drawing is the top document. You want to change the installation - you change the drawing - the authority to change the drawing comes through change control. When you allow authors to call up tests and inspection they think are correct, you are heading for anarchy and regulatory problems. All testing on protocols must show the authority for the test,

  • The drawing reference.
  • The cGMP reference.
  • The VMP reference.
  • The URS reference.


Just instructing authors of these facts is often sufficient to make them realize that they are not designing the equipment, a lot of thought went into the design, at the design stage. These thoughts and the resulting design specification were more than likely the subject of many peer reviews and finally company approval. They can not be altered without going through change control.


Validation Protocol Packages

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. 

After due diligence is used to review the current Good Manufacturing Practice (cGMP) legislation (21 CFR Part 11/210/211/820) along with the FDA guidance documents (not mandatory but probably advisable) it becomes rather obvious why there is cascade of documentation and why each document in this cascade is obligatory.

At this stage it becomes patently obvious that the suite of documents we produce is exactly what the regulators expect to find already in place.  These documents sequentially cascade from the URS through VRA, DQ, IQ, OQ, P1Q and finish with the P2Q.  This progression is of the utmost importance since the documents are inter-referenced and must be executed sequentially.  This is one of the main reasons why it is important that the documents are designed and written as a package.  A package that will have the correct sequential and chronological sequences authored in across all the relevant documents.


FACILITIES QUALIFICATION.



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

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 validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template 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; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation 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 Protocol. 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 medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the 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.



Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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Validation Master Plan (Issue 7) -- $115.00

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols and is a great document to author and use. This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Documentation Matrix (Issue 6.) -- $29.00

This Matrix must sit along-side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to all the associated documents; the A to D prefix shows the progress stage.

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