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.
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,
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.
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.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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.
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.
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.