There is a heated debate in the forums about the responsibility of outside consultants when they prepare validation protocols for a client. Is the consultants legal responsibility for the accuracy, safety and compliance of the protocol to requirements, abdicated as soon as the client approves the protocols?

Unless they are pretty inexperienced the approvers for regulatory required documents will not approve protocols and other such documents carte blanche.

The (acceptable) minimum signatories are usually the author, the owner, the engineering manager and quality assurance manager. Many companies use a whole parcel of signatories, however here for simplicity we will stick to a format that is very widely used in the industry.

If we then assume that the equipment or process being validated is a mix of electronics / instruments / software / fluidics and compressed gases, do you honestly think that all these proposed document reviewers and or approvers have the technical and practical knowledge to approve the protocols, per se.

If you believe that they should, then, you are not compliant with GMP’s, which proclaim you must be suitably qualified to for all of the GMP tasks you execute. So the text in the signatory approval box is different for each signatory and highlights exactly what they are approving. I.E. the QA may be certifying that the document conforms to all the requirements for such a document given in the company quality manual.

As a validation consultant it is not unusual to find yourself working with company that has only a minimal degree of engineering support (shift fitters and a maintenance manger). So as the consultant in engineering matters the buck stops at you. If you have to bring in, a specialists to assist you; then let us hope your contract division has budgeted for these costs within the contract, as you can expect no profession assistance from your client.

So the consultant remains responsible for the technical aspects of the documentation they were commissioned to produce.

A recent warning letter demonstrates just how few companies use a Gap Analysis to validate that they are compliant. CAPA discrepancies continue to be the biggest single source of problems. However the daddy of them all recently has been a well known company that had carefully documented the levels of experience and educational standards required for various GMP sensitive roles (In accordance with GMP), only for the FDA to find the persons in these jobs were not qualified properly. (click here to read)

Do use a Gap Analysis and avoid these embarrassing events. Gap Analysis Tool (Issue 2.) -- $115.00


Validation Risk Assessment (Issue10.) -- $125.00

This popular Validation Risk Assessment (VRA) has now been edited and enlarged to include Part 11 assessment tables for you to use in classifying which of your predicate records require to be stored in compliance with 21 Part 11, and which do not. It also includes an Excel spreadsheet to allow you to establish a permanent record of all such judgements, as is now mandated by the regulatory authorities.


Combined IQ / OQ Protocol.
New from Validation Online a Combined almost ready to use; IQ-OQ protocol. Designed to cover equipment in general and specifically laboratory type equipment, with or without embedded or programmable software. This is not a list of chapter headings. It is a fully detailed interactive IQ and OQ protocol.

Combined_IQ-OQ_Issue-1 -- $125.00

Are you ready for an inspection?

With HEPA filters, the manufacturers recommended dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download.  Regulators ask to review your writen justification for these filter change PD's; make certain you have them.

Purchase your copy of this test script now at Special Price of $22.00.

The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $22.00.