Once again there is great debate in the forums about procedures and GAMP 5. 

I have stated several times the GAMP series of documents is a consensus of opinions from a small selection of individuals employed in the industry.  How well do they cover the whole FDA regulated spectrum from API to radiological?  Well that is hard to be definitive about.    In trying to be all things to all persons they become contentious in certain areas.  These areas of contention are to complex to try and answer in this brief letter.  However we do address them on our site.  Briefly, it is in your own company’s interest to use cGMP’s along with all the associated guidelines to author your own company bespoke practices and procedures documents.  Use GAMP as a guide by all means, however you can tailor and streamline your own procedures to give a much more cost effective solution.    

We continue to be asked about the role of the VMP.

The regulators expect to see no more than two VMP documents in place for any one facility.  That is there will only be two top level validation plans representing how validation has been integrated into all production activities.  These are usually, a standard VMP covering the facility, plus a secondary VMP covering a subject or subjects that may involved differing methodology from the plant in general, such as computers or software, or extensive equipment systems such as Distributive Networks (DCS) or Building Management Systems (BMS).

However when it comes to projects, the situation is rather different.  Validation Plans are used to define scope and document validation requirements, and where equipment or systems have similar validation requirements, a single VP will suffice.  However where the; what, where, why and who, criteria’s are different, more than one VP is required.  When more than one VP is required, then a VMP is required to explain, define and authorize the additional VP’s.  It is therefore quite normal to see major refits and modifications being covered by a VMP.  This does not affect the validity of the main plant VMP.

We give continuous support for all our documentation, and can author any specialized documents you may require.

Vendor Auditing.  This task is also the subject of many inquiries.  Everyone involved in vendor audits must be aware that, they are auditing because it is a regulatory requirement.  They must also be aware of the fact that the outcome of their audit can affect the commercial viability of the audited company.  So it is essential to have a very sound and detailed audit document, and to be aware of the under listed points.

  1.        Your immediate superior must review your completed audit.
  2.        Your manager or director can review your completed audit.
  3.        The regulators can ask to review your completed audit.
  4.        The audited company can contest your audit.
  5.         The auditee can sue if they find audit was not impartial.
  6.        In a worse case, your audit could be the subject of litigation.
From all this you can surmise that the more documented an audit is, the more evidence you have to substantiate the audit conclusions.  The more an audit is based on verbal diatribe the more precarious it becomes.

Please do not hesitate in contacting me if you require further information.