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
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.
of contention are to complex to try and answer in this brief letter.
However we do address them
on our site.
it is in your own company’s interest
to use cGMP’s along with all the associated guidelines to author your
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
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
validation plans representing how validation has been integrated into
production activities. These are usually, a standard VMP
facility, plus a secondary VMP covering a subject or subjects that may
differing methodology from the plant in general, such as computers or
or extensive equipment systems such as Distributive Networks (DCS) or
Management Systems (BMS).
when it comes to projects, the situation is rather
different. Validation Plans are used to define scope and
validation requirements, and where equipment or systems have similar
requirements, a single VP will suffice. However where the;
why and who, criteria’s are different, more than one VP is
more than one VP is required, then a VMP is required to explain, define
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
company. So it is
essential to have a
very sound and detailed audit document, and to be aware of the under
Your immediate superior must review your
manager or director can review your completed
- The regulators can ask to review your
audited company can contest your audit.
The auditee can sue if they find
audit was not
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
more an audit is based on verbal diatribe
the more precarious it becomes.
do not hesitate in contacting me if you require further