Validation For Sub-Contracting Companies.
are entering into a contract to supply machined parts to a medical device
manufacturer. Do we have to
validate our machine shop?
have no direct requirements from the FDA.
It is the company that uses your facilities and abilities that must
ensure your company practices and procedures (with regard to the subcontract
work) are compliant with all the relevant FDA and cGMP requirements and
guidelines (not withstanding Utah Medical).
it can only be highly beneficial for your company to be able to state that you
operate within the requirements of 21 CFR Part 820 and indeed have been
independently audited for compliance with cGMP and Part 820. It is; at the end of the day, a good and
rigorous QA and QC system. For the
busy procurement manager to find a subcontractor who is compliant is a real-time
bonus. It also greatly enhances his
standing with all the QA/QC staff who are relieved of the unenviable task of
trying to whip a none compliant contracting company into some degree of often
reluctant compliance. Download a
copy of the Part 820 requirement here.
where does one start. In your case
I would start by purchasing from us a Vendor Audit document and executing
against your facility. This will
give you a basic indication of what a major company is ideally looking for in
selecting a subcontracting company.
work (from here on we mean the regulated medical device work) you contract to
execute on behalf of your client must be fully specified and formally documented
in a format that can be reviewed by the regulatory authorities (contract /
specifications / drawings / processes / tests / inspections). Costs and or prices may be obscured or
deleted as required. No loose ends
need to put a Validation Master Plan (VMP) for your facility
in place. This document must
outline (for a visiting auditor/regulator) how you have integrated cGMP into all
your controlled activities. Also details of job title responsibilities, scopes
and organograms. Along with details
of product and personnel ingress/egress flows, drawings and specifications for
all plant facilities/utilities/processes/testing/storage. This is the first document an auditor
will ask for. It is a live document
and must reflect all things to all people.
work must be carried out using approved documented procedures (live controlled SOP’s or method statements
subject to QA/QC control amendment and cancellation). All production and test equipment must
be risk assessed and validated accordingly. (validation automatically includes
calibration, maintenance and many other considerations). All personnel (and contracting
staff) require training records that indicate they are competent for the tasks
they perform (no one is exempt from this requirement not even the CEO).
validation it is essential that time is not wasted on frivolous activities. This is where you must use a Validation
Risk Assessment (VRA) to document your justification for the scope of validation
that you intend to use. The FDA now
requires a written justification for all validation scopes. All process equipment from tumbling
barrels to multi-axis machining centres must be validated. What do you validate; everything and
anything that could affect the quality and or efficacy of the final
mandate that all processes and methods used to produce a regulated product must
be documented and be company approved.
In the majority of cases the end user wants the SOP in hard copy. The original approved SOP will reside in
a safe and secure location in change control (this is a regularly audited
depends on your company practices and procedure (which also must be documented
and approved) as to whether the SOP is in electronic format with or without e
signatures. The security is by
password it one instance and physical security in the other; either way to be
FDA compliant the original approved SOP must be held securely, with controlled
access available to authorised persons only. It is a secure system; with many
approved and serialised copies in circulation and the master, under lock and
key, where would you start to make unauthorised changes?
control must at all times (another regularly audited point) know the location of
all the SOP copies in circulation and must have the capability to be able to
recall them for incorporation of amendments or destruction.
auditor I have audited for these features for many years, I have never found a
case of unauthorised SOP changes. I
have found many cases where the operators failed to follow the SOP. This always puzzles me; why shoot your
self in the foot over something so obvious, but a glance through the warning
letters shows this is still one of the major causes of FDA citations.
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.
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
Purchase your copy of this test script now at Special Price of