Validation For Sub-Contracting Companies.
We are entering into a contract to supply machined parts to a medical device manufacturer. Do we have to validate our machine shop?
You 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).
However 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.
So 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.
The 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 are permissible.
You 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.
All 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).
In 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 product.
The FDA 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 requirement).
It really 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?
Change 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.
As an 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 them.
Purchase your copy of this test script now at Special Price of $16.00.