GMP Violations and Citations.
As this year draws to near its ending it is sad, frustrating and worrisome to read an FDA Warning Letter (WL) that cited a company for using a Design Qualification (DQ) protocol in which 75% of the test scripts had no Summation of Test Results. How is it possible for a company to produce a protocol that is so appallingly inadequate? A DQ is subjected to several peer reviews and in its final acceptable form; review and sign off by management. Click here (its free) and ensure your test scripts are formatted correctly.
It is shocking to see companies shooting themselves in the foot as above, but the next WL not only proves that it happens all the time, but also shows the enormity of it. This WL concerns a company carrying out EO sterilization of regulated product for third parties. Their obvious total disregard of the cGMP requirements means that all the sterilizations they contracted to do, have been categorized as ‘Adultered’. The enormity of this is absolutely staggering since the product so categorized; has all been consumed and or applied and or implanted. Do you use subcontracting companies? If so; do you have a completed approved Vendor Audit document that verifies their cGMP status and will it stand up to regulatory inspection and perhaps even judicial judgement?
This current year has seen us introduce several new documents and document packages. The most popular new documents haves undoubtedly been the combined IQ-OQ-PQ protocol and SOP for equipment, followed very closely by the IQ-OQ-PQ protocol and SOP for computers. These documents have been supplied to customers in 22 different countries and to circa 60% of the multinationals. As a trial we soon be offering these documents not only through our normal PayPal payment process; but also using Google Checkout. If Google appears popular we will offer it as an alternative on all sales. In the meantime if you want to make a purchase and can’t or don’t want to use PayPal, please CLICK IN BOX BELOW and lets us know how we can assist.
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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.