FDA and Personal Accountability.

We have encountered many companies that claimed that they operated a ‘no blame culture’, where employee regulatory compliance is questioned.  They in their infinite wisdom seemed to think this was perfectly acceptable.  The harsh facts are that the regulators expect everyone to be accountable for their respective actions and are quite prepared (after due legal process) to demand custodial sentences for serious infringements.  We have on several occasions had to edit client policy documents (in the light of regulatory comments) to reflect that certain regulatory infringements by staff, would no longer be considered as minor mistakes and would carry more severe penalties; such as employment termination and accountability assessment.  Below is an extract from an FDA document regarding CAPA compliance; it is informative to note how often they refer to the individual’s responsibility and accountability.        

 Content of the Corrective Action Operating Plan (CAPA) - The corrective action operating plan should include:

v      An analysis of the audit findings, including an analysis of-all identified instances of wrongful acts associated with applications submitted to FDA, identification all individuals who were or may have been associated with or involved in the wrongful acts, and identification of defective practices, procedures, products, and applications;

v      The disposition of any recommendations made by the consultant;

v      A description of the actions taken and to be taken to achieve correction of fraud and other wrongful acts or deficiencies identified by FDA and discovered by the internal review;

v      A timetable for implementation of the corrective actions;

v      Identification of the persons responsible for taking and assuring the satisfactory completion of each of the corrective actions according to timeframes;

v      A comprehensive ethics program that describes standards for employees and procedures for educating employees about the program and for enforcing the program; and

v      The procedures for monitoring the effectiveness of the operating plan and to assure that the applicant can be expected to manufacture products in compliance with current good manufacturing practices and application requirements.

In addition, the corrective action operating plan should establish a mechanism for assuring that supervisory, technical, and scientific employees are made aware of the requirements of the Federal Food, Drug, and Cosmetic Act in their area of responsibility, as well as the requirements under 18 USC 1001.

SOP Security.

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.

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The SOP for Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
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