Citations; even for simple things can be very costly.

Whether these companies are poorly managed or just feel they are doing sufficient to keep the regulators satisfied is a mystery to us.  For over twenty years we have faced regulatory inspection; most scheduled; several snap (unscheduled) inspections, and long ago it became obvious that the cheapest and most expedient policy was to ensure all your systems were set up in accordance with regulatory expectations, and to set up  strong audit teams to ensure every department adhered (continually) to these company approved and documented regimes’.

Satisfying regulatory citations requires a considerable investment in costs and time, and that is the problem, it is not an investment.  It is a complete waste of company resources.  We have reproduced (below) some of this month’s batch of problems from warning letters.  It really is alarming that there are sections of the industry that are so blasé about regulatory requirements and cGMP.

If we consider the company that did not validate their Calibration Management System; well now they have to validate it.  However where will the regulators stop?  Will they apply their normal interpretation ‘that any process performed using none validated systems or processes is considered to be ‘adultered’.  In that case all adultered calibrations will have to be repeated.  However you cannot ignore the fact that product was produce while these systems were out of calibration;  Might they also consider the product ‘adultered’?

It is likely that the very least that would be required is a complete review of the product produced, and an analysis of possible deviations that the adulteration could produce.  The very worst case could lead to a product recall.  

At this stage the original cost or inconvenience of validating the Calibration Management System must surely appear completely insignificant.

Same Old ! Same Old !

1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50(b).

3. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints as required by 21 CFR 820.198(a).

3. The (b)(4) Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.


5. Schedules for the adjustment, cleaning, and other maintenance of equipment were not adequately established, per 21 CFR 820.70(g)(1). For example, your Preventative Maintenance Program procedure, PMP-WI001, requires maintenance records to be maintained for five years; however, your firm was only able to produce records for two years,


8. Procedures for corrective and preventive actions have not been adequately established per 21 CFR 820.100(a). Specifically, your Corrective and Preventive Action procedure, SLP-15, Revision 2, fails to include several of the provisions listed in 21 CFR 820.100(a) such as:

1. Failure to establish and maintain adequate procedures to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved, as required by 21 CFR 820.75(a).

2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device and that all activities required under this section and their results be documented, as required by 21 CFR 820.100(a)(4) and (b).

This Months Fast Moving Documents.

Software Validation SOP (Issue-2) -- $22.00


Software Validation Master Plan (issue-2) -- $115.00

Software Validation Risk Assessment (Issue 2) -- $125.00

Software User Requirements Specification. (Issue 2) -- $115.00

Software Validation Plan (Issue 2) -- $89.00

Software Design Qualification. (Issue 2) -- $89.00

Software Installation Qualification. (Issue 2) -- $89.00


Software Operational Qualification. (Issue 2) -- $89.00

Software Performance Qualification. (Issue 2) -- $89.00

Software Validation Package (Issue 1) -- $699.00

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.

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.
Purchase your copy now at Special Price of $ 22.00.