FDA Warning Letter - Alarm Management

Date: 25 May 11
Link FDA 483 (PDF - New Window)

Observation
b. During routine operations, if there is an alarm event (e.g., time out, high and low temperature for washing and siliconizing, instrument line failure, jacket gauge failure and steam header failure) during the wash and depyrogenation process, the [redacted] Stopper Washer captures the alarm condition via a print out and the data is

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EU Annex 11 - Computer System Inventory

EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory).

This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the

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FDA Warning Letter - Change Control

Date: 25 Aug 11
Link: FDA Warning Letter (New Window)

ObservationThis observation relates to the revalidation following changes of a Cutting and Packing Machine, however it could be applied to any computerised system. 2. Your firm failed to ensure that the automatic, mechanical, or electronic equipment, or other types of equipment including computers or related systems, will perform a function

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FDA Warning Letter - Secure Desktop

ObservationDate: 25 April 11
Link FDA Warning Letter (New Window)
4. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R 211.68(b)].

For example, your firm lacks control of the (b)(4) computer system which monitors equipment,

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Risk Management – A Continuous Process

Introduction
As discussed in previous posts the regulatory expectation is that risk management will be applied to all lifecycle phases of a computerised system. The recent issue of EU Annex 11 includes risk management at all stages of the computer system lifecycle.

GAMP 4 first introduced the concept of risk management and risk assessments and following the issue of the ASTM E52500 Specification

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FDA Warning Letters - Risk Assessments

IntroductionAlthough to date I have not found any references within the FDA warning letters directly relating to computerised systems and risk assessments within the pharmaceutical / biotechnology industry it is interesting to review inspection findings where risk assessments have been detailed.

In this post there is a review of two FDA warning letters which reference the use of documented risk

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Applying Computer System Security (GAMP)

It is a regulatory requirement that access to computerised systems is limited to authorised users. This not only limited to systems that contain electronic records but all systems that are used to fulfil regulated activities.

This post focuses on the FDA and MHRA / EU requirements regulatory requirements for security management of computerised systems within the pharmaceutical and biotech

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