FDA Warning Letter - Microsoft Excel Spreadsheet

Date: 13 June 2012
Link FDA 483 (New Window)

Observation

5. Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed in the release of drug products [21 C.F.R. 211.68 (a)]

For example, your firm did not verify the accuracy of Excel spreadsheets used to calculate product assay analytical results, for all products manufactured for

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FDA Warning Letter - Raw Data

Date: 23 February 2012
Link FDA 483 (New Window)
Observation4. Your firm has not established 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. Your firm also fails to maintain a backup file of data entered into the computer or related system [21 CFR § 211.68(b)].


For

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FDA Warning Letter - Automated System Validation

Date: 03 February 2012
Link FDA 483 (New Window)
ObservationAlthough this observation does not directly relate to 21CFR211.68 for computerised systems it still has an impact on the validation requirements of an automated system within a tablet manufacturing and packing line.

4. Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to

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Definition of Raw Data

Within EU Chapter 4 – Documentation there is a clear definition of Raw Data and the requirements to retain the raw data.

Records: Provide evidence of various actions taken to demonstrate compliance with instructions, e.g. activities, events, investigations, and in the case of manufactured batches a history of each batch of product, including its distribution. Records include the raw data which

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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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