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| home > epc > summer 2003 > 21 cfr part 11 - gamp risk assessment methodology for delivering compliance measures |
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European Pharmaceutical Contractor
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Computer systems validation in general, and the FDA's ruling on electronic records and electronic signatures (1) in particular, have been a major source of concern for the pharmaceutical industry for a number of years. In February 2003 the FDA introduced new draft guidance (2) that signaled a significant development in the agency's thinking. This new thinking picks up on the themes of the FDA's major initiative announced in August 2002 Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach (3). Importantly, the new draft guidance recommends the use of risk assessment techniques across several key aspects of 21 CFR Part 11, however the guidance itself does not offer any help on how to conduct risk assessment.
This paper builds on the author's recent experiences in using risk assessment as a vehicle for delivering compliance measures in line with the new draft guidance on 21 CFR Part 11. An example of a preclinical safety in vitro experiment system is used to illustrate how the GAMP risk assessment method may be applied.
The New Draft Guidance
The new draft guidance states that the agency has decided to "re-examine Part 11" and that as a consequence of this re-examination, they may "revise provisions of that regulation". The new draft guidance then sets out the FDA's intent to use discretion in their enforcement in order to "avoid unnecessary expenditures of resources to comply with Part 11 requirements that may be revised through a rulemaking". One key theme of the new draft guidance is risk management. Specifically, the FDA recommends the use of risk management to drive the following decisions:
The extent of validation required (lines 207-210), to meet the intent of 21 CFR Part 11.10(a) u Whether to use audit trails or other appropriate controls (lines 227-230) in order to meet the intent of 21 CFR Part 11.10(e)
The means by which electronic records will be retained (lines 271-273) in order to meet the intent of 21 CFR Part 11.10(c).
The other key theme of the new draft guidance is a re-emphasis of the predicate rules. It mentions the predicate rules no less than 27 times in only five pages of guidance. Through its comments and examples, the new draft guidance ably illustrates that many of the principles of 21 CFR Part 11 were already well established within the predicate rules, and that these rules also give useful guidance on reasonable interpretation of the demands of Part 11.
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