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European Pharmaceutical Contractor
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European pharmaceutical companies wishing to supply the US market are regulated by the US Food and Drug Administration (FDA). There has been a 10-year dialogue between the FDA and global drug manufacturers about the acceptance of and mechanisms for implementing validated electronic signatures to replace manual sign-off throughout the drug development and manufacturing process. This article reflects on the practical impact on European pharmaceutical companies of the regulation finally agreed between the FDA and the industry, affectionately known to all as 21 CFR Part 11.
Modern LIMS to Help Support 21 CFR Part 11
In the early 1990s, members of the pharmaceutical industry met with the US Department of Health and Human Services and the Food and Drug Association (FDA) to determine how a paperless record system could be accommodated under the current Good Manufacturing Practice (GMP) regulations. In March 1997, after a six-year iterative development process with the industry, the FDA issued the final rule. Following a five-month grace period, the rule became effective on 20th August 1997.
The rule sets forth the criteria under which the FDA considers electronic records and electronic signatures to be equivalent to paper records and handwritten signatures. The rule is an extension to the predicate rules for GXPs - GLP: 21 CFR 58 for laboratories; GMP: 21 CFR 211 for manufacturing; 21 CFR 820 for medical devices; and GCP: 21 CFR 320 for clinical environments. 21 CFR Part 11, the FDA's final rule on using electronic records and electronic signatures, affects all pharmaceutical companies in Europe that sell products in the US. Even for those who do not sell within the US now, this regulation is still very important because in the near future all regulatory authorities will be working according to a similar standard.
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