Chemical Industry response to 21 CFR Part 11 changes

I was going to complain about how slow the chemical industry has been in reporting significant changes to the FDA interpretation of the 21 CFR Part 11 rules on Electronic Records and Electronic Signatures in FDA-mandated activities. The agency has recinded all current guidance on the Rule and has issued a new draft guidance that is due for final ruling soon.

It turns out that there has been relatively little in the mainstream Chem Eng outlets at all. This may reflect the relatively small numbers of chemical engineers employed in the pharmaceutical industry compared to the number of chemists. Or it could be that there are better outlets for pharmaceutical-specific interests.

My father, also a chemical engineer, just mentioned seeing a reference to the rule in a trade publication, and then I received the May 2003 Chemical Engineering Progress, which also had commentary on the changes to the rule (register to read). The new guidance was issued in February 2003. C&E News, which has a much wider distribution, did have an article about a month after the FDA recalled all guidances with respect to 21 CFR Part 11 and issued a new draft guidance: C&EN: BUSINESS - FDA RECONSIDERS ELECTRONIC FILING

The Food & Drug Administration last month proposed curtailing enforcement of a rule regulating electronic filing of records and data by pharmaceutical manufacturers. The agency said confusion over the scope of the rule, 21 CFR Part 11, and concern about the cost of compliance is forcing it to review the rule and possibly to revise it.

The WWW Virtual Library on Chemical Engineering has an excellent, but old, list of periodicals, if you are curious for more.

2 Comment(s)

Kazm said:

ChemiSearch.com is the world largest chemical industry search engine.

chemical engineering professionals are very similar to pharmacist.these professionals problem is very frequent ..for this the step taken by FDA interpretation of the 21 CFR Part 11 rules on Electronic Records and Electronic Signatures in FDA is not so unrealistic...so far all will be benfited from it......however thanks for your very useful view.....

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This entry was published on May 20, 2003 12:51 PM and has 2 comment(s).

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