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Documents required by USA GMP (21CFR211)

March 9, 2012

Dominic Parry

The article covers the requirement of written procedures required by 21 CFR211.  As with the similar blog articles on documents required by EU GMP and ISO 9001 the reader should note that the words “written procedure” are not the same as “procedure”.  The word “procedure” is mentioned many times in GMP, but strictly speaking an activity only needs to be formalised into a controlled document if the words “written procedure” exists.

Here are the 25 times that a written procedure is required by 21CFR211 (1978 version).  Apologies if I have missed any.

  • Section 211.22(d)-Responsibilities and procedures of the quality control unit;
  • Section 211.56(b)-Sanitation procedures
  • Section 211.56(c)-Use of suitable rodenticides, insecticides, fungicides, sanitizing agents;
  • Section 211.67(b)-Cleaning and maintenance of equipment;
  • Section 211.68(a)-Proper performance of automatic, mechanical, and electronic equipment;
  • Section 211.80(a)-Receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers or closures;
  • Section 211.94(d)-Standards or specifications, methods of testing, and methods of cleaning, sterilizing, and processing to remove pyrogenic properties for drug product containers and closures;
  • Section 211.100(a)-Production and process control;
  • Section 211.110(a)-Sampling and testing of in-process materials and drug products;
  • Section 211.113(a)-Prevention of objectionable microorganisms in drug products not required to be sterile;
  • Section 211.113(b)-Prevention of microbiological contamination of drug products purporting to be sterile, including validation of any sterilization process;
  • Section 211.115(a)-System for reprocessing batches that do not conform to standards or specifications, to insure that reprocessed batches conform with all established standards, specifications, and characteristics;
  • Section 211.122(a)-Receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials;
  • Section 211.125(f)-Control procedures for the issuance of labeling;
  • Section 211.130-Packaging and label operations, prevention of mixup and cross contamination, identification and handling of filed drug product containers that are set aside and held in unlabeled condition, and identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch;
  • Section 211.142-Warehousing;
  • Section 211.150-Distribution of drug products;
  • Section 211.160-Laboratory controls;
  • Section 211.165(c)-Testing and release for distribution;
  • Section 211.166(a)-Stability testing;
  • Section 211.167-Special testing requirements;
  • Section 211.180(f)-Notification of responsible officials of investigations, recalls, reports of inspectional observations, and any regulatory actions relating to good manufacturing practice;
  • Section 211.198(a)-Written and oral complaint procedures, including quality involving specifications failures, and serious and unexpected adverse drug experiences;
  • Section 211.204-Holding, testing, and reprocessing of returned drug products; and
  • Section 211.208-Drug product salvaging.

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2 Comments

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  1. Vilma Villalta #
    March 9, 2012

    Where costly fines and severe “punishment” are at stakes, due to failure to comply with regulations, it is not surprising that certain keywords are spelled and emphasized repeatedly. This is something that some mathematicians or physicists find burdensome or even redundant but it makes sense.

  2. March 12, 2012

    Written procedures are not enough. They must be in operation. If you have written procedures but they do not work, during an inspection it will be a finding. You have to prove also in written reports that your procedures are in operation.

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