Do your batch records have all the required information?

According to 21 CFR 211.186 and 21 CFR 211.188,  mater production records must be prepared for each drug product to assure uniformity from batch to batch. Batch records must include:

  • Identity of individual major equipment and lines used.
  • Identification of each component, in-process material, container or closures used including their lot number and quantity.
  • Any sampling and any laboratory results
  • Inspection of the packaging and labeling area before and after use.
  • Label control records including copies of labels used.
  • Identification of the person performing or checking each significant step and the date.
  • Any investigations made.

A company recently received the following observation:

….. Batch production and control records do not include complete information relating to the production and control of each batch.


a.         The batch production records failed to include the distinctive identification of the raw material used in the manufacturing of a drug product. There is no raw material inventory card maintained by the firm for traceability.

b.         The amount of raw materials and excipients added to the batch is not verified by a second person.

c.         The batch record does not contain manufacturing and control instructions or sampling and testing procedures.

d.         No batch records include a copy of the finished product label.

e.         They do not include the description of the drug product containers and closures used in the packaging process.

f.          There are no packaging records being maintained.

To view more observations pertaining to review of batch records, refer to the following GMP Trends® Issues: 1113, 1102, 1088, 1086.

For more observations pertaining to manufacturing controls, see our new Issue 1118 available today.  It also has observations pertaining to quality systems, laboratory controls, and medical devices.

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