A company recently received the following observation:
…..Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically, your firm has not validated its cleaning procedures for effectiveness and the ability to minimize the risk of drug product contamination and cross-contamination from different drug products manufactured using the same processing equipment and utensils.
According to the Code of Federal Regulations (21 CFR 211.67 Equipment Cleaning and Maintenance), an effective equipment cleaning program must have the following features:
- All equipment and utensils in the manufacturing, processing, packaging or holding of a drug product shall be cleaned, maintained, and, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination.
- There should be written procedures for cleaning and maintenance of equipment, including utensils. These procedures should include, but are not necessarily limited to, the following: responsibility for the cleaning and maintenance, a schedule of cleaning maintenance. The procedures should have sufficient detail of methods, equipment and materials used for the cleaning and maintenance.
- Records should be kept of the maintenance, cleaning, sanitizing, and inspection as detailed in 21 CFR 211.180 and 211.182.
According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to equipment cleaning (21 CFR 211.67(a), and 21 CFR 211.67(b)) have been in the top 10 observations cited by the FDA each year.
For more information on how to establish and maintain an effective equipment cleaning program, refer to the following FDA guidance documents, Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients issued September 2016 and Questions and Answers on Current Good Manufacturing Practices for Drugs issued March 2018.
For more observations pertaining to manufacturing controls, see our new Issue 1062 available today. It also has observations pertaining to quality systems, sterile manufacturing controls, and medical devices.
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