Are you following your written cleaning procedure?

Establishing written cleaning procedure

According to the Code of Federal Regulations (21 CFR 211.67 Equipment Cleaning and Maintenance), an effective equipment cleaning procedure 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 21CFR 211.180 and 211.182.

A company recently received the following observation:

….. Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Specifically, your firm’s SOP …, “Equipment Cleaning & Sanitation”, is not supported by validation or verification. For example:

a.         The cleaning agents specified in this SOP included …  Your SOP also mentions …, yet you have no water system to produce … and you have no records for the purchase of … from your suppliers.

b.         In practice, … and … were used to clean equipment, and not the … and … specified in your SOP.

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 procedure, refer to the following FDA guidance documents, FDA Presentation: Facilities and Equipment: CGMP Requirements and Questions and Answers on Current Good Manufacturing Practices – Equipment.

To view more observations pertaining to equipment cleaning, refer to the following GMP Trends® Issues: 1096, 1088, 1086, 1085.

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