Equipment

The cGMPs are pretty explicit when it comes to equipment used in the manufacturing, holding, and packaging of drugs.

21 CFR 211.67(a) states that equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

In a recently posted warning letter at a compounding pharmacy FDA investigators identified that hoods used in compounding of drug products were not cleaned (observation of a white powder residue in the joints between the plastic front panel, pivot hinges, and between the work surface and the back panel.  Additionally, the FDA investigators observed the firms operator manually filling gelatin capsules using a worn plastic store club card – certainly not appropriate pharmaceutical filling equipment.  Lastly in terms of the equipment citations, the investigators identified a cabinet surrounding the utensil dishwasher was in a poor state of repair, potentially contaminating cleaned utensils.

A review of the FDA Inspections Observations for FY 2016 identified 180 citations per the following distribution:

The top 3 categories of findings attributable to subpart D include:

  • Approximately 46% of the findings were attributed to 21 CFR 211.67(b) – failure to establish and/or follow written procedures for the cleaning and maintenance of equipment.
  • Approximately 36% of the findings were attributed to 21 CFR 211.67(a) – failure to clean, maintain, or sanitize at appropriate intervals to prevent malfunctions and/or contamination that would alter the safety, identify, strength, quality or purity (SISPQ) of the drug product.
  • Finally approximately 7.2% of the findings were attributed to 21 CFR 211.67(c) – failure to keep adequate records for the maintenance, cleaning, sanitizing, and/or inspection of equipment.

A review of FDA Turbo data identifies that there has been a slight increase in the number of equipment related inspection observations from 2006 to 2016:

Have a question about 21 CFR 211.67, Subpart D – Equipment?  Contact Dr. Van Doel, or use PV’s Contact Us form to submit your question.