In a recently posted warning letter, the manufacturer of over-the-counter (OTC) oral rinses and oral moisturizing drug products received a citation concerning 21 CFR 211.42.

The firm used the same manufacturing equipment to manufacture the GMP over-the-counter oral rinses and oral moisturizing drug products and numerous non-pharmaceutical materials (Co-Manufacturing) in your facility, including an industrial car care product, [redacted] polish and sealant.  As noted in the warning letter, the car care product is paraffin-based and labeled as “Harmful or fatal if swallowed” and “Keep out of reach of children.”  Additionally – the company manufactures leather treatments [redacted] Leather Care, [redacted] Leather Lotion) and sealants [redacted] Poly Sealant, using the same mixing tank and filling line used for OTC oral drug products (co-manufacturing).

This firm was also cited for failure to have adequate laboratory testing 21 CFR 211.165b.  As identified in the warning letter the firm released 24 batches of OTC drug products between 2013 and 2015 without performing analyses to assess whether they met all microbiological finished product specifications.

Lastly – the firm was cited for not having an adequate quality control unit 21 CFR 211.22a.  In this case the firm’s oversight of drugs manufactured by the firm, and testing provided by the contract laboratory was inadequate.  The FDA identified the contact testing laboratory had not validated the test method used to detect Burkholderia Cepacia. This inspection occurred in July of 2016.  However, the firm had similar issues identified by FDA in inspections conducted in 2013 and 2016  which only supports the inference that the firm’s quality unit is not adequate.

While a different scenario, the potential for cross contamination between industrial and GMP (co-manufacturing) is documented in the FDA’s Validation of Cleaning Processes (7/93):

One event which increased FDA awareness of the potential for cross contamination due to inadequate procedures was the 1988 recall of a finished drug product, Cholestyramine Resin USP. The bulk pharmaceutical chemical used to produce the product had become contaminated with low levels of intermediates and degradants from the production of agricultural pesticides. The cross-contamination in that case is believed to have been due to the reuse of recovered solvents. The recovered solvents had been contaminated because of a lack of control over the reuse of solvent drums. Drums that had been used to store recovered solvents from a pesticide production process were later used to store recovered solvents used for the resin manufacturing process. The firm did not have adequate controls over these solvent drums, did not do adequate testing of drummed solvents, and did not have validated cleaning procedures for the drums.

Previous Commissioning and Qualification – An Overview
Next cGMPs for Outsourcing Facilities, Draft Rev 2