Fundamental GMP Deficiencies at Disinfectant Manufacturer

The FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptic and hand sanitizer in Puerto Rico due to numerous and fundamental GMP deficiencies.

The FDA objected that the above pharmaceutical products are manufactured with the same equipment as non-pharmaceutical products such as industrial cleaning products. It is unacceptable to the FDA that pharmaceuticals are manufactured with the same equipment as is used to manufacture non-pharmaceutical products. The risk of cross-contamination is unacceptable.

Furthermore, the FDA regarded the cleaning procedures as inadequate. The manufacturer cannot demonstrate that the cleaning procedures are adequate to clean the equipment in a reproducible and effective manner. In addition, the drug production and storage areas were found to be in a non-clean condition and the filling equipment was found to be dirty.

Other deficiencies outlined by the FDA in the Warning Letter include the lack of validation of the water system and the lack of process validation of the manufacturing processes.

Finally, the FDA criticises the manufacturer's quality organisation. According to the FDA, this organisation failed to fulfil its responsibility to ensure that the manufactured products comply with the cGMP requirements and meet the established specifications for identity, strength, quality and purity. For example, the lack of incoming inspection of ingredients, the lack of a stability programme, inadequate training of employees in manufacturing and packaging, lack of procedures for processing OOS results, preparation of annual product evaluations, change control, etc. are cited.

 On the FDA website you can find the original Warning Letter issued to Gascó Industrial Corporation.