Sterility Concerns Get Patheon Manufacturing Services a Form 483

May 1, 2015

A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483.

During a Sept. 9 to 12 inspection, investigators found that the firm’s system for cleaning and disinfecting the room and equipment to produce aseptic conditions was deficient. Additionally, the company’s equipment and utensils were not sanitized at appropriate levels to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Investigators observed that thermal paper the company uses in its sterile drug making process is not decontaminated prior to its use in the aseptic core. The outer bag is sanitized, but once inside the core, the thermal paper is placed inside the equipment without being sanitized. Investigators’ discussions with management confirmed the paper is not sterile, and they said the process to prevent the creation of non-viable and viable particles is not adequate.

Sterile Processing

Further, inspectors noticed that aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Methods for the trending of microbiological data are deficient — the procedure does not define what constitutes a negative trend, nor define the interpretation of data, investigators said.

Finally, the FDA observed that appropriate laboratory testing procedures for sterility are not followed.

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