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GMP non-compliance observed by MHRA at two US sites for Pharmaceutics International Inc.

The Medicines and Health Care products Regulatory Agency (MHRA) has observed critical deficiencies at US based contract manufacturing organization Pharmaceutics International, Inc. for two of its Maryland facilities (Hunt Valley, Maryland and Cockeysville, Maryland).

GMP violations observed as outlined in the reports of non-compliance published to the European Medicine Agency’s (EMA) Eudra GMP database are as detailed below:

• Inspectors identified a "failure of organizational and technical measures to minimize the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment”. • Inspectors also identified failure of the quality unit to ensure the effective operation of the quality system," at both sites during inspections. • The sites displayed a "gross failure of change management," by using an "unqualified" high-performance liquid chromatography system, and an employing an "unacceptable approach to production equipment qualification. • Organizational data governance failures relating to the generation and checking of analytical data obtained from electronic systems and inadequate investigation into previous data integrity failures. • Deficiencies in sterilization and depyrogenation processes • Insufficient control of aseptic operations to provide the required level of sterility assurance

As a result of the above deficiencies MHRA has withdrawn Pharmaceutics International, Inc Good Manufacturing Practice Certificate (GMP). The agency has also recommended a recall of products made at both facilities including investigational products used in clinical trials, "where market alternatives and medical criticality permits." Batches of products from both sites will be banned from the EU, until the statements of non-compliance are removed.



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