FDA 483 - Gland Chemical Private Limited - August 07, 2018

An FDA inspection conducted at Pfizer Healthcare India Private Limited's Waluj facility from July 30 to August 7, 2018, identified six significant observations related to compliance with Good Manufacturing Practices (GMP). The observations primarily concerned the firm's Quality System, Production System, Facilities and Equipment, and Laboratory Controls. Key issues included the Quality Unit's failure to adequately evaluate intermediates and finished Active Pharmaceutical Ingredients (APIs) before release. This involved instances where particle contamination led to reworked batches, which were then released without sufficient validation or justification for the reprocessing procedure. Additionally, in-process materials were stored for extended durations without retesting to assess the impact on quality, and essential stability data was lacking to support API retest or expiry dates for critical attributes like endotoxin and microbiological specifications. Further observations noted deficiencies in production control records, specifically incomplete manufacturing instructions for an intermediate product. Critical equipment used in API production lacked proper operational qualification. In the laboratory, control procedures were found deficient, including the unvalidated re-use of testing vials leading to out-of-specification results, and an inadequate system suitability procedure for HPLC analysis. Pfizer Healthcare India Private Limited is required to respond to these observations, detailing corrective actions taken or planned to address each finding and ensure sustained compliance with regulatory standards.