FDA 483 - Apitoria Pharma Private Limited - October 25, 2016

This FDA Form 483 document outlines observations made during an inspection regarding inadequate validation of equipment cleaning procedures. The facility's operations involve manufacturing products that require specific cleaning protocols.

The primary violation noted is that equipment cleaning validation studies do not adequately support a validated holding period for dirty equipment before cleaning. Specifically, SOP AQA-020, effective January 20, 2016, requires establishing a (b)(4) holding period through three acceptable cleaning runs, but this has not been performed for all product-specific equipment trains. Consequently, current cleaning procedures rely on an unvalidated (b)(4) holding period.

Furthermore, equipment cleaning validation procedures are deficient as they do not include testing for the efficacy of bioburden or endotoxin removal. This is a critical finding for equipment trains used to manufacture products with bioburden or endotoxin specifications, indicating a potential risk to product quality and patient safety. The observations highlight deficiencies in the facility's quality system and manufacturing controls related to cleaning validation.