FDA Issues Warning Letter to German API Manufacturer
FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.
FDA issued a warning letter to BBT Biotech GMBH, a Germany-based API manufacturer. The warning letter, issued on May 16, 2016, cited the company for failing to comply with current good manufacturing practice for APIs.
During inspection of the facility, FDA inspectors determined the company failed to follow a documented on-going stability testing program to monitor the stability characteristics of APIs. FDA also cited the company for failure to follow a change management system in order to evaluate any changes that could affect the production and control of manufactured APIs. This could affect the product’s quality, FDA said in the letter.
According to FDA, BBT Biotech GMBH also failed to investigate out-of-specification results. The company neglected to exercise control over computer systems. While inspecting the facility, FDA found that multiple employees had been sharing one username, which prevented the company from tracing online actions to specific employees.
Source: FDA
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
