In the world of subjective tests, it can be difficult to investigate when things go wrong or when analysts have a different view of an appearance test. For example: The titrimetric test has an endpoint of blue-green, according to USP. The new analyst obtains an OOS result. The experienced analyst says the endpoint color should […]
Although the FDA’s regulatory requirements for acceptance of vendor test results in lieu of testing is clearly specified in 21 CFR 211.84 for incoming raw materials and container closures, the FDA has not put forth specific regulations for the acceptance of single-use consumables. Biologics manufacturers may use dozens or even hundreds of different single-use consumables […]
The FDA Quality Management Maturity (QMM) program has generated an increased interest in quality culture in the pharmaceutical industry. The Center for Drug Evaluation and Research (CDER) has established a program to encourage manufacturers of drugs (including biologics), with the stated purpose of implementing QMM programs to: Foster a strong quality culture mindset; Recognize establishments […]
Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]
In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]
The FDA guidance “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry” (May 2022) (here) applies to APIs and other raw materials, as well as finished products, but does not address specific considerations for APIs and excipients. Here at Lachman, we work with manufacturers of multiple product types and have the following advice […]
