GMP News - Aseptic / Microbiology

Questions - and answers about Bioburden. A first excerpt of the most important questions during the ECA Bioburden Workshop.

After about 10 years, the EDQM has now published a draft revision of Chapter 2.6.7 on mycoplasma testing, which will be available for comment until the end of June.

In December 2021, the FDA published its long-awaited Draft Guideline on 100% Visual Inspection of Parenterals. Comments were accepted until mid-February 2022. Members of the Advisory Board of the ECA Visual Inspection Group took advantage of this opportunity and submitted numerous comments.

Stainless steel is predominantly used in pharmaceutical equipment engineering. The 316L variant is basically regarded as standard; material incompatibilities of the steel with the product are more or less neglected. This is different with plastics. In addition to leach-out, aging and surface finish, other quality characteristics are often specified. But are there generally applicable requirements for plastics in pharmaceutical equipment engineering?

As a result of the increased demand for disinfectants, especially for hand hygiene, the number of inferior products with deficiencies in composition and/or approval is increasing rapidly. This is accompanied by an increase in Warning Letters from the FDA to disinfectant manufacturers.

In a recent Form 483 issued as part of an FDA inspection conducted at an Indian sterile manufacturer, the FDA criticized the manual visual inspection, among other things.

As part of its Q&A series, the FDA has published a draft guidance on various quality topics, including questions on endotoxin testing.