GMP News

A set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).

The Japanese Pharnacopoe has published a new chapter draft of "Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay" for comment.

A complete revision of Ph. Eur. chapter 2.4.20. Determination of elemental impurities has been published in Pharmeuropa.

In June 2018, when it became known that the antihypertensive medicinal product Valsartan contained nitrosamines, no one had any idea how widespread these unwanted side-products were. Read more here to find out what action the EMA and EDQM have taken in the past and in response to the latest cases of nitrosamine contamination.

In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

The FDA has published a final guideline for non-clinical studies of "Oncology Therapeutic Radiopharmaceuticals" to close the gaps in the existing FDA and ICH Guidelines.

Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

The European GDP Association, representing more than 2.000 professionals from across the globe, has nominated Prabjeet Dulai as Director Regulatory Affairs and Communication.

The United States Pharmacopeia (USP) is currently introducing various chapters and stimuli articles. Some of these are also relevant for storage and transport activities.

Again the US-American FDA has issued a Warning Letter which primarily describes defects in the water system as well as deficiencies in the handling of CAPA & OOS and in the cleaning.

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.