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 issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.
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 british MHRA is currently publishing a series of blog posts discussing the theft of medicines and the risk to public health.
The United States Pharmacopeia (USP) is currently introducing various chapters and stimuli articles. Some of these are also relevant for storage and transport activities.
The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.
Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).
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.
In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.