GMP News - Inspections/Audits

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

In May, the FDA published a Warning Letter to a US American sterile manufacturer of ophthalmic drugs which highlights serious deficiencies, especially in sterile production and in the general understanding of GMP. Read more here.

Due to the deficiencies discovered during an inspection performed in July 2018, the US FDA has now issued a Warning Letter to a US pharmaceutical manufacturer of homeopathic drug products. Microbiological impurities in the products and the water used to manufacture the medicinal products are an essential aspect of the complaint.

The FDA has recently issued another Warning Letter to an US pharmaceutical manufacturer describing serious GMP deficiencies. This concerns among others the water system, the QC laboratory and quality assurance.

The US FDA published its regular inspection report on Human Cell, Tissue and Cell based Products (HCT/Ps), which also includes current data from 2018.

Deviations and CAPA are still hotly debated topics in GMP inspections. This is shown once again by a recent Warning Letter issued by the U.S. FDA.

The EMA has published a new Questions and Answers (Q&A) document on the Mutual Recognition Agreement (MRA) between the EU and the FDA. Read more about the impact of the MRA on regulatory submissions and variations.