GMP News - Inspections/Audits


How to prepare for Russian Inspections

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



Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and Other Deficiencies

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.



MRA Countdown: 10, 6, 4, 2, ...

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.



Warning Letter for Sterile Manufacturer of Ophthalmic Drugs in the US

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.



Fundamental GMP defects at manufacturer of homeopathic drugs

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs for human and veterinary use.



Numerous GMP Deviations found at US Manufacturing Site

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.



MRA EU - FDA has approved two more countries

With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.



FDA Warning Letter: GMP Deficiencies at US Pharma Manufacturer, e.g. in Water System

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.



FDA issues Warning Letter to Manufacturer of Human Cells, Tissue or Cell based Products

The FDA has published a Warning Letter to a manufacturer of umbilical cord blood products for therapeutic use in humans due to deficiencies in the classification and manufacture of the products.



FDA publishes Inspection Report for Cells, Tissues and Cell Products

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.



Warning Letter for US Contract Manufacturer: Cleaning, Contamination Control and Stability Studies criticised

In March, the American authority FDA issued a Warning Letter to a US pharmaceutical manufacturer due to numerous violations of GMP. Among other things, inadequate cleaning of the equipment, errors in the stability studies as well as in contamination control were found.



Inadequate CAPAs lead to FDA Warning Letter

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.



US FDA Warning Letters for inadequate Batch Records

The U.S. FDA posted new Warning Letters to pharmaceutical companies which ignored basic GMP principles.



Current Q&A on the MRA EU-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.



Warning Letter: FDA criticises Supplier Qualification

The full programme is part of a recent FDA Warning Letter, which the FDA sent to a manufacturer in the US only in February: Supplier Qualification, contract management, release procedure.


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