News

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

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.