GMP News - Inspections/Audits

From September 26 to September 29 the US FDA published four Warning Letters. One company is located in China and the other three are based in Europe. Read more about the four FDA Warning Letters

It has been a hot inspection summer. FDA Warning Letters and EU Non-Compliance Reports seem to increase at the moment. It is worrying that the GMP non-compliance issues apparently get more serious than in the past. But what is the reason for the increasing GMP non-compliances?

Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.

Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.

Various competent authorities are performing inspections. But who is subject to such an inspection?

Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for qualifying suppliers?

In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Read more about the compliance actions taken against Polydrug.