20/21 November 2019
The British Medicines Authority MHRA has issued a GMP Non-Compliance Report for Yung Shin Pharmaceutical Ind Co Ltd in Taiwan. The company manufactures sterile products. The inspection was triggered by a DCP submission. So far, no product from this site has been marketed in the EU. During the inspection, a lack of GMP control of moist heat sterilisation processes was identified. The wide-ranging problems include both the validation and the technical implementation with regard to the equipment.
Besides, the Spanish Authority has also published a GMP Non-Compliance Report for RENOWN PHARMACEUTICALS PVT. LTD. in India. It was the first inspection of the site which intended to manufacture products for the EU market. The inspection was triggered by a marketing authorisation filed in Ireland. As the batch release should have been performed in Spain, the Spanish Authority was responsible. Critical GMP deficiencies were observed like for example "Defective performance of cleaning", "Inappropriate validation of cleaning procedures", "Failures in line clearance", as well as "Lack of mechanisms to ensure integrity of analytical data". It seems that some data have been changed subsequently. Data integrity problems keep on being identified by EU and FDA in India.
A GMP Non-Compliance Report has also come from the Bulgarian Authority for VETPROM AD. Here again, finished medicinal products were concerned - particularly those which involve sterile manufacturing. In total, 27 GMP deviations were observed. Among them, 8 have been classified as "major deviations". Basically, from the inspectors' view, the pharmaceutical quality system doesn't appear to be functioning. Among other things, some API manufacturers haven't been audited within the supplier qualification process. Moreover, further deficiencies were found like the methods for the sterility test and the requalification of the sterilisation procedure.
Source: EMA's EudraGMDP Database