IGMPI India



GMP Non-compliance Reports available in EudraGMDP

A GMP Non-Compliance Report has come from the Bulgarian Authority for Vetprom AD regarding finished medicinal products particularly those which involve sterile manufacturing.

The British Medicines Authority MHRA has issued a GMP Non-Compliance Report for the sterile manufacturer Yung Shin Pharmaceutical Ind Co Ltd in Taiwan.During the inspection, a lack of GMP control of moist heat sterilization 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. This was the first inspection of the site which intended to manufacture products for the EU market. 'In Inspection, 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. The inspection was triggered by a marketing authorization filed in Ireland.