IGMPI India

October 7, 2015

October 7, 2015

PAN Drugs receives warning letter from USFDA

USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.

MHRA issues recall notice of Lacri-Lube eye ointment

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of

Another Import Ban for Polydrug Laboratories

USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for

Health Canada lifts its ban from two Apotex facilities in India

Health Canada has lifted its ban from Apotex two Indian facilities. Canada’s drug regulator reinspected the two plants in June and determined

33 drugs were found to be of not of standard quality during Surprise inspection

Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.

Vivimed Labs successfully completes USFDA inspection of its manufacturing facility

Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said “the USFDA inspectors concluded

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Final Concept Paper Published by ICH for a new ICH Q12 guideline

ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.

The concept paper was published with a view to provide harmonized approach to technical and regulatory considerations for the lifecycle management of pharmaceutical products which was lacking till date. The concepts in ICH Q8, Q9, Q10 and Q11 did not give full information of the benefits of the risk based approach applied across the changes in the lifecycle of pharmaceutical product.

The proposed ICH Q12 Guideline along with ICH Q8 to Q11 Guidelines will provide strategies for the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more efficient manner across the product lifecycle which will be beneficial in the innovation and continuous improvement leading to the better understanding of post approval CMC changes among the regulators.