Tag: GMP compliance

EAEU GMP Certificates to Be Accepted and Recognized within EAEU from 1 January, 2021

Starting January 1, 2021, only GMP certificates issued under the EAEU rules will be accepted and recognized within the EAEU. But national GMP certificates will be valid for 3 years until their expirat...

Foreign Manufacturers of Veterinary Products’ Inspections for GMP Compliance in 1H 2019

Inspection activities aimed at confirming the compliance of a manufacturer of veterinary medicinal products with the requirements of Good Manufacturing Practice (GMP) are carried out by the Federal Se...

EU Published Guidance to Help Verify Compliance with the Regulation

Back in 2011, the European Commission (EC) published Directive 2011/62/EC, the so-called Falsified Medicines Directive (FMD). The main goal was to support the fight against counterfeit medicines. T...

PhoenixMD and WuXi STA Produced Multikilogram Drug Supply for TNBC Treatment

PhoenixMD and WuXi STA have produced a multikilogram drug supply for PMD-026 under GMP manufacturing practices. Phoenix Molecular Designs (PhoenixMD), a privately-held biotechnology company designi...

Fundamental GMP Deficiencies of Homeopathic Drugs Manufacturer

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs for human and veterinary use. As one such deficiency, the FDA listed a missing CAP...

Guide for Sterility Testing Requirements

Cherwell Laboratories, specialist suppliers of products for environmental monitoring and process validation, has published an eBook titled, “Failure is not an option: Why sterility testing is so impor...

Russian Experts Analyzed Risk in Validation Planning

At the end of January, FSI «SID & GP» and the Pharmstrategy company held a regular expert-advisory workshop within the joint program of promoting implementation of the best practices in the Russia...

Tetra Temporarily Freezes Phase 3 Clinical Program

Tetra Bio-Pharma Inc., today announced that it has temporarily suspended its phase 3 clinical program due to impurities found in its PPP001 investigational drug being administered to patients. This su...

Swissmedic GMP Compliance Document for Foreign Manufactures

The Swiss authority Swissmedic has published a new auxiliary document. This document is intended to clarify which documents should be submitted as part of an authorisation application with type IA/IAI...