This EMA GMP certificate was issued following an inspection conducted byPoland'sChief Pharmaceutical Inspector inDecember 2019. The inspection covers not only biosafety testing services specifically provided for Henlius' HLX02 (Trastuzumab), but also the facility's entire quality and manage...
This additional EMA GMP certificate was issued following a remote inspection conducted by Poland's Chief Pharmaceutical Inspectorate in April 2021. The comprehensive inspection covered not only the Quality Control (QC) testing of a Master Cell Bank (MCB) and Working Cell Bank (WCB) used for the ...
WuXi Biologics Biosafety Testing Facility Received Second EMA GMP Certificate SUZHOU, China, August 2, 2021– WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, ...
SUZHOU,China,Aug. 2, 2021/PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that only 13 months after receiving its first GMP certificate, it has once again received a European Medici...
Evidence of GMPcompliance: When submittinga new application for an MA, the applicant has theresponsibility tomake sure that the proposed manufacturers hold a valid MIA, a valid GMPCertificate (or equivalent). In the same way, during the life-cycle of aproduct, the MAH must ensure that the ...
GMP Guide: Annex 11 (Computerised Systems)GMP指南:附录11(计算机化系统) Action: Specialised input(职责:提出专家意见) Guideline on the manufacture of thefinished dosage form (V)制剂生产指南(V) Guideline on quality of water forpharmaceutical use (H+...
GMP certificate is not available, a statement should be provided confirming that the finished product manufacturer has evaluated all the manufacturers of sterile excipients with regards to their quality system related to the sterilisation of the excipient. For products for human use this evaluation ...
Evidence of GMPcompliance: When submittinga new application for an MA, the applicant has theresponsibility tomake sure that the proposed manufacturers hold a valid MIA, a valid GMPCertificate (or equivalent). In the same way, during the life-cycle of aproduct, the MAH must ensure that the ...
The site where sterilisation of the packaging materials takes place may not have undergone inspection by an EU authority and consequently may not hold an EU GMP certificate in relation to this activity1. When GMP certification is not available, certification that the sterilisation has been conducted...
The Iranian biosimilar company CinnaGen has achieved a notable first for the Middle East and North Africa (MENA) region. It has obtained good manufacturing practice (GMP) certification from the European Medicines Agency (EMA), becoming the first full-cycle biologic plant to be approved in the re...