Quality Systems

Apr 18, 2018
By Pharmaceutical Technology Editors
The European Pharmacopoeia Commission has approved a general monograph laying down harmonized requirements for LBPs for human use and two general chapters addressing microbiological contamination of LBPs.
Apr 16, 2018
By Pharmaceutical Technology Editors
A new report gives an overview of the work of the International API Inspection Program.
Apr 13, 2018
By Pharmaceutical Technology Editors
Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.
Apr 12, 2018
Equipment and Processing Report
The Parenteral Drug Association’s Data Integrity Task Force helps industry members understand regulatory requirements for data integrity.
Apr 11, 2018
By Pharmaceutical Technology Editors
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
Apr 11, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.
Apr 09, 2018
By Pharmaceutical Technology Editors
Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.
Apr 06, 2018
By Pharmaceutical Technology Editors
The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.
Apr 06, 2018
By Pharmaceutical Technology Editors
The contract manufacturing organization’s facility in Boulder, CO, has passed general inspection from FDA.
Apr 05, 2018
By Pharmaceutical Technology Editors
The agency’s plan outlines its approach to implementing medical product programs and the use of financial resources.
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