M Q&A: Submission of applications for prequalification of magnesium sulfate injection (6 October 2014) PDF Guideline/guidance
M Quality assessment training, Denmark, 18-21 May 2014: Prequalification overview and update Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Active pharmaceutical ingredient assessment: impurities Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Bioequivalence: general considerations and Q&A Presentation
M Quality assessment training, Denmark, 18‒21 May 2014: Good manufacturing practice issues in quality assessment Presentation
M Quality Assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 2, Second updated edition, Good manufacturing practice and inspection PDF Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product (BTP) Approved by Stringent Regulatory Authority (SRA) - QIS-BTP-SRA DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Authority (SRA) (QIS-BTP-SRA) DOCX Guideline/guidance
M Quality Information Summary (QIS) of the Biotherapeutic Product Approved by Stringent Regulatory Authority (SRA) (QIS-BTP-SRA) DOCX Template
M Quality Information Summary (QIS) of the Finished Pharmaceutical Product (FPP) Approved by the Reference Stringent Regulatory Authority (SRA) DOCX Template
M Quality information summary (QIS) of the finished pharmaceutical product (FPP) approved by the reference stringent regulatory authority (SRA) (QIS-SRA) (28 October 2013) DOCX Template
M Quality Information Summary (QIS) of the FPP Approved by the Reference SRA for use outside of the SRA Region DOCX Template