Bars

News

• Tuesday 8th of October 2019

• FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis

  In support of sponsors, applicants and research institutions, the FDA examines in more detail the variability of internal standards in analytics and their consequences. The authority has now published a document entitled "Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers".

• ATMP from Third Countries - New Q&A Paper on Batch Release published

  With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

• Wednesday 2nd of October 2019

• FDA criticizes Lack of Compliance with ICH Q7 Guidance

  According to the U.S. FDA, the Chinese firm failed to establish an adequate quality system and lacks quality oversight on documentation.

• Track & Trace: EMVO stakeholders call for inspections

  Seven months into the operational phase a significant number of manufacturers and supply chain actors have not yet connected to the EU verification system. Now, the EMVO stakeholders encourage the NCAs to undertake inspections on all supply chain actors.

• FDA Guide for Non-clinical Studies of Oncological Therapeutic Radiopharmaceuticals

  The FDA has published a final guideline for non-clinical studies of "Oncology Therapeutic Radiopharmaceuticals" to close the gaps in the existing FDA and ICH Guidelines.

• FDA´s Enforcement Report - Recent Recalls

  The FDAs Enforcement Report tracks and displays updates to recalls. The July 2019 listings contain several Class II recalls due to various cGMP deviations and two Class I ratings. One of the Class I ratings resulted from the finding of glass particulates in an injection.

• How to prepare for ANVISA Inspections

  Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

• EMA website on Permitted Daily Exposure (PDE) limits

  The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The EMA has compiled everything essential on health-based exposure limits and PDE limits on their website.

• Tuesday 1st of October 2019

• European GDP Association nominates Director Regulatory Affairs and Communication

  The European GDP Association, representing more than 2.000 professionals from across the globe, has nominated Prabjeet Dulai as Director Regulatory Affairs and Communication.

• GDP: The growing Issue of Theft

  The british MHRA is currently publishing a series of blog posts discussing the theft of medicines and the risk to public health.