Measurement Uncertainty for the Pharmaceutical Industry
The USP recently published a stimuli article regarding the discussion of measurement uncertainty (MU) which is a component of the lifecycle approach to analytical procedures. Read more about the USE OF MEASUREMENT UNCERTAINTY IN THE PHARMACEUTICAL INDUSTRY.
Impressive Non-Compliance Report for Romanian Drug Manufacturer
The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on an inspection in summer 2017 is available there, as well.
Revision of EU GMP Chapter 1 to enhance Quality Risk Management
The European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.
What are the FDA's plans for 2018? The Center for Drug Evaluation and Research (CDER) has answered that question in their list of FDA guidelines in the planning or to be revised.
EMA publishes ICH Q12 Draft with Deadline for Comments
The EMA issued the draft of the Guideline ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management and its Annexes for commenting.
FDA strengthens Public Warning and Notification of Recalls
To expedite release of recall information the FDA published a draft guidance to ensure better, more timely information reaches consumers. Read more about FDA’s policy on public warning and notification of recalls.
Effect of the new Annex 13 on Complaints and Recalls
The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 in regard to complaints and recalls?
How is the Data Governance System to be implemented in your Company?
The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented? Find out more about the requirements and specifications of the PIC/S guideline for the pharmaceutical Data Governance System.
Manufacturing and Importation Authorisation holders must not change the terms of the authorisation without prior approval of the authority. But also other GMP related changes require notification to the national competent authority.
A functioning quality assurance unit normally guarantees a minimum level of GMP. If this entity is missing, however, basic GMP requirements are not met. Read here, which basic GMP documents FDA inspectors found missing while visiting a pharmaceutical company.
The final "Detailed Commission guidelines on GMP for IMPs for human use" have been published in Annex 13 of the EU GMP-Guidelines. What has changed in comparison to the previous Annex 13 with regard to IMP labelling?
Five new Warning Letters - Four Batch Record Review Citations
Data integrity is for sure still a hot topic in inspections. But it seems inspectors are getting more back to the roots: document and batch record design and review.
The new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.