The US FDA published a form 483 criticising the shipping practice of a pharmaceutical company. They simply ignored temperature excursions and respective complaints.
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.
Relating to the increasing use of nanomaterials in manufacturing and the possible following risks for manufacturing staff the WHO issued a new guideline document entitled "WHO guidelines on protecting workers from potential risks of manufactured nanomaterials" .
Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain. Read more about the EU, PIC/S and FDA requirements concerning Audit Trails and their reviews.
The long-awaited draft of the new Annex 1 was published in December 2017. Besides mainly contents concerning sterile production, it also contains various updates on the manufacturing and distribution of water to be used in pharmaceutical production.
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?
The annual report 2016 of the GCP Inspectors Working Group (IWG) has been published. According to the report EU inspectors have found more than 1000 clinical trial deficiencies in 2016. Read more about the Annual report of the Good Clinical Practice Inspectors Working Group 2016.
Additional changes to the USP general chapter <1090> have recently been proposed by the USP General Chapters—Dosage Forms Expert Committee. Read more about the revision of USP chapter Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution.
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.