The International Pharmacopoeia (Ph. Int.) is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Now, the 11th Edition of the Ph. Int. has been published.
FDA Warning Letter: Lack of Temperature and Humidity Control
The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.
Tasks of Quality Control Unit during Validations - FDA Perspective
In addition to guidelines, interpretations of the FDA's CGMP rules can often be found in Warning Letters. A current Warning Letter describes the FDA's expectations of the Quality Control Unit for validations, among other things.
Fundamental GMP Deficiencies at Disinfectant Manufacturer
Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.
The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM. The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.
USP: New General Chapter Supplier Qualification <1083>
On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.
Brexit: Agreement on Northern Ireland Protocol also with Consequences for Medicines
The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.
EDQM: Supplement 11.2 of the European Pharmacopoeia available
Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
Consultants: A Universal Remedy for GMP Deficiencies?
The question in the title "Are consultants a universal remedy?" is of course a bit provocative. Yet the sole involvement of a consultant following a 483 deficiency report from the FDA is often insufficient. Why?
The European QP Association published a new version 9.0 its "Code of Practice for QPs". It now also comprises a new chapter "Ethics for the Qualified Person - A Professional Code of Conduct" in addition to general revisions and a revised Annex 1 with the national requirements.
What Errors can occur with Swab Sampling during Cleaning Validation?
Two sampling techniques are generally used in cleaning validation. The rinse test and the swab test. The following are notes on potential issues with the swab test.
On the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare), the list of available reference standards is updated at regular intervals. It indicates which reference substances have been replaced by new batches and which standards have been removed from the list of reference substances (since January 2023) or will be deleted in the future (as of April or July 2023).
Denmark provides further Guidance on Medical Cannabis
The Danish Medicines Agency has prepared a new guidance for the pilot programme on cannabis products. Amongst others, the document contains GMP and other quality requirements for Danish-made cannabis products.
USP is Announcing a Proposal to Modify the Glass General Chapter <660>
Due to the current shortages of glass vials the USP is announcing a proposal to modify General Chapter <660> Container— Glass. In particular, the revision is anticipated to remove the glass classifications based on composition.