The revised USP general chapter <1226> VERIFICATION OF COMPENDIAL PROCEDURES has been approved.
The time has come for Cannabis "Made in Germany". The German Federal Institute for Drugs and Medical Devices (BfArM) has completed the award procedure for the cultivation of cannabis.
In May, the FDA published a Warning Letter to a US American sterile manufacturer of ophthalmic drugs which highlights serious deficiencies, especially in sterile production and in the general understanding of GMP. Read more here.
What do authorities require regarding cleaning validation? Official GMP inspection reports deliver helpful answers to this question. Through the Freedom of Information Act, the FDA is required to publish inspection results. This is particularly the case with Warning Letters. Here, even details of deficiencies regarding cleaning validation are included in the Warning Letter.
The WHO has published a draft document on "Environmental Aspects of GMP" and plans to include the topic of waste and wastewater management into GMP Guidance.
The FDA has recently issued a Warning Letter to a US manufacturer of OTC topical products describing serious GMP deficiencies. This concerns among others the water system, the QC (chemical, microbial and stability tests), and the process validation.
The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.
The MHRA Inspectorate recently clarified the agency´s expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs.
The US FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug development.
The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database.