GMP NEWS 2019

The FDA has confirmed two other EU Member States to carry out GMP inspections at a level equivalent to that of the US. Only two states are still missing to implement the Mutual Recognition Agreement (MRA) between the FDA and the EU.

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

A draft for a new German Pharmacopoeia monograph entitled "Cannabis Extract, Standardized (Cannabis extractum normatum)" has been published in the (German) Bundesanzeiger.

The revised USP general chapter <1226> VERIFICATION OF COMPENDIAL PROCEDURES has been approved.

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.

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 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 MHRA Inspectorate recently clarified the agency´s expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs.

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.