FDA Blockchain Pilot

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.


MRA Countdown: 10, 6, 4, 2, ...

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.


MHRA reports serious GCP breaches including Data Integrity

The British Medicines and HealthCare Regulatory Agency (MHRA) recently published the 2018 metrics report for serious GCP breaches reported to the agency.


The ICH publishes E8(R1) Draft Guideline for comment

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.


Revised USP Elastomeric Components Chapters

The previous draft chapters were canceled. Therefore, USP´s General Chapters–Packaging and Distribution Expert Committee has published new proposals on elastomeric components.


German Pharmacopoeia Draft Monograph for Cannabis Extracts

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


MHRA plans to apply AQbD principles

The MHRA plans to apply analytical quality by design principles, including the analytical target profile (ATP), to its pharmacopoeia (BP).


Revised USP Chapter <1226> Verification of Compendial Procedures

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


Cannabis - BfArM awards remaining contracts

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.


Warning Letter for Sterile Manufacturer of Ophthalmic Drugs in the US

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.


cGMP Cleaning Validation - FDA's Current Requirements

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. 


GMP Deficiencies at Topical Products Manufacturer

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.


Revised USP chapter <3> Topical and Transdermal Product Quality Tests

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.


WHO plans Inclusion of environmental Aspects in GMP

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.


EMA's Annual Report on the EudraVigilance Database

The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database.


How to manage Safety Data in a blinded Trial?

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


FDA´s final REMS Guideline

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.


GDP-Inspector: Why Supplier Qualification is important

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


New office-based GDP-Inspection Process in UK

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 


New WHO Draft for GDP Guidance

The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.


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