Warning Letter for Indian Sterile Manufacturer

Indian sterile manufacturer Emcure Pharmaceuticals has once more received a warning letter from the FDA with concerns to the root cause analysis of deviations in sterility testing.


Analytical Quality by Design: MHRA´s Questions and Answers

In order to encourage stakeholders to take the opportunity to send comments on the application of AQbD to pharmacopoeial standards, the MHRA provides some Questions and Answers.


Medical Devices Warning Letters Statistics for the first half of Fiscal Year 2019

In both years 2017 and 2018 (period from October 1 to September 30), we reported a noticeably low number of Warning Letters. This seems to go on in 2019.


FDA's Answers to questions on GMP-compliant Chromatography in the Quality Control Laboratory

The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.


What is a Combination Product?

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).


Warning Letter due to Deficiencies in the Purified Water System

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.


MRA: Can Import Testing be completely stopped now?

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.


ISPE publishes revised Guideline on Commissioning and Qualification

The ISPE Baseline Guide Vol. 5 on Commissioning & Qualification has been in place since 2001 and was thus no longer up to date. Recent developments, e.g. towards a lifecycle model, were not reflected in the document. Now the ISPE Baseline Guide Vol. 5 has been completely revised. 


How to quickly find out about FDA requirements for Medical Devices?

In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.


Experiential Learning Program of the CDRH

Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is...


FDA Feedback after an Inspection at a Medical Device Manufacturer

In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?


How to detect Falsified Medicines

Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them.


New GDP Non-Compliance Reports

New GPD Non-Compliance Reports have been published in the EudraGMDP database, leading to a suspension of the WDA of the inspected companies.


FDA Blockchain Pilot

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


Hard Brexit: MHRA Preparations

The Biritsh Medicines and Healthcare products Regulatory Agency (MHRA) has published several guidelines for a possible no-deal scenario.


Warning Letter due to GMP Deficiencies in Tableting

An Indian manufacturer of solid dosage forms recently received a Warning Letter from the US FDA after the authority had revealed serious deficiencies in the tablet production.


Ongoing severe Quality Deficiencies lead to regulatory Action - Part 1

The second Warning Letter within six months reveals fundamental issues in quality management. Learn more about the new FDA warning letter to US company Akorn.


Comprehensive FDA Warning Letter Analysis - Stability Testing on the Rise

Over and over again, FDA inspectors discover violations of long-established GMP requirements. Read more about which trends in the areas of quality control and production can be identified from the analysis of the Warning Letters issued in the last 21 months.


Is the Audit Trail Review required for Electronic Health Records?

MHRA´s GCP inspectors have recently seen various types of Electronic Health Records (eHRs) during their investigator site inspections and in several cases they have given major findings.


FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)

With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.


GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information