GMP News - Validation


New Top Lecture available - FDA´s Thinking about Modern Qualification and Validation

What is the FDA´s current thinking with regard to Modern Qualification and Validation? You will find out in a recent lecture from FDA Director Grace McNally.



How did the EMA Q&A Document on the use of PDE Values come about?

In June you could already read about the Q&As of the European Medicines Agency (EMA) on the use of PDE (HBEL) values in connection with cross contaminations and cleaning validation. The EMA has now published a report which describes how these questions and answers came into being.



Non-Compliance Report for Indian API manufacturer

During an inspection in March 2018, the French competent authority discovered various GMP violations at the site of an Indian manufacturer. Learn more about the Non-Compliance Report issued on behalf of the EMA.



Are you familiar with the Verification Guide ASTM E 2500?- ECA Modern Qualification Survey Results

Last week part I of ECA´s survey about "Modern Qualification" was published. In the following you will find further results of ECA's survey on modern qualification.



FAT & SAT not frequently used as Part of Qualification - ECA Modern Qualification Survey Results

The ECA set up a survey to find out to what extent qualification and validation programmes are integrated as actually made possible by the EU Annex 15 and the FDA Process Validation guide – and to what extent suppliers are involved. Read more about the Qualification/Validation Survey results.



Data integrity still in the focus of FDA: new warning letter to Japanese API manufacturer

The topics data and data integrity are still in the focus in FDA inspections. Find out more about the details of a warning letter to Japanese API manufacturer Yuki Gosei Kogyo Co. Ltd.



FDA criticises missing stage 3 in validation lifecycle

In a five-page warning letter to an OTC manufacturer, the US Food and Drug Administration (FDA) criticises, inter alia, the missing program for continued  process verification.



ICH M11: CeSHarP

In June 2018 the ICH Assembly agreed to work on a new guideline ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".



GCP: FDA Draft on Data Integrity in Clinical Studies

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.



No second chance for a first impression - inspection result by a European supervisory agency

The Maltese competent authority has performed an initial inspection at the facility of an Indian manufacturer and packer in March 2018. This resulted in a Non-Compliance Statement regarding GMP.



Manufacturing without process validation and stability testing - the quickest way to receiving a warning letter

If a company neglects basic GMP principles, it is not very likely for it to pass an FDA inspection. Read here, what violations concerning the testing of incoming materials, the final testing of finished products and the control of production processes lead to a warning letter.



Warning letter due to non-validated Analytical Methods

Procedures for the analysis of GMP-liable products must be validated. Read here, what deficiencies involving the validation of analytical methods and the handling of OOS results almost inevitably lead to a Warning Letter.



Be prepared when the GCP inspector asks about Data Integrity

Recently a post in the MHRA blog informed about common findings GCP Inspectors have seen across a number of recent inspections. Read more about Data integrity in Clinical Trials.



FDA Requirements on Process Validation - a Warning Letter provides Information

The coming into force of the new FDA guidance on process validation in 2011 led to a shift in paradigm. Validation is a three-stage life cycle now and also includes commercial production in stage three. What does that mean for implementing the FDA proces validation guidance though? 



Missing Audit Trail Review led to Warning Letter

Chinese manufacturer Zhejiang Ludao Technology received an FDA Warning Letter in February, 2018. During the FDA inspection, the missing Audit Trail Review for the HPLC system was particularly criticised.


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