GMP News - Validation


FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.



New Brazilian ANVISA Guide for the Validation of Computerised Systems

On 14 April 2020, the Brazilian regulatory authority ANVISA published a new guideline for the validation of computerised systems which is to replace the guideline of the same name from 2010. Find out more about the main contents and further developments here.



Publication of the WHO Document on Limits in Cleaning Validation

The issue of (cross-) contamination and, in this context, cleaning validation have played an important role in the GMP environment for decades. For some years now, health-based exposure limits have been added as a possible alternative. In a draft guideline, the WHO has addressed this topic.



Remote GCP Inspections

The EMA released a new guidance explaining how remote Good Clinical Practice (GCP) inspections should be conducted during the COVID-19 pandemic.



Derogations for Equipment Qualification due to COVID-19

End of May, another new part under the heading "GMP Flexibilites" was added to the Questions & Answers document prepared by the EC, the CMDh, the Inspectors Working Group and the EMA. This new part now includes special features for the qualification of equipment (question 6.2).



New Chapter in the European Pharmacopoeia on Multivariate Statistical Process Control

In our News dated 19.08.19, we had mentioned the draft of a new Ph. Eur. chapter  (5.28) regarding Multivariate Statistical Process Control. This chapter has now been adopted and will be published in the October 2020 issue.



Derogation for Process Validation due to Covid-19

In order to be able to continue to provide the population with high-quality, effective and safe medicinal products during the Covid-19 pandemic, Europe is taking exceptional measures. A Q&A document has been prepared in cooperation between the European Commission, the Coordination Group on Mutually Recognised and Decentralised Procedures (CMDh), the Inspectors Working Group and the European Medicines Agency (EMA). At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites".



FDA Warning Letter to US Drug Maker

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a US-based drug maker for significant violations of current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, including the failure to investigate out-of-specification (OOS) test results and to follow proper documentation practices.



Design Qualification from the FDA's Perspective

Is there a specific FDA requirement for a Design Qualification? The answer is (actually) No.



EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

The EMA recently published a notice to sponsors which clarifies the responsibilities in regard to the qualification and validation of computer systems and data Integrity in clinical trials.



Audit Trail in the Centre of an FDA Warning Letter

The modification and deletion of electronic data must be documented by an audit trail. A missing audit trail led to a Warning Letter to the Indian company Shriram Institute for Industrial Research.



Remote Access to Critical GxP Systems by Service Providers

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain?



What does "State of Control" mean for the FDA?

In the context of process validation, the FDA attaches considerable importance to a "state of control". The FDA expects evidence of this "state of control" as part of stage 3 "continued process verification" within the validation lifecycle. Now, what exactly does the FDA want to see? Parts of the answer to this question can be found in Warning Letters.



How to handle Legacy Systems if no Audit Trail is available or a "User Login" is not possible?

The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 7: How to handle Legacy Systems if no audit trail is available or a "user login" is not possible?



How does the FDA deal with Processes that cannot be validated?

In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Read more about the correspondence.


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