GMP News - Validation

26.08.20

PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-Contamination

In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper?

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19.08.20

PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit

In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) re-issued document PI 052-1. What is in it?

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19.08.20

Data Integrity Issues at the Focus of a Warning Letter for a US-American Company

Data integrity issues remain at the focus of FDA inspections. Insufficient or missing controls to ensure the integrity of electronic test data were one of the reasons for the Warning Letter issued to the American company Stason Pharmaceuticals.

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12.08.20

Audit Trail Review for Devices with "Standard Audit Trail" Functions

The topics data integrity/audit trail generate a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: What is the procedure for devices with standard audit trail functions if only a fraction of the data is relevant for the audit trail review?

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29.07.20

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.

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15.07.20

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.

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24.06.20

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.

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17.06.20

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.

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10.06.20

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).

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10.06.20

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.

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03.06.20

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".

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03.06.20

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.

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27.05.20

Design Qualification from the FDA's Perspective

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

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19.05.20

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.

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13.05.20

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.

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