News

What is meant by Good Documentation Practice?

Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance. This raises the question: what exactly is meant by the term 'Good Documentation Practice'?

More
Use of AI Agents leads to the first FDA Warning Letter relating to AI

The FDA Warning Letter to Purolea Cosmetics Lab dated 2 April 2026 also referred to shortcomings in the use of AI (Artificial Intelligence). What specific issues did the FDA raise regarding the use of AI agents?

More
Cycloolefin-Copolymere (COC)

Das Kapitel 3.1.17 "Cyclo-olefin copolymers (COC)" der Europäischen Pharmakopöe (Ph. Eur.) wurde in der im Januar 2026 veröffentlichten Ausgabe 12.3 der Ph. Eur. korrigiert.

More
FDA Warning Letter: Q-Unit failed to document API release

In January 2026, the U.S. FDA issued a Warning Letter to the Indian company "Chemspec Chemicals Private Limited" after having inspected its site in July/August 2025. The observation mentioned in the Warning Letter is related to the lack of Quality Oversight, Good Documentation Practices and Data Integrity principles.

More
APIC: Update to the Data Integrity FAQs

In October 2025, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published version 3 of the document 'Data Integrity Frequently Asked Questions (FAQ)' on its website. In the new version, 'Chapter 5. Record life cycle management:' has been updated.

More
ECA extends Special PharmaCongress Offer 3 for 1

Due to high demand, the ECA has extended its special offer of sending two additional participants free of charge for each registered participant and a two-year membership for all congress participants and PharmaTechnica visitors until 31 January. After that, the 2-for-1 offer will apply until the congress.

More
Data Integrity & IT Compliance Group Developments September through December 2025

Find out what the ECA Data Integrity & IT Compliance Group was working on and accomplished in the last four months of 2025 - in the latest report.

More
Content Review of the Audit Trail Review

Which individuals in which roles are responsible for reviewing the audit trail? What role does QA play?

More
Executing the Audit Trail Review

How and by whom is the audit trail review carried out? Is a four-eyes principle (always) necessary?

More
Data Integrity and the ICH Q7 Guidance - Part II

It is important to understand that (quality) risk management is essential to the implementation and maintenance of Data Integrity concepts. In order to control the risks they need to be categorized. Such a categorization must be simple and easy to be applied fast, consistently and reliably.

More
x
Search