News

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
Risk-based Determination of the Scope and Frequency of Audit Trail Reviews

The scope and frequency of audit trail reviews should be determined on a risk basis. Is there a regulatory basis for this?

More
Data Integrity and the ICH Q7 Guidance - Part I

The question we want to explore is whether Data Integrity is a completely new approach or just a different perspective on already existing GMP requirements as those arising from ICH Q7.

More
x
Search