How can the specific requirements for sterile products be taken into account in the quality management system?

11.03.2024

Question of the Week

The Pharmaceutical Quality System (PQS) of a sterile manufacturer should cover the specific requirements of sterile products and thus ensure that the risk of particulate and microbial contamination (including endotoxins) is minimized.

[GMP Compliance Adviser, Chapter 12.C]

Would you like to discover more?

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

Switzerland: Updated MRA with the EU to Ease Market Access of Medical Devices

20.03.2026

News

Switzerland: Updated MRA with the EU to Ease Market Access of Medical Devices

MedTech Europe and partner associations welcomed the EU–Switzerland agreement package, including the long-awaited update of the Mutual Recognition Agreement (MRA).

FDA: Draft Guidance on Responding to Form 483 Observations

09.03.2026

News

FDA: Draft Guidance on Responding to Form 483 Observations

The US Food and Drug Administration (FDA) has issued a draft guidance on responding to Form FDA-483 observations following drug CGMP inspections. The document provides recommendations on how manufacturers should structure their responses and what information they should include.

Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

09.03.2026

Question of the Week

Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

Here's the answer:

Veterinary GMP 2026: The New Regulatory Framework

09.03.2026

LOGFILE Feature

Veterinary GMP 2026: The New Regulatory Framework

Implementing Regulations (EU) 2025/2091 and 2025/2154 consolidate the GMP requirements for veterinary medicinal products into a distinct and legally binding framework for the first time. While establishing regulatory independence for the veterinary sector, they remain substantively aligned with the EU GMP Guide.

Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

06.03.2026

News

Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

Team-NB, the European association of medical device Notified Bodies, sees the proposed MDR and IVDR revision as an opportunity to improve efficiency, transparency and predictability in conformity assessment.

EMA: GMP Documentation for the Sterilisation of an API

05.03.2026

News

EMA: GMP Documentation for the Sterilisation of an API

The EMA Q&A on the quality of medicines has been updated with a new question: “What kind of GMP documentation is required for an API manufacturer performing sterilisation of an active substance?”