EDQM: CEPs for Sterile Substances

06.12.2024

News

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published further guidance for the preparation of dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance.

This document clarifies the conditions for acceptability of this type of dossiers and describes the documentation to be provided.
The documentation to be provided for the sterile substance concerns the following aspects:
•    Justification for method of sterilisation
•    Manufacturing areas
•    Summary of manufacturing process related to sterile filtration/aseptic processing
•    Information on filters used
•    Validation of the filters used
•    Sterilisation of filters and processing equipment
•    Pre-filtration bioburden
•    Re-use of filters
•    Aseptic processing
•    Process simulation/validation
•    Sterilisation of packaging
•    Re-test period

Source:

EDQM: Newsroom

Meet the GMP Compliance Adviser

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:

How is First Air Verified and Monitored During Aseptic Process Qualification?

24.08.2026

Question of the Week

How is First Air Verified and Monitored During Aseptic Process Qualification?

Here's the answer:

Outsourced Activities in the GDP Environment Part I: Supplier Management

24.08.2026

LOGFILE Feature

Outsourced Activities in the GDP Environment Part I: Supplier Management

Supplier management is the systematic management of a company´s relationship with its suppliers. It encompasses supplier qualification and customer audits as described in the following excerpt from GMP:KnowHow Pharmalogistics (GDP).

FDA: Draft Guidance on Assessing Container Closure Systems for Drugs and Biologics

20.08.2026

News

FDA: Draft Guidance on Assessing Container Closure Systems for Drugs and Biologics

On 14 August 2026, the US Food and Drug Administration (FDA) announced the publication of a new draft guidance document entitled ‘Container Closure Systems for Human Drugs and Biological Products’.

FDA: New FDA Commissioner Dr. Heidi Overton

19.08.2026

News

FDA: New FDA Commissioner Dr. Heidi Overton

President Donald Trump has named White House aide Heidi Overton to lead the US Food and Drug Administration (FDA). Overton will fill the position previously held by Marty Makary, who left the agency in May. This announcement was made on Trump's Truth Social account on 19 August. Her nomination is subject to confirmation by the Senate.

IPEC: Stability Guide for Excipients has been Updated

13.08.2026

News

IPEC: Stability Guide for Excipients has been Updated

The IPEC Stability Guide for Pharmaceutical Excipients has been updated and is now available as version 3 (2026), as announced on the IPEC (International Pharmaceutical Excipients Council) website.

EU: “Forever Chemicals” in a Conflict of Interests

13.08.2026

News

EU: “Forever Chemicals” in a Conflict of Interests

On 14 July 2026, the European Parliamentary Research Service (EPRS) published a comprehensive briefing on PFAS (per- and polyfluoroalkyl substances), also known as ‘forever chemicals’. The document is intended to serve as a technical basis for MEPs in their upcoming political decisions on PFAS regulation and summarises the current state of scientific knowledge, regulation and procedures.