EU GMP ANNEX 15: What You Need To Know

EU GMP ANNEX 15:
CLEANING VALIDATION
A CRITICAL COMPONENT
TO COMPLIANCE

On October 1st, 2015, changes to the EU Guidelines on GMP [Annex 15] went into effect. This is a significant revision from the previous versions of Annex 15, especially in regards to the cleaning validation process.

On the most basic level, Annex 15 states that cleaning validation should be performed in order to confirm the effectiveness of any cleaning procedure for all product contact equipment.

Other highlights from Annex 15 also include:

• Limits must be appropriately documented and based on a toxicological evaluation (ADE/PDE Values) with documented risk assessment to health-based exposure and established cleaning agent limits.
• Repeated cleaning testing and retesting until acceptable residue results are obtained is not considered an acceptable approach.
• A visual check for cleanliness is an important part of acceptance criteria for cleaning validation – it is generally not acceptable for this criterion alone.
• Simulating (cleaning) agents may be used with appropriate scientific justifications

Achieving a validated state should be the basis for determining the extent of technical and organizational measures required to control risks for cross contamination.

Reminder:

The cleaning validation process is regulated by many groups including: World Wide GMPs (EU Annex 15), Active Pharmaceutical Ingredients Committee (APIC), Pharmaceutical Inspection Convention (PIC), WHO Supplementary Guidelines on GMP, Health Canada and US FDA. Most of these organizations require rationales to be logical, practical, achievable and verifiable.

Science-With-Cleaning:

Dober’s scientific approach to cleaning combines a targeted formulated detergent with an effective cleaning process to help you achieve validation, eliminate the need to reclean, increase efficiency and improve your bottomline. Upon completion of an Application Cleaning Methodology (ACM), we provide you with an Analytical Technical Transfer package detailing your Chematic detergent with TOC and HPLC analytical methods, including ADE/PDE values.

Initiate your FREE ACM today!