The Active Pharmaceutical Ingredients Committee (APIC) has published two new documents: Guidance on aspects of cleaning validation in active pharmaceutical ingredients plants and GDP for APIs: “How to do” Document.
Guidance on aspects of cleaning validation in active pharmaceutical ingredients plants: This document is an update of the original guidance on cleaning validation in API manufacturing plants and reflects the outcome of discussions between APIC member companies on how cleaning validation requirements could be fulfilled and implemented as part of routine operations. APIC is also aligning this guidance with the ISPE Risk MaPP Guide that follows the quality risk management processes as described in the ICH Q9 Guidance on Quality Risk Management.
The purpose of this document is to assist companies in the formulation of cleaning validation programs and includes examples of how member companies have dealt with specific areas and issues that arise when performing cleaning validation. It provides a starting point for internal discussions and should not be considered as a technical standard. The topics addressed in this guidance document include acceptance criteria, levels of cleaning, control of the cleaning process, bracketing and worst case rating, determination of the amount of residue, and cleaning validation protocol.
GDP for APIs: “How to do” Document: With the application of GDP for APIs becoming mandatory under the EU Falsified Medicines Directive (Directive 2011/62/EU), this document provides guidance, based on practical experience, on how to implement the Guidelines on the Principles of Active Substances for Medicinal Products for Human Use draft published by the European Commission DG SANCO.