New PIC/S Guidance Documents (PI 043-1; PI 045-1; PI 046-1; and PI 047-1)Geneva, 20 June 2018: the following new PIC/S Guidance documents have been adopted:
- New PIC/S Aide-Memoire on “Cross-Contamination in Shared Facilities” (PI 043-1).
The purpose of this Aide-Memoire is to assist GMP inspectors in the assessment of the risks to the product from cross-contamination in shared facilities. This document provides guidance for GMP inspectors to use in preparation for, and performance of, inspections. It promotes a risk-based approach. This new Aide-Memoire has been successfully developed by the PIC/S Working Group on Controlling Cross Contamination in Shared Facilities, led by Graeme McKilligan (UK / MHRA) and the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB). - PIC/S Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1);
- PIC/S Guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1);
- PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).
These PIC/S Guidelines transpose for PIC/S purposes the corresponding European Commission (EC) guidance documents. This transposition further strengthens harmonisation between PIC/S and the EU. The Guidelines are in essence equivalent with some minor editorial differences. The Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities is also closely linked to revised Chapter 5 of the PIC/S GMP Guide.
The transposition of these Guidelines has been successfully completed by the PIC/S Sub-Committee on the Harmonisation of GM(D)P, led by Paul Gustafson (Canada/RORB).
The new PIC/S Aide-Memoire and PIC/S Guidelines will enter into force on 1 July 2018. The Guidelines are applicable on a voluntary basis for non-EU/EEA PIC/S Participating Authorities.
To download the PIC/S Aide-Memoire on Cross-Contamination in Shared Facilities (PI 043-1) and the PIC/S Guidelines (PI 045-1); (PI 046-1) and (PI 047-1), please consult the page “Publications”
|手机版|蒲公英|ouryao|蒲公英
( 京ICP备14042168号-1 ) 增值电信业务经营许可证编号：京B2-20243455 互联网药品信息服务资格证书编号：(京)-非经营性-2024-0033
发表于 2018-6-21 08:13:46
置顶卡
变色卡
楼主
