MHRA Questions and Answers for Specials （MHRA特价的问题和答案）.pdfVIP

MHRA Questions and Answers for Specials manufacturer’s 1. Introduction Purpose 2. Scope 3. Q As 4. Glossary 5. Reference documents 6. Revision History 1 INTRODUCTION PURPOSE The purpose of this document is to provide guidance for Manufacturing Specials (MS) licence holders in the interpretation of the GMP requirements to be applied when manufacturing unlicensed medicines. Questions and Answers have been used to promote easy updates when further clarification on specific topics is required. The document includes guidance on the appropriate standards for the manufacture of aseptically prepared products under an MS licence using essentially closed systems. However it is important to recognise that all aseptically prepared products where open systems are used, should be manufactured in accordance with the standards outlined in the EU Guide, specifically Annex 1. This QA does not replace any of the requirements for unlicensed medicines already contained in Guidance Note 14 (GN 14). 2 SCOPE The guidance in this document is for the manufacture of products under an MS licence. It is not intended to cover the importation of unlicensed products although many of the expectations are common. The general guidance within this document will also apply to radiopharmaceuticals. This document does not contain any guidance relating to Advanced Therapy Medicinal Products which came into operation in December 2008 in accordance with European regulation No 1394/2007. 3 Q As 3.1 Quality Management 3.1.1 What is the expectation for the preparation of a Product Quality Review (PQR) for MS manufacturers? • Given the range of products produced, the absence of a Marketing Authorisation and, in general, th