Pharmaceutical contract manufacture and analysis

Transcription

1 Pharmaceutical Quality Group Monograph No. 7 (revised) Pharmaceutical contract manufacture and analysis June The Institute of Quality Assurance (IQA) All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without the written permission of the Institute. ISBN

2 CONTENTS General Introduction Foreword Acknowledgements 1 Introduction 2 Definitions 3 General Responsibilities 4 Commercial Discussions 5 Secrecy or Confidentiality Agreements 6 Transfer of information 7 Assessment of the Contractor 8 Technical Agreement 9 Regulatory Aspects 10 The Role of the Qualified Person 11 Validation 12 Deviations and Change Control 13 Periodic Re-assessment of Contractors 14 Contract Analysis Page GENERAL INTRODUCTION The Pharmaceutical Quality Group in the United Kingdom developed from a small group of pharmaceutical quality executives who met initially in 1977 to assist in the preparation of a supplier questionnaire for discussion at the 1978 seminar of the European Organisation for Quality Control. The group has expanded since that time and is now incorporated with the Institute of Quality Assurance. The objectives of the group are: 1. To promote the open exchange of information and experience concerning pharmaceutical quality matters. 2. To promote the development of a consistent approach to pharmaceutical quality and good pharmaceutical practices (GXP). 3. To promote the status of, and to represent, Qualified Persons and other pharmaceutical quality assurance professionals. 4. To promote education and training in the achievement of pharmaceutical quality in line with current requirements for continuing professional development (CPD) and as a means of reducing risks to the quality of pharmaceuticals throughout the supply chain. The Pharmaceutical Quality Group initiated a project in 1983 with the intention of writing a series of monographs, the prime objective of which was to augment the published, official Codes of Good Manufacturing Practice (GMP) by providing practical, comprehensive and non-mandatory guidelines. The target audience was identified as management and supervisory personnel engaged in the manufacture and supply of medicines with particular emphasis on their future training and education.

3 1.0 INTRODUCTION 1.1 Contract manufacture is defined as the manufacture (or partial manufacture) of a product to the order of one person or organisation (the Contract Giver or Customer) by another independent person or organisation (the Contract Acceptor or Contractor). 1.2 Manufacture in this context is identified as the act of processing or packaging a rnedicinal product or device to a given specification. 1.3 Contract manufacture should be considered as an extension of the Customer's operations. Consequently the Customer should require the same standards of Good Manufacturing Practices (G.M.P.) for a Contractor's operations as he would his own. In addition, the Customer must ensure that the Contractor holds the relevant legal authorisations for the work to be carried out. Contract manufacture may also be classified as manufacture in the Customer's own affiliated companies, whether local or overseas. 1.4 The manufacture and supply of raw materials and packaging materials is not normally regarded as contract manufacture. There may, however, be instances where starting materials are processed so as to render them suitable for pharmaceutical use (e.g. contract milling). These may need to be covered by a formal agreement that ensures that the relevant G.M.P. requirements are understood and observed. 1.5 Contract analysis may also be considered in the terms outlined in this monograph (reference section 14.0). 1.6 The responsibilities and activities undertaken by each party need to be clearly stated in a formal agreement, separate from but additional to the legal business 'contract' formed by the placement of an order. 1.7 Commercial matters need to be appreciated as being distinct from technical matters and need to be detailed separately with due consideration for compliance with local legislation.

4 3.0 GENERAL RESPONSIBILITIES 3.1 The Customer ultimately bears the SPECIFIC responsibility for ensuring that: the product specifications used by the Contractor comply with the relevant legal requirements such as the Marketing Authorisation and label declarations. the product, as manufactured, meets the specification. the required quality is maintained during transport, distribution and storage. all aspects of the contract arrangements are carried out in accordance with Good Pharmaceutical Manufacturing Practice and with the requirements of the Marketing Authorisation and any licences that the Contractor holds for manufacture and assembly. all work is carried out in premises covered by appropriate licences granted by appropriate local authorities. 3.2 The Contractor bears the SPECIFIC responsibility for ensuring that: there is continued compliance to the agreement. compliance to general, local and EC regulatory and statutory requirements relating to good manufacturing, laboratory and warehousing and distribution practices is maintained. At each stage specific responsibilities of each party must be decided. The following sections deal, in order, with the aspects noted in the flow-chart, appendix 1.

5 8.0 TECHNICAL AGREEMENT 8.1 Having established the acceptability of the Contractor, the Customer and Contractor must establish the exact responsibilities of each party and state these in a formal agreement signed by representatives of all parties concerned. The Customer and the contractor should each appoint competent representatives (from Quality Assurance and, if necessary, from Production and Product Development) to agree the technical content of the agreement. In doing this, they should consider and state the person(s) responsible as relevant to the operations to be undertaken by each party. 8.2 General Considerations The following areas need to be addressed and stated: the responsibilities of the 'Qualified Persons" in the customer's and the Contractor's organisations (see section 10.0). assurance that the Contractor continuously complies with 'good pharmaceutical practices' and relevant legislation. provision of reasonable access by the Customer to the Contractor's premises. responsibility for validation of each stage in the operation (see section 11.0). arrangements for changes or amendments to the technical aspects of the agreement (see section 12.0). channels of communication. statement of assurance that the Contractor will not undertake processor activities that could jeopardise the quality of the product. supply of any relevant information following an MCA or similar official inspection of the Contractor's premises that could impact upon the continued supply of the product.