European Medicines Agency
Inspections
Public
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95 London, 19 May 2005 CPMP/QWP/4359/03 EMEA/CVMP/205/04
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE
祭母
(CHMP)
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE
(CVMP)
GUIDELINE ON
PLASTIC IMMEDIATE PACKAGING MATERIALS
DRAFT AGREED BY QUALITY WORKING PARTY October 2003 ADOPTION BY CPMP/CVMP FOR RELEASE FOR
CONSULTATION
February 2004 END OF CONSULTATION (DEADLINE FOR COMMENTS) 31 August 2004 AGREED BY QUALITY WORKING PARTY February 2005 ADOPTION BY CHMP/CVMP April/May 2005 DATE FOR COMING INTO EFFECT 1 December 2005
This guideline replaces the Guideline on Plastic Primary Packaging Materials (Rules Governing Medicinal Products 3AQ10a).
TABLE OF CONTENTS
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1INTRODUCTION (3)
1.1 Objective of the Guideline (3)
1.2 Scope of the Guideline (3)
Principles (4)
1.3 General
2LOCATION OF DOCUMENTATION TO BE PROVIDED IN THE MARKETING AUTHORISATION APPLICATION (4)梦到屋顶漏水
3DATA TO BE SUBMITTED (5)
information (5)
3.1 General
3.2 Specifications (5)
4EXTRACTION STUDIES (6)
5INTERACTION STUDIES (6)
Studies (7)
5.1 Migration
Studies (7)
5.2 Sorption
6TOXICOLOGICAL INFORMATION/DOCUMENTATION (7)
7GLOSSARY (8)
APPENDIX I: DECISION TREE ON THE PRESENTATION OF THE DOCUMENTATION (9)
APPENDIX II: DECISION TREE ON THE PRESENTATION OF THE DOCUMENTATION OF PLASTIC PACKAGING MATERIAL (10)
APPENDIX III: CORRELATION TABLE FOR PRESENTING THE INFORMATION (11)
1 INTRODUCTION
1.1 Objective of the Guideline
This Guideline superdes the Guideline on Plastic Primary Packaging Materials published in the Rules Governing Medicinal Products 3AQ10a and address the information on plastic materials being ud as immediate packaging for active substances and medicinal products to be submitted in marketing authorisation applications.
It concerns the application of Part 1, Module 3, ctions 3.2.1.6, 3.2.2.2 and 3.2.2.7 of Annex I to Directive 2003/63/EC, amending Directive 2001/83/EC for human medicinal products, and Part 2, ctions A, C and G of Annex 1 to Directive 2001/82/EC for veterinary medicinal products, respectively, to plastic immediate packaging materials.
1.2 Scope of the Guideline
The guideline covers the specific requirements for plastic immediate packaging materials. It is not intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e.g. performance.
The guideline is limited to plastic immediate packaging materials, i.e. packaging materials intended to be in direct contact with the active substance or medicinal product. The materials may be part of the container, the closure or al or of other parts of the container closure system(s). Elastomeres a
nd natural and synthetic rubber are not within the scope of this guideline.
This guideline should not be applied retrospectively to already marketed products in their authorid packaging material. However, in new registration applications or in variation applications to introduce a new immediate plastic pack, plastic immediate packaging materials for active ingredients and medicinal products have to comply with the requirements outlined in this document, regardless whether the material is going to be ud for the first time or has already been ud for packaging of active substances or medicinal products.
Principles
1.3 General
The data to be provided for plastic packaging materials depend on the physical state of the active substance (e decision tree in Appendix I) and the pharmaceutical dosage form and route of application of the medicinal product (e decision tree in Appendix II). The data should be prented according to the standard format described in the Notice to Applicants (Volume 2B of The Rules governing Medicinal Products in the European Union), CTD-Module 3, 3.2.S.6, 3.2.P.2.4 and 3.2.P.7, for human medicinal products or in the Notice to Applicants (Volume 6B of The Rules governing Med
icinal Products in the European Union)Part 2 ctions A, C and G,for veterinary medicinal products. A correlation table on the location of the EU-CTD dossier versus the previous version for human medicinal products (NTA, Vol. 2B, edition 1998) and the current version for veterinary medicinal products (NTA, Vol. 6B, edition 2004), respectively, is provided in Appendix III.
The guideline should be read in conjunction with the current versions of the guidelines on Development Pharmaceutics (CPMP/QWP/155/96), Stability Testing: Stability Testing of New Drug Substances and Products (CPMP/ICH/2736/99) – Revision of CPMP/ICH/380/95 – and Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products (CPMP/QWP/122/02, corr.) for human medicinal products and the guidelines on Development Pharmaceutics for Veterinary Medicinal Products (CVMP/315/98), Stability Testing of New Veterinary Drug Substances and Medicinal Products (CVMP/VICH/899/99) and Stability Testing of Existing Active Substances and Related Finished Products (CVMP/846/99) for veterinary medicinal products, respectively.耳朵烫
Furthermore, the provisions of Community legislation on plastic materials and objects in contact with foodstuffs, in particular Commission Directive 2002/72/EC relating to Plastic Materials and Articles intended to come into contact with foodstuffs, should be taken into account, when indicated in this gu
ideline.
2 LOCATION OF DOCUMENTATION TO BE PROVIDED IN THE MARKETING
AUTHORISATION APPLICATION
For ea of reading, reference regarding the location of information in the marketing authorisation application is only given for the CTD structure relevant to human medicinal products. Information on the location of information for veterinary products can be found in the correlation table provided in Appendix III.
Container Closure System for the Active Substance [3.2.S.6]
This part of the dossier should provide information on plastic materials ud for container closure systems for active substances. This should include:
• general information on type and nature of the material according to ction 3.1;
• specifications of the plastic material (e ction 3.2)
• results of extraction and interaction studies, where necessary (e ction 4 and 5), and/or toxicological documentation, where necessary (e ction 6);
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Development Pharmaceutics [3.2.P.2.4]
The data collected during the development of a preparation should be prented to justify the choice of the plastic material(s) in relation to the stability, integrity and compatibility of the medicinal product, to the method of administration and to any sterilisation procedures, if applicable. The data should include details on
• the compatibility of the plastic material with the medicinal product by performing extraction and interaction studies, where appropriate (e ction 4 and 5), and/or toxicological documentation, where applicable (e ction 6).
• the photostability of the plastic material should be discusd if degradation products of the material caud by the impact of light may have a significant impact on the container/medicinal
product compatibility
游镜泊湖• the influence of the manufacturing process of the medicinal product on the plastic material, where a
pplicable (e.g. sterilisation conditions).
Container Closure System for the Medicinal Product [3.2.P.7]
The information to be provided in this part of module 3 should include:
• a description of the container closure system, indicating all components of plastic material;
• general information on the plastic material lected for the component, as outlined in ction 3.1 of this guideline.
• specifications for each plastic material, as outlined in ction 3.2;
3 DATA TO BE SUBMITTED任贤齐歌
information
3.1 General
For all plastic materials that are ud as immediate packaging material for actives substances or medicinal products
• the chemical name of the material
• the chemical name(s) of any monomer ud
have to be indicated.
Further information is required where non-solid active substances or non-solid medicinal products are in contact with plastic materials as indicated below.
For plastic materials intended for packaging of non-solid active substances:
• the complete qualitative composition of the plastic material (including additives, such as antioxidants, stabilirs, plasticirs, lubricants, solvents and/or dyes) if the active substance packaging material is not described in the European Pharmacopoeia or in the pharmacopoeia of
a Member State, and the supplier cannot certify compliance with foodstuff legislation.
For plastic materials ud in packaging of non-solid medicinal products:
• the name of the material supplier, if the medicinal product is intended for inhalation, parenteral or ophthalmic administration
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• the complete qualitative composition of the plastic material as listed above, if the medicinal product is intended for inhalation, parenteral or ophthalmic administration and the material is neither described in the European Pharmacopoeia, nor in the pharmacopoeia of a Member State or, additionally, in cas where the monograph authoris the u of veral additives from which the manufacturer may choo one or veral in defined limits. The qualitative composition should also be provided for non-compendial packaging materials ud for non-solid medicinal products intended for oral and topical (except ophthalmic) administration, when the supplier cannot certify compliance with foodstuff legislation.
3.2 Specifications
When establishing the specifications of plastic packaging materials being in contact with active substances or medicinal products, reference should be made to the appropriate monographs of the European Pharmacopoeia or the monograph of the pharmacopoeia of a Member State. When referring to a monograph, compliance should be demonstrated.
If the plastic material is not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State, an in-hou monograph has to be established according to the list below, taking into account the general methods of the pharmacopoeia:
