May 2019
Draft document for comments
1 GOOD STORAGE AND DISTRIBUTION PRACTICES
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3 (May 2019)
4 DRAFT FOR COMMENTS
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7 © World Health Organization 2019 8
9 All rights rerved. 10
11 This draft is intended for a restricted audience only, i.e. the individuals and organizations having received this draft. The draft 12 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 13 form or by any means outside the individuals and organizations (including the organizations' concerned staff and member 14 organizations) without the permission of the World Health Organization. The draft should not be displayed on any website. 15
16 Plea nd any request for permission to: 17
18 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of Esntial 19 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland, fax: (41 22) 791 4856, email: 20 kopps@who.int . 21
上下四方22 The designations employed and the prentation of the material in this draft do not imply the expression of any opinion 23 whatsoever on the part of the World Health Organization concerning th
e legal status of any country, territory, city or area or 24 of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps reprent approximate 25 border lines for which there may not yet be full agreement. 26
27 The mention of specific companies or of certain manufacturers’ products does not imply that they are endord or 28 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and 29 omissions excepted, the names of proprietary products are distinguished by initial capital letters. 30
31 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. 32 However, the printed material is being distributed without warranty of any kind, either expresd or implied. The responsibility 33 for the interpretation and u of the material lies with the reader. In no event shall the World Health Organization be liable for 34 damages arising from its u. 35
36 This draft does not necessarily reprent the decisions or the stated policy of the World Health Organization.
37 38加班费规定
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SCHEDULE FOR DRAFT WORKING DOCUMENT QAS/19.793: 39
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GOOD STORAGE AND DISTRIBUTION PRACTICES
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Page 3 GOOD STORAGE AND DISTRIBUTION PRACTICES
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1.INTRODUCTION
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1.1.Storage and distribution are important activities in the supply chain management of 46
medical products. Various people and entities are generally responsible for handling, storage 47
and distribution. Products may be subjected to various risks at different stages in the supply 48
chain, i.e. during purchasing, storage, distribution, transportation, repackaging, and relabelling.
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Further, substandard and falsified products are a real threat to public health and safety.
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Conquently, it is esntial to protect the supply chain against the penetration of such 51
products.
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1.2.This document ts out appropriate steps to assist in fulfilling the responsibilities 54
involved in the different stages within the supply chain and to avoid the introduction of 55
substandard and falsified products into the market. The relevant ctions should be considered 56
as particular roles that entities play in the storage and distribution of medical products.
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初中名著
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1.3.This guideline is intended to be applicable to all persons and outlets involved in any 59
aspect of the storage and distribution of medical products from the premis of the manufacturer 60
真诚反义词of the product to the person dispensing or providing pharmaceutical products directly to a 61
patient or his or her agent. This includes all parties involved in trade, storage and distribution 62
of medical products, manufacturers and wholesalers, as well as other parties such as brokers, 63
suppliers, distributors, logistics providers, traders, transport companies and forwarding agents 64
and their employees.
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1.4.The relevant ctions of this guideline should also be considered for implementation 67
by, amongst others, governments, regulatory bodies, international procurement organizations, 68
donor agencies and certifying bodies, as well as all parties involved in any aspect of the trade 69
and distribution of pharmaceutical products, including health care workers.
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1.5.The guidelines can also be ud as a tool in the prevention of the distribution of 72
substandard and falsified products. It should, however, be noted that the are general 73
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guidelines which may be adapted to suit the prevailing situations and conditions in individual 74
countries. National or regional guidelines may be developed to meet specific needs and 75
situations in a particular region or country.
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1.6.To maintain the original quality of medical products, every party active in the supply 78
chain has to comply with the applicable legislation and regulations. Every activity in the storage 79
and distribution of medical products should be carried out according to the principles of good 80
manufacturing practices (GMP), good storage practice (GSP) and good distribution practice 81
(GDP) as applicable.
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1.7.This guideline does not deal with dispensing to patients as this is addresd in the World 84
Health Organization (WHO) good pharmacy practice (GPP) guide (xx). The guidelines 85
should also be read in conjunction with other WHO guidelines (xx).
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2.SCOPE
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2.1.This document lays down guidelines for the storage and distribution of medical 90
products. It is cloly linked to other existing guidelines recommended by the WHO 91
Expert Committee on Specifications for Pharmaceutical Preparations, such as 92
referenced in ction (xyz).
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2.2.Depending on the national and regional legislation, the guidelines may apply equally 95
to products for human and for veterinary u. The guidelines thus cover products for which a 96
prescription is required by the patient, products which may be provided to a patient without a 97
prescription, biologicals, vaccines and medical devices.
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2.3.The document does not specifically cover GMP aspects of finished products in bulk, 100
distribution of labels or packaging as the aspects are considered to be covered by other 101
guidelines. The principles for the distribution of starting materials (active pharmaceutical 102
ingredients (APIs) and excipients) are also not covered here. The are laid down in the WHO 103
guidance “Good Trade and Distribution Practices for Pharmaceutical Starting Materials” (7). 104
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3.GLOSSARY
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The definitions provided below apply to the words and phras ud in this guideline. Although 108
an effort has been made to u standard definitions as far as possible, they may have different 109
meanings in other contexts and documents.
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active pharmaceutical ingredient (API)
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Any substance or mixture of substances intended to be ud in the manufacture of a 113
pharmaceutical dosage form and that, when ud in the production of a drug, becomes 114
an active ingredient of that drug. Such substances are intended to furnish 115
pharmacological activity or other direct effect in the diagnosis, cure, mitigation, 116
treatment or prevention of dia, or to affect the structure and function of the body. 117
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专业教育ALCOA
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A commonly ud acronym for “attributable, legible, contemporaneous, original and accurate”. 120
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Auditing
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An independent and objective activity designed to add value and improve an organization’s 123
operations by helping the organization to accomplish its objectives by using a systematic, 124
disciplined approach to evaluate and improve the effectiveness of risk management, control 125
and governance process.
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batch
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我流是什么意思
A defined quantity of pharmaceutical products procesd in a single process or ries of 129
process so that it is expected to be homogeneous.
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batch number
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A distinctive combination of numbers and/or letters which uniquely identifies a batch, for 133
example, on th e labels, its batch records and corresponding certificates of analysis.
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