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嘉峪檢測網(wǎng) 2026-04-09 20:43
國內(nèi)的藥品包材GMP附錄已于2026年1月1日生效，除此之外，國外有哪些與包材生產(chǎn)相關(guān)的法規(guī)與指南呢？
GMP (Good Manufacturing Practice) in the manufacture of primary and secondary packaging materials is crucial for ensuring the quality and suitability of container closure systems. It is an important element in guaranteeing consistent quality, safety and functionality when these materials are later used to package pharmaceutical, cosmetic or food products.
在內(nèi)包裝和外包裝材料的生產(chǎn)中，GMP對于確保容器密封系統(tǒng)的質(zhì)量和適用性至關(guān)重要。這是在這些材料日后用于包裝藥品、化妝品或食品時，保證其質(zhì)量、安全性和功能性的關(guān)鍵要素。
“包裝材料的GMP”存在嗎？
ISO 15378 - 'Primary packaging materials for medicinal products'defines GMP principles in the development, production and quality control of primary packaging materials for medicinal products and specifies requirements for a quality management system for primary packaging material manufacturers. It combines ISO standard 9001:2008 with GMP for pharmaceutical packaging materials. It is primarily intended for suppliers of primary packaging materials, but the GMP requirements are suitable for a wide variety of (pharmaceutical) packaging materials. The standard also includes relevant GMP requirements for the distribution of primary packaging materials for medicinal products.
ISO 15378-《藥品內(nèi)包裝材料》定義了藥品內(nèi)包裝材料在開發(fā)、生產(chǎn)和質(zhì)量控制方面的GMP原則，并規(guī)定了內(nèi)包裝材料生產(chǎn)商的質(zhì)量管理體系要求。它將 ISO 9001:2008 標準與藥品包裝材料的GMP相結(jié)合。該標準主要針對內(nèi)包裝材料的供應(yīng)商，但GMP要求適用于各種（藥品）包裝材料。該標準還包含了藥品內(nèi)包裝材料分銷的相關(guān)GMP要求。
Other available standards are:
其他可用的標準有：
The PS 9000:2016 standard (Good Manufacturing Practice relating to the manufacture of packaging materials for medicinal products) developed in the UK by the PQG (Pharmaceutical Quality Group) in collaboration with the pharmaceutical industry and its suppliers. It is based on ISO 9001:2015 and is recognised as a standard by the British Medicines and Healthcare Products Regulatory Agency (MHRA). This standard specifies GMP requirements and guidance for a quality management system (QMS) intended for suppliers of packaging materials and printed packaging materials for the pharmaceutical industry.
英國制藥質(zhì)量小組（PQG）與制藥行業(yè)及其供應(yīng)商合作制定的PS 9000:2016標準（藥品包裝材料GMP）。該標準基于ISO 9001:2015，且已被英國藥品和醫(yī)療產(chǎn)品監(jiān)管局（MHRA）認可為標準。此標準規(guī)定了藥品行業(yè)包裝材料和印刷包裝材料供應(yīng)商的質(zhì)量管理體系的GMP要求和指導(dǎo)方針。
Sterile packaging materials: The EMA Guideline for the sterilisation of medicinal products, active substances, excipients and primary containers includes GMP requirements for the selection and validation of sterilisation processes for primary packaging materials used for aseptically manufactured medicinal products. Sterile primary packaging materials, such as ready-to-use (RTU) or ready-to-sterilize (RTS) materials, are also covered by the revised Annex 1 (Manufacture of sterile medicinal products) of the EU GMP guidelines. This applies in particular to the GMP compliance evidence of the company providing the sterilisation service.
無菌包裝材料：EMA關(guān)于藥品、活性物質(zhì)、輔料和內(nèi)包裝容器滅菌的指南包含了用于無菌生產(chǎn)的內(nèi)包裝材料的滅菌工藝選擇和驗證的GMP要求。無菌內(nèi)包裝材料，如即用型（RTU）或即滅菌型（RTS）材料，也受歐盟GMP指南修訂后的附錄1（無菌藥品的生產(chǎn)）的約束。這尤其適用于提供滅菌服務(wù)的公司的GMP合規(guī)性證據(jù)。
Defect classification lists - these play a crucial role in the assessment of the release decision for the packaging batch (both at the supplier and at the user) and in the processing of complaints. Some of them also contain templates for supplier certificates and technical agreements.
缺陷分類清單——這些在評估包裝批次的放行決定（在供應(yīng)商和用戶處）以及處理投訴方面發(fā)揮著關(guān)鍵作用。其中一些還包含供應(yīng)商證書和技術(shù)協(xié)議的模板。
印刷包裝材料
Printed packaging materials are important information carriers for medicinal products. Incorrect or false information on cartons, labels or package leaflets is the most common reason for recalls of finished medicinal products.
印刷包裝材料是藥品的重要信息載體。藥品包裝盒、標簽或包裝說明書中出現(xiàn)錯誤或虛假信息，是導(dǎo)致成品藥品召回的最常見原因。
According toChapter 5 'Production' of the EU GMP Guidelines, 'printed and embossed information on packaging materials should be clear, lightfast and abrasion-resistant'.
根據(jù)歐盟GMP指南的第5章“生產(chǎn)”部分，“包裝材料上的印刷和壓印信息應(yīng)清晰、耐光且耐磨”。
The creation, verification and compliance with packaging specifications and print data in cooperation with the supplier therefore plays a major role in printed packaging materials. In addition, the requirements for serialisation and verification (in accordance with Delegated Regulation (EU) 2016/161) of the medicinal products concerned must be implemented. Another requirement of the EU Falsified Medicines Directive concerns tamper-evident packaging, which is intended to make potential tampering with the packaging visible.
因此，在與供應(yīng)商合作的過程中，確保包裝規(guī)格和印刷數(shù)據(jù)的正確制定、驗證以及符合相關(guān)要求，在印刷包裝材料的生產(chǎn)過程中起著至關(guān)重要的作用。此外，還必須執(zhí)行有關(guān)藥品的序列化和驗證要求（依據(jù)《授權(quán)法規(guī)》（歐盟）2016/161），這些要求旨在實現(xiàn)藥品包裝的防篡改功能，以便使任何對包裝的篡改行為能夠被察覺。
可提取物和可浸出物
There are currently no globally uniform guidelines for extractables and leachables (E&Ls). The draft ICH Q3E guideline on the evaluation and control of E&Ls therefore attempts for the first time to create a harmonised scientific framework for the evaluation of E&Ls from packaging materials, application systems (devices) and manufacturing processes. The new ICH Q3E guideline is intended to assist both applicants and regulatory authorities by focusing on the risk management process. The guideline is therefore of considerable importance for pharmaceutical development, approval and the life cycle management of medicinal products.
目前全球范圍內(nèi)尚無統(tǒng)一的關(guān)于可提取物和可浸出物（E&L）的規(guī)范標準。因此，ICH Q3E 關(guān)于 E&L 評估與控制的草案首次嘗試構(gòu)建一個統(tǒng)一的科學(xué)框架，用于評估包裝材料、應(yīng)用系統(tǒng)（設(shè)備）和生產(chǎn)流程中的 E&L。新的 ICH Q3E 指南旨在通過關(guān)注風(fēng)險管理流程來為申請人和監(jiān)管機構(gòu)提供幫助。因此，該指南對于藥物開發(fā)、審批以及藥品生命周期管理具有相當重要的意義。
藥典各論
Specifications and requirements for testing primary packaging materials and material components can be found in the monographs and general texts of pharmacopoeias such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). The following list provides aselection of relevant chapters:
有關(guān)測試內(nèi)包裝材料及材料組件的標準和要求，可在諸如《美國藥典》和《歐洲藥典》等藥典的各論和通則中找到。以下列表列出了相關(guān)章節(jié)的選取范圍：
Glass 玻璃:
USP <660> Glass Packaging Systems
USP <1660> Evaluation of the Inner Surface Durability of Glass Containers
Ph. Eur. Chapter 3.2.1 Glass Containers for Pharmaceutical Use
Plastics 塑料:
USP <661> Plastic Packaging Systems
USP <661.1> Plastic Materials of Construction
USP <661.2> Plastic Packaging Systems for Pharmaceutical Use
Ph. Eur. 3.2.2 Plastic Containers and Closures for Pharmaceutical Use
Ph. Eur. 3.1 Materials for the manufacture of containers (e.g. 3.1.17 Cyclo-olefin copolymers (COC), 3.1.16. Cyclo-olefin polymers (COP), 3.1.3 Polyolefins, etc.)
Elastomers 彈性體:
Ph. Eur. 3.2.9. Rubber stoppers
USP <381> Elastomeric Components
USP <382> Elastomeric Component Functional Suitability
USP <1382> Assessment of Elastomeric Component Functional Suitability
Silicones 硅:
USP <383> Cured Silicone Elastomers
Ph. Eur. 3.1.9 Silicon Elastomer for Closures and Tubing
Container Performance and Container-Closure Integrity (CCI):
容器性能與容器密封完整性（CCI）
USP <671< Containers-Performance Testing
USP <1207> Package Integrity Evaluation-Sterile Products (including subchapters)
E&Ls 可提取物和可浸出物:
USP <1663> Assessment of Extractables
USP <1664> Assessment of Leachables (including subchapters)
Ph. Eur. Chapter 2.4.35 Extractables in Plastic Materials
Biocompatibility: USP <1031> The Biocompatibility of Pharmaceutical Packaging Systems
Supplier Qualification: USP <1083> Supplier Qualification
To date, there are still no harmonised pharmaceutical standards for metal packaging. To ensure the safety, suitability and compatibility of metal packaging systems, the USP is therefore proposingtwo new general chapters (<662> and <1662>) dealing with the characterisation of metal materials, components and systems used for the packaging of pharmaceutical products.
截至目前，針對金屬包裝的統(tǒng)一藥品標準仍未制定完成。為了確保金屬包裝系統(tǒng)的安全性、適用性和兼容性，USP因此提議新增兩個通用章節(jié)（<662> 和 <1662>），分別涉及用于藥品包裝的金屬材料、組件及系統(tǒng)的特性分析。
來源：Internet
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