EFPIA药品包装白皮书

White Paper onpharmaceutical packaging The pharmaceutical sector is one of the most regulatedin Europe and the world, operating effectively withinan evidence-based framework to maintain the higheststandards,ensuringpackagingnevercompromisespatient safety or product effectiveness. The purpose ofpharmaceutical packaging is to contain, protect, transport,and identify drug products until patient administrationand/or use, and to include relevant information for safeand efficacious product use. User-friendliness for patientsand safety of use (i.e., child-resistant closures) are alsoimportant elements in designing primary packaging incontact with medicines. components that contain the immediate package andare intended to provide additional protection to the drugproduct (EU Medicinal Product Directive, 2001/83/CE3). Other global systems, such as The Wiley Encyclopediaof Packaging Technology4, identify primary, secondary,and tertiary packaging subsystems of pharmaceuticalpackaging,whereprimarypackagingisdefinedasmaterialsindirectphysicalcontactwiththeactivepharmaceutical ingredient or finished product. Secondarypackagingreferstoadditionalpackagingbeyondthe actual container in which a medicinal product isstored and normally consists of non-contact packagingmaterials.Examplesincludeprintedorunprintedcartons, labels, leaflets or inserts, overwraps, and transitcontainers such as folding boxes. Tertiary packagingprotects the product and the packaging during storageanddistributionenvironments.Tertiarypackagingusually includes corrugated shipping containers, gaylordcontainers, and pallets. Pharmaceuticalpackaging1playsacriticalroleinmultiplemanufacturingstepsthatamedicinalproduct has to undergo in order to become a finishedproduct, including the filling and labeling processes.Thepharmaceuticalpackagingsystemthatcontainsand protects the finished product is referred to as thecontainer closure system, which is the sum of packagingcomponentsthattogethercontainandprotectthedosage form (ICH Q1A2). The packaging system includesboth the immediate packaging components that are indirect physical contact with the active pharmaceuticalingredient or finished drug product and outer packaging Thereareseveralmaterialsandformatsusedforpharmaceutical packaging, including different types ofplastics, glass, aluminum, paper board, etc.5 Regulatory and Technical Specifications for Pharmaceutical Packaging 1)Regulations for drug product packaging and Drug Administration (FDA), the manufacturer mustinclude documentation regarding the immediate andouter packaging subsystems in the application. The pharmaceutical industry is a highly regulated industry.Regulatory oversight is a means to ensure the qualityof drug products and, ultimately, the safe and effectiveuse of drug products by patients. To meet the regulatoryrequirements, it is the responsibility of the pharmaceuticalmanufacturertodesign,develop,andvalidatetheirproductsinaccordancewithaqualitymanagementsystem. The production process for the drug productanditspackagingmustbeconductedundergoodmanufacturing practice (GMP)6, which includes batchcontrol,processvalidation,andprocessqualification.Adherence to GMPs minimizes risks to the product andsubsequent risks to patients’ health. When an applicationfor a medicinal product is submitted to a regulatoryagency, such as a Marketing Authorization Application tothe European Medicines Agency (EMA)7,8, or a New DrugApplication to the Food For key examples of the regulatory guidance documentsand requirements governing the various aspects of drugproduct packaging, refer to Annex 1 of this document. The EU environmental regulatory landscape is evolvingrapidly, and there is also interplay with pharmaceuticalregulatory requirements. As pharmaceutical productshave a long development time and making changescan take several years, alignment between these tworegulatory spheres and the early publication of detailedguidance in delegated acts, e.g., for the EU Packagingand Packaging Waste Directive9(soon to be replaced bythe Packaging and Packaging Waste Regulation), are keyto ensuring EFPIA members can develop and implementstrategies responding to this dynamic landscape in time. Additionally, the immediate packaging system for thedrugproductisoftenrequiredtomaintainsterilityover the product shelf-life, in particular for injectableproducts. Pharmaceutical packaging often require ChildResistance features provided in primary or secondarypackagingbasedonrequirementandformats.The secondary packaging system requires proper labelingand serialization for functions such as identification andanti-counterfeit protection and often requires tamperevidence and child-resistant features. Thus, compared toother industries, such as cosmetics, food, and consumerproducts, pharmaceutical packaging has more stringentrequirements. 2)Technical specifications for pharmaceuticalpackaging To meet the regulatory requirements, United StatesPharmacopeia(USP)10andEuropeanPharmacop