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Quality Management of Packaging Materials for Medicines and Medical Devices

In India, the regulations governing the Quality Management of Medicines and Medical Devices by Central Drugs Standards and Control Organization are through Indian Drugs Cosmetics and Medical Devices Act and Rules. The International Standards applicable for Quality Management of medical devices are ISO 13485 and the associated standards such as ISO 14971 on Risk Management, ISO 10993 on Biocompatibility evaluations, ISO 14155 on Clinical Evaluations. There are other international standards which are applicable depending on nature of medical devices. The regulations in other regional and national health care administrations are European Medical Device Regulations, Quality systems Regulations of USA, Medical Devices Regulations of Canada etc.

Packaging materials are integral part of medical devices and medicines, which are packed in them. The packaging materials are quite a constituent part of ensuring the efficacy, safety and reliability of medicines and medical devices. The packaging materials serve as containers and closures for the medicine and medical devices, offer protection from mechanical damage, environmental factors and ensure stability of the medicine and medical devices contained in them.

Therefore, it is important that the packaging materials are designed, manufactured and supplied to manufacturers of medicines and medical devices according to well established quality management systems and medicines and medical devices are packed in them and processed as per the requirements. In this article, an overview of the Quality Management Systems applicable for packaging materials are described.

Classification and types of packaging materials

The packaging materials are made of a variety of materials, such as glass, plastics, paper, laminates, rubber, other polymers and composite materials. From the perspective of Quality Management Systems, the packaging materials could be classified as primary, secondary and tertiary packaging materials. The primary packaging materials are those which are in direct contact with the medical device or medicine contained in them. Examples of primary packaging materials are: containers such as plastic containers, bottles, vials, ampuls, aluminium foils, foil laminates, paper laminates, plastic laminates, pouches etc. When bottles or vials are used, the corresponding closure systems also form the primary packing materials. They perform the functions of being the containers for the medicines and medical devices, ensuring ease of administration as per therapeutic indication, facilitating handling and distribution of the contents in such way that the contents are protected from environmental factors, contamination including chemical, particulate and biological contaminants, and ensuring stability of the contents. The labelling information as per the regulatory requirements are either printed or affixed as label on the primary packing materials. It is important that the material and design of primary packing materials are compatible with the product contained in them, with respect to physical, chemical and sterility requirements of the products. They should be tamper proof and provide adequate protection against misuse of and damage to the contents.

The secondary packaging materials are those in which the medicines and medical devices in their primary pack are assembled in number of units appropriate for handling, storage and distribution to wholesale, retail and individual users and customers. They should have appropriate labeling information either printed or affixed on them. They could be made of cardboard and fibreboard, plastic containers or corrugated boxes.

The tertiary packaging materials are those in which the secondary packs are assembled and shipped to destinations for further distribution in supply chain. They are usually made of corrugated boxes.

Quality Management requirements for packaging materials:

The Quality Management packaging materials is interrelated to the quality management systems of medical devices and medicines which are contained in them. The quality management systems appropriate for packaging materials is ISO 9001 -Quality management systems - Requirements, interface with ISO 13485 Medical devices — Quality management systems - Requirements for regulatory purposes and in addition, for primary packaging materials ISO 15378 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP). In the following sections of this article, essential principles of the above standards are described.

Implementation of Quality Management System in compliance with the requirements of ISO 9001:

The manufacturers of packaging materials are well recommended to have a quality management system in compliance with the requirements of ISO 9001: 2015. Though the compliance with the requirements of ISO 9001 is a voluntary standard, most of the manufacturers of medicines and medical devices expect the suppliers of packaging materials to implement a QMS in compliance with the requirements of ISO 9001. The compliance is verified by the manufacturers of medicines and medical devices by conducting audits of the manufacturer of packaging materials and or requiring the compliance to ISO 9001 be demonstrated by certification by a certification body. It is important that the certifying body be accredited to a national accreditation body, because the certification by unaccredited body is not of any recognition and does not add value to business by the manufacturer of packaging materials.