Manufacturing authorisation shall mean the decision issued by the competent authority confirming that the manufacturer meets the conditions imposed on facility/ies for the production of a medicinal product and/or an investigational medicinal product with respect to premises, equipment and staff, and implements the principles and guidelines of Good Manufacturing Practice.
Manufacturer of a medicinal product shall mean a natural or legal person holding the manufacturing authorisation issued by the competent authority for the production of a medicinal product and/or an investigational medicinal product,
Good Manufacturing Practice shall mean the part of the quality assurance system which ensures that medicinal products are consistently and permanently produced and controlled in accordance with the relevant quality standards and in line with their intended purpose.
Pharmaceutical quality assurance means the total sum of organised activities and procedures with the objective of ensuring that medicinal products and investigational medicinal products are of the quality required for their intended use.
Individual parts of manufacturing of medicinal products include all operations from the supply of materials and products, the manufacture of medicinal products in the narrow sense, immediate packaging, outer packaging, quality control, batch release, import, storage and delivery to wholesale distributors.
The manufacturing of medicinal products in the narrow sense is divided according to manufacturing procedures and pharmaceutical forms and includes all manufacturing procedures from receiving starting materials, pharmaceutical and technological forming to packaging of medicinal products. Quality control is divided according to types of conducted tests and includes physical and chemical, biological and microbiological tests that may include microbiological testing of non-sterile and sterile products.
Certificate of good manufacturing practice is a certificate with limited validity term which represents final evaluation of compliance of a manufacturing process or its parts with the requirements of good manufacturing practice.
Manufacturing site means a defined area on the address where an integral manufacturing process or its individual parts are carried out.
The manufacturing site for active substances means a defined area on the address where an integral manufacturing process or its individual parts for active substances are carried out.
Documentation on the manufacturing site means a document developed by the manufacturer of the medicinal product which includes information on the quality management policy and all activities carried out on that manufacturing site.
A VMP manufacturer is a legal or natural person responsible for manufacturing and development of VMPs, their quality, safety and efficacy, depending on whether the VMP was manufactured by the manufacturer or a third party manufacturer.
Good manufacturing practice shall mean a part of the quality assurance system that ensures that products are consistently produced and controlled in accordance with the relevant quality standards appropriate to their purpose pursuant to regulations in force.
The pharmaceutical quality assurance system is the total sum of organised procedures within an entity which ensures that VMPs fulfil the quality requirements for their application.