Batch certification. 7.6.1. After detailed review of the batch documentation of each batch, GW is responsible to ensure that a Certificate of Compliance with GMP (CoC, confirmation statement) is included or attached to the CoA, Deviation Statement if applicable, that is signed by a Quality Assurance person (Qualified Person).
Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer (‘self certification’) after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation/product approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products/drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant marketing authorisation/product approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMPs. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In the European Community the ‘qualified person’ is referred to in Article 21 of Directive 75/319/EEC, and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 (1).
Batch certification. 4. Each batch exported shall be acc ompanied by a batch certificate prepared by the manufa cturer (self-certification) after a full qualita tive analysis, a quantitative analysis of all the active c onstituents and all the other tests or checks necessary to ensure the quality of the product in acc ordance with the requirements of the marketing authorization. This certificate shall attest that the batch meets its specifications and shall be kept by the importer of the batch. It will be made available upon request of the competent authority. When issuing a certificate, the manufa cturer shall take account of the provisions of the current WHO certification scheme on the quality of pharmaceutic al products moving in international commerce. The certificate will detail the agreed specifications of the product, the reference of the analytic al methods and the analytical results. It shall contain a statement that the batch processing and packaging rec ords were reviewed and found to be in conformity with GMP. The batch certificate shall be signed by the person responsible for releasing the batch for sale or supply, i.e. in the European Community the "qualified person" referre d to in Article 21 of Second Council Directive 75/319/EEC of 20 May 1975 on the approxim ation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In Australia, the responsible persons are for manufa cturing quality control as specified in the Therapeutic Goods Regulation 19(b) under the Therapeutic Goods Xxx 0000.
Batch certification. If required, upon reception of the above mentioned elements, CA shall perform the certification of the Product (or group of products included in the shipment) for the territory. Authorization to release product for the territory, sale should be provided directly and solely by CA. A certificate authorizing shipment to customer will be issued by CA.
Batch certification. Each batch exported will be accompanied by a batch certificate issued by the manufacturer ("self certification") after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the Marketing Authorisation / Product Approval. When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products / drugs moving in international commerce. This certificate will attest that the batch meets the specifications and has been manufactured in accordance with the relevant Marketing Authorisation / Product Approval, detailing the specifications of the product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing and packaging records were reviewed and found in conformity with GMP. The batch certificate will be signed by the person responsible for releasing the batch for sale or supply. In Switzerland the qualified person is referred to in article 10 of the IOCM-Manufacturing Directive (May 18, 1995, No. 241.11) and in articles 4 and 5 of the Ordinance on immunobiological products and in Canada, the nominated person responsible for manufacturing quality control is as specified in the Food and Drug Regulations, Division 2, Section C.02.014 1.
