Common use of Batch certification Clause in Contracts

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. 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 authorisationMarketing Authorization/product approvalProduct 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 authorisationMarketing Authorization/product approvalProduct 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).