Batch certification Clause Samples
The batch certification clause establishes the requirement for certifying groups of products or services together as a single unit, rather than individually. In practice, this means that once a batch—such as a shipment of manufactured goods or a set of deliverables—meets specified standards or passes inspection, a certificate is issued covering the entire group. This approach streamlines the certification process, reduces administrative burden, and ensures consistency across all items in the batch, ultimately facilitating efficient quality control and compliance verification.
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).
7.6.2. A copy of one complete Batch Record shall be sent to NOVARTIS annually and upon request.
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 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.
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.