Batch Certificate definition
Batch Certificate means (a) a certificate issued by the manufacturer of a lot or batch of a drug that is exported from the country of manufacture under a mutual recognition agreement, which certificate includes (i) a detailed description of such drug, (ii) analytical test methods and results performed on such lot or batch, (iii) addresses of the buildings where such lot or batch was manufactured, packaged, labeled and tested, (iv) a master production document for such drug, and (v) certification that Good Manufacturing Practices were followed; or (b) such other consistent, but more detailed definition as provided in the Quality Policy Manual.
Batch Certificate means a certificate issued by the Bureau certifying or attesting that a particular import consignment or shipment of the commodity as sampled and attested conforms to the specified Tanzania Standards or International or foreign standards recognized by the Bureau;
Batch Certificate or “Certified Batch” means that (i) each Batch of API or Product has undergone a full qualitative and quantitative analysis of API and other relevant constituents to ensure that the quality of the API and Product complies with the requirements of the marketing authorization of the importing country (ii) the Batch Certificate must attest that the Batch meets the specifications and has been manufactured in accordance with the marketing authorization of the importing country, detailing the specifications of the API / Product, the analytical methods referenced, the analytical results obtained, and containing a statement that the batch processing, packaging and quality control records were reviewed and found in conformity with GMP and (iii) a completed Batch Disposition Sheet that is approved by AMICUS, which approval will not be unreasonably withheld, delayed, or conditioned, and for which an example is set forth in Appendix G. Batch Disposition Sheet.
Examples of Batch Certificate in a sentence
On Delivery, Supplier shall provide to Purchaser a Batch Certificate and a Certificate of Analysis for the Drug Product Delivered or a Certificate of Analysis for the Commercial API Delivered, as applicable, and any other documentation required to be provided on Delivery as expressly set forth in the Quality Agreement or as mutually agreed by the Parties from time to time.
More Definitions of Batch Certificate
Batch Certificate means the certification of the Batch signed by a Qualified Person pursuant to Clause 8
Batch Certificate means the signed statement by a representative of Supplier with appropriate authority to formalize the batch certification to accompany each batch of Drug Product Delivered to Purchaser, as further defined in the Quality Agreement, which certifies that such Drug Product has been Manufactured and tested in compliance with cGMP and the applicable Specification;