Define: Certificate of Manufacture

How is Certificate of Manufacture defined in a legal contract?

• Certificate of Manufacture means a document which verifies each lot of a product is made and tested in line with specifications, Good Manufacturing Practices (GMPs), the finalized Master Batch Records and other relevant regulatory documents. Both the Certificate of Manufacture and Certificate of Analysis are delivered as one singular document. Seen in 2 SEC filings
• Certificate of Manufacture means a document that affirms a specific batch of a product has been processed in compliance with GMPs and the final executed batch production and quality control records. Seen in 2 SEC filings
• Certificate of Manufacture means a document issued by the manufacturer stating that a Batch has been processed and/or packaged in accordance with registration documents and the Master Batch Record, and is in alignment with GMPs. Seen in 2 SEC filings
• Certificate of Manufacture means a statement indicating that the lot of product was manufactured in conformity with cGMPs and the batch record. It enumerates any incident reports and investigations associated with the lot of Product. Seen in 1 SEC filing

Note: The Genie AI Legal Assistant pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.

Search EDGAR for 'Definitions of certificate of manufacture' yourself to verify these results. We are always keen to point people to source documents.

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Which definition should you use?

🤔 Our AI Legal Assistant has combined and improved the above descriptions to create market-standard 'Genie definitions' below, with guidance on which documents and which industry to use for each.

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Genie Definition 1

• Certificate of Manufacture means a document affirming a product batch has been processed in line with specifications, GMPs, and master batch records.

Relevant Contract Types

• Manufacturing Agreement
• Supply Agreement
• Product Development Agreement

Relevant Circumstances

• Establishing manufacturing or production processes
• Quality assurance checks
• Verification of compliance with industry regulations or standards

Relevant Sectors

• Pharmaceutical
• Automotive
• Food and Beverage
• Electronics

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Genie Definition 2

• Certificate of Manufacture means an authenticated statement, listing any incidents or investigations linked with a product batch, conforming to cGMPs and batch records.

Relevant Contract Types

• Quality Assurance Agreement
• Vendor Agreement
• Distribution Agreement

Relevant Circumstances

• Ensuring quality control across supply chains
• Addressing any complications or issues during the manufacturing process
• Compliance with regulatory expectations

Relevant Sectors

• Healthcare
• Cosmetics
• Aerospace
• Chemical

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