Common use of Documentation and Records Clause in Contracts

Documentation and Records. 5.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. X

Appears in 3 contracts

Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)

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Documentation and Records. 5.01 8.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. X  οƒΎ

Appears in 2 contracts

Samples: Quality Agreement, Quality Agreement

Documentation and Records. 5.01 8.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. X🞏 🞏 πŸ—Ή

Appears in 1 contract

Samples: Quality Agreement

Documentation and Records. 5.01 8.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. Xβœ”

Appears in 1 contract

Samples: Quality Agreement

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Documentation and Records. 5.01 6.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. Xο€Ž x

Appears in 1 contract

Samples: Supply Agreement (Mannatech Inc)

Documentation and Records. 5.01 8.01 Have a controlled system to initiate, review, revise, approve, obsolete and archive all Good Manufacturing Practices documentation. At a minimum, all production, control, and distribution records Records should be retained for at least 1 one (1) year after the expiry date of the batch. For APIs Product with a retest datesdate, records Records should be retained for at least 3 three (3) years after the batch is completely distributed. X.

Appears in 1 contract

Samples: www.socma.org

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