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.)
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. Xο― ο― οΎ
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. Xπ π πΉ
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. Xβ
Appears in 1 contract
Samples: Quality Agreement
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 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.
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Samples: www.socma.org