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Posted On: 09/01/2021 9:16:32 PM
Post# of 36564
Actually, you are incorrect. If you look up the definition of quality agreement:
Based on below, they reached the agreement for PPD to help them with what they need in the respect of, which is detailed there.
A Quality Agreement is a document that defines both specific quality parameters for a project AND which party is responsible for the execution of those parameters. The level of detail may vary depending on the developmental stage of the project.
What is the FDA position on quality agreements?
The FDA’s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidance published in 2016. The guidance explicitly states that manufacturing activities are the most important element of a quality agreement.
What do quality agreements do for an excipient?
They enable excipient users and suppliers to create a quality partnership between the two companies. Quality agreements are legally binding agreements that are mutually negotiated between users and suppliers of excipients. They are intended to be an agreement between quality departments.
Based on below, they reached the agreement for PPD to help them with what they need in the respect of, which is detailed there.
A Quality Agreement is a document that defines both specific quality parameters for a project AND which party is responsible for the execution of those parameters. The level of detail may vary depending on the developmental stage of the project.
What is the FDA position on quality agreements?
The FDA’s current position on quality agreements is outlined in the “Contract Manufacturing Arrangements for Drugs: Quality Agreements” guidance published in 2016. The guidance explicitly states that manufacturing activities are the most important element of a quality agreement.
What do quality agreements do for an excipient?
They enable excipient users and suppliers to create a quality partnership between the two companies. Quality agreements are legally binding agreements that are mutually negotiated between users and suppliers of excipients. They are intended to be an agreement between quality departments.
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