Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Stability requirements packaging changes

In addition, post-approval studies would also be necessary if there is any change to the processing or packaging of the drug product. More details of stability requirements and regulations are discussed in Chapter 5. [Pg.14]

Once several batches of raw materials have been reviewed and tested to demonstrate that they will conform with the functional and quality requirements, the full excipient and packaging specifications can be finalised. Excipient and pack performance should be evaluated from a stability evaluation of the product and feedback from experience in clinical trials. Ideally, the specifications should be finalised for the start of Phase III clinical trials. If for some reason, the excipient or packaging material has to be changed for Phase III supplies, then some or all of the steps involved in the selection of materials, compatibility and stability studies may have to be repeated. [Pg.318]

Changes in the packaging material, e.g., replacing plastics by glass, may require changes in the packaging procedure and therefore affect product stability. [Pg.126]

See other pages where Stability requirements packaging changes is mentioned: [Pg.107]    [Pg.22]    [Pg.66]    [Pg.1691]    [Pg.1691]    [Pg.123]    [Pg.716]    [Pg.95]    [Pg.97]    [Pg.100]    [Pg.490]    [Pg.99]    [Pg.387]    [Pg.421]    [Pg.563]    [Pg.573]    [Pg.575]    [Pg.587]    [Pg.53]    [Pg.54]    [Pg.244]    [Pg.211]    [Pg.121]    [Pg.9]    [Pg.1345]    [Pg.499]    [Pg.3349]    [Pg.1479]    [Pg.1690]    [Pg.28]    [Pg.42]    [Pg.302]    [Pg.507]    [Pg.63]    [Pg.26]    [Pg.604]    [Pg.244]    [Pg.2]    [Pg.90]    [Pg.195]    [Pg.95]    [Pg.96]    [Pg.102]    [Pg.103]    [Pg.104]   
See also in sourсe #XX -- [ Pg.102 ]



SEARCH



Packaging Requirements

Requirement changes

Stability requirements changes

© 2024 chempedia.info