Solid oral dose process validation.....
Pazhayattil, Ajay.

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  • Solid oral dose process validation.. Volume Two,. Lifecycle approach application
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Solid oral dose process validation./ by Ajay Pazhayattil ... [et al.].
    其他題名: Lifecycle approach application
    其他作者: Pazhayattil, Ajay.
    出版者: Cham :Springer International Publishing : : 2019.,
    面頁冊數: xii, 108 p. :ill., digital ;24 cm.
    內容註: Preface, Introduction, Chapter 1: Stage 1 Quality by Design Product Development QbD product development methodologies -- Chapter 2: Stage 1 Scale Up, Tech Transfer Process -- Considerations for process scale up and transfer -- Chapter 3: Stage 2 Batch determination, Sampling & Testing Plan -- PPQ batch determination method, scientifically supported sampling and testing plans -- Chapter 4: Stage 3A Continued Process Verification -- Stage 3A assessment methodology for newly launched products -- Chapter 5: Stage 3B Continued Process Verification -- Routine CPV monitoring plan for commercial products.
    Contained By: Springer Nature eBook
    標題: Solid dosage forms. -
    電子資源: https://doi.org/10.1007/978-3-030-27484-9
    ISBN: 9783030274849
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