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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustrySpecifications

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical... [Setting specifications for drug substances and drug products is a complex process. Many factors must be considered such as patient requirements, clinical and development experience, and global regulatory expectations. The specification setting process starts with determining the critical attributes and parameters of the product and manufacturing process that need to be controlled to ensure a high quality, safe, and efficacious product for the patient. During the development process, risk assessmentsRisk assessments, prior knowledge, and experimentation should yield which attributes and parameters need to be controlled and the range over which they can vary and still produce a high quality product. The next step is to understand the global regulatory expectations for setting specifications including compendial requirements. There must be an understanding of the markets the product will be sold in since regulatory requirements vary from market to market. International Conference on Harmonization Q6A (1999a) and International Conference on Harmonization Q6B (1999b) represent efforts to harmonize expectations around specification setting. A review of regulatory and compendial expectations will likely add attributes to the list that require specifications. It will also be important to understand which drug product attributes must meet specifications throughout the shelf life of the product.] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical IndustrySpecifications

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Publisher
Springer International Publishing
Copyright
© Springer International Publishing AG 2017
ISBN
978-3-319-50184-0
Pages
227 –267
DOI
10.1007/978-3-319-50186-4_7
Publisher site
See Chapter on Publisher Site

Abstract

[Setting specifications for drug substances and drug products is a complex process. Many factors must be considered such as patient requirements, clinical and development experience, and global regulatory expectations. The specification setting process starts with determining the critical attributes and parameters of the product and manufacturing process that need to be controlled to ensure a high quality, safe, and efficacious product for the patient. During the development process, risk assessmentsRisk assessments, prior knowledge, and experimentation should yield which attributes and parameters need to be controlled and the range over which they can vary and still produce a high quality product. The next step is to understand the global regulatory expectations for setting specifications including compendial requirements. There must be an understanding of the markets the product will be sold in since regulatory requirements vary from market to market. International Conference on Harmonization Q6A (1999a) and International Conference on Harmonization Q6B (1999b) represent efforts to harmonize expectations around specification setting. A review of regulatory and compendial expectations will likely add attributes to the list that require specifications. It will also be important to understand which drug product attributes must meet specifications throughout the shelf life of the product.]

Published: Feb 17, 2017

Keywords: Acceptance limits; Blend uniformity; Compendial tests; Composite assay; Dissolution; Percentiles; Process capability; Protein concentration; Release and shelf life limits; Similarity factor (f 2 ); Simulation; Three sigma limits; Tolerance intervals; Uniformity of dosage units

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