Pharmaceutical Technologist - January 2008 - (Page 24)
Newcombe and Watson development vary from company to company and product to product. An applicant might choose either an empirical approach or a more systematic approach (Table 1). A systematic approach to development (also defined as QbD) can include, for example, incorporation of prior knowledge, results of studies using DoE, use of quality risk management, and use of knowledge management throughout the life cycle of the product. Product and process understanding can be updated with the knowledge gained during the product life cycle.6 Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. To design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analysing for chemical attributes, such as identity and purity is mature, certain physical attributes (i.e., solid form, particle size, and particle shape) are more difficult to analyse and control. The proposed benefits of PAT to the industry are reduced time-to-market and, potentially, a reduced regulatory burden for post-approval changes. The ultimate goals are continuous process Table 1 Differing approaches to pharmaceutical development.* Aspect Overall pharmaceutical development Minimal approach • Mainly empirical • Development research often conducted one variable at a time Enhanced, quality by design approach • Systematic, relating mechanistic understanding of input material attributes and process parameters to drug product CQAs • Multivariate experiments to understand product and process • Establishment of design space • PAT tools utilized Manufacturing process • Fixed • Validation primarily based on initial full-scale batches • Focus on optimization and reproducibility • Adjustable within design space • Life cycle approach to validation and ideally, continuous process verification • Focus on control strategy and robustness • Use of statistical process control methods • PAT tools utilized with appropriate feed forward and feedback controls • Process operations tracked and trended to support continual improvement efforts post-approval. Process controls • In-process tests primarily for go/no go decisions • Off-line analysis Product specifications • Primary means of control • Based on batch data available at time of registration • Part of the overall quality control strategy • Based on desired product performance with relevant supportive data Control strategy • Drug product quality controlled primarily by intermediate and end product testing • Drug product quality ensured by risk-based control strategy for well understood product and process • Quality controls shifted upstream, with the possibility of real-time release or reduced end-product testing Life cycle management • Reactive (i.e., problem solving and corrective action) • Preventive action • Continual improvement facilitated * Table is abstracted from ICH Q8 Annex (6). 24 JANUARY 2008 PHARMACEUTICAL TECHNOLOGIST
Table of Contents for the Digital Edition of Pharmaceutical Technologist - January 2008
Pharmaceutical Technologist - January 2008
Contents
Editor's Comment
News
Morpheus
Market Watch
Lagging Japanese Drug R&D
Croatia’s Innovation
Integrating PAT with Biopharmaceutical Development and Manufacture
Q&A
Pharmaceutical Technologist - January 2008
Pharmaceutical Technologist - January 2008 - Pharmaceutical Technologist - January 2008 (Page 1)
Pharmaceutical Technologist - January 2008 - Pharmaceutical Technologist - January 2008 (Page 2)
Pharmaceutical Technologist - January 2008 - Contents (Page 3)
Pharmaceutical Technologist - January 2008 - Contents (Page 4)
Pharmaceutical Technologist - January 2008 - Editor's Comment (Page 5)
Pharmaceutical Technologist - January 2008 - News (Page 6)
Pharmaceutical Technologist - January 2008 - News (Page 7)
Pharmaceutical Technologist - January 2008 - News (Page 8)
Pharmaceutical Technologist - January 2008 - News (Page 9)
Pharmaceutical Technologist - January 2008 - Morpheus (Page 10)
Pharmaceutical Technologist - January 2008 - Morpheus (Page 11)
Pharmaceutical Technologist - January 2008 - Market Watch (Page 12)
Pharmaceutical Technologist - January 2008 - Market Watch (Page 13)
Pharmaceutical Technologist - January 2008 - Lagging Japanese Drug R&D (Page 14)
Pharmaceutical Technologist - January 2008 - Lagging Japanese Drug R&D (Page 15)
Pharmaceutical Technologist - January 2008 - Lagging Japanese Drug R&D (Page 16)
Pharmaceutical Technologist - January 2008 - Lagging Japanese Drug R&D (Page 17)
Pharmaceutical Technologist - January 2008 - Croatia’s Innovation (Page 18)
Pharmaceutical Technologist - January 2008 - Croatia’s Innovation (Page 19)
Pharmaceutical Technologist - January 2008 - Croatia’s Innovation (Page 20)
Pharmaceutical Technologist - January 2008 - Croatia’s Innovation (Page 21)
Pharmaceutical Technologist - January 2008 - Croatia’s Innovation (Page 22)
Pharmaceutical Technologist - January 2008 - Integrating PAT with Biopharmaceutical Development and Manufacture (Page 23)
Pharmaceutical Technologist - January 2008 - Integrating PAT with Biopharmaceutical Development and Manufacture (Page 24)
Pharmaceutical Technologist - January 2008 - Integrating PAT with Biopharmaceutical Development and Manufacture (Page 25)
Pharmaceutical Technologist - January 2008 - Integrating PAT with Biopharmaceutical Development and Manufacture (Page 26)
Pharmaceutical Technologist - January 2008 - Q&A (Page 27)
Pharmaceutical Technologist - January 2008 - Q&A (Page 28)
Pharmaceutical Technologist - January 2008 - Q&A (Page 29)
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