Control Strategies for Drug Product Continuous Direct Compression—State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products

Author:

Almaya Ahmad,De Belder Lawrence,Meyer Robert,Nagapudi Karthik,Lin Hung-Ren Homer,Leavesley Ian,Jayanth Jayanthy,Bajwa Gurjit,DiNunzio James,Tantuccio Anthony,Blackwood Dan,Abebe Admassu

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference25 articles.

1. ASTM E2968–Standard Guide for Application of Continuous Processing in the Pharmaceutical Industry.

2. Modernizing pharmaceutical manufacturing: from batch to continuous production;Lee;J Pharm Innov.,2015

3. International Conference on Harmonisation. Guidance for Industry Q10 Pharmaceutical Quality System, April 2009, 17.

4. ASTM E2587–Standard Practice for Use of Control Charts in Statistical Process Control.

5. ASTM E2281–Standard Practice for Process and Measurement Capability indices.

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