Excipients and Quality Assurance

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New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

Pharmaceutical excipients are frequently manufactured in fine chemical or food chemical plants. The concepts of Good Manufacturing Process (as defined in 21 CFR 210) can be applied to excipients but the requirements of ICH Q7A (APIs) and 21 CFR paragraph 211 (medicinal products) are not appropriate to excipient manufacture. Many excipients are manufactured on dedicated plants using continuous processing. The concepts of the master batch manufacturing record and batch definition are different for such operations compared to the conventional batch manufacturing used to produce APIs and medicinal finished products.

FinnBrit Consulting can advise clients on issues relating to the application of the principles of GMP to excipient manufacture and supply. We also invite you to contact IBS Consulting in Quality LLC at http://ibsquality.com for assistance with excipient GMP compliance.

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