An NSF International Company Mr Frank H Murphy
Consultant
MS Organic Chemistry
- [email protected]
- + 1 857 277 0060
Frank has over thirty-five years’ experience with The Dow Chemical Company (Dow) in R&D, Product Stewardship and Regulatory Affairs. The last ten years at Dow as an internal consultant on issues associated with regulatory compliance of Dow’s products in Cosmetics, Feed, Food and Pharmaceutical areas in the USA. Some of the areas covered were US Food and Drug Administration (FDA) regulations compliance including DMF filing and maintenance and the required registrations activities under GDUFA and GMP compliance, International Conference on Harmonization (ICH) guidance documents, United States Pharmacopeia (USP) monograms, kosher certification and halal certification programs. Managed the content of a standardized customer response database that allowed routine customer inquiries in the Cosmetics, Feed, Food and Pharmaceutical areas to be answered without involving regulatory personnel. Evaluated and approved the composition of products used as indirect food additives (food contact), direct food additives, excipients and APIs for compliance with applicable US FDA Code of Federal Regulations (CFR).
Lead Good Manufacturing Practices (GMP) implementation and auditing for Dow globally, this includes GMPs for active pharmaceutical ingredients, excipients, direct food additives and food contact materials. Incorporated GMP guidelines into the Dow’s operating discipline management system (ODMS) so that GMP is now part of the normal quality management system for plants that manufacture materials covered by GMP.
Member of International Pharmaceutical Excipient Council taking part in all major committees, co-author on numerous of IPEC’s current and underdevelopment guidance documents. Attended the IPEA Excipient GMP Auditing Workshop and the EXCiPACT™ TRAINING Workshop, Pharmaceutical Excipient GMP/GDP Standards, achieving a pass-rate in the post-course examination.
