DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....Links to Worldwide GMP Codes and Regulations
The main prerequisite to work under cGMP is the right knowledge and understanding of the actual pharmaceutical regulations related to the specific sales market. This page summarizes the relevant links to regulatory agencies.
Below are links to the main international and national GMP Codes (Directives, Regulations) worldwide:
International Conference on Harmonization (ICH):
ICH Home Page
ICH Guidelines – Quality, Safety, Efficacy, Multidisciplinary,
including Common Technical Document (CTD) and Electronic Common Technical Document: (eCTD)
World Health Organization (WHO):
WHO: Home Page
WHO: Medicines (Medicines Policy and Standards…)
WHO: Medicines: Quality Assurance – Links to WHO Guidelines, including WHO GMP
WHO: Certification Scheme for the Quality of Pharmaceuticals
WHO: Prequalification Programme
World Trade Organization (WTO):
WTO: Home Page
WTO: TRIPS Gateway (Trade-Related Aspects of Intellectual Property Rights)
World Intellectual Property Organization (WIPO):
WIPO: Home Page
WIPO: Patent Search
Free Patents Online:
Free Patent Search, Free Patent PDF Downloads, Free Intellectual Property Alerts
- WHO – GMPs for Active Pharmaceutical Ingredients (APIs)
- WHO – GMPs for Finished Pharmaceutical Products
- WHO – GMPs for Herbal Products
- ICH – GMPs for Active Pharmaceutical Ingredients
- IPEC – GMPs for Pharmaceutical Excipients (available for purchase from this link to IPEC)
- Australia (TGA) – Code of GMPs
- Canada (HPFBI) – GMP Guidelines
- Europe (EU) – GMPs
- Japan (MHW) – GMPs (available for purchase in English from this link to Yakuji Nippo publishers)
- United States (FDA) – cGMPs for Finished Pharmaceutical Products
FDA Home Page
http://www.fda.gov
FDA Freedom of Information Index
http://www.fda.gov/foi/electrr.htm
FDA Warning Letters
http://www.fda.gov/foi/warning.htm
FDA Recalls
http://www.fda.gov/opacom/Enforce.html
FDA Inspection Guides
http://www.fda.gov/ora/inspect.ref/iglist.html
FDA Compliance References
http://www.fda.gov/ora/compliance.ref/default.htm
CFR Titles
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
U.S. Code
http://www.uscode.house.gov/usc.htm
CBER Guidelines
http://www.fda.gov/cher/guidelines.htm
CDER Guidelines
http://www.fda.gov/cder/guidance/index.htm
CDRH Guidelines
http://www.fda.gov/cdrh/ggpmain.html
CDRH Documents
http://www.fda.gov/cdrh/topindx.html
CGMP
http://www.fda.gov/cder/dmpq/index.htm
Investigation Operations Manual
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html
FDA Medwatch (Medical Product Reporting Program)
http://www.fda.gov/medwatch
FDA Phone Book (Staff Directory & Search Program for Employees of HHS-includes email addresses)
directory.psc.gov/employee.htm
GMP Regulations
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DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,
Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.
Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.
His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs
He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published worldwide .
He has good proficiency in Technology Transfer, Spectroscopy , Stereochemistry , Synthesis, Reactions in Org Chem , Polymorphism, Pharmaceuticals , Medicinal chemistry , Organic chemistry literature , Patent related site , Green chemistry , Reagents , R & D , Molecules , Heterocyclic chem , Sourcing etc
He suffered a paralytic stroke in dec 2007 and is bound to a wheelchair, this seems to have injected feul in him to help chemists around the world, he is more active than before and is pushing boundaries, he has one lakh connections on all networking sites, He makes himself available to all, contact him on +91 9323115463, amcrasto@gmail.com
New Drug Approvals 