Go back
Rules And Guidance For Pharmaceutical Manufacturers And Distributors 2022(1st Edition)
Authors:
Medicines And Healthcare Products Regulatory Agency
Cover Type:Hardcover
Condition:Used
In Stock
Include with your book
Free shipping: April 04, 2024Popular items with books
Access to 3 Million+ solutions
Free ✝
Ask 10 Questions from expert
200,000+ Expert answers
✝ 7 days-trial
Total Price:
$0
List Price: $103.84
Savings: $103.84(100%)
Book details
ISBN: 0857114395, 978-0857114396
Book publisher: Pharmaceutical Press
Get your hands on the best-selling book Rules And Guidance For Pharmaceutical Manufacturers And Distributors 2022 1st Edition for free. Feed your curiosity and let your imagination soar with the best stories coming out to you without hefty price tags. Browse SolutionInn to discover a treasure trove of fiction and non-fiction books where every page leads the reader to an undiscovered world. Start your literary adventure right away and also enjoy free shipping of these complimentary books to your door.
Rules And Guidance For Pharmaceutical Manufacturers And Distributors 2022 1st Edition Summary: The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as "The Orange Guide”, is the essential reference for all manufacturers and distributors of medicines in the UK. It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines. The new 11th edition has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020. Comprehensive new content Amended extracts from the Human Medicines Regulations 2012 relating manufacture, importation and assembly wholesale dealing brokering medicine manufacturing, importing and distributing active substances The Code of Practice for Qualified Persons, Guidance on Manufacture and Importation UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors or active substances UK guidance risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products. New guidance conditions of holding a manufacturing authorisation for investigational medicinal products, importing guidance for investigational medicinal products from countries on a list to Great Britain, Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight, list of approved countries for import, pharmacovigilance for wholesalers, the naming of sites on a wholesale dealer’s licence, self-inspection for wholesale dealers and the responsible person for import. Plus, revised GMP Annexes 2 and 17, and Commission guidance on principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, for medicinal products for human use and for active substances for medicinal products for human use. The Orange Guide is compiled by the Medicines and Healthcare products Regulatory Agency.
Customers also bought these books
Frequently Bought Together
Top Reviews for Books
Michelle Duran
( 4 )
"Delivery was considerably fast, and the book I received was in a good condition."