Strengthening the Supply Chain for Pharmaceutical Ingredients - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Strengthening the Supply Chain for Pharmaceutical Ingredients
The US and EU move forward with measures to fortify the pharmaceutical supply chain.


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 9, Issue 7

References
1. EMA, "Falsified Medicines," http://www.emaeuropa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8, accessed June 16, 2013.

2. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).

3. FDA, "FDA Obtains Waiver from European Commission to Facilitate Export for US Pharmaceutical Manufacturers," Press Release (June 21, 2013).

4. EMA, Good Distribution Practice of Medicinal Products for Human Use (London, March 2013).

5. EMA, "Key Deliverable of Falsified Medicines Directive Achieved," Press Release (Apr. 8, 2013).

6. FDA, "Food and Drug Administration Safety and Innovation Act Title VIIDrug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments," Fed. Regis. 78 (118) 36711-36715 (June 19, 2013).

7. FDA, Draft Guidance for Industry–Contract Manufacturing–Arrangements for Drugs: Quality Agreements (Rockville, MD, May 2013).

8. ICH, Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Geneva, 2000).

9. ICH, Q9 Qualified Risk Management (Geneva, 2005).

10. ICH, Q10 Pharmaceutical Quality Systems (Geneva, 2008).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here