Strengthening the Supply Chain for Pharmaceutical Ingredients - Pharmaceutical Technology

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 FDA, Draft Guidance for Industry–Contract Manufacturing–Arrangements for Drugs: Quality Agreements (Rockville, MD, May 2013).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


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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
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
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