Ensuring Sterility of Parenteral Products - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Ensuring Sterility of Parenteral Products
Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 37, Issue 4, pp. 62-67

References

1. The Local, “Dirty bottle likely source of bacteria in Mainz infant deaths,” Press Release, Aug. 27, 2010.

2. CBS News, “Lethal medicine linked to meningitis outbreak,” Press Release, Mar. 10, 2013.

3. R.P. Vonberg and P. Gastmeier: J. Hosp. Infect., 65 (1) 15-23 (2007).

4. C.M. Clothier, Clothier Report, Report of the Committee appointed to inquire into the circumstances, including the production, which led to the use of contaminated fluids in the Devonport section of Plymouth General Hospital, London: Her Majesty’s Stationery Office, 1972.

5. M.A. Kainer et al, N Engl J Med., 367 (23) 2194-2203 (2012).

6. B. Cox, A Lesson on Outsourcing: The NECC Fungal Meningitis Outbreak, The Gold Sheet, 46 (11) 1-6 (2012).

7. J.S. Eglovitch, Lack of Microbiological Controls Have Grave Consequences for Compounders, The Gold Sheet, 46 (11) 16-18 (2012).

8. B. Verjans and C. Reed, Biopharm. Intl., 25 (3) 46-58 (2012).

9. S.V.W. Sutton, J of GXP Compliance, 16 (4) 59-63 (2012).

10. D. Niccum and P. Hairston in Environmental Monitoring: A Comprehensive Handbook, Volume 6, Jeanne Moldenhauer, Ed. (PDA, Bethesda, MD 20814, 2012), pp. 219-240.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
24%
Attracting a skilled workforce
30%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
30%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here