Statistical Implications of the CGMPs: A 30-Year Retrospective - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe
Statistical Implications of the CGMPs: A 30-Year Retrospective
This article looks at the current good manufacturing practice regulations from a statistical perspective while addressing their requirements and implications and inviting the industry to assess its past performance in meeting the regulations.
Jul 2, 2007
By: Lynn D. Torbeck
Pharmaceutical Technology

« Previous
12345

13. ICH Q6A Specification: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances and ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (International Conference on Harmonization, 1999).

14. ICH Q8 Pharmaceutical Development (International Conference on Harmonization, Geneva, Switzerland, 2006)

15. ICH Q9 Quality Risk Management (International Conference on Harmonization, Geneva, Switzerland, 2006)

16. FDA/CDER/CVM/ORA, Guidance for Industry:PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, 2004).

« Previous
12345

ADVERTISEMENT

blog comments powered by Disqus
About the Author

Lynn D. Torbeck

international consultant and trainer
http://www.torbeck.org

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314. Articles by Lynn D. Torbeck
LCGC E-mail Newsletters

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

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
18%
To all process for new products only
13%
To select process for new products only
22%
To select processes for both new and legacy products
22%
Do not use QbD
24%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>
Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Featured Jobs

More Jobs
Source: Pharmaceutical Technology, 7/2/2007
 Click here