Supplements to the PQRI Workshop Results - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Supplements to the PQRI Workshop Results

Pharmaceutical Technology


Where an official product purports to conform to the standards of the USP- NF the manufacturer must assure that each batch conforms to each monograph requirement. This assurance must be achieved by appropriate means, including process validation and controls and end product testing. Therefore, in some cases it may not be necessary for a manufacturer to test each batch for each monograph requirement.

Sec. 420.500 - Interference with Compendial Tests (CPG 7132a.01)

A compendial drug product containing an added substance which interferes with the compendial assay of the product would be adulterated under 501(b) of the Act.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
Source: Pharmaceutical Technology,
Click here