Pharmaceutical Quality Systems - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Quality Systems
Myth versus Reality: What does Q10 implementation really mean for my company?


Pharmaceutical Technology
Volume 32, Issue 8

Myth: Quality systems do not apply to biologics or medical devices.

Reality: With regard to inspections from a US perspective, Q10 applies equally to drugs, biologics, and new products. It is not applicable to device inspections, however, it serves to make the approaches more parallel. —J.C.F.

Myth: My company has not caught up with Q8 or Q9, we can't possibly start implementing Q10.

Reality: While Q8, Q9, and Q10 are intended to be a trilogy, it is possible to implement Q10 without having implemented Q8 (i.e., a company could decide not to adopt quality-by-design [QbD] but to still have a modern, effective quality system with management commitment to quality, policies for risk management, and oversight of outsourcing activities and knowledge management, CAPA, etc). Looking ahead, Q11 Development and Manufacture of Drug Substances, has entered the harmonization process. Q11 is an "enabler" for Q8 Pharmaceutical Development. If active pharmaceutical ingredient manufacturers do not adopt QbD, it is going to be almost impossible for the drug product manufacturer to do so. —K.G.

Source: The above questions and responses were compiled from the June 2008 Quality Systems in a Global Market webcast (4) as well as from questions posed to the webcast panelists after the event.

For more on this topic, see All Roads Now Lead to Quality Systems


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.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
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
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here