BASF Receives EXCiPACT Certification - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

BASF Receives EXCiPACT Certification


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 10, Issue 2

BASF has received the EXCiPACT Certificate for pharmaceutical excipients for the group of polyvinylpyrrolidone (Kollidon) polymers, produced in Ludwigshafen, Germany. The certificate was issued by mdc medical device certification GmbH, one of EXCiPACT’s internationally-recognized certification bodies. The certification demonstrates that BASF manufacturers and distributes pharmaceutical excipients according to the EXCiPACT GMP.

The EXCiPACT scheme can be made available when the regulators in the EU and USA require the holder of the marketing authorization for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients, BASF reports. The US Food and Drug Administration and the European Medicines Agency require drug producers to qualify excipient suppliers and suppliers must be prepared to receive increasing numbers of audits from their customers. EXCiPACT helps to avoid additional audits in a cost-effective manner for all parties concerned because one single audit will be all it takes to prove an excipient complies with current GMP and GDP requirements, according to a BASF statement.

BASF is the third company that has been certified by EXCiPACT according to the EXCiPACT Association’s Global Steering Committee. BASF will conduct recertification audits every three years, plus annual surveillance audits to ensure the continued safety and quality of excipients.

Source: BASF

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: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here