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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here