The Changing Regulatory Landscape: How Drug Sponsors And CMOs Can Navigate It Together
The changing regulatory environment is shaping a new paradigm between drug sponsors and contract manufacturing organizations (CMOs). One key aspect is demonstrated quite nicely in a case study from February 2012 (read it here), when the FDA issued a warning letter to a contract manufacturing organization. The warning letter stated in part:
“In your response, you state that you have informed your clients on the importance of validating the methods, but they have chosen not to validate the methods. In addition, you state that you will inform them again in writing. Your response, however, is inadequate because you do not provide your firm's planned corrective actions for this CGMP violation. You are responsible for ensuring that the test methods used by your firm are validated.” (Emphasis added)
WHITE PAPERS & CASE STUDIES
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
Safeguarding The Global Pharmaceutical Supply Chain
In today’s highly competitive world of pharmaceutical development, researchers are increasingly turning to locations in Asia, Africa, Latin America, and Eastern Europe to conduct critical studies. The benefits are clear — progressive pharmaceutical legislation, a welcoming business environment, low-cost operations, skilled technical personnel and easy access to large pools of treatment-naïve patients.
Points To Consider When Developing A TMF (Trial Master File) Strategy
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
3 Tips For Safe, Secure Healthcare Shipping
All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical
5 Steps To A Reliable CAPA Process
It sounds simple, but lack of CAPA process documentation is a frequent reason for FDA 483 citations. Planning and organization lay the foundation for a strong CAPA program.
Mitigating Risk To Compliance With Integrated Quality Systems
The North American company in this white paper is a global leader in the field of filtration, separation and purification processing equipment for the pharmaceutical, biotech and industrial markets.
PRODUCTS & SERVICESMore Products & Services
LIFE SCIENCE WEBINARS
H.R. 3204 Drug Quality And Security Act
After so many years of struggling with how to comply with the California ePedigree requirement, we now need to know how to comply with the new federal requirement, H.R. 3204. This webinar will review DQSA requirements and timelines.
PAT-Enabled Process Optimization & Control
PAT is a risk-based strategy for designing, analyzing and controlling manufacturing processes. The Critical Process Parameters (CPPs) are identified in line with the definition of the Critical Quality Attributes (CQAs) of intermediates or final products. PAT offers a number of tools for measuring and controlling these CPPs.
Sartorius has the right choice of solutions you need: discover our world of Synchronized PAT Solutions.
Adoption of Membrane Chromatography in the Vaccine Industry
This educational webinar will discuss a high throughput process development (HTPD) approach using Mustang® membrane to define the optimal operating conditions resulting in the best quality of the virus product and demonstrate the predictive power of this methodology as applied to the purification of influenza virus.
Successfully Managing The Risks And Challenges Of Orphan Drugs
Orphan drugs, while life changing and in many cases life saving for patients, are fraught with challenges for biotech and pharmaceutical manufacturers. These range from locating the patients and their physician caregivers, to making sure the patients can pay for these therapies, to the overcoming the numerous risk points in moving very expensive and in most cases temperature controlled goods to patients all over the globe. This webinar looks at addressing these issues. The experienced speakers will guide you through the salient points and considerations when dealing with these challenges.