This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.
|Articles|November 15, 2016
- Pharmaceutical Technology-11-15-2016
- Volume 2016 eBook
- Issue 3
Extending QMS to Contract Partners
Author(s)Agnes Shanley
Advances in cloud-based IT and user interfaces make it easier to collaborate, but a strong foundation, based on knowledge of data and risk management principles, is needed first.
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This interview with Patricia Santos Serrao, director of clinical and regulatory solutions, and Matt Lowe, executive vice president of Master Control, discusses the roots of problems with corrective and preventive action (CAPA) and documentation of standard operating procedures (SOPS), and how Quality Management Systems (QMS) software is being improved to address them, and to make it easier to collaborate and communicate with contract partners.
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Too Much by Half: Misapplication of the Half-Cycle Approach to Sterilizationalmost 10 years ago
Investigation Effectiveness Drives Human Performance Excellencealmost 10 years ago
Is Global Regulatory Gridlock Slowing Modernization?almost 10 years ago
Paperless Batch Records for the Massesalmost 10 years ago
Could Greater Transparency Improve Pharmaceutical Quality and Compliance?almost 10 years ago
Ensuring Quality in Pharmaceutical Raw Materialsalmost 10 years ago
Microbiological Testing: Time is of the EssenceAdvertisement
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