Quality

Apr 13, 2017
At CPhI North America 2017, the US Pharmacopeial Convention will be discussing its upcoming revision and modernization of the standards for elemental and organic impurities.
Apr 12, 2017
By Pharmaceutical Technology Editors
The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.
Apr 12, 2017
By Pharmaceutical Technology Editors
The agency cited the company’s India facility for batch failures and data integrity problems.
Apr 10, 2017
Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.
Apr 07, 2017
By Pharmaceutical Technology Editors
The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.
Apr 02, 2017
Pharmaceutical Technology
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics
Apr 02, 2017
Pharmaceutical Technology
Industry fears limited benefits as FDA readies voluntary data tracking program.
Apr 02, 2017
Pharmaceutical Technology
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
Apr 02, 2017
Pharmaceutical Technology
New study shows China biopharma companies face staffing shortages.
Apr 02, 2017
Pharmaceutical Technology
The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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