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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
September 02, 2021
Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.
August 31, 2021
It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
August 24, 2021
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
August 09, 2021
KVK Tech is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL because of customer complaints of unusual grittiness in the product.
August 06, 2021
Syntec receives warning letter where FDA finds deviations from CGMP for APIs.
August 03, 2021
A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.
August 02, 2021
Consider how to apply ALCOA+ to a building management system in non-clinical laboratories.
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
New challenges arise in extractable and leachable studies for cell and gene therapy products.