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© 2022 MJH Life Sciences and BioPharm International. All rights reserved.
© 2022 MJH Life Sciences™ and BioPharm International. All rights reserved.
June 01, 2022
Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.
May 16, 2022
To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.
May 11, 2022
The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.
May 01, 2022
Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.
Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.
April 25, 2022
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
April 15, 2022
Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.
April 12, 2022
FDA is reviving efforts to establish a Quality Management Maturity program.
April 08, 2022
Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.
April 01, 2022
Data may be used to improve (or remove) a corrective action/preventive action.