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August 02, 2019
Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.
Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
Senior managers of OTC drug companies are on a learning curve, as FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
August 01, 2019
Performing a compliance gap assessment and focusing on six key factors in your facility’s process definition and controls can help your facility pass its next FDA inspection with flying colors.
July 31, 2019
CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.
July 26, 2019
EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.
July 23, 2019
Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.
July 17, 2019
MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.
As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?