Standards & Regulations

Aug 02, 2018
Pharmaceutical Technology
Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.
Jul 18, 2018
By Pharmaceutical Technology Editors
Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.
Jul 12, 2018
By Pharmaceutical Technology Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 02, 2018
Pharmaceutical Technology
EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
Jun 01, 2018
Pharmaceutical Technology
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
May 14, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
May 14, 2018
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
May 11, 2018
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
May 07, 2018
Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.
May 02, 2018
Pharmaceutical Technology
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning.
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