Regulatory/GMP Compliance

Jun 02, 2018
Pharmaceutical Technology
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Jun 02, 2018
Pharmaceutical Technology
PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.
Jun 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.
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 31, 2018
By Pharmaceutical Technology Editors
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
May 30, 2018
By Pharmaceutical Technology Editors
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.
May 30, 2018
By Pharmaceutical Technology Editors
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
May 29, 2018
By Pharmaceutical Technology Editors
This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.
May 23, 2018
By Pharmaceutical Technology Editors
The agency issued guidance on over-the-counter topical drug products that address maximal usage trials.
May 23, 2018
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
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