GMPs

Jan 22, 2018
By Pharmaceutical Technology Editors
Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.
Jan 12, 2018
Labels must have special features to prevent tampering of pharmaceutical packaging.
Jan 11, 2018
By Pharmaceutical Technology Editors
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
Jan 11, 2018
By Pharmaceutical Technology Editors
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
Jan 05, 2018
By Pharmaceutical Technology Editors
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
Jan 03, 2018
By Pharmaceutical Technology Editors
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
Jan 02, 2018
Pharmaceutical Technology
Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.
Jan 02, 2018
Pharmaceutical Technology
A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.
Jan 02, 2018
Pharmaceutical Technology
Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the US Drug Supply Chain Security Act serialization deadline.
Jan 02, 2018
Pharmaceutical Technology
Process validation is an extension of biologics development processes.
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