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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
July 18, 2016
The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.
July 12, 2016
The agency reviews hemophilia A, skin, and diabetes treatments, among others.
The agency completes its risk assessment of the blood cancer treatments.
July 11, 2016
The agency announced that it has completed the review of the GDUFA backlog one year ahead of schedule.
July 08, 2016
The agency says that the routine large-scale compounding of drugs that are exact copies of existing medications undermines the the drug approval process.
July 06, 2016
The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.
FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.
July 02, 2016
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.