FDA Law Blog: Biosimilars
FEBRUARY 5, 2024
Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.
pharmaphorum
MAY 25, 2022
But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.
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GMPSOP
MAY 26, 2023
Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. Why is change control management important in pharmaceuticals?
GMPSOP
MAY 26, 2023
Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. Why is change control management important in pharmaceuticals?
pharmaphorum
OCTOBER 27, 2022
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.
GMPSOP
AUGUST 23, 2022
Table of Contents Quality risk management principles are already effectively utilized in many areas of pharmaceuticals manufacturing business. Additional documents included each month. Additional documents included each month. Assessing validation failures/deviations 4. All written and updated by GMP experts.
Quality Matters
AUGUST 3, 2023
While focuses on evaluating and establishing supplier reliability for pharmaceutical manufacturing companies and compounding pharmacies, its high-level elements of supplier qualification can also be applied to suppliers of foods and dietary supplement ingredients. Senior Director, General Chapters Global Science and Standards Division.
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