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Previous Blogs

Patient receiving medication from doctor
Oncology Lymphoma Regulatory Requirements Parenteral Packaging
How are you responding to pharmacopoeia expectation of parenteral preparations?

By Victoria Morgan

August 19, 2020

Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?

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A nurse extracting a medication from a vial into a syringe
New USP Chapters Compliance Regulatory Requirements
Are You Ready? Compliance with New USP Chapters <381>, <382>, <1381> and <1382>

By Daniel Bantz

June 04, 2019

It is imperative for the pharmaceutical industry to be prepared to comply with new compendia chapters as soon as they are enacted. This comprises both knowing of proposed changes as soon as announced and being well prepared to accommodate them. USP Chapter <381> is changing, and Chapters <382>, <1382> and <1381> are being created. The Pharmacopeia Forum for final comments has been published.

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