GMPs

Aug 18, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
Aug 14, 2017
By Pharmaceutical Technology Editors
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
Aug 02, 2017
Pharmaceutical Technology
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
Aug 02, 2017
Pharmaceutical Technology
The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2017
Pharmaceutical Technology
Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.
Jul 25, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
Jul 18, 2017
By Pharmaceutical Technology Editors
The agency cited the Italian company for aseptic processing failures.
Jul 12, 2017
By Pharmaceutical Technology Editors
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
Jul 12, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
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