GMPs

Oct 02, 2017
Pharmaceutical Technology
Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
Sep 28, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
Sep 27, 2017
By Pharmaceutical Technology Editors
The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.
Sep 25, 2017
Pharmaceutical companies should prepare for the impact of recalls to minimize risk to consumers and the company.
Sep 19, 2017
By Pharmaceutical Technology Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 02, 2017
Pharmaceutical Technology
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
Aug 23, 2017
By Pharmaceutical Technology Editors
FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.
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.
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