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August 18, 2017
The agency published guidance on identifying trading partners under DSCSA.
FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.
August 14, 2017
A pilot program will offer instruction on scientific and regulatory guidelines including training on GMPs and quality.
The agency sent a warning letter to Cellex-C International regarding GMP violations found at the company’s Toronto facility.
August 10, 2017
Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.
August 02, 2017
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.
Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.
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.
August 01, 2017
Research suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.