Regulatory/GMP Compliance

Apr 01, 2017
BioPharm International
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the value of internal audits and how the information gained can be applied.
Apr 01, 2017
BioPharm International
As regulators strive for balance in cGMPs for cell, gene, and tissue therapies, risk-management principles must guide decisions involving process media and additives.
Mar 21, 2017
By BioPharm International Editors
FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
Mar 15, 2017
By BioPharm International Editors
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
Mar 09, 2017
By BioPharm International Editors
The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.
Mar 07, 2017
By BioPharm International Editors
The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.
Mar 02, 2017
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
Mar 01, 2017
BioPharm International
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.
Feb 28, 2017
By BioPharm International Editors
The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.
Feb 15, 2017
By BioPharm International Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
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