Regulatory/GMP Compliance

An increasing number of warning letters shows that FDA is observing more problems with pharmaceutical contract manufacturing.

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

A mutual recognition agreement to accept inspection data from eight EU regulatory authorities may reduce inspection burdens at global drug facilities.

FDA sent a warning letter to Ridge Properties, LLC, after inspectors found a variety of current good manufacturing practice violations at the company’s Salem, OR facility.

This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.

Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.

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.

The draft guidance gives recommendations for reproductive toxicity testing and labeling.

FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.

Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.

The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

The US Pharmacopeial Convention is hosting a variety of workshops in Autumn 2017 on a wide range of topics including continuing education, bioassays, and peptides.

FDA has signed a confidentiality commitment with the European Commission and the European Medicines Agency that allows FDA to share confidential information with EU regulations.

FDA sent a warning letter to Bicooya Cosmetics Limited after inspectors found rodent feces at the company’s Zhejiang, China facility.

The directors of FDA’s Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health praised Congress’ reauthorization of user fee programs.

The agency published guidance on identifying trading partners under DSCSA.

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.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

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.

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

The agency cited the Italian company for aseptic processing failures.

The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.