Regulatory/GMP Compliance

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

Industry and regulators seek global system that reduces regional differences.

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

New tools and policies aim to support more complex manufacturing processes.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.

Mass-produce cell and gene therapies presents the biopharma industry with a unique set of challenges.

The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.

FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.