Regulatory/GMP Compliance

This article explores the emergence of subjectivity in ICH Q9 (R1).

The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

Harmonization of global regulations fosters innovation and ensures quality medicines.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

Revolutionary therapies restructure pharmaceutical manufacturing.

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

Analytical methods and tools play a pivotal role in cleaning validation.

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.

Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.