Quality Systems

Agnes Shanley is senior editor of Pharmaceutical Technology.

Articles

Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.

Serialization: Scaling Down for the Final Stretch

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

US and EU Talk Inspections, Generics, and Advanced Therapies at Bilateral Meeting

Josh Eaton is senior project manager for Scientific and Regulatory Affairs at the Parenteral Drug Association, eaton@pda.org

PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.

Industry Perspectives and Practices on PUPSIT

Sean Milmo is a freelance writer based in Essex, UK.

Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.  

Meeting the EU Serialization Deadline

The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.

Shimadzu's New Spectrophotometer Enhances Usability, Performance, and Compliance

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs. 

European and Indian Pharmacopoeias Coordinate on Quality Standards

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

Harmonizing GMP Inspections

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

EMA Updates Flu Vaccine Recommendations

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

EMA and the Netherlands Finalize Seat Agreement

A new report gives an overview of the work of the International API Inspection Program.

Regulatory/GMP Compliance, Europe