Audits and Inspections

A properly designed validation program will detect variation and ensure control based on process risk.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

FDA sent a warning letter to Skylark CMC Pvt. Ltd. after employees refused to let agency inspectors enter the company’s Ahmedabad, Gujarat, India facility.

Bio/pharma companies are successfully launching novel therapies; however, the industry still needs to work on manufacturing innovation.

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.

The agency sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates.

The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The agreement now includes 15 European Union (EU) member states.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

Inspectors found quality issues at bB BioChem Laboratories Inc, a California-based manufacturer of over-the-counter drug products.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

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.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

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

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The latest continuing resolution funds the government for three weeks.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.