Quality Systems

A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design - primarily regarding air flow and laminarity.

A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO).

FDA Holds Biosimilars Public Hearing

USP is working to ensure quality standards and to increase public information.

IP rights and levels of innovation have opened a bit of controversy regarding decisions being made by Indian courts and legislators.

A conversation with Mike de la Montaigne, president of Eisai Machinery, USA Inc., about the possibilities for conducting fully automated product inspections.

As technology advances, industry's needs are growing.

Scientists and practitioners must work together for the overall good of the patient.

A new center may provide evidence for improving care, but could discourage coverage of treatments.

A Q&A with officers of the departments of State Food and Drug Administration, China, moderated by Ji Xie.

Drug manufacturers have to be more than just "audit ready."

Remaining calm, cool, and collected during mergers and inspections is a feat in itself.

The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

Applied statisticians are forever searching for the enemy of quality-variability.

There has been increasing cooperation between the EMA and the FDA in recent years, and this looks set to continue in the future.

PPD and Bend Research Form Collaboration; Ricerca Makes Senior Appointment; And More.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

The US Pharmacopeia (USP) has announced two new collaborations.

As part of a team, you will prepare meetings of European Pharmacopoeia groups of experts, contribute to the preparation of working documents for these groups, contribute to the elaboration and revision of European Pharmacopoeia texts and follow up meetings with a view to publication of scientific texts and memoranda.

As part of the Certification team, you will evaluate dossiers submitted with requests for revision of certificates of suitability to the European Pharmacopoeia and prepare draft reports; you will ensure consistency of assessment reports for similar products and consistency of the reports with the policy of the procedure, if necessary analysing and reporting any discrepancies.