Quality Systems

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The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.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

During Oct. 5-12, 2010, more than 40 countries cooperated in an international week of action to combat the online sale of counterfeit and illegal drugs and to raise awareness of their associated health risks.

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

The US Food and Drug Administration has posted on its website the minutes of the PDUFA V reauthorizaton stakeholder meeting.

Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), talks about his company?s conversion from a paper-based to an electronic training-management system.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

The reopened debate over embryonic-stem-cell research could stifle many other scientific pursuits.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

From disagreement to denial, being cordial about quality control can be challenging.

In light of compendial changes, representatives of the US Pharmacopeia and an industry consortium provide perspectives on cap and ferrule labels.

President Obama and HHS eye innovation and countermeasures to protect public health.

The EDQM inspection program helps to ensure the quality of APIs on the European market.

There are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.

Although the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.

There are apparent inconsistencies between the use of these reference materials and the manufacture of the reference solutions that are actually used in the regulated test method.