Quality Systems

Company is notified of GMP violations at facility in Catania, Italy.

FDA Releases Guidance on Self-Selections Studies

USP has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network in China.

Ruling has implications for intellectual property protection for innovator drugs in India.

Latin America's diverse growing market seeks regulatory harmonization.

Industry is moving toward closed-loop control of continuous processing.

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.

The mysteries of rounding are exposed; strict, unbiased rounding can be applied.

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

The Thai government is ramping up efforts to promote and develop the biotechnology sector in a bid to enhance its global competitiveness.

Strengthening government control or striving for compliance with international standards?

David Elder, vice-president, technical at PAREXEL, discusses US legislation allows for inspection of generic-drug activities.

Draft guidance combines and supersedes previous guidance documents.

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

In the context of international trade, the need to develop global quality standards for medicines is increasing.

FDA's Brian Hasselbalch provides an overview of trends found in FDA quality inspections over the past year.

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

Keith Bader, senior director of technology at Hyde Engineering + Consulting discusses his presentation ?Establishing a design space: cleaning process development and validation,? which will be presented at Interphex 2013

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013

FDA's Commissioner discusses pharmacy compounding, EMA updates guidance

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

FDA issues list of 2013 guidance documents.

The Rostov-on-Don Medicines Quality Control Laboratory is the first official medicines control laboratory in Russia to have achieved internationally recognized ISO accreditation.

The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

FDA's requirements for API manufacturers in regards to ICH Q7.

Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

A roundup of regulatory news from across the global pharmaceutical industry.