Quality Systems

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.

Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

QbD paradigm advances process understanding in development and manufacturing.

Vaccine development is benefiting from manufacturing advances and support for global health.

Brazil's major vaccine producer innovates with stem-cell research.

Factors for assessing excipient variability, the associated challenges developers need to address to design and manufacture solid oral drug products, and solutions for such challenges are examined.

The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.

An alternative chapter has been added to the European Pharmacopoeia for dosage uniformity.

The European Medicines Agency?s Committee for Orphan Medicinal Products (COMP) is seeking to expand its international cooperation in 2013.