Quality Systems

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Manufacturers are taking measures to comply with new package safety rules.

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

Accelerated testing and production create challenges in documenting product quality.

Using best practices for manual or automatic inspection can improve the inspection process.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

The root cause of drug shortages is mismanagement of variation.

USP evaluates quality attributes for synthetic peptides.

Discovery of split and broken tablets led to drug recalls.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

FDA and EMA set up regular meetings to harmonize drug safety actions.

FDA provides recommendations for submitting analytical procedures and methods validation data.

USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.

Thirteen companies are accepted for participation in the supply chain program.

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

NSF-IPEA now can provide excipient auditing and certification.

EMA releases an update on its flu vaccine guidance.

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

High technology assessments are having an impact on biosimilars development in Europe.

PDA works with FDA to create pharmaceutical quality metrics.

ISPE and PDA take on the challenge of recommending quality metrics.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.

The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.

Non-compliance issues show that users find dealing with computer systems challenging.

Traditional project decision-making is compared with a QbD approach.