Quality/GMPs

New identifiers and tracking requirements aim to block illegitimate products.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

HHS plan makes progress in ensuring availability of safe vaccines.

Agencies extend successful pilot program to further harmonization of QbD topics.

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

Accelerated testing and production create challenges in documenting product quality.

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

USP evaluates quality attributes for synthetic peptides.

This series presents a practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three stages of the process validation lifecycle. In Parts I and II, risk analysis and process characterization studies were used to assign criticality risk levels to critical quality attributes and critical process parameters, and the concept of a continuum of criticality was established. In Part III, the author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.

Design of experiment is a powerful development tool for method characterization and method validation.

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

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

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

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

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

EMA releases an update on its flu vaccine guidance.

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

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

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

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

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

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.