Quality/GMPs

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

Biopharma companies should not overlook India's growing market.

USP releases new and revised standards for organic impurities in medicines for public comment.

The European Medicines Agency's Annual Report highlights the agency's drug approvals, projects, and initiatives for 2013.

EMA notifies EU healthcare professionals of the falsified cancer drug Herceptin.

USP evaluates raw materials used in the chemical synthesis of peptides.

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.