Quality/GMPs

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

Advances in adventitious agent detection methodology are bringing benefits, but more work needs to be done.

The European Union has a challenging task ahead as it strives to harmonize regulations on advanced therapy medicinal products.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, speak with BioPharm International.

Sue Schniepp, Chair, PDA Regulatory and Quality Advisory Board, and Hal Basemen, Chair, PDA, spoke with BioPharm International about resolving drug shortages.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

Pharmaceutical Technology spoke with Monica Caphart, FDA, and Susan Schniepp, PDA, about the 2015 PDA/FDA Joint Regulatory Conference taking place in Washington, DC, in September.

The agency takes action against websites that illegally sell unapproved medications.

The International Conference on Harmonization finalizes Q&A document on APIs.

The agency streamlines risk and mitigation information.

The agency launches initiative to stimulate pediatric drug development.

Quality-risk management tools can assist biopharma companies in mitigating risks when outsourcing crucial elements of the drug-development process.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

The agency cited VUAB Pharma, located in the Czech Republic, for cGMP deviations.

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

This article reviews the definition of HCPs, risks posed by HCPs, regulatory concerns, commonly accepted ELISA methods for HCP measurement and their limitations, and orthogonal methods available for HCP characterization.