Quality Systems

A global API marketplace increases the burden of supply chain monitoring for drug companies.

The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

Global outbreaks energize vaccine R&D and drive production modernization.

Pharmaceutical Technology spoke with FDA to get the agency’s insights on how the industry can ensure quality in solid and semi-solid dosage products.

The European Commission publishes regulations on mandatory packaging safety features to fight counterfeiting.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

The report examines the increased number of companies cited by regulators for data integrity issues.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

Advanced electronic batch recording (EBR) manages workflows and recordkeeping for compliance and production efficiency.

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.

CDER is now prioritizing review of generic drug products for which there is only one approved drug product on the market.

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

The authors present analysis of the state of control of intermediate identity and quality, based on analysis of recently submitted DMFs.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

Wear-resistant materials and coatings protect tablet punches and dies from abrasive formulations.