Failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. 

Prioritizing Cleaning Validation

International pharmacovigilance can be challenging, particularly for small biotechs.

Navigating International Pharmacovigilance

Understanding a CAPA request is step one in developing a robust plan to address CGMP deficiencies. 

Responding to FDA CAPA Requests 

Decontamination, automation, and containment are important considerations.

Annex 1 and Isolator Operation

Topic

Shahid Manzur is principal, Consulting, EY, shahid.manzur@ey.com

Articles

Automated systems help detect and resolve quality issues.

Best Practices for Pharma Manufacturing Quality Teams

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

EMA Approves New Manufacturing Site for Moderna COVID-19 Vaccine

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

Immodulon Gains Allowability of Claims for Key European Patent Application

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process. 

New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process

An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.

FDA Approves ANDA for Albuterol Sulfate

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA Publishes Guidance Documents to Enhance Supply Chain Security

FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.

Quality Systems

Prioritizing Cleaning Validation

Navigating International Pharmacovigilance

Responding to FDA CAPA Requests

Annex 1 and Isolator Operation