Quality Systems

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

As biopharma companies and research institutes work to develop vaccines against COVID-19, policy makers and health officials debate strategies for ensuring fair and equitable distribution of anticipated preventives.

The COVID-19 pandemic has raised several questions about the safety of the pharmaceutical materials supply chain. Is onshoring the answer?

Pharmaceutical Technology spoke with Matthew Woodcock, director of LLamasoft, a supply chain analytics company that assists companies in their decision-making and supply chain challenges, about the impact the COVID-19 pandemic has had on the pharmaceutical supply chain.

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

Dissolution testing is an important aspect of drug development as it provides stability parameters and helps predict drug behavior in-vivo.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

When in-person training may not be feasible, there are still opportunities to ensure employees receive the required training, says Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.

Contract service providers offer vital services to bio/pharma companies of all sizes. Establishing an effective working relationship and managing operations are key to avoiding compliance issues.

Hiring the right quality consultant can provide expertise and save costs.

Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

Industry should be seeking more information from FDA on how it will restart its current inspection program.

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

FDA Commissioner Hahn commits to a science-based review and approval process.

483s and Warning Letters Point to Inadequate Quality Oversight

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

FDA can better monitor quality production of domestic versus foreign firms.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.