Quality Assurance/Quality Control

Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

Innovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.

SCA Pharmaceuticals is voluntarily recalling 10 lots of heparin sodium because of the presence of incorrect preservative, benzyl alcohol.

The COVID-19 pandemic has highlighted the challenges and complications of sourcing, tracking, and testing materials for pharmaceuticals. Pharmaceutical Technology spoke with Joe DiMartino, Luminata solution manager at ACD/Labs about the impact COVID-19 is having on the pharmaceutical supply chain and how companies can prepare for these challenges.

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.

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.

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

Efforts are already underway to harmonize standards and regulatory approaches for testing of raw and ancillary materials, but continuous improvement is required.

EU regulators are requesting more effective action be taken to tackle serious impurities in APIs and finished products.

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.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

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

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

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.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

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

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