Quality Control/Quality Assurance

Document integrity is critical in the provision of raw materials for cell and gene therapy manufacturing.

A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

One get obtain a clearer assessment of gene-editing outcomes through more exacting analytical tools.

Having a clear clinical strategy early on can shave time off overall development projects.

Extensive work has greatly expanded the possibilities for fetal bovine serum sourcing.

Thanks to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

FDA is reviving efforts to establish a Quality Management Maturity program.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Data may be used to improve (or remove) a corrective action/preventive action.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape.

CAR-T cell therapy development is a complex process that requires standardization.