Quality Assurance/Quality Control

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

The product is being recalled because of Burkholderia cepecia contamination.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

A holistic approach to validation and quality assurance is essential.

Nostrum Laboratories is recalling Metformin HCl Extended Release Tablets because of NDMA above the acceptable daily intake limit.

Successful migrations require careful planning to meet business needs and maintain data integrity.

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for solid oral dosage forms.

Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

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.