Quality Control/Quality Assurance

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Pharmaceutical Technology spoke with Jens Andersson, purchasing director at Cambrex Karlskoga, about the best way to ensure the security of the bio/pharmaceutical materials supply chain.

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

The company has said that all three of its operating sites in China started back up on Feb. 12 and that it is closely monitoring the outbreak.

The report details OPQ’s accomplishments over the past five years.

By establishing effective management of data and knowledge, it will be possible to employ advances, such as artificial intelligence and synthetic biology, to their full potential in upstream bioprocessing.

Data management is crucial in bio/pharmaceutical laboratory settings from discovery steps through clinical studies and varies based on the development phase.

Complex protein structures pose analytical challenges that can be addressed by advanced mass spectrometry technologies and workflows, which can be used to comprehensively characterize them.

The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.

Increased reliance on foreign producers raises concerns and spurs collaborations.

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.

The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.

Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.

FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.

Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.

Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.