Quality Assurance/Quality Control

Syntec receives warning letter where FDA finds deviations from CGMP for APIs.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.

Consider how to apply ALCOA+ to a building management system in non-clinical laboratories.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.

International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.

Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.

The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.

The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.

ISPE’s virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.

Understanding an FDA corrective and preventive actions request is step one in developing a robust plan to address CGMP deficiencies.

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel.

Waters and Genovis will work to develop automated workflows for the fast and constant characterization of critical quality attributes of monoclonal antibodies and other protein-based drugs in bioprocess development, formulation, stability testing, and quality control.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

This article explores the evolution of FDA’s approach to inspections of drug and biologics manufacturing facilities during the COVID-19 pandemic.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.