Quality Control/Quality Assurance

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.

Gore’s new flexible freeze containers are designed to protect high-value drug substances from container breakage or leakage.

More consistent and reliable production processes are critical for advancing innovative treatments.

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.

Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk. Click here to view a PDF of this article.

The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.

FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.

FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.

BioPharm International spoke with Sharon Ayd, founder & CEO of Ayd Biopharmaceutical Consulting Services, about what the future holds when it comes to ensuring quality in biopharmaceuticals.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.

The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.