The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
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The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon and conductivity data
Cleaning validation is an important element to current good manufacturing practice (cGMP) manufacturing to ensure purity, quality and potency of drug product. Above all, patient safety is the primary concern.
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU.
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
Enrolment of new patients in the TELLOMAK trial, which has been evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas, has been suspended.
A new centre has been established by the FDA that will allow the agency to improve the quality and safety of compounded drugs by providing educational programmes to outsourcing facilities.
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).