Quality Assurance/Quality Control

483s and Warning Letters Point to Inadequate Quality Oversight

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.

FDA can better monitor quality production of domestic versus foreign firms.

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.

The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.

The products are being recalled because of missing graduation marks on the dosing cups

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has opened up access to the texts of the European Pharmacopoeia (Ph. Eur.) to support developers of COVID-19 vaccines.

The company is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of the detection of N-Nitrosodimethylamine.

Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.

Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.

The EU’s pharmaceutical strategy has the potential to shake up the policies and regulations of the region’s medicines sector.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

Survey results indicate that the current regulatory approval pathway for excipients creates a challenge for the use of novel excipients.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

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

Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.

A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.