Quality Assurance/Quality Control

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.

Industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.

Technical services and regulatory affairs consulting group, Diamond Pharma Services, has announced its acquisition of PharmaCentral-a pharmacovigilance services and medical affairs business based in Dublin, Ireland.

The company is recalling the product because of out-of-specification results for high molecular weight polymers.

The company is voluntarily recalling 13 lots of the product because of particulate matter found in reserve sample vials.

The company is recalling Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles because of failed dissolution specifications.

The company is recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) due to potential N-Nitrosodimethylamine (NDMA) contamination.

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

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.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

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.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

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.

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.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

A brief overview of three notable cases of adverse drug reactions.