Finished Product Analysis

Automatic visual inspection machines and artificial intelligence highlight inspection deficits for parenteral containers and units.

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.

Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

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

Analytical solutions are improving for raw material testing, drug product release process development, and more.

The Raised Stopper Inspection machine from Antares Vision verifies proper sealing of freeze-dried vials.

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Leveraging vast quantities of analytical data requires digitalization and platform integration.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Flow imaging microscopy can be used to identify particulates and their sources.

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.

X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.