Quality Assurance/Quality Control

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

Informing your clients of possible changes in equipment is imperative when upgrading a laboratory, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Archana M. Akalkotkar, PhD, research scientist I at Charles River, discusses the use of process validation to ensure quality.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

In this study, the authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety. This comparison can serve as a method for prioritization of APIs for development of PDEs.

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

More life-sciences companies are starting to manage global suppliers holistically.

By working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

Could greater market transparency improve pharmaceutical quality and regulatory compliance?

The new facility will focus on formulation development, drug product analytical development, and quality control.

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Electrophilic and other reactive compounds, and their precursors, must be measured and removed to ensure patient safety.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

Instruments are introduced for elemental impurity analysis and materials identification.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Industry experts and FDA’s Office of Pharmaceutical Quality discuss the challenges, trends, and regulations involved in ensuring quality in solid and semi-solid dosage forms.

Understanding of the risks associated with FMEA is crucial in lot release testing.

Visible residue limits have been shown to be a valuable tool in validated cleaning validation program.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to create a robust CAPA system and how to identify root cause.