Process and Scaling

Industry awaits the final revision of USP General Chapter and the impact it will have on the evaluation of sterile product package integrity.

Quality-by-design tools improve efficiency in scale-up of pharmaceutical processes.

In-silico design facilitates process optimization and evaluation of process control strategies.

Process design experimental data and risk assessments are used to predict expected process performance and establish process performance qualification acceptance criteria.

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the manufacturing process following a change in the manufacturer.

Multivariate data analysis (MVDA) is being used to effectively handle complex datasets generated by process analytical technology (PAT) in biopharmaceutical process development and manufacturing.

Use of modeling software can help improve process understanding, and can be used in open- or closed-loop control.

Real-time, noncontact imaging and spectroscopy techniques provide insight into pharmaceutical processes.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

The all-synthetic 3M Emphaze AEX Hybrid Purifier contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.

Working with biological matrices and understanding the intended use are crucial.

This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.

With a quality-by-design approach, robust processes can help deliver quality product consistently.

Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.

Meggle Group Wasserburg has been granted an EXCiPACT certificate.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

FDA found violations of cGMP at finished-drug manufacturer in India.

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.