Authors
Latest:
Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Latest:
The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
Latest:
Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Latest:
How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
Latest:
Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Latest:
Energy Conservation in Pharmaceutical ManufacturingThe authors discuss opportunities for energy efficiency in pharmaceutical manufacturing.
Latest:
Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
Latest:
How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
Latest:
Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
Latest:
Establishing a Minimum Incubation Time for Biological IndicatorsThe industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
Latest:
Small Changes, System-Wide ImpactA look at elastomer changeout times shows how industry knowledge improves operations and cost.
Latest:
Partnerships Remain Crucial to Future DevelopmentWorking together affords many unseen opportunities for pharmaceutical innovation.
Latest:
Nuclear Magnetic Resonance as a Bioprocessing QbD ApplicationThe author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.
Latest:
Optimizing Drug Delivery for Modern BiologicsThe author discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.
Latest:
Comparison of Atomization Conditions Between Different Spray Guns Used in Pharmaceutical Film CoatingConsideration of the key process variable will define the ease with which coating processes can be transferred from development to production. This study investigates those factors influencing atomization from two spray guns and examines how development-scale procedures on interchangeable drum coating equipment compare with those typically used in a production environment.
Latest:
Trends Affecting Biopharmaceutical ManufacturingAlmost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
Latest:
Using an Electronic Tongue to Optimize Taste-Masking in a Lyophilized Orally Disintegrating Tablet FormulationThe electronic tongue technology provides a technically suitable and cost-effective method for screening and directing taste formulation, while eliminating both safety concerns and subjective bias.
Latest:
Continuous Manufacturing—the Future of Pharmaceutical ManufacturingContinuous manufacturing is key to the future of pharmaceutical manufacturing.
Latest:
Evaluating Impurities in Drugs (Part II of III)In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.
Latest:
Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
Latest:
A New Definition for API Starting MaterialsThe FDA guidelines that stipulate the conditions for starting materials are currently being superseded. PhRMA and several European pharmaceutical manufacturers have already added their voices to the ongoing discussion and, as this editorial explains, the debate is far from over. Rules are important, but industry is looking to a future when health care authorities are less inclined to impart total control over every aspect of production.
Latest:
Energy Conservation in Pharmaceutical ManufacturingThe authors discuss opportunities for energy efficiency in pharmaceutical manufacturing.
Latest:
Bioavailability EnhancementSoluplus®, a graft copolymer of PEG comprising polyvinyl acetate and polyvinyl caprolactam, was specially designed to solubilize poorly water-soluble drugs.
Latest:
Bioavailability EnhancementSoluplus®, a graft copolymer of PEG comprising polyvinyl acetate and polyvinyl caprolactam, was specially designed to solubilize poorly water-soluble drugs.
Latest:
How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
Latest:
Fast-Melting Tablets: Developments and TechnologiesBoth academia and industry have been encouraged to generate quick­dissolving dosage forms as the demand for fast­disintegrating tablets and capsules has steadily increased.
Latest:
Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Latest:
A Robust CAPA System for a Global Supply ChainEnterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
Latest:
Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods.Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.
