- Eye on Excipients: Developments regarding titanium dioxide regulation
- Spotlight on Nutraceuticals: Adapting to change is the name of the game
- Validation, verification, and monitoring of tablet and capsule blister pack inspection systems
- COVID-19’s impact on FDA inspections and manufacturer risk
- Spotlight on Nutraceuticals: How to perform an out-of-specification investigation
- Comprehensive equipment and utility change control for GMP production facilities
- Back Page: The FDA’s increasing oversight of E&L testing in pharma
- FDA warning letters cite drug manufacturers for failing to test excipients or verify COAs
- Back Page: How proposed EU microplastics legislation could impact the pharma industry
- Back Page: Current discussions in Europe regarding titanium dioxide safety
- Spotlight on Nutraceuticals: Dust collection systems for dietary supplement manufacturing processes
- Spotlight on Nutraceuticals: Complying with new FDA requirements for dietary supplement nutrition labels
- Care and handling of fluid-bed dryer filters
- Mutual recognition agreements and other FDA activities for monitoring the US drug product supply chain
- Back Page: What does a validation expert do and why do I need one?
- The evolution of on-dose product identification
- A look into the world of cannabinoid formulation
- Using Quality by Design in the formulation of tablets and capsules
- Back Page: Recent developments regarding a Novel Excipient Qualification process
- Spotlight on Nutraceuticals: FDA draft Guidance on new dietary ingredients: Do you need to file?
- Control strategy considerations during formulation and process development
- Back Page: Serialization: Too late to start?
- Eye on Excipients: Updates and harmonization of USP standards
- Elemental analysis by WD-XRF: A simplified approach
- Back Page: Have a plan before the FDA arrives
- Back Page: Options for conducting elemental impurities testing
- Back Page: Cup depth and tablet consistency
- Back Page: Gelatin capsules and dissolution
- Back Page: Glad you asked: Lead times, track and trace
- Back Page: You can’t correct for randomness
- Back Page: Excipients in the news
- Back Page: Regulatory compliance: Patients talk
- Back Page: The “non-critical” excipient: Does it exist?
- Back Page: FDA hones Guidance on PCIDs
- Back Page: Dissolution performance of empty capsules: Does the supplier make a difference?
- The four pillars of pharmaceutical validation
- Spotlight on Nutraceuticals: The buck stops where? Clarifying responsibility under quality agreements
- Understanding and implementing the new standard for excipient GMP
- A bright future for Rx-to-OTC switches
- When to use dimensional tablet sorters
- The new dietary-supplement GMPs: An invitation to science
- Spotlight on Nutraceuticals: Navigating the landscape of structure/function statements
- Eye on Excipients: On-site audits of suppliers
- Eye on Excipients: Excipient quality
- Spotlight on Nutraceuticals: Sports supplements: Protecting consumers with supplement safety
- Ten tips for selecting cartridge dust collection equipment for tabletting operations
- Eye on Excipients: New-excipient safety data
- Spotlight on Nutraceuticals: Ingredient identity testing: The road to GMP compliance
- Eye on Excipients: A new framework for using new excipients?
- New developments in dissolution testing of tablets and capsules
- Eye on Excipients: Croscarmellose sodium
- Selecting a vibratory sieve to check-screen highly potent powders
- The 10 most common 483s and how to avoid them
- Eye on Excipients: IPEC meeting
- Time to revise CPSC protocol testing
- The problem areas in meeting dietary-supplement cGMPs
- Eye on Excipients: FDASIA’s effect on excipients
- Eye on Excipients: Facts about phthalates
- Using an automated workstation to improve operations and simplify investigations
- Recent challenges in dissolution testing, including USP initiatives
- Track and trace: Options for compliance
- Gaining reassurance from third-party auditing
- Assessing an analytical method for the dissolution profile of an extended-release tablet in accordance with QbD
- How to ensure your dust collection system complies with combustible-dust standards
- Validation of dissolution test procedures
- Eye on Excipients: What’s in excipients?
- The role of the ingredient supplier in cGMP compliance
- Eye on Excipients: Third-party auditing
- Eye on Excipients: Elemental impurities (March 2013)
- Identifying the right magnetic separator for removing ferrous contaminants
- Spotlight on Nutraceuticals: GMP compliance: The top seven pitfalls
- Drug product recalls: An overview of the process
- The advantages of fully automated dissolution testing
- Eye on Excipients: Stability testing
- Dispelling solid dosage misinterpretations of the USP-NF
- Consistency, conformity keys to vanquishing validation woes
- Mixing and cleaning efficiency of a 200-liter perforated coating pan equipped with shark fin baffles
- Implementing cleaning validation requires process understanding
- Spotlight on Nutraceuticals: NDI Draft Guidance: A year later
- Spotlight on Nutraceuticals: Top 10 ways to get an FDA warning letter
- Contracting with the dietary supplement cGMPs in mind
- How to validate a tablet press
- New ADIs and GMPs spell C-H-A-N-G-E
- Compliance challenges facing the nutraceutical and dietary-supplement industries
- Hospital unit-dose blisters: New format comes with new challenges
- Environmental monitoring systems: Overview and the path toward validation
- Responses to the final GMP rule for dietary supplements
- Rethinking stability testing for tablets and capsules in containers
- Containment of high-potency drug products: Outsourcing and other challenges
- In-place cleaning and washing: Determining the need for CIP and WIP systems for tablet presses
- USP’s offers toolkit for dissolution laboratories
- Management responsibility for a serialization and aggregation system
- Spotlight on Nutraceuticals: Clearing the regulatory hurdles to bring a supplement product to market
- Embracing QbD and PAT in nutraceutical production
- Eye on Excipients: Excipient regulations
- Eye on Excipients: Elemental impurities (May 2012)
- Spotlight on Nutraceuticals: What standard? Investigation raises questions about DNA testing
- Does IVIVC make sense?
- Selecting a cartridge dust collection system for tablet coating operations