Regulatory Authority Inspection Comparison
26 November 2024 | By
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
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Whitepapers & App Notes
Application note: The need for rapid methods in the compounding pharmaceutical industry
This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.
Selecting Fill/Finish Manufacturing Technologies
With a growing pipeline of biologics, increase in vaccine production, and small batch sizes targeting small patient populations, there’s increasing demand for advanced manufacturing tech.
Whitepaper: What to expect from a regulatory inspection, an NSF expert guide
Regulatory inspections can be challenging, but proper preparation turns them into opportunities for improvement and compliance demonstration.
Whitepaper: Risk-Based Approach to Development – Injectable Combination Product
Drug-device combination products offer advantages for patients but are complex and challenging to develop. Establish a holistic approach to DDCP development and assess and manage risk throughout the process.
Whitepaper: Optimise organisational culture & quality maturity
31 October 2024 | By NSF
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
Delivering market success for concept to patient
24 October 2024 | By
Whitepaper - Delivering Market Success for Pharma Partners from Concept to Patient
A data-driven approach to Container Closure Integrity
Selecting container closure components with confidence:A data-driven approach to Container Closure Integrity.
Application note: Single temperature analysis for environmental monitoring samples
This application note explores how to determine the feasibility and the impact of the single temperature for environmental monitoring microorganisms.
eBook: From Vial to Prefilled Syringe
Simplify your move from a vial to a prefilled syringe – lifecycle planning for containment and delivery of biologics drug products
eBook: Cut through complexity in drug development ebook
How you can cut through complexity, gain speed and get your drug to the patient as soon as possible.
eBook: Successfully navigating complex and evolving regulatory environment for combination products
With complex processes and stringent regulatory requirements, the path to developing a combination product can be uncertain and challenging
Science of scale for spray-dried intermediates
5 August 2024 | By
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
Whitepaper: USP <645> Water Conductivity Regulations
31 July 2024 | By
This whitepaper looks at benefits of measuring conductivity on-line, and calibration and temperature compensation criteria for USP compliance.
Synthesis and Route Design to Tackle API Complexity
22 July 2024 | By
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
