Emerging Markets And Your Global Regulatory Strategy
For pharmaceutical companies aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients.
WHITE PAPERS & CASE STUDIES
Final Testing For Injectable Drug Products And Infusions To USP<788> And EP 2.9.19
It is a regulatory requirement to test injectable and infusion drug dose forms for particulate contamination. In recent years, the major pharmacopoeial texts have been harmonized and now the test method and the pass/fail requirements are equivalent.
Don’t Get Blindsided By New USP Quality Standards
The U.S. Pharmacopeial Convention’s (USP’s) Chapter 41 minimum quality standards for weights and balances have been updated after twenty years – and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December 2013. By Dirk Ahlbrecht, Sartorius Group
The Sizing Of Non-Spherical, Sub-Micron Particles Using Polarization Intensity Differential Scattering (PIDS™)
Nearly all laser-based particle-sizing devices make no allowance for the shape of the materials under test, regardless of the size of the particles. The reason for this lies with the underlying assumptions used for calculating size distributions from the raw data generated during the analysis.
Determination Of Cell Aggregation In Bacteria Cultures For Contact Lens Disinfection Efficacy Testing
The percentage of aggregates in bacteria cultures may be determined by employing the Coulter Principle, also known as Electrical Sensing Zone (ESZ) technique. The ISO International Standard 13319 describes this technique. By Andres Lobeiras, Product Manager, Beckman Coulter, Inc
QC Testing: Quality Control Methods That Make A Difference
By Robert McGregor, Global Marketing and High End Product Manager, Brookfield Engineering Laboratories, Inc.
How do you bring consistency to QC testing? Pharmaceutical products that meet manufacturability criteria and provide high level consumer satisfaction undergo a battery of tests before being distributed to the consumer. Using affordable instrumentation to perform QC tests, which certify that tablets, capsules, elixirs, ointments, etc. have the right physical properties, is essential for today’s successful business.
Safe And Effective Filtration In Containment
In containment, it is essential that airflow must match the filter rated flow used in the system. By Russ Krainiak And Ronnie Harris