Establishing Target Fills for Semisolid and Liquid Dosage Forms
To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.
Articles in this issue
Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients
April 2005
Management Controls for GMP Compliance
The Sector Chart: A New Engineering Graph for Pharmaceutical Processes
Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
PAT and Process Understanding: A Call to Arms
Cold Chain Concerns
Evolutions in Direct Compression
X-ray Microtomography of Solid Dosage Forms
Orient Express
Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms
Famine in Field Inspection
Establishing Target Fills for Semisolid and Liquid Dosage Forms
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