This Month’s Focus: Quality, Validation & Regulatory Compliance
Tips for transferring legacy products and processes
The many mergers and acquisitions of the last 5 years often involved moving legacy products from sites where they were manufactured for decades. Here are some tips on making it a smooth transition.
Effect of sampling methods on vitamin D blending uniformity
The sampling method you use can affect content uniformity results. In this study, samples taken with a sampling thief had a large RSD of vitamin D content, while samples taken from a discharge stream had a smaller RSD. Content uniformity testing results using single-tablet samples agreed with results from samples taken using the discharge method.
Incorporating comprehensive serialization in the pharmaceutical industry
As US companies race to meet their obligations under the Drug Supply Chain Security Act, they’re committing substantial capital and other resources to serialization (track and trace). Make sure your investment pays off.
Back Page: Have a plan before the FDA arrives
How you manage the visit can be every bit as important to passing the FDA’s inspection as the technical aspects of your operation.
Leak-testing blister packages: The limitations of the blue dye method
Most blister package applications are considered low risk, but concerns about the integrity of blister packaging have increased as the number of hormone-based and steroidal treatments has grown. Make sure your test method is reliable.
Eye on Excipients: Selecting lactose for DPI formulations
This edition of the column focuses on lactose for use in dry powder inhaler (DPI) formulations and specifically on how the particle size distribution and the device influence the performance of the finished dosage form.
Annual Buyer’s & Reference Guide
January: Capsule Filling
June: Solid Dosage Sourcebook
July: Excipients & Formulation
October: Quality, Validation & Regulatory Compliance
November: Annual Buyer’s Guide
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2. Dissolution Testing
2. Multi-layer Tabletting
2. Powder Transfer & Containment
2. Mixers & Blenders
2. Tablet & Capsule Identification