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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.

General Features

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.

November Content

Annual Buyer’s & Reference Guide

Issue Focuses

January: Capsule Filling

March: Outsourcing

April: Coating

May: Packaging

June: Solid Dosage Sourcebook

July: Excipients & Formulation

September: Tabletting

October: Quality, Validation & Regulatory Compliance

November: Annual Buyer’s Guide

Contact the editor:
Matthew Knopp
1155 Northland Drive
St. Paul, MN 55120
Fax 651-287-5650

Thank You!

T&C relies on professionals like you to keep our readers informed about the latest technology, methods, and equipment. Thank you for considering T&C for placement of your article.

Special Sections
Capsule Filling
1. Granulation & Drying
2. Dissolution Testing
Outsourcing: Formulation, Manufacturing, Packaging, Research & Lab Services
1. Counters/Bottle Fillers
2. Dedusters
1. Test & Inspection Equipment
2. Multi-layer Tabletting
1. Particle Size: Reduction, Separation, & Analysis
2. Powder Transfer & Containment
Solid Dosage Sourcebook
Excipients & Formulation
1. Tooling
2. Mixers & Blenders
Liquid Capsule Filling
Quality, Validation, & Regulatory Compliance
1. Blister Packaging
2. Tablet & Capsule Identification
Annual Buyer’s Guide
*Issue includes “Spotlight on Nutraceuticals” insert.

Buyers Guide
Inhalation Magazine