Manufacturing

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

FDA updates guidance to reflect advances in technology.

Foam granulation is much easier to control under mechanical dispersion conditions, which is where most industrial processes operate.

FDA specifies the DUNS UFI system for registration of domestic and foreign drug establishments.

FDA revises boxed warnings for extended-release and long-acting opioid analgesics and postmarket study requirements.

Regulatory Authorities Discuss Elemental Impurities Standards

Mylan completes expansion of its transdermal patch facility in Vermont.

FDA inspections reveal possible inaccurate sterility testing.

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

Merck & Co gets FDA approval to manufacture bulk varicella at its in Durham, North Carolina for use in chickenpox and shingles vaccines.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.

Avacta?s Optim 2 instrument provides a practical solution for determining the conformational stability of adjuvant bound vaccines, eliminating the need for awkward and time consuming standard analytical techniques. [more?..]

New FDA supply chain policies aim to strengthen inspection and oversight processes.

Are strategic partnerships in clinical research a model for CMC services?

I Holland has introduced the next generation to its range of MF polishers, the MF40 automated punch, and die polishing machine.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.

Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.

Omega Design Corporation offers the LabelSync 450 Vision Module, designed to capture and sync a bottle?s unique serialized label with its individual line code.

The Bosspak VTC 100 electronic tablet and capsule counter from Romaco?s is designed to fill pharmaceutical solids or food supplements into bottles at high speed.

Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.

CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.

John Yin, an applications specialist with Freeman Technology, discusses the importance of powder-characterization techniques for optimizing pharmaceutical product development and manufacturing processes.

Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.

The authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.