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Eye Drop Production Sterility Problems Bring Reason For US FDA Guidance Into Sharper Focus

 
• By Malcolm Spicer

Since FDA provided draft guidance on quality considerations for ophthalmic drugs, steady stream has continued of OTC brand recalls due to manufacturers’ failure to ensure sterility in production processes and purity of ingredients and other components.

• Source: Shutterstock

The weeks following the US Food and Drug Administration’s publication of a draft guidance on manufacturing quality for eye drops and other topical ophthalmic products provided further proof the document was needed.

Since providing the draft guidance on quality considerations for ophthalmic drugs including solutions, suspensions, emulsions, gels, ointments and creams intended...

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