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Dalton Receives Compliant Rating from Health Canada

Inspection covered sterile and non-sterile drug products, APIs and more

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Subsequent to a Good Manufacturing Practices (GMP) inspection conducted at Dalton Pharma Services’ GMP manufacturing facility during March 2018, it has successfully received a ‘Compliant’ rating from the Health Products and Food Branch Inspectorate of Health Canada.

This inspection covered the scope of sterile and non-sterile drug products, active pharmaceutical ingredients (API), raw material controls, existing quality management systems, documentation, equipment, processes and engineering. The compliant rating means that the company has successfully demonstrated these activities are in compliance with the high standards of the Canadian Food and Drugs Act and its associated regulations.

“In the wake of recent serious quality issues in the contract manufacturing industry noted by regulators, this successful audit by Health Canada reaffirms Dalton`s commitment to providing products and services of the highest quality and standards to our clients,” said Peter Pekos, president and chief executive officer, Dalton Pharma Services.

“We believe this positive audit is a direct result of having quality and compliance as cornerstones for our business and successfully demonstrates that our facilities and activities are in compliance with the high standards of Canadian Food and Drugs Act and associated regulations,” said Natalie Lazarowych, director of quality, Dalton Pharma Services. “Dalton will strive to consistently provide the highest quality products and services at all times.” 

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