Regulatory Compliance

Pharmalytic has demonstrated through FDA, MHRA and client inspections that activities implemented within our quality system ensure our service fulfils all quality requirements.

We conduct analysis for the Pharmaceutical industry in accordance with the principles and guidelines of current Good Manufacturing Practice (cGMP). 

The effectiveness and applicability of our Quality Management system is regularly monitored though self inspection procedures and quality audits. Pharmalytic personnel also undergo periodic GMP training to ensure the Company understands, and is adhering to, GMP requirements.

Since 1994, our laboratories have been routinely inspected by the Medicines and Healthcare Product Regulatory Agency (MHRA) for compliance to GMP. The most recent inspection, conducted by the UK GMP Medicines Inspectorate in November 2000, produced no critical findings and confirmed that our operations were in general compliance with the principles and guidelines of GMP.

The Pharmalytic testing facility was inspected by the U.S. Food and Drug Administration (FDA) in May 2002 and found to be in compliance with current good manufacturing practice. No deviations from cGMP were found and no record of observations of non-compliance (FDA-483) was issued.

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