GMP

GMP Document Review Project

By |April 14th, 2016|

DSA was recently by hired by one of our manufacturing clients in in Asia to determine if their manufacturing documents would meet Health Canada expectations.

Health Canada requires that all GMP records are made available in English or French. The first part of the project for the client, was to undertake translation of all […]

DSA gets timely DEL approval for a Foreign Manufacturing Site

By |August 24th, 2015|

Current Health Canada performance standards are at 250 days for approval of foreign sites.

AuditForeign site approvals require submission of one of the following types of evidence.

  • Regulatory Authority Inspection Report
  • Certificate of GMP Compliance for MRA Countries
  • Corporate or Consultant Audit Report

DSA recently filed a DEL amendment which was […]

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