During the audit, your company’s quality system and premises would be assessed for compliance with the GDP requirements. As such, you are advised to be familiar with the HSA Guidance Notes on Good Distribution Practice and ensure that the premises and quality system (Standard Operating Procedures, Records, Forms, etc.) are available for the audit.
Upon receiving the application via PRISM, an officer will contact you to arrange for a suitable date for the audit. All deficiencies raised during the audit would have to be satisfactorily addressed and a follow-up audit may be conducted to verify your proposed corrective actions. If the outcome of the audit is satisfactory, the approval of the GDP Certificate will be granted within 10 working days from the date of close-out of the audit (excluding any stop-clock time incurred by the applicant), and an officer will contact you for the collection of the GDP Certificate.