审计程序

To maintain compliance with our quality and safety standards and to support the continuous improvement of our QMS, 澳门葡京赌场注册制药 has a robust and independent audit program that covers the product lifecycle. 

The audit program is governed by global procedures and covers 澳门葡京赌场注册制药 internal sites and functions as well as suppliers. The scope of each audit depends on the type of operations conducted. The frequency of audits is based on activities performed and applicable risk assessments. The 澳门葡京赌场注册制药 quality audit program normally conducts more than 1 500 audits per year covering internal functions, sites and external suppliers in areas including Good 制造业 Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and pharmacovigilance.

An annual audit plan is established to take into account audit frequency and assessed risks. Audits are performed by certified auditors. The subsequent audit report is reviewed and approved independently and distributed to the auditee (internal function, manufacturing site or external supplier) who is responsible for submitting a corrective and preventative action plan which, 在协议, 实现. The audit is closed when all actions in the plan have been completed.