The audit lifecycle comprises all the steps from audit planning until closing any possible observation detected during the audit execution. The lifecycle can be divided into three big parts with different activities in each of them:

1. AUDIT PLANNING

a. Audit request: Affiliated members and clients request the audits of their interest. AFA performs the optimization process and the sponsors and the price of the audit are established.

Audit request

b. Agreement on the Audit Date: Once the company to be audited contact data is available, a formal request with proposed dates is done. The date is agreed.

c. Auditor assignment: an auditor is assigned and hired from the group of AFA qualified auditors taking into account the type and objectives of the audit.

2. AUDIT PREPARATION AND EXECUTION

a. Sponsor Specific requirements request: The date of the audit is communicated to the sponsors, and the specific requirements for the audit are requested. These specific requirements allow the establishment of the objectives and the agenda preparation.

Sponsor Specific requirements request

b. Sending the audit agenda to the company to be audited: AFA sends a proposal for the agenda of the audit to the company to be audited.

c. Preparation of the audit: the assigned auditor prepares the audit and collects all the necessary documentation for the audit execution.

d. Conducting the audit: The audit is carried out following what is established in the agenda agreed with the auditee. At the end of the audit, a wrap-up meeting is done where any observation found and possible solutions are discussed.

Shortly alter the audit is performed; the hired auditor sends a preliminary report to the audited company that allows to clarify any misunderstanding, if needed. In addition, a rapid response and a remediation plan are requested. This reply is reviewed by the auditor and is included in the full draft report that is being prepared.

e. Issuance of the draft report:in approximately 5 weeks alter the audit is performed; the auditor issues the audit report draft, which is sent for review to the audit sponsors. A one-week review period is established.

f. Issuance of the audit report: once the review period is finished, AFA issues the final version of the audit report, which is printed and signed. The original audit report is sent to each sponsor.

3. AUDIT FOLLOW-UP

a. Communication of the final results to the audited company: AFA sends an audit report (Audit Report Letter) to the audited company. In this report, the observations found are identified and the corrective actions are included (if they have been received). Where appropriate, a GMP Audit Certificate is sent.

b. Bi-annual Remediation Plan follow-up: AFA performs the management and follow-up of the remediation plan (if applicable). Every six months an update of the Action Plan is requested to the audited company until all the observations are completely closed.

c. Remediation Plan update review: the auditor reviews the coherence of the correctives measures defined in the update of the Remediation Plan. Clarifications are requested, if needed.

d. Remediation Plan Update to the sponsors: an update of the Remediation Plan and any possible evidences are sent to the sponsors of the audit.