A pharmaceutical quality audit is a systematic and independent examination wherein you will establish whether the activities that your company performs are compliant with standard regulations. You will also determine whether they are effectively implemented to achieve the required objectives.
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Quality audits, whether internal or external, are essential to a good pharmaceutical quality management system. With the help of quality audits, your pharmaceutical company will effectively evaluate compliance with regulatory requirements and get the required feedback, which is needed for improvement.
Types of Audits in the Pharmaceutical Industry
In general, your pharmaceutical company will face three types of quality audits:
Internal audits
External audits
Unannounced audits
Auditee’s management responsibility:
To reach agreement on the audit plan.
To ensure auditee (s) are made available.
To resolve logistical problems.
Overall responsibility to keep the auditors safe.
Attend the opening and closing meetings.
To acting the audit report findings.
To ensure reasonable facilities are made available.
Auditee (s) responsibility:
To be co-operative and answer questions asked by auditors.
To provide a sample as requested.
Try not to have distractions call interruptions etc.
To assist in identifying areas of improvement.
To answer truthfully and respectfully.
Make aware auditors regarding emergency exits.
Lead auditor (s) responsibility:
Plan the audit by using effective resources.
Function as a representative of the audit team when communicating with the auditee.
Organize and direct audit team members.
Guide and support auditors in training.
Lead the audit team to reach the audit conclusions.
Prevents and completes the audit report.
Maintain confidentially.
Arrive on time.
Auditor (s) responsibility:
Support the team leader.
Prepare checklist.
Arrive on time.
Participate in opening meeting.
Carry out assigned tasks.
Keep to the timetable.
Document all findings.
Keep the auditee informed.
Assist team leader with reports.
Safeguard all documents.
Maintain confidentiality.
Guides and observers.
Identifying individuals to participate in interviews.
Confirming timings.
Arranging access.
Safety security rules are known and respected.
Observing the audit on the part of the auditee.
Providing clarification or assisting in collecting information.
