(2) quality audit-up

QUALITY AUDITPharmacist Profession Program

Faculty of Pharmacy-Pancasila University

2

Really..????

3

Introduction

4

Quality Audit Systematic, Independent and documented process

for obtaining audit evidence and evaluating it objectively, to determine the extent to which audit criteria are fulfilled.

(ISO 9000:2005) It may be useful to supplement self inspection with

quality audit. Quality audit consist of an examination and assessment of all part of a quality management system with specific purpose of improving it.

(CPOB, 2012)

5

Type of Quality Audit Audit Compliance

Compliance to obligation, legal requirement, regulation. Audit Performance

Organization target

6

Principles of Auditinga. Integrity, foundation of professionalismb. Fair presentation, obligation to report truthfully

and accuratelyc. Due professional care, Application of diligence and

judgment in auditingd. Confidentiality, security of informatione. Independencef. Evidence-based approach

Principle of Self Inspection Purpose of self-inspection is to evaluate

whether a company’s operations remain compliant with GMP

Assists in ensuring quality improvement The programme should

cover all aspects of production and quality control

be designed to detect shortcomings in the

implementation of GMP

recommend corrective actions

set a timetable for corrective action to be completed

Principle of Self Inspection

Performed routinely Also on special occasions such as

Recalls

Repeated rejections

When a GMP inspection is announced by the

national drug regulatory authority

Principle of Self Inspection Self-inspection team should consist of

personnel who: can evaluate the situation objectively

have no conflict of interest, have no revenge in mind

should have experience as observers of a self-

inspection team before becoming a team member

can be lead self-inspector with experience as team

member

Procedure should be documented Effective follow-up programme

10

Definitions1. Auditor : executor2. Auditee : object3. Lead Auditor : team leader4. Minor finding 5. Major finding 6. Critical finding 7. CAPA : Corrective Action & Preventive Action

11

Internal Audit OrganizationPlant Manager

QA Manager

Lead Auditor

Auditor Member Auditor MemberAuditor Member

12

Quality Audit Cycles

Preparation•Receiving Audit Brief

• Identify Scope• Identify Resources•Document Review•Create Audit Plan•Create Checklist

Conducting•Opening Meeting•Tour of Site•Generating Audit Findings & Conclusions

Reporting & Follow up•Prepare report•Closing Meeting•Follow up of Corrective Action

Surveillance

13

Preparation Receiving Audit Brief : from Auditee or

QA (internal) Identify Scope : Scope of process

that will be audited Identify Resources : What auditor

need?? Document review Create Audit Plan : Rundown audit and

send to auditee Create Checklist : As guidelines

14

Lead AuditorResponsibilities :1. To manage team2. Make audit planning3. As team representative4. Make final report5. Lead audit meeting

15

Conducting Opening meeting : Audit objective,

greetings Tour of Sites : Verify Conducting and Conclusion

16

Audit Findings Nonconformity (NC)

Problem Statement

Evidence Requirement

NC

17

Grading Findingsa) Critical: A deficiency which has produced, or may

result in a significant risk of producing, a product which is harmful to the intended user.

b) Major: A deficiency which has produced or may produce which does not comply with its marketing authorization/specifications; and/or indicates a major deviation from the regulation or standard.

c) Minor: A deficiency which cannot be classified as either critical or major, but which may indicate a departure from GMP.

18

Reporting and Follow Up Prepare report : A report should be

made at the completion of self inspection.The report should include : Result Evaluation & conclusion Recommended corrective action

Closing Meeting : Report Auditing Result

Follow Up

19

SurveillanceThe continuing monitoring and

verification of the status of procedures, methods, conditions, processes, products and services, and the analysis of record. In relation to stated references to ensure the specified requirements of Quality are being met.