Tugas Manajemen Mutu

Disusun oleh :

Lina Sulistia Nurrahmani

Linda Puspitasari Maya Safitri

2011000150
2011000151 2011000152

Meli Maulani

2011000153

PROGRAM PROFESI APOTEKER FAKULTAS FARMASI UNIVERSITAS PANCASILA JUNI 2012

Contains
Introduction Items for self inspection Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Introduction
Self inspection basicly is a way to reevaluate all aspect of production and quality control objectively from any aspect that can affect the quality assurance.

Self inspection should be conducted in an independent and detailed way by designated competent person from the company who is qualified and expert in their own field or by external independent audits.
The procedure and record of self inspection should be documented, all recommendations for corrective action should be implemented, and there should be an effective follow-up programme.

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Items for Self Inspection

Personnel Premises including personnel facilities Maintenance of buildings and equipment Storage of starting materials, packaging materials, and finished product Equipment Production and in process control Quality control Documentation Sanitation and hygiene Validation and revalidation programmes Calibration of instruments or measurements systems Recall procedures Management of complains Control of labels Result of previous self inspection and any corrective steps taken

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Team of self inspection

Management should appoint a team of self inspection consisting of at least three members who are expert in their own field and understand Good Manufacturing Practices.
The members of the team maybe appointed from inside or outside of the company. Each member should be independent in performing the inspection and evaluation.

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Method of self inspection

1. Routine Comprehend Inspection This inspection should be done for new pharmacy company or if a pharmacy company want to expand their operation area. Concise Inspection * This inspection is perform to evaluate the good manufacturing practices from a pharmacy company. Follow Up Inspection * Inspection to observe the result of improvement act Special Inspection * Inspection to follow up the complain about incompliance of professional practice standard. Survey Inspection Inspection to evaluate a new companies performance which their operation area is unidentified before.

2.

3. 4.

5.

* : This inspection can be done without any permission

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Coverage and frequency of self inspection

Self inspection may be conducted by part of unit, depend on the company requirement A complete self inspection should be conducted at least once a year
The frequency should be stated in the procedure for self inspection

Introduction Items for self inspection Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report

Self inspection report

A report should be made after the self inspection is completely finished.

Follow-up action
Quality audit Suppliers audit and approval

The report may include : a. self inspection results b. evaluation and conclusion c. recommended corrective actions

Introduction Items for self inspection Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report

Follow-up action
The company management should evaluate both of the self inspection report and the corrective actions. There should be an effective follow-up programme

Follow-up action
Quality audit Suppliers audit and approval

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Quality audit
It may be useful to supplement self inspection with a quality audit A quality audit consist of an examinations and assessment of all or part of a quality management system with spesific purpose of improving it.

A quality audit is usually conducted by outside or independent specialist or a team designated by the management for this purpose

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

SupplierS audit and approval

The head of quality management should have responsibility together with other relevant departments for approving suppliers. A list of approved suppliers of starting and packaging materials should be established and reviewed. Before suppliers are approved and included in the approved suppliers list or specification, they should be evaluated. If an audit is required, it should determine the supplierss ability to conform with GMP standard. All established suppliers should be evaluated regularly

Introduction

Items for self inspection

Team of self inspection Method of self inspection Coverage and frequency of self inspection Self inspection report Follow-up action Quality audit Suppliers audit and approval Conclusion

Conclusion
Inspeksi diri dan audit mutu sangat penting dalam suatu industri farmasi karena dapat meningkatkan mutu dari produk obat yang dihasilkan.