Presentation toCME at HKL

Shariah Management System

PRESENTED BYUMAIMAH SALAMSHARIAH OFFICER

ROYCE PHARMA MANUFACTURING SDN BHD

RPM : FIRST SHARIAH COMPLIANT PHARMACEUTICAL COMPANY

MAINLY DRIVE

Royce Pharma mainly drive on first Shariah Compliant Pharmaceutical Company

Related with : -

1) MS 9001 : 2008 Quality Management System

2) MS 1900 : 2005 Quality Management System based on Shariah Compliant

3) MS 2424 : 2012 Halal Pharmaceutical

MS 2424 : 2012 / MS 1900 : 2005

Guideline to perform co-ordinated activities to direct

and control an organization towards achieving Customer Satisfaction according to Shariah requirements

Guideline to perform co-ordinated activities to direct and control an

manufacturing and handling towards achieving Halal Pharmaceutical

product

MS 2424 : 2012 / MS 1900 : 2005

STANDARD

MS 9001 : 2008

20132013

2016

Quality Management System

Quality Management System based on Shariah

Halal Pharmaceutical

REFERENCE

• Based on ISO9001:2008 Standard

• PIC/s guide to GMP for medicinal product

• Focus on 8 Principles• Ultimate Reference;

– Al Quran– Al Hadith– Al Ijma’– Al- Qiyas– And others related method Problem Solving

Tools

IMPEMENTATION FOCUS

ALL 12 DEPARTMENT : 1.Production2.Quality Control3.Research and Development4.Business and Development5.Human Resources6.Finance7.Purchasing and Warehouse8.Engineering9.Information and Technology10.Shariah11.Quality Assurance12.Regulatory

OBJECTIVE1. To inculcate, enhance and practise Shariah requirements

into an organisation quality management system that emphasises on Universal Values

2. To enhance the good governance and efficiency of the organisation which is consistent with the Islamic Principles; and;

3. To provide confidence and enhance Satisfaction among muslim and other stakeholders of the organisation.

4. To achieve “Keberkatan” and “Keredhaan” from Allah Ta’ala for complying to the Shariah requirements.

OBJECTIVE

COLLABORATE

• Has attracted considerable attention from many Malaysian organisations

• Currently more than 20 organisations already certified

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1. Kolej Komuniti Gerik Perak (KKGP)2. KFC Manufacturing Sdn. Bhd (Logistic Division)3. Sindora Berhad 4. Malaysian Electronic Payment System (MEPS)5. Al-Rajhi Bank6. Pusat Zakat Negeri Melaka7. Universiti Tenaga Nasional (UNITEN)8. JPP USIM9. Maahad Tahfiz Negeri Pahang10. Tissue Bank, USM Kubang Kerian11. Majlis Agama Islam Negeri Sembilan (MAINS)12. Pusat Kutipan Zakat Negeri Pahang13. Penang International Halal Hub (PIHH)14. Jabatan Agama Islam Terengganu (JaHEAT)15. Bahagian Pendidikan Sumber Manusia (BPSM

SUK Selangor)16. Hospital Angkatan Tentera Terendak17. Jabatan Agama Islam Pulau Pinang

(sumber rujukan : www.malaysiancertified.com.my)

OTHERS USER MS 1900 : 2005

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Road Map Towards MS1900:2014 Implementation & Certification

Overview

Establish ISOSteering Comte.

Training(MS

Component)

Training(Documentation)

DocumentationPreparation

Implementation

Training(Internal Audit)

PerformingInternal Audit

ManagementReview

1st Stage Audit(Appointed CB)

Pre-ComplianceAudit

Compliance Audit by

Appointed CB

GapAnalysis

MS Certified

OVERVIEW

Top Management Commitment

Dedicated Steering Committee

Proactive Staff Involvement

Commitment To Agreed Work Plan

Teamwork

Success RecipeSuccess Recipe

THANK YOU!