COMPANY PROFILE REDHACARE SDN BHD ( H)

Transcription

1 COMPANY PROFILE REDHACARE SDN BHD ( H)

2 Edited by: AR Designed by: WMR All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, copied or transmitted without the prior written consent of the publisher except that the material may be photocopied for non-commercial purposes without permission from the publisher. This document is available in alternative formats on request from the publisher.

3 CONTENTS 1. THE COMPANY Redhacare sdn. bhd. Main services Customer focus Company profile 2. THE APPROACH Mission Strategy 3. THE PEOPLE The team Personnel profile 4. THE CLIENTS 5. REDHACARE GROUP OF COMPANIES 6. CERTIFICATION & CLIENT REFFERAL

4 THE COMPANY 1

5 Redhacare Sdn Bhd Redhacare Sdn Bhd is a Good Manufacturing Practice (GMP) & Good Laboratory Practice (GLP) Consultancy and GMP & GLP System Provider Company specializing in Design, Construction, Commissioning and Qualification for the Sterile & Non-Sterile Pharmaceutical Facilities, Biopharmaceutical Facilities, and Laboratories Facilities including Biosafety Laboratories. Apart from specializing in the GMP & GLP facility set-up, the company also providing services in GMP & GLP documentation and operational training; Equipment procurement & qualification; Product Scale-up; and Commercial Operation. GMP Equipment Procurement, Installation & Qualification Utilities and Processing Equipment Scale-up and Commercial Production Documentation and training, including product registration Good Laboratory Practices including ISO/IEC Accreditation Laboratory design & construction, Laboratory documentation including Analytical method validation, Measurement Uncertainty & Proficiency Test BioSafety Laboratories (Level 2 & 3) Laboratory design - build- commission, documentation, training, WHO/Australian Biosafety Standard certification Our Main Services Construction of GMP Plant Design-build-commission GMP Document Provider Design Qualification, User Requirement Specification, Factory Acceptance Qualification, Installation & Operational Qualification, and Performance Qualification, Personnel Qualification Validation (process and cleaning) and Validation Master Plan GMP & GLP Consultancy and Training GMP & GLP Education - Cyber Putra Cyberjaya, Selangor, Malaysia Diploma in Pharmacy Certificate & Diploma in GMP Complimentary Medicine & Paramedic Product Registration Bioequivalence Study

6 Our Customer Focus Pharmaceutical Industry Cosmetic and Traditional Industry Biotechnology Industry Medical Equipment Industry Learning Institutional (Pilot Plant) Any Industry related to GMP Operation Laboratory (Research and Commercial)

7 Consultancy Services Facility Concept Design / Front End Studies, Scientific & Management Consultancy Equipment Design & Selection, Regulatory Affairs, Validation Technology Transfer, Start up & Training, Operational Improvements Engineering Management Accreditation Commercial Architecture Building Services Clean Utilities Process Engineering Controls & Instrumentation Commissioning Value, Risk Management Preconstruction services Construction Management Program Management Project Management ISO 9001 ISO/IEC HACCP Biosafety Lab Level 2 & 3 WHO, Australian Standard Build, Operate Transfer Due Diligence Cost Engineering Construction Civil/Architectural, Mechanical & Electrical, Building Management System, Network & Telecommunication, Machinery, Certification

8 Company Profile Registered Name REDHACARE SDN. BHD. Address 1-02A, JALAN TUN PERAK 6, TAMAN TUN PERAK, CHERAS KUALA LUMPUR, MALAYSIA Tel: Fax: Web: Nature Of Business Date of Incorporation Company Registration Number Prinipal Banker Project Management, Construction, Equipment Procurement, Consultancy & Training Provider 28th July H CIMB Bank Taman Mutiara, Cheras Chairman Tan Sri Datuk Dr Johari bin Mat Directors Syed Redzuan bin Syed Salim Shatri Dr Yuszahanim binti Yusoff Dato Dr. Mohd Yahya bin Nordin Dr Mazlan bin Mohamad Dr Abdul Ali bin Raja Mohamed

9 THE APPROACH 2

10 Our Mission To become the preferred GMP & GLP system provider for clients who needs current GMP & GLP solutions for their highly regulated business requirements. This mission is in line with our motto Professional Partnership. For Quality. Our Strategy Deliver the best services to our clients through professional partnership.

11 THE PEOPLE 3

12 Our Team Every customer inquiries or any orders undertaken by Redhacare Sdn Bhd is directly handled by highly trained and qualified personnel to ensure our firm grip on best services, quality and professionalism. We understand the importance of having the full commitment and professional partner relationship in mind while carrying out our responsibilities. Therefore our team will provide high degree of support from Receiving of the Customer Order up to After Delivery of the System and Services.

13 Board of Directors Chairman Tan Sri Datuk Dr. Johari bin Mat Managing Director Syed Redzuan bin Syed Salim Shatri Dr Yuszahanim binti Yusoff (Executive Director) Dato Dr. Mohd Yahya bin Nordin (Executive Director) Dr Mazlan bin Mohamad (Operation Director) Dr Abdul Ali bin Raja Mohamed (Business Development Director) above from left: Tan Sri Datuk Dr. Johari bin Mat Syed Redzuan bin Syed Salim Shatri Dr Yuszahanim binti Yusoff below from left: Dato Dr. Mohd Yahya bin Nordin Dr Mazlan bin Mohamad Dr Abdul Ali bin Raja Mohamed

14 Tan Sri Datuk Dr. Johari bin Mat Chairman Tan Sri Dr Johari had a distinguished 33 years career with the Malaysian Adminis trative and Diplomatic Service. He had held important positions as Secretary General of three Ministries, namely Education, Domestic Trade, and National Unity and Social Development during 1991 to He was the Director of INTAN (National Institute of Public Administration ) and the Klang Valley Planning Secre tariat in the Prime Minister s Department during 1981 to Dr Johari obtained his B.A. (Hons) from University of Malaya (1968), MPA and Ph.D from University of Southern California, USA (1976/1979) and AMP (Advanced Management Program) from Harvard University (1997). He was con ferred the honorary Dr. Ed. (Doctor of Education) by University of Malaya in He is a chartered member of the Malaysian Institute of Planners. Currently Tan Sri Johari is involved in public and private companies that have business interests in higher education, transportation and environmental manage ment, plantation agriculture and consultancy services. Among others, he is Chairman of United Plantations Berhad and the founding President of Cyber jaya University College of Medical Sciences. He is on the Board of GlobalPorts Sdn. Bhd., Edumonde Sdn. Bhd., Spatial Consult Sdn. Bhd., and member of the Academic Council, University Canada West, Victoria, BC, Canada. Presently, Dr Johari is the President of the Malaysian Danish Business Council. Syed Redzuan bin Syed Salim Shatri Managing Director Mr. Syed Redzuan, born in 1966, a Malaysian, is the Managing Director Redhacare Sdn Bhd.He obtained his B. Pharm (Hons) from Institut Teknologi Bandung, Indonesia and M. Phil in Pharmaceutical Technology from the University of Bradford, UK. He is a registered pharmacist by profession. Started his career with the Sterling Drug (GlaxoSmithKline Beecham) in 1994 before joining RAZA Manufacturing (Pharmaniaga) in 1998 until Currently, he is on the Board of Cyber Putra College.

15 Dr Yuszahanim binti Yusoff Executive Director Dr. Yuszahanim was born in Kg Raja, Besut, Terengganu, Malaysia in She graduated from the Padjadjaran University, Bandung, Indonesia with a degree in Degree of Dental Surgeon (DDS) in She currently operates her own Dental Clinic. Dato Dr. Mohd Yahya Nordin Executive Director Dato Dr. Mohd Yahya Nordin served the Government of Malaysia for about 33 years as Administrative and Diplomatic Officer (or PTD). His last post prior to retirement in December 2005 was as the first Secretary General of the Ministry of Higher Education. Earlier he was the Secretary General for the Ministry of Human Resources. During his government service, he served about 15 years in the National Institute of Public Administration conducting courses and lecturing various fields including town planning and local government. Equally significant is his contribution in the higher education sector where he served the Ministry of Education for about 10 years as the Under Secretary for Higher Education Division including been the founding member of the National Accreditation Board (LAN) which became the present Malaysian Qualification Agency (MQA). During that period he was also instrumental in reforming the higher education sector during the late 1990 s which involved the enactment of various legislation pertaining to the development of higher education in the country. Dr Mazlan bin Mohamad Operation Director Dr Mazlan Mohamad is a Doctor in Veterinary Medicine DVM graduated from University Putra Malaysia.Started his career as a Technical Sales Executive in Sin Heng Chan (Malaya) Berhad in 1984 before joining Antah Pharma Sdn Bhd as Sales Manager, in In 1998, he joined Malaysian Technology Development Corporation (MTDC) and become Executive Director for Malaysian Vaccines & Pharmaceuticals Sdn Bhd which is subsidiary of MTDC in He joined Redhacare since 2008 as Operation Director.

16 Dr Abdul Ali bin Raja Mohamed Business Development Director Dr Abdul Ali, born in 1953, a Malaysian, is a medical doctor graduated from University of Madras, India. Started his career as a House Officer in the Ministry of Health in 1981 before joining Faculty of Medicine and the University Malaya Medical Centre in 1984 until He has 26 years experience in the management of acute emergencies, trauma care and disaster management. Currently, he is the CEO of Cyber Putra College and director of Academy of Paramedical Sciences, Cyberjaya University College of Medical Sciences

17 Management Team Bachelor of Chemistry in Industry (Universiti Teknologi Malaysia) Ahmad Rijaluddin has more than 7 years experience in GMP documentation and management system (Non-Conformances, Investigation and Problem Analysis, Deviation, CAPA and Change Control). One of his key strength is in Process Improvement System. He also has wide experience on the project management especially on the GMP facility and laboratory design and consultation. 2. Bachelor of Science (Microbiology) (Universiti Kebangsaan Malaysia) Paridah has wide experience as a QC Manager, GMP Lead Auditor, Vendor Audit, and as a trainer for GMP/GLP compliance. She also has been Management Representative for ISO14000 and committee member for the ISO9000, ISO17025 and OHSAS18000 Quality Management System. She has been key personnel for USFDA registration, coordinator for Laboratory Information Management System (LIMS) and Coordinator for the Excellent Towards Quality (ETQ) or Document Management System. Paridah also has wide experience in setting up a Chemical & Microbiology Laboratory for Small Volume Parenteral Manufacturing Plant. 3. BSc (Hons) Biomedical Science (Universiti Kebangsaan Malaysia) Malarvelidevi has wide experience in drug product registration with the local Drug Control Authority (DCA). She also has extensive knowledge in the international regulatory requirements such as FDA, TGA, PICs and EU. She is experienced in coordinating and monitoring of Bioequivalence Studies.

18 Bachelor of Mechanical Engineering, Universiti Teknikal Malaka, Malaysia Mohd Khalil Mohd Zaki has an extensive experience how to handle the machine and equipment in industry. Also expert in drafting (AutoCAD), laboratory in a factory design and documentation. He also have knowledge in Good Manufacturing Practices. 5. BEc Finance ( International Islamic University Malaysia, Malaysia) Yuszah Nor Hidayah has extensive experience in finance and banking field. She also has experience as a processing executive at EON Bank Berhad and responsible to evaluate and process the application for loan. Also has knowledge in manage the financial statement and has experience work with group finance function.

19 THE CLIENTS 4

20 CLINI-FOOD SDN BHD (GROUP OF HI-CITY, BIOSIS BHD) PHARMACEUTICAL MANUFACTURING COMPANY SOLID, CAPSULE, SOFT-GEL, LIQUID & SEMI SOLID PRODUCT CLINI-FOOD SDN BHD, Pharmaceutical Manufacturing Facility, Penang Address: Lot 1215, Mukim 12 Sungai Bakap, Penang, Malaysia. - Cream Mixing & Filling System - Tablet & Capsule Manufacturing - Soft-Gel Manufacturing Line Project Cost: RM 20 Million Duration of Project: Feb 2008 May 2009 Scope of Services: - Facility & Utility Design & Build - Equipment Design & Procurement - Commissioning & Qualification - Documentation Development - Validation - Calibration - Consultancy & Training Filling & Labelling Machine Area of Consultancy & Construction: - Grade D (GMP Clean / Classified Area) - Grade D (GMP Unclassified Area) - Warehouse - HVAC System - Purified Water System (Christ) - Waste Water Treatment Plant - Compressed Air (Oil Free System) - Liquid Mixing & Filling System

21 UNIVERSITI PUTRA MALAYSIA, SERDANG BACTERIA VACCINE FOR VATERIANARY MANUFACTURING FACILITY (GMP) Veterinary Vaccine Manufacturing Facility, IBS, UPM, Malaysia Address: Institute of Bioscience UPM Putra Infoport UPM Serdang, Selangor Project Cost: RM 13.9 Million Duration of Project: May 2010 Oct HVAC System - Highly Purified Water System - Pure Steam (Sterilize) System - Compressed Air (Oil Free System) - Bio Waste Treatment System - Bioreactor & Processing Equipment - Filling & packing Line - IPQC Equipment - Laboratory Cabinet & Equipment Scope of Services: - Facility & Utility Design & Build - Equipment Design & Procurement - Commissioning & Qualification - Documentation Development Area of Consultancy and Construction: - Grade B & C (GMP Cleanroom) - Grade D (GMP Unclassified Area) - Warehouse (Cold Room) - Laboratories (Analytical & Microbiological) 50L & 500L Fermentor GMP Cleanroom Downstream Equipments

22 XORIX SDN BHD PHARMACEUTICAL MANUFACTURING COMPANY LIQUID & SEMI SOLID PRODUCT XORIX Pharmaceutical Manufacturing Facility, Dungun, Terengganu Address: Lot 1,2,3 & 4 Kawasan Perindustrian Batu 7, Dungun Terengganu Darul Iman Project Cost: RM 16 Million - HVAC System - Purified Water System (Stilmas, Italy) - Compressed Air (Oil Free System) - Liquid Manufacturing & Filling Line - Cream Manufacturing & Filling Line - IPQC Equipment - Laboratory Cabinet & Equipment Duration of Project: Jan 2007 Mar 2008 Scope of Services: - GMP Documentation (SMF/VMP/URS/ DQ/IQOQ/PQ/PV/AMV/SOP/Change Control) - Facility & Utility Design & Build - Equipment Design & Procurement - Commissioning & Qualification - Documentation Development - Product Development, Scale-up & Commercialization - Validation (Process & Cleaning) - Calibration - Consultancy & Training Area of Consultancy & Construction: - Grade D (GMP Clean/Classified Area) - Grade D (Unclassified Area) - Laboratory - Pilot Plant (R&D) - Warehouse - Waste Water Treatment Plant Holding Tank & Filling Machine Cream Mixing Tank

23 IIUM PHARMACY SDN BHD PHARMACEUTICAL PILOT PLANT & MANUFACTURING COMPANY SOLID, CAPSULE, LIQUID & SEMI SOLID PRODUCT IIUM PHARMCY SDN BHD, Kulliyah of Pharmacy, IIUM Kuantan, Pahang, Address: Jalan Istana, Bandar Indera Mahkota 25200, Kuantan, Pahang Project Cost: RM 12 Million Duration of Project: Jun 2008 Jun 2009 Scope of Services: - Equipment Design & Procurement - Commisioning & Qualification - Documentation Development - Validation - Calibration - Consultancy & Training Area of Consultancy and Construction: - Grade D (GMP Cleanroom) - Grade D (GMP Unclassified Area) - Laboratories (Analytical & Pilot Plant) - Liquid Mixing System - Cream Mixing System - Liquid Filling & Packing Line - Cream Filling & Packing Line - IPQC Equipment Liquid Mixing Tank 1000L Liquid Holding Tank 100L

24 N.A.Z MEDICAL SUPPLIES SDN BHD MEDICAL DEVICES MANUFACTURING COMPANY HAEMODIALYSIS SOLUTION PRODUCT N.A.Z Medical Supplies, Enstek Technopark, Nilai, Seremban, Negeri Sembilan Address: Lot 34618, PT 29466, Bandar Baru Enstek, Mukim Labu, Daerah Seremban, Nilai, Negeri Sembilan. Project Cost: RM 30 Million Duration of Project: Jan 2010 Jun 2011 Scope of Services: - GMP Plant Concept Design - Detail Engineering - GMP Facility Construction - Critical Utility & Process Machinery - Procurement & Installation - Commissioning & Qualification - GMP Documentation (SMF/VMP/URS/ DQ/IQOQ/PQ/PV/AMV/SOP/Change Control) - Consulting & Training - Product Registration Area of Consultancy & Construction: - Grade C & D (GMP Clean/Classified area) - Grade D (Unclassified area) - Laboratory - Pilot plant (R&D) - Warehouse - Waste Water Treatment Plant & Drainage System - HVAC System - Highly Purified Water (HPW) System - Compressed Air (Oil Free System) - Processing Equipment - Laboratory & IPQC Equipment Compressed Air System Mixing & Holding Tank 10,000L HPW System - Generation

25 TECHNOLOGY PARK MALAYSIA ISO/IEC 17025, 2005 Laboratory Consultation Technology Park Malaysia, Sungai Besi, Negeri Sembilan Address: Sungai Besi, Wilayah Persekutuan Kuala Lumpur Duration of Project: May 2009 Sep 2009 Scope of Services & Consultancy: - Analytical Method Validation - Measurement Uncertainty - Proficiency Testing - Documentation - Adequacy Internal Audit - Consultancy & Training

26 UNIVERSITI SULTAN ZAINAL ABIDIN (UNISZA) BESUT CAMPUS Agro Biotech Laboratory Design Consultation BSL2 & BSL3 Design Consultation UNISZA Besut Campus, Besut, Terengganu Address: Besut, Terengganu Project Cost: RM 280 Million Duration of Project: Feb 2009 Sep 2010 Scope of Services: - Laboratory Design - Commissioning & Qualification - Documentation Development Area of Consultancy: - Teaching and R&D Laboratory for AgroBiotech (128 Laboratories) - Bio Safety Level (BSL) 2 & Bio Safety Level (BSL) 3 Laboratory

27 UNIVERSITI SULTAN ZAINAL ABIDIN (UNISZA) KOTA CAMPUS Medical Faculty Design Consultation UNISZA Kota Campus, Kuala Terengganu, Terengganu Address: Kuala Terengganu, Terengganu Project Cost: RM 18 Million Duration of Project: Feb 2009 Aug 2009 Scope of Services: - Laboratory Design & Build - Documentation Development Area of Consultancy: - Teaching and R&D Laboratory - Operation Theatre

28 REDHACARE GROUP OF COMPANIES 5

29 Education Cyber Putra College Management & Health Sciences Institute Offering certificate & diploma program in Pharmacy, GMP, GLP and Traditional Complementary Medicine Cyber Putra College (CPC) was founded in line with a special interest in developing unique quality programs related to Allied Health and humanitarian based that are much needed in the development of the community. CPC is based between Cyberjaya and Putrajaya. Currently we have three Diploma programs that have been approved by Malaysian Qualification Accreditation (MQA) and Kementerian Pengajian Tinggi (KPT). The programs are Diploma in Pre-Hospital Paramedic Practices, Diploma in Pharmacy and Diploma in Good Manufacturing Practice. Details of the programs: NO CURRENT PIONEER PROGRAMMES STATUS 1. Diploma in GMP Approved by MQA 2. Diploma in Pharmacy Approved by MQA 3. Diploma in Prehospital Paramedic Practice Approved by MQA UPCOMING PROGRAMMES STATUS 4. Diploma in Software Tissue Manipulation Awaiting Approval from MQA 5. Diploma in Software Engineering Awaiting Approval from MQA 6. Diploma in Nutritional Medicine Awaiting Approval from MQA 7. Diploma in Psycho Hypnotherapy Awaiting Approval from MQA PREPARATION PROGRAMMES STATUS 8. Diploma in Childcare and Parenting Under Preparation 9. Diploma in Reflexology Under Preparation 10. Diploma in Occupational Safety and Health Under Preparation 11. Diploma in Disaster Management Under Preparation 12. Diploma in Medical Assistant Under Preparation CERTIFICATE COURSES STATUS 13. Certificate In Emergency Medical Responder MQA Approved / PSMB Claimable 14. Certificate Train The Trainers In Massage Therapy MQA Approved / PSMB Claimable 15. Certificate In GMP MQA Approved / PSMB Claimable PROGRAMMES WITH JPK STATUS 16. Therapeutic Massage Approved by JPK 17. Reflexology Approved by JPK

30 VISION Cyber Putra College aspires to be an institute of higher learning and skills training in niche and distinctive areas focusing in Allied Health and Social Enterprise management. MISSION Cyber Putra College has positioned itself to be a niche market college specializing in uniquely different courses from the mainstream that are needed in Malaysia: in areas related to allied medical/health, public policy management, pharmaceutical and manufacturing programs, humanitarian and other related programs. CPC s missions are: To plan and conduct educational and learning programs in Allied Health meeting the current and future markets, in response to the lifelong learning needs of our diverse population. To plan, develop and conduct programs in Social Enterprise Management with quality higher education of international standard through a holistic learning environment. To provide learning experience in new areas focusing to our aging and potential stressful society through education, research and strong partnerships with Government, Institutions, Industries, and other sectors of the community.

31 BOARD OF DIRECTOR Y.BHG. DATO DR. MOHD YAHYA BIN NORDIN Chairman DR. ABDUL ALI B. RAJA MOHAMED Chief Executive Officer Y.BHG. TAN SRI DATUK DR HJ JOHARI BIN MAT Founding Director TN. SYED REDZUAN BIN SYED SALIM SHATRI Director MR. LEE KIYAU LOO Director EN. FAISAL BIN ABD RAHMAN Director

32 Product Development & Commercialization Oleopharm Sdn Bhd JV Company between Redhacare Manufacturing Sdn Bhd and University Malaya Development and Manufacturing of Palm Oil-Base-Excepient for Suppository, Cream & Food Product Biosafety Laboratory Redhacare Biolabs Sdn Bhd Design-Build-Commission Biosafety Lab (Modular Suite and Mobile Laboratories) Level 2 & 3 with compliance and certification to WHO/Australian Biosafety Standard and ISO17025 Laboratory Accreditation. Laboratory Accreditation (ISO/IEC 17025:2005) Redhacare Biolabs Sdn Bhd Consultation services for Laboratory Accreditation for Chemistry & Biotechnology laboratories.