NUTRAMEDICA LABORATORIES SDN BHD MANUAL <br />2010<br />ISI KANDUNGAN <br /><ul><li>ISI KANDUNGAN MUKA SURATNutramedica La...
Produk Kosmetik – perlu didaftarkan dengan Kementerian Kesihatan Malaysia bahagian Biro Pengawalan Farmaseutikal Kebangsaa...
SOP permohonan pengkelasan produk
SOP permohonan semakan label
SOP permohonan sijil halal Jakim
SOP permohonan sijil penjualan bebas produk makanan (FSC)
SOP permohonan sijil penjualan bebas produk cosmetic (FSC)
SOP permohonan sijil kesihatan (health certificate)
SOP permohonan produk buatan Malaysia
SOP pengiraan sebut harga sampel produk kosmetik/ makanan
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Dokumen penyerahan tugas

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Dokumen penyerahan tugas

  1. 1. NUTRAMEDICA LABORATORIES SDN BHD MANUAL <br />2010<br />ISI KANDUNGAN <br /><ul><li>ISI KANDUNGAN MUKA SURATNutramedica Laboratories Sdn Bhd (NLSB)Bidang tugas pegawai R&DBidang tugas pembantu pegawai R&DBidang tugas pembantu makmalPerkhidmatan disediakan NLSB dan sebut hargaCarta alir business (Business Flow)Senarai semak permohonanPendaftaran produk (product registration)Pembangunan produk (product development)Carta alir pembangunan produk Prosedur pelaksanaan piawai (SOP)SOP permohonan produk notifikasiSOP permohonan pengkelasan produkSOP permohonan semakan labelSOP permohonan sijil halal JakimSOP permohonan sijil penjualan bebas produk makanan (FSC)SOP permohonan sijil penjualan bebas produk cosmetic (FSC)SOP permohonan sijil kesihatan (health certificate)SOP permohonan produk buatan MalaysiaSOP pengiraan sebut harga sampel produk kosmetik/ makananSOP penyediaan sampelSOP permohonan sampelSOP menyimpan rekod klien dalam komputerSOP penggunaan computerSOP penggunaan smart cardBPFK (Biro Pengawalan Farmaseutikal Kebangsaan)Amalan pengilangan baik (GMP)JAKIMKementerian Perdagaan dan Hal Ehwal Pengguna (KPDNHEP)Senarai borang (list of form)Senarai permintaan sampel dan status (product requisition & status)Laporan bulanan penyediaan sampelLaporan bulan penyediaan sampel kosmetikLaporan bulanan penyediaan sampel makananJangka hayat produk (product shelf life)Pengujian produk (product testing)Sijil analisis (COA)Ujian mikrobiologi (microbial test)Ujian logam berat (heavy metal test)Ujian fakta pemakanan (Nutrition facts analysis)Ujian keberkesanan (efficacy test)Senarai peralatan makmalSenarai fail Senarai bahan mentah makananSenarai bahan mentah kosmetikLampiran </li></ul>Nutramedica Laboratories Sdn Bhd<br />Nutramedica Laboratories Sdn Bhd (NLSB), a wholly owned Bumiputra company incorporated on 1st April 2008 belongs to Nutraherbs Sdn Bhd (NSB). The company is dedicated to produce quality herbal and plant based products and other nutraceutical products based on herbal and plant extracts with non analytical profiles and efficacies to penetrate increasingly sophisticated global marketplace.<br />NLSB is a biotech company with a strong R&D and technology capabilities. The strength of the company lie on its core activities in producing personal care, health & wellness products based on scientifically validated herbal and plant extracts.<br />NSB has been in business for over 12 years specializing in manufacturing of herbal and plant based products. It is a GMP certified manufacturer of HALAL quality herbal and plant based personal care and health supplements for applicant companies with existing operations. <br />All products are scientifically formulated by NLSB for NSB in-house scientists, who are experts in the fields of herbs and medicinal plants, food and nutrition, alternative medicine and aromatherapy. The company is regularly in consultations with scientists from universities and research institutions in addition to its own experts in the above disciplines.<br />To date, NLSB in conjunction with NSB has 20 clients providing technical advice, product formulations and products analysis and certifications on OEM basis. The formulations are customized for each client. Presently the company is involved in formulations of skin care and health products with both large and start-up companies. The company’s leading edge is not only in supplying high quality products, but also assisting clients in product formulation, product packaging and product knowledge by offering seminars and consultations.<br />Among NLSB clients are: <br />Avon Cosmetics (M) Sdn Bhd<br />Luxor Network Sdn Bhd<br />Bencoolen Sdn Bhd<br />Forest‘s Secret Sdn Bhd<br />Johor Biotech Corporation<br />Hiraq Training & Marketing Sdn Bhd<br />Platinum Herb Sdn Bhd <br />The company is led by a team of experienced and well qualified personnel with a combined work experience of more than 30 years in the areas of Chemist, Alternative Medicine, Food Technologist, Technology Management and Financial Management, Business Management. Expertise from other areas such as safety and toxicology studies are sourced out from SIRIM, FRIM and other universities.<br />As a parent company, NSB also manufacture herbal & nutraceutical products in different forms including capsule, liquid, powder, tablets. NSB offer the following:<br />State of the art in the development and manufacturing of cosmetics using facilities that meet international standards such as Good Manufacturing Practice (GMP), Good Hygiene Practice (GHP), Hazard Analytical Critical Control Point (HACCP) and Halal Standard and delivering the highest quality goods to our customers. The company provides innovative solutions for all nutraceutical needs and a customer service based private label manufacturer.<br />Highest quality finished products with sound quality assurance programs in place.<br />A wide range of functional plant-based cosmetic products on request by clients.<br />Bidang Tugas Pegawai R&D<br />Position:Head of R&D<br />Reports to:Chief Executive Officer <br />Responsibility<br />Responsible to develop formulas, specifications and label declarations.<br />Responsible in the development of new products and improvement of products for client. These would include improvement of existing lines, line extensions, and factory efficiency.<br />To ensure compliance to all halal requirements in related to usage of raw material, packaging material and production equipment and process.<br />To demonstrate creatively in the identification of potential areas for innovation and in the development of new technology through the novel application of ingredients, formulation and processing.<br />Make test samples of products .To make sure the sample is stable, by conducting stability test. Test products for flavor, texture, color and nutritional content as applicable.<br />Ensure compliance to finished product specification and nutrition labels.<br />Analyze data and communicate results.<br />To prepare various reports to ensure complete communication of project status, progress, issues, solutions, timeline, and accountability.<br />Utilize problem-solving techniques to improve products and processes <br />Conduct design of experiments and process capability studies where needed.<br />Manage a portfolio of product development projects through effective planning and flawless execution <br />Application of standard consumer science techniques to prototype development and optimization. <br />Application of standard quality control procedures such as raw material and finished product specifications<br />Excellent communication and interpersonal skills in order to effectively interact with internal and external customers and suppliers <br />Responsible to assist in the on-line cosmetics registration as per the Ministry of Health (BPFK) requirements and other registrations and legislations from JAKIM or other related organizations.<br />Any other tasks as directed by the Chief Executive Officer or Executive Chairman<br />Authority<br />Approve purchase requisition not exceed than RM 300.00<br />Approve staff leave<br />Appraise staff performance<br />Bidang Tugas Penolong Pegawai R&D <br />Position:R&D Assistant<br />Reports to:Head of R&D (HOD)<br />Responsibility<br />Responsible for the entire process of product launches to production<br />Manage production and to ensure that products meet specifications and standards.<br />To participation in process development and optimization.<br />Responsible in the development and evaluation of product/process technology.<br />Develop formulas, specifications and label declarations.<br />Responsible in the development of new products and improvement of products for client. These would include improvement of existing lines, line extensions, factory efficiency.<br />To demonstrate creatively in the identification of potential areas for innovation and in the development of new technology through the novel application of ingredients, formulation and processing.<br />Make test samples of products .To make sure the sample is stable, by stressing the product for one to three months under different conditions. Test products for flavor, texture, color and nutritional content.<br />Ensure compliance to finished product specs and nutrition label.<br />Analyze data and communicate results.<br />To prepare various reports to ensure complete communication of project status, progress, issues, solutions, timeline, and accountability.<br />Utilize problem-solving techniques to improve products and processes <br />Assist with design of experiments and process capability studies<br />Able to manage a portfolio of product development projects through effective planning and flawless execution <br />Application of standard consumer science techniques to prototype development and optimization. <br />Application of standard quality control procedures such as raw material and finished product specification<br />Excellent communication and interpersonal skills in order to effectively interact with internal customers and external suppliers <br />Responsible to assist in the on-line cosmetics registration as per Ministry of Health (BPFK) requirements and other registration and legislation under food and beverages from JAKIM or other related organizations.<br />Perform other related duties and responsibilities as required from time to time<br />Proper maintenance of product test samples.<br />Authority: Nil<br />Bidang Tugas Pembantu Makmal <br />Position:Lab Assistant<br />Reports to:R&D Assistant<br />Responsibility<br />Responsible for the entire process of product launches bench to production<br />Manage production and to ensure that products meet specifications and standards.<br />Process development and optimization responsible in the development and evaluation of product/process technology.<br />Develop formulas, specifications and label declarations.<br />Responsible in the development of new products and improvement of products for client. These would include improvement of existing lines, line extensions, factory efficiency.<br />To demonstrate creatively in the identification of potential areas for innovation and in the development of new technology through the novel application of ingredients, formulation and processing.<br />Make test samples of products .To make sure the sample is stable, by stressing the product for one to three months under different conditions. Test products for flavor, texture, color and nutritional content.<br />Ensure compliance to finished product specs and nutrition label.<br />Analyze data and communicate results.<br />To prepare various reports to ensure complete communication of project status, progress, issues, solutions, timeline, and accountability.<br />Utilize problem-solving techniques to improve products and processes <br />Assist with designed experiments and process capability studies<br />Able to manage a portfolio of product development projects through effective planning and flawless execution <br />Application of standard consumer science techniques to prototype development and optimization. <br />Application of standard quality control procedures such as raw material and finished product specification<br />Excellent communication and interpersonal skills in order to effectively interact with internal customers and external suppliers <br />Responsible to assist in the on-line cosmetics registration as per Ministry of Health (BPFK) requirements and other registration and legislation under food and beverages from JAKIM or other related organizations.<br />Perform other related duties and responsibilities as required from time to time<br />Authority: NIL<br />Perkhidmatan disediakan NLSB dan sebut harga<br />NoServicesQuantity (if any)Price (RM)Lead timeRemarkProduct Formulation     1Cosmetic and food formulation ≤ 5 product5002 weeks Product Registration    1Product notification (cosmetic)13502 weeks 2Product MAL No (traditional)110006 to 8 month 3Free sale certificate (cosmetic)11002 weeks   Free sale certificate (food)≤ 5 product1503 weeks 4Product classification (food)1502 weeks 5Label checking (food)1503 weeks 6Advice for labelling 125003 weeks 7Health certificate (food)11503 weeks 8Logo buatan Malaysia11002 weeks 9Halal certification≤ 5 product10003 to 5 month   6 ≤ 10 product1200    11 ≤ 15 product1400    16 ≤ 25 product1700   RM 50 will be added for each additional  50   product    Product Testing     1Certificate of analysis (cosmetic)1200  2Certificate of analysis (food)1200  3Microbiological test (Min requirement)1200  4Efficacy test16500  5Challenge test1700  6Nutrition facts1250  7Heavy metal test (Min requirement of MOH)1TBC  8Viscosity test175  Training / Consultancy    1Product formulation training TBC  2Halal application trainig TBC  3GMP training TBC  4General Halal training TBC  5PIF training TBC  6CFS Training TBC  7Health Certificate training TBC  8How to start a business TBC  9Principle in starting the business TBC  10Setting a GMP factory TBC  <br />Carta alir business (Business Flow)<br />Sila lihat di lampiran <br />Senarai semak permohonan<br />Permohonan produk notifikasi – kosmetik <br />Permohonan pengkelasan produk – makanan<br />Permohonan semakan label - makanan<br />Permohonan sijil halal Jakim – makanan dan kosmetik<br />Permohonan sijil penjualan bebas produk makanan (FSC)<br />Permohonan sijil penjualan bebas produk cosmetic (FSC)<br />Permohonan sijil kesihatan (health certificate) - makanan<br />Permohonan produk buatan Malaysia<br />Permohonan untuk minuman air berbungkus (AMB)<br />Permohonan memperbaharui smart card<br />Permohonan smart card daripada DG Cert Sdn Bhd<br />Permohonan pelaksanaan HACCP<br />Permohonan pelaksanaan GMP (makanan)<br />Lain-lain permohonan<br />Pendaftaran produk (product registration)<br />NLSB menghasilkan produk makanan dan kosmetik di peringkat R&D dan produk tersebut perlu didaftarkan. Pendaftaran produk di bahagikan kepada 2:<br /><ul><li>Produk Makanan – perlu didaftarkan dengan Kementerian Kesihatan Malaysia bahagian kawalan kualiti makanan (BKKM) iaitu unutk pengkelasan
  2. 2. Produk Kosmetik – perlu didaftarkan dengan Kementerian Kesihatan Malaysia bahagian Biro Pengawalan Farmaseutikal Kebangsaan (BPFK)</li></ul>Pembangunan produk (product development)<br />Pembangunan produk (internal request)<br />Kenal pasti target pasaran<br />Kenal pasti konsep produk<br />Kenal pasti harga produk<br />Mengenalpasti bahan mentah (ex stock/ halal/ biodegradable/ green/ harga)<br />Produk formulasi (laboratory scale) beserta kaedah proses yang sesuai<br />Ujian pengguna (customer testing)<br />Laporan produk (product evaluation) <br />Perbaiki formula (jika perlu)<br />Ujian produk (Certificate of Analysis)<br />Ujian Pilot (pilot test) <br />Perbaiki kaedah proses (jika perlu)<br />Sediakan penerangan produk (product description)<br />Sediakan mock up label <br />Formula disimpan <br /> Pembangunan produk (customer request)<br />Carta alir pembangunan produk <br />Prosedur pelaksanaan piawai (SOP)<br /><ul><li>SOP permohonan produk notifikasi
  3. 3. SOP permohonan pengkelasan produk
  4. 4. SOP permohonan semakan label
  5. 5. SOP permohonan sijil halal Jakim
  6. 6. SOP permohonan sijil penjualan bebas produk makanan (FSC)
  7. 7. SOP permohonan sijil penjualan bebas produk cosmetic (FSC)
  8. 8. SOP permohonan sijil kesihatan (health certificate)
  9. 9. SOP permohonan produk buatan Malaysia
  10. 10. SOP pengiraan sebut harga sampel produk kosmetik/ makanan
  11. 11. SOP penyediaan sampel
  12. 12. SOP permohonan sampel
  13. 13. SOP menyimpan rekod klien dalam komputer
  14. 14. SOP penggunaan computer
  15. 15. SOP penggunaan smart card</li></ul>BPFK (Biro Pengawalan Farmaseutikal Kebangsaan)<br />Amalan pengilangan baik (GMP)<br />JAKIM<br />Kementerian Perdagaan dan Hal Ehwal Pengguna (KPDNHEP)<br />Senarai borang (list of form)<br />Senarai permintaan sampel dan status (product requisition & status)<br />Laporan bulanan penyediaan sampel<br /><ul><li>Laporan bulan penyediaan sampel kosmetik
  16. 16. Laporan bulanan penyediaan sampel makanan</li></ul>Jangka hayat produk (product shelf life)<br />Pengujian produk (product testing)<br />Sijil analisis (COA)<br />Ujian mikrobiologi (microbial test)<br />Ujian logam berat (heavy metal test)<br />Ujian fakta pemakanan (Nutrition facts analysis)<br />Ujian keberkesanan (efficacy test)<br />Senarai peralatan makmal<br />Senarai fail <br />Senarai bahan mentah makanan<br />Senarai bahan mentah kosmetik<br />Lampiran <br />

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