about us - simpor pharmasimporpharma.com/contents/simporpharma-brochure.pdf · about us simpor...

10

Upload: dangtuong

Post on 23-Jul-2018

214 views

Category:

Documents


0 download

TRANSCRIPT

About UsSIMPOR PHARMA SDN BHD, a pioneer manufacturer and contract manufacturer based in Brunei Darussalam, is built to the global standards of pharmaceutical industry.

Simpor Pharma has a new milestone for Brunei Darussalam - as the first GMP and Halal Pharmaceutical manufacturing company in Brunei, aiming to meet certifications from various authoritative organizations.

Our VisionSIMPOR PHARMA SDN BHD shares the same objective with the Government of Brunei Darussalam; becoming the global leader in the Halal industry for pharmaceutical products, health supplements, as well as cosmetics.

Simpor Pharma also aims to deliver customized services to meet global contract manufacturing needs, providing cutting edge technologies that are ready for all manufacturing requests, along with private labels.

Good Manufacturing

Practice

Health Canada

Natural Products Association

GMP Certified

TGA Health Safety Regulation

PIC/S GMP

World Health Organization

Ministry of Health Brunei Darussalam

Halal Certified

Certification

Other specialized services for manufacturing and private labels include colour coatings, logo printing, packaging and labelling.

Simpor Pharma will become a significant player for exporting Halal pharmaceutical products, Health Supplement & Cosmetics in Brunei, Asia and around the world.

Quality ControlOur GLP-compliant Quality Control Department equipped with high-tech instrumentation of international standards ensures that all our products and processes are in conformation to national and international standards.

These highly advanced instrumentations are staffed by an experienced and highly-skilled workforce.

Chemical Testing

The laboratory contains the latest testing equipment needed for the verification of chemical compounds in raw materials and finished products. Much of the analyses involved include the use of equipment such as:

- ICP ( Inductively Coupled Plasma Optical Emission Spectrometer )- UHPLC ( Ultra High Pressure Liquid Chromatography )- TOC ( Total Organic Count )- GC ( Gas Chromatograph )- FTIR ( Fourier Transform Infrared Spectrophotometry )- UV/Vis ( Ultraviolet / Visible Spectrophotometry )- Titrimetric and Potentiometric assays- Moisture, Friability and Harness Testing- Disintegration & Disolution Test- Stability Test

Quality AssuranceSimpor Pharma has an established and rigorously enforced Quality Management System covering every aspect of manufacturing.

Change Control Programme

Management of Retention Samples

Process & Cleaning Validation

Product Quality Review

Document & Records Management

Analytical Method Validation

Stability Programme

Quality Risk Management

Equipment Qualification & Validation

Training

Microbiological Testing

Simpor’s standard practice is to do microbiological testing on all raw materials and finished products to the current USP standards. The microbiology laboratory is segregated within the main manufacturing facility. Its primary function is to verify the absence of harmful bacterial and other microbial contamination.

- Total Bacteria Count

- Total Yeast and Mold Counts

- Testing for and identification of: Staphylococcus aureus, Escherichia coli, Pseudomonas, anaerobic bacteria, Clostridium perfringens and Clostridium species

HalalBeing the first Brunei’s Halal Pharmaceutical where the entire plant is Halal certified, Simpor Pharma’s objective and importance is to assure products manufactured are halal according to the Islamic Law to meet the demand of Muslim customers not just locally but globally as well.

Only Halal materials are used in all production, and anything haram are strictly prohibited to avoid cross contamination. As a manufacturing company that strictly follows GMP, Simpor Pharma has a dedicated Halal Management Team who develop, implement and maintain Halal Assurance System - a system that is not only GMP-compliant but also ensures the integrity of Halal products, from acquisition of raw materials to the production of finished products.

Halal Assurance SystemHalal Policy

Halal Materials SOP

Halal Management Committee

Cleaning and Hygiene

Services

Services include:

Manufacturing

Packaging

Quality Control ( Lab Testing )

Research & Development ( Formulation )

Products include:

Softgels Tablets

Hard Shell Capsules

Powders & Granular

Oral Liquids

Creams & Gels

Manufactured products include: Over-the-counter ( OTC ) medicine

Generics and Ethical drugs

Health Supplements

Cosmetics

Regardless of format, Simpor Pharma has the complete capabilities to successfully produce and deliver the finished goods at the standards expected and exceeding those set by clients.

Customized Services ForAll Your NeedsSimpor offers contract manufacturing for products in many dosages. Custom requests for manufacturing, along with private labels, are also available for Nutraceuticals, Pharmaceuticals, and Cosmetics.

All Simpor Pharma products are proudly made in Brunei Darussalam under rigorous quality controls, measured by the most current GMP standards and adhering to the strictest Halal guidelines and practices.

FacilitiesThe whole plant has been constructed with customized structures that meet the pharmaceutical requirements (PIC/S, Guide to Good Manufacturing Practice for Medicinal Products) for design, construction materials, HVAC, Purified Water and utilities. The manufacturing areas are all controlled in Class 100,000 Cleanroom standard as per the requisite classification norms.

All laboratories and equipment follow strict rules for complying with government

High Shear Granulator Bin Blender

Fluid Bed Granulator

Hard Shell CapsuleEncapsulation Machine

Fully Automatic Bottle Packaging Lines

Softgels Encapsulation Machine Cream Mixing Machine

Tablet Press MachineWith Metal Detector

Coating Machines

regulations, PIC/S GMP, and contractual obligations. On-site laboratories include chemical, microbiological and R&D perform tests on all incoming materials, in-process products, validations and finished products as well as environment tests.

Everyday, dedicated employees of the plant contribute their know-how to guarantee the highest quality in all stages of production.

Adequate temperature controlled warehouse space has been made available to handle incoming raw and packaging material, in-process stocks as well as storage of finished products. Warehouse access is restricted to designated personnel, security cameras have been installed and the flow of materials follows corporate procedures throughout raw material sampling, quarantine, releases, issuance to production and finished product storage.

Softgels & Gelatin Shells PowdersTypes:

Regular Softgels

Chewable Softgels

Cosmetic Softgels

Enteric Coated Softgels

Bovine Gelatin Softgels

Fish Gelatin Softgels

Types:

Regular Powders

Fine Powders

Effervescent Powders

Granular

Advantages:

Better Bio-availability

Higher Absorption Rate

Easy To Swallow

Elegant Appearance

Superior Odor Masking

Longer Shelf Life

Advantages:

Water Soluble

Rapid Absorption

Concentrated Liquid

Multi-purpose

PRODUCTION CAPABILITIES

40 MillionSoftgel capsules per day

PRODUCTION CAPABILITIES

20,000 Tonsof Powder & Granular per annum

PRODUCTION CAPABILITIES

50 MillionTablets per day

PRODUCTION CAPABILITIES

10,000 Tonsof Liquid per annum

Tablets Oral LiquidsTypes:

Core Tablets

Chewable Tablets

Film Coated Tablets

Sugar Coated Tablets

Moisture ShieldCoated Tablets

Enteric Coated Tablets

Effervescent Tablets

Sustained ReleaseTablets

Types:

Calcium EnrichedDrinks

Iron Enriched Drinks

Vitamins Enriched Drinks

Omega Drinks

Energy Drinks

Vitamin D Drinks

Herbal Drinks

Isotonic Drinks

Customized Drinks

Advantages:

Large Variety Of Compositions

Broad Range Of Shapes and Sizes

Multiple Use And Functionality

Advantages:

Faster Absorption Than Solids

Palatable

Better For Consumers Who Have Trouble Swallowing Than Others

PRODUCTION CAPABILITIES

7.2 MillionCapsules per day

PRODUCTION CAPABILITIES

324 Tonsof Cream & Gels per annum

Hard Shell Capsules Creams & GelsTypes:

Regular GelatinCapsules

Vegetarian Capsules

Fish Gelatin Capsules

Beadlet Capsules (Can be time release)

Enteric Coated Hard Shell Capsules

Types of Gels:

Moisture PreservationGel

Eye Gel

Lubricating Gel

Anti-ageing Gel

Anti-acne Gel

Skin Smoothening Gel

Customized Creams & Gels

Advantages:

Quicker Lead Time

Vegetarian Capsules are available

Types of Creams:

Anti-wrinkle CreamAnti-ageing CreamAnti-acne CreamMoisture PreservationCreamEye CreamDay CreamNight CreamSkin Lightening CreamSkin Smoothening CreamBB Cream

Simpor Pharma Sdn BhdLot P18, P19, P28, P29,Salambigar Industrial Site,Jalan Utama Tanah Jambu,BU1129, Brunei Darussalam.

Tel: +673-239-3668

Fax: +673-239-3788

Email: [email protected]

Website: www.simporpharma.com

I N N O V A T I O N A T I T S B E S T