CURRENT GOOD MANUFACTURING PRACTICES (CGMP) FACILITY 

The company has established state-of-the-art manufacturing facilities conforming to the most stringent international cGMP rules and regulations. Sharif Pharmaceuticals' manufacturing facilities at Rupganj, Narayanganj is the cynosure of all eyes, well equipped with world-class production facilities.Sharif Pharmaceuticals Limited is one of the largest and finest pharmaceutical facilities in Bangladesh. The company focuses on providing high quality products with zero defects by establishing very sensible and high standard manufacturing processes and by maintaining all stringent quality control procedures.

ZONE CONCEPT

The risk of contamination and cross contamination has been taken into serious considerations while designing the plant. As the best available precautionary measures, the "Zone Concept" of current Good Manufacturing Practices (cGMP) has been meticulously implemented in the designing of the Heating Ventilation Air Conditioning (HVAC) system conforming to the WHO-cGMP guidelines. Segregation of every critical processing activity in each zone is ensured to avoid cross contamination. Respective zones, areas and even uniforms are marked with specific colors to ensure total segregation. 

HVAC SYSTEM

European standard heating, ventilation and air conditioning system (HVAC) has been installed. Each zone has separate cGMP AHUs (Air Handling Units) with 0.4 micron pre-filters, 0.22 micron HEPA filters, dehumidification unit and dust extraction systems. The HVAC system comprises of 16 separate air handling units (AHU) covering optical clean and clean areas. Air environment conditioned in each area with respect to temperature, humidity, filtration, particle counts, etc. Air Class 100000 is maintained in general production area as an extra precaution to ensure highest level of product safety which is devoid of any contamination. External contamination is prevented by installing Class 100 sampling and dispensing booth.

EXCELLENCE IN INFRASTRUCTURE THROUGH CGMP ASPECTS

Production Area has been made by Sandwich Panels & Self Leveling Epoxy floor because it is Impervious, Non-porus, Non shedding, Free of Cracks and Dirt-retaining holes and Easily washable.No wood or asbestos component has been used. Building Automation System (BAS) is installed which continuously monitors temperature, humidity and pressure in all production areas. In addition, the system monitors the high hazard areas of solvent storage room in case of solvent leak and/or fire.

MICROBIOLOGY LABORATORY

This laboratory accommodates the necessary staff and equipment to support Dalton's rigorous environmental monitoring program for the GMP area. The biological safety cabinets and incubators are used for on-site bioburden testing, microbial identification and environmental monitoring of the GMP area.

ASSURING QUALITY

Our Quality Assurance (QA) has established quality in work, and that activities that require good quality are being performed effectively all those planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements for quality. Our QA team ensures "all that we do is written down and all what is written down is done".Sharif Pharmaceuticals Limited is committed to provide consistent product is safety, strength, efficacy and purity. It follows all documented procedures in if activities.

EXCELLENCE THROUGH A HIGHLY SENSIBLE QA SYSTEM

Our Quality Assurance (QA) department has established quality in work to provide enough confidence that a product or service will satisfy the given requirements for quality. Our QA team ensures "all that we do is written down and all what is written down is done". Sharif Pharmaceuticals Limited is committed to provide consistent product safety, strength, efficacy and purity. It follows all standard documented procedures in its activities.

WORLD CLASS QUALITY CONTROL (QC) LAB

The backbone of our company is the Quality Control laboratory. Our Analytical Services area was architecturally designed to house a vast array of analytical equipment. The well equipped QC lab has world's most precision equipment to ensure the highest level of product quality. All equipment are located for maximum efficiency of space and data communication.

STATE-OF-THE-ART EQUIPMENT

Our QC lab is equipped with following world class high precision equipment :Autoclave, UK

Total Organic Carbon (TOC), Japan

Dissolution Tester, India 

Tablet Hardness Tester, Germany 

Tablet Friability Tester, India 

Stability Chamber, India 

Karl Fischer Titrator, Switzerland

Potentiometric Titrator, Switzerland 

Atomic Absorption Spectrophotometer, Japan

High Performance Liquid Chromatography (HPLC), Japan

Double Beam UV Spectrophotometer, Japan

Digital Polarimeter, UK

Automatic Refractometer, UK

Moisture Analyzer, Germany

Incubator, Germany

Electronic Analytical Balance, Germany

Disintegration Tester USP, India

WATER TREATMENT & DISTRIBUTION SYSTEM

The Reverse Osmosis (RO) water purification system is based on modern Electrode De-ionisation (EDI) technology with the use of Osmotron System having several treatment procedures e.g. chlorine dosing, sand filtration, sodium m-bisulphite dosing, carbon filtration, softener treatment, cartridge filtration etc. It is built-in with self sanitizing system by ozone and UV rays with online monitoring of pH, temperature and conductivity. The quality of purified water strictly complies with the USP specifications.Water from purified water plant is distributed to different user points through closed distribution loop system. These distribution loops are made with 316 SS pipes with simless joints made by orbital welding and checked by boroscopic tests. Whole system circulates for twenty four hours.

WAREHOUSE

The centrally air-conditioned warehouse is located in a separate area and is divided into four parts.Warehouse has a Cold Room maintaining 2-80 C temperature. There is a dedicated sampling area in the warehouse equipped with separate change-room, air lock doors under laminar airflow (LAF) and air-conditioning system to ensure clean air (Class 100000). Separate rooms and protected areas are available for printed labels, returned goods, rejected materials, controlled substances etc. There is also a separate finished goods room.

SAFETY MEASURES

Automatic fire detection system comprising of heat, photo-electric and ionization detectors, has been setup in the entire plant. Besides fire detector, automatic alarm and central display facilities are also available. Emergency exit facilities are available in all of the covered areas.

COMMITMENT TO ENVIRONMENT

Sharif Pharmaceuticals is committed to keep our soil, water and air clean. Environmental issues are approached with due importance and effective measures. To make the plant eco-friendly, Sharif Pharmaceuticals has established an effective effluent treatment system.Effluent Treatment Plant (ETP) is effective in neutralizing all liquid effluents to ensure environment friendly discharges. Tests for untreated and treated effluents are conducted on regular basis according to environment and safety protocols. All solid wastes are separated according to their nature and subsequently treated according to the set procedures. Sharif Pharmaceuticals is one of the most environment concerned pharma plants in Bangladesh that installed incinerator for burning solid toxic wastes at 12000 C generated from different  production areas. 

MARKETING AND SALES

Marketing and sales activities are beginning with full efforts across the country. Our sales team is operating their activities all over the country dividing into 12 regions comprising a total of 350 MIOs. The marketing and sales team is highly professional who have a long experience on pharmaceuticals marketing and sales. The prime vision of our marketing and sales team is on creativeness through strategic marketing and providing rapid supports to the medical fraternity. 

DISTRIBUTION

Sharif Pharmaceuticals Limited is starting its journey with its own distribution channel which will ensure uninterrupted delivery of all medicines to the every door step of the chemists. We are starting with eight depots throughout the country namely Dhaka, Chittagong, Comilla, Sylhet, Jessore, Bogra, Rangpur and Barisal. We hope these depots will fulfill the company's commitment of ensuring medicine supply in every nook and corner of the country.

WORLD CLASS FACILITY MEETS ALL STRINGENT SPECIFICATIONS OF CGMP

State-of-the-art layout design that ensures cross contamination free production area, unidirectional material flow and minimum cross over in personnel movement.Production area has been made by Sandwich Panels & Self Leveling Epoxy floor. European standard HVAC system ensures class 100000 primary production zone, precisely controlled temperature and humidity as per product requirement and pressure differential in different areas to avoid cross contamination.Isolated and dedicated production facilities for Cephalosporin products.The backbone of our company is the Quality Control (QC) laboratory. The QC lab has been well equipped with world's most precision equipment to ensure the highest level of product quality.Zero-discharge Effluent Treatment Plant (ETP) has been constructed using latest technology.