STANDPHARM PAKISTAN (PVT

In STANDPHARM specifically designed Q.C and Q.A operations are being carried out under the supervision of specifically qualified and experience heads on latest state of the art sophisticated electronic equipment. Specific aspects of laboratory operations and overall quality control procedures conform to the written standard procedures. Specifications and Analytical procedures are suitable, applicable, and in conformance with commitments and compendia. Specific methodology is used to test a new product and development work. Our laboratory is equipped with latest modern state-of-the-art analytical instruments, such as: H.P.L.C. (High Performance Liquid Chromatography) Schimadzu Japan Thermonex U.S.A FTIR Thermo Nicollet U.S.A Spectrophotometer Thermonex U.K Potentiometer Switzerland Karl Fischer Autotitrator Switzerland Dissolution apparatus Our Laboratory records represent the technical ability of the staff which is continually enhanced by Internal Quality Audits (IQA) and in-house/external cGMP trainings. SOPs required for all systems and operations are available, complete and adequate. Laboratory data, laboratory procedures, methods and equipments, including maintenance, calibration, and method validation data depict the overall quality of the laboratory operation and the ability to comply with cGMP regulations. Through our unique combination of state-of-the-art, analytical instrumentation, process equipments that meet global development standards and world-class scientific expertise; we ensure that our clients receive outstanding added value. Quality Assurance (QA), a vital technical tool for ensuring Model Quality Assurance System (MQAS), is an integral part of Standpharm for keeping our clients and customers happy and guarantees that our manufacturing plant operates in full compliance with cGMP guidelines and fulfils our commitment to excellence and aim to provide top quality products to our consumers. Quality Control Management is linked with quality related structure as Production, Quality, Import, Engineering, Raw and Packaging Materials, Warehouse and Plant management. The major task of this division includes: Organization of the Q.C system. Surveillance of Q.C system, auditing of supplier. Self inspection, monitoring & control of manufacturing environment & plant hygiene. Administration of all documents relevant to quality. Validation of process, equipment, equipment cleaning, and analytical method / Performance, calibration of machinery, equipment and instruments. Stability studies and impurity profiles as per ICH guidelines. Change Control Environmental Conservation Safety of Personnel Personnel Management Increased efficiency of our production processes Minimum waste due to shortcomings And final and utmost client and customer satisfaction Standpharm maintains state-of-the-art cGMP stability storage conditions. Its storage standard meeting ICH guidelines, it has six hundred liter capacity and certified by T.U.V Germany, WHO, F.D.A approved and I.S.O certified by AFAQ France. Temperature and humidity set-point windows are ±2°C and ±5% RH, respectively, with deviations outside set-point ranges resulting in an immediate alert. Storage chambers are supported by full generator backup in case of power failure. In Standpharm the concept of Quality includes not only the product quality as such but also encompass.