
Chemipharm appoints Compliance Control Ltd. to help with their Computer Systems Validation Strategy
November 2011
Chemipharm was founded in 1972 by Dr. Gamal Kamel as the first private sector importer of pharmaceutical products in Egypt. Over the last 35 years, Chemipharm has developed and maintained an invaluable reputation as Egypt's most respectable and high standards pharmaceutical distributor.
In 2003, based on our continuous growth, Chemipharm has established its own manufacturing facility in the 6th of October Industrial Zone. The modern GMP plant produces pharmaceutical products of all major forms (tablets, capsules, syrups and ointments). In August 2011 Chemipharm extended its facilities by adding a new sterile area to produce ampoules, vials and eye drops; and a new cephalosporin facility to produce both oral and sterile forms of cephalosporin antibiotics.
The company's strategy is based on continuous improvement and growth.
With the above strategy in mind Chemipharm appointed Compliance Control Ltd. to help with their Computer Systems Validation Strategy. In particular the brief was to ensure that all Computer Systems, ranging from ERP to Equipment conformed to the latest regulatory standards. A high level Validation Master Plan has been created along with a Computer Systems Validation Policy and Procedures. Several intensive training courses have been carried out and a range of Retrospective and Prospective Validation activities are in progress.
Compliance Control Ltd. will also configure their online Integrated Electronic Quality and Document Management System: ComplianceControl Centre, which will help to manage and control all quality activities.
Chemipharm will also be using Oracles’ User Productivity Kit, which will help with the preparation of their Validation documentation and Training material.
Michael Atallah, Business Development Manager, Chemipharm Industries stated: “We were looking for a company with a track record in Computer Systems Validation and also with experience of working in Egypt, EU and the USA. Compliance Control Ltd. has provided 3 consultants over the past 6 months to help us with our strategy. They have brought immediate expertise to our team and are in the process of knowledge transfer. As part of our drive into the European market we wanted an organization with proven experience ensuring our organization can meet EU regulatory requirements”
David Forrest, Chief Executive of Compliance Control Ltd. stated:”It is a real pleasure working with Michael and his colleagues at Chemipharm. It is pleasing that our experience has been acknowledged by Chemipharm by the award of this project. Chemipharm have a lot of experience in Equipment Validation, but we bring the additional Software Validation skills to complement their team. The use of ComplianceControl Centre will really help them to have control and visibility over all their Quality Key Performance Indicators”
For further information on Chemipharm, refer to: www.chemipharm.com
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