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| Quality Management Corporate Quality Policy PENTAPHARM is led by a quality-oriented management. Quality thinking and quality orientation form the foundation of our business policy. Senior management supports and monitors the continuous improvement of all processes and activities. A quality management system incorporating Good Manufacturing Practice (GMP) into an ISO 9001:2000 environment is in place. Depending on their activities, individual responsibilities concerning the quality of our products are specified for our employees. All quality-related activities are defined in writing and are fully documented. No material will be released for use outside the control of PENTAPHARM before the Quality Control department has completed the quality evaluation. Corporate Quality Management System The Corporate Pentapharm Management Manual describes the PENTAPHARM system. It has been created to provide an efficient management tool for the Pentapharm group. Documents are organised into two parts "leadership" and "operations", encompassing leadership process tasks such as Human Resources, Quality Supply Chain Management, and Finance, as well as operational processes such as Manufacturing, Research and Development, and Marketing. The PENTAPHARM system defines three hierarchical levels for QM documents: |
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 Master processes (overview documents) General guidelines. valid for several departments Standard Operating Procedures, checklists, forms |
Written procedures describe how to prepare documents in the required format.
Quality Management Organisation Our quality management is responsible for the development, maintenance and evolution of all quality-related issues. It is independent of the other organisational parts and meets both quality assurance (QA) and quality control (QC) requirements.Quality Control The Quality Control department (QC) is responsible for quality control of raw materials, primary packing materials, intermediates and final products. QC is organized in three sections with respect to their specific task: |
| Biology / Microbiology laboratories: microbial counts, identification of contaminants, efficacy of antimicrobial preservation, endotoxin test, water system monitoring, environmental monitoring  |
| Analytical laboratories: instrumental analyses e.g. HPLC, GC, UV/IR spectroscopy, titrations, etc., classical chemical and physico-chemical analyses e.g. thin layer chromatography (TLC), SDS-PAGE, melting point, viscosity, etc., testing of physical parameters and incoming control of primary packing materials  |
| Haemostasis laboratories: medico-analytical testing such as clotting time of blood and plasma  |
Highly qualified lab technicians are led by experienced laboratory managers. They are in charge of monitoring the test performance according to written procedures and of defining the reliability of the test results. PENTAPHARM's cosmetic ingredients are produced according to Cosmetic Good Manufacturing Practices as issued by the European Federation of Perfume, Cosmetic and Toiletries Industry (COLIPA) or the European Federation for Cosmetic Ingredients (EFfCI). Audit Programs Internal audits (self-inspections) are performed routinely by trained quality management personnel. Internal audits are planned and documented every year in the audit plan. Each internal audit is documented as protocol and report. Additionally, product-specific GMP audits are performed routinely every year. External bodies such as customers, national authorities (Swissmedic, RHI), international authorities (FDA, EDQM) and the Swiss Association for Quality and Management Systems (SQS) also perform regular audits. |