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Quality assurance in the pharmaceutical industry
Quality assurance in the pharmaceutical industry
Quality assurance in the pharmaceutical industry
Quality assurance in the pharmaceutical industry
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Quality assurance in the pharmaceutical industry


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  • 1. Quality: the foundation of innovationMedicines must be pure, safe and effective. That’swhy research, development, production anddistribution are always linked to compliance withglobal and local rules for the pharmaceutical andbiotech industry. Pharmaceutical companies mustsatisfy the GMP, GLP, GCP and GDP directivesissued by the Food & Drug Administration (FDA)and the European Medicines Agency (EMA).Furthermore, they want to be certified for ISOstandards (e.g. ISO 13485, ISO 17025 and ISO15189).Ordina’s Quality Competence Centre supports youwhen setting up and implementing qualityguarantees by providing consultancy, auditservices and training. QASS041010ENG Ordina Belgium • Blarenberglaan 3B• B-2800 Mechelen • Belgium  +32 (0)15 29 58 58
  • 2. Quality assurance in the pharmaceutical industryQuality: the foundation of innovation Services by OrdinaQuality: high return on investment ChallengesResearch, development, production and distribution in the How do you accurately define your production processespharmaceutical and biotech industry are inextricably and demonstrate that they satisfy the qualitylinked to compliance with global and local rules. That also requirements? How do you validate the critical stepsapplies to the development and production of medical in your processes? Are your procedures clearlydevices. In order to fulfil the strict criteria, pharmaceutical documented and your operators thoroughly trained?companies constantly invest in quality management at How do you set up a registration system used to show thattheir chemical, biotechnological and pharmaceutical you produce in accordance with the procedures, but thatproduction facilities. Concern for quality is the thread from also detects deviations and builds up a detailed productionR&D, through the various phases of clinical research, to history? Do you adequately deal with quality complaints?large-scale production and distribution. Quality Do you use these complaints to improve your processes?management is essential for safe products, reliable Ordina offers specialised support related to all theseprocesses and satisfied customers. challenges.Based on GAMP SolutionsGood Manufacturing Practice (GMP) ensures that Validation and documentation of processes and systemspharmaceutical products are produced consistently and You need a quality control process for everyinspected in accordance with quality standards. GMP gives pharmaceutical product: from the lab analysis to the testsguidelines for production facilities, personnel, procedures at every production step. By validating your processes,and documentation. The International Society for applications and equipment, you prove that your productPharmaceutical Engineering (ISPE) prescribes Good satisfies the quality requirements. Ordina validates andAutomated Manufacturing Practices (GAMP) for the documents in an efficient and structured manner.implementation of software systems. These help you set Trainingup your systems in conformity with the rules. GAMP Ordina organises training sessions on themes like GAMP,contains guidelines for the design, testing and GxP, medical devices and methodologies for the validationmaintenance of automation systems. It can also serve as a of equipment, processes, computer systems and methods.guiding principle for the validation of equipment, methodsand processes. Ordina’s approach to quality guarantees Audit servicesand validation rests on GAMP. Ordina audits pharmaceutical companies with regard toAlso for laboratories and suppliers the implementation of GxP guidelines and validationThe pharmaceutical industry tries to restrict entry checks a minimum. That’s why Ordina also performs quality Optimisation of your quality management systemguarantee projects at the supplier side. You don’t want Ordina analyses your Quality Management System,complex systems. That’s why our approach is pragmatic advises you on points for improvement and optimises theand aims for simplicity. business value. Ordina improves the system withMany laboratories struggle with the implementation of applications for Learning Management, DocumentISO-15189 or ISO-17025 regulations. Ordina uses its Management, Laboratory Information Management,pharmaceutical industry experience to develop a suitable, Corrective Action & Preventive Action (CAPA), and Changerisk-based quality system in compliance with all imposed Control. Based on experience with various packages,regulations. Ordina assists you in your choice. 2
  • 3. Quality assurance in the pharmaceutical industryExperts in qualityBased upon legislation and recognised Validation focused on what is genuinelymethodologies importantOrdina’s approach to quality assurance is based on Assisted by best practices, our specialists together withinternational legislation, as well as recognised your team design a validation approach in accordancemethodologies and standards. Your solution fulfils all with the principles of Science Based Risk Managementcurrent quality requirements. Our experts are well versed (GAMP5). By selecting the right priorities, you avoidin GxP regulation (mainly GMP and GLP), 21CFR part 11 inefficiency due to unnecessary validation and(electronic data and signatures), ISO 9001, ISO 13485, ISO documentation. We determine which parameters (‘critical17025 and ISO 15189. They are familiar with quality attributes’) are crucial for optimum processmethodologies like GAMP (Good Automated control, based on knowledge of processes. We focus theManufacturing Practice), LSV (Lab System Validation) and validation on these parameters.CSV (Computer System Validation). Validation specialists: excellent project leadersOrdina Validation Academy Our validation specialists are used to working in aOrdina’s Quality Competence Centre consists of industrial structured manner and they communicate well. Many ofengineers, bio-engineers and industrial pharmacists. They them are certified in PRINCE2, a project managementhave experience in rules and business processes. They methodology. Their experience in change management,have completed the Ordina Validation Academy: a risk analysis and a structured approach makes themthorough training course lasting at least two years at perfectly employable as project engineers or projectAlcon, where our employees learn how a pharmaceutical leaders – even for projects unrelated to qualitycompany operates and how validation methodologies in practice. The Ordina Validation Academy is not anexperiment: it has been proving its merit for years. Experience in pharmaceutical companies Ordina has more than seven years of practical experienceValidation tailored to your business processes in quality guarantees in the pharmaceutical sector.Ordina starts from your business processes in order to References include companies like Alcon, Schering-Plough,determine the validation demands. This is why we draw up Janssen Pharmaceutica, Pfizer and Qualiphar.a Business Integrated Model (BIM) for each project. Weinvestigate which processes we have to support by usingbusiness process modelling tools. With their help, we drawup user requirements and attune these to the processes.This interaction is essential, as clear specifications are thebasis of successful projects. 3
  • 4. Quality assurance in the pharmaceutical industry Ordina Belgium … … wants to be the proactive and interactive ICT partner … works for companies like Agfa, ArcelorMittal, of big, medium-sized and small companies. Offering end- Belgacom, BNP Paribas Fortis, bpost, Electrabel, Helvoet to-end solutions in consultancy, ICT and outsourcing. Pharma, Indaver, Infrax, ING, Janssen Pharmaceutica, Starting from a profound business and process know- KBC, Nike, NMBS/SNCB, Omega Pharma, Tropicana, how, Ordina facilitates innovation, on the basis of Pfizer, Smals and Volvo. technological craftsmanship. Clarity in ICT is our device. … is expert and results-driven. But with Ordina as your … provides you with consultancy, ICT and outsourcing partner, you can expect more. You can expect us to be services. A single point of contact for your integrated honest, fair and respectful in doing business, with great portfolio. From strategy to tactical and operational commitment and a sense of responsibility. And we do solutions. From package to custom software. From what we promise. architectures to tools. From projects to right sourcing and … is close to you. Flexible, pragmatic and reachable. In applications management. All on the right scale for you. terms of capacity and synergies, a big player. Together … bundles business know-how with superior technology with Ordina in the Netherlands, we have 3900 ICT people expertise. Our competence centres convert your at your disposal. Ordina is among the fastest-growing ICT processes into ICT. Ordina works for banks and insurance companies in the Benelux. companies, government, utility and telecommunications Read more on companies, retail, transport and industry. Ordina offices in Belgium Ordina office in Luxembourg Blarenberglaan 3B, B-2800 Mechelen, tel. +32 (0)15/29 58 58 Route d’Arlon 94, L-8311 Capellen, tel. +352 26 30 33-25 Gouv. Roppesingel 25, B-3500 Hasselt, tel. +32 (0)11 30 38 38 4