Many small life-sciences companies agonise over the setup of a quality management system. With good reason, because a well-designed QMS (Quality Management Systems) does more than help you comply with regulations. It also ensures that the business model is adopted by the entire organisation. Everyone knows what the company expects of him or her. Only, how do you go about doing this? How do you build an effective system with limited resources and manpower for your specific needs? At Quality by Design, Pannoc found what it was looking for: a collaboration model tailored to small organisations, access to a wealth of specialist knowledge, and a pragmatic approach with consideration for an SME budget.
Pannoc in Olen develops, manufactures, packages and sells drugs, cosmetics and pharmaceutical auxiliary substances in the form of creams, ointments, gels, lotions and solutions for external use. It has manufactured own brands and operated for third parties on a contract basis for 35 years now. The company currently has 15 employees.
Half measures in QA not an option
Leen Van de Water is responsible for quality assurance (QA), and as Qualified Person also for the release of products. ‘As a company active in the pharmaceutical industry, we have to comply with the GMP guidelines and the Belgian raw materials legislation,’ she says. ‘The regulations are becoming increasingly stricter. Since 2013, the European Cosmetics Directive has also come into effect. This sharpens the focus on the safety of cosmetic products for the consumer. You have to be able to demonstrate that a product meets all requirements.’
‘As a result, quality management is becoming ever more complex and time-consuming. If you want to guarantee the conformity of your processes and procedures, the proverbial short-term cosmetic solution won’t cut it. Half measures are not an option in QA. We needed reinforcement. Hiring a permanent member of staff means a fixed cost and a long-term commitment. That is why we chose to look for external support.’
Junior with backup
‘Of all providers, Quality by Design had the best credentials. Their collaboration model and approach were well received. Not every task needs to be carried out by an expensive, seasoned specialist. Rather, QbD adopts a tandem formula. A highly trained junior does the lion’s share of the work and is assisted by an experienced senior one to two days a week. Via our junior, we have access to all specialist knowledge at QbD, in many fields. With small partners who only have specialists in one particular field, you don’t have that luxury. What’s more, the option to hire a permanent member of staff, if and when we want to, remains open to us.’
Procedures and manuals
‘In May 2013, QbD carried out a quick scan of the entire quality system at Pannoc,’ Leen Van de Water continues. ‘This resulted in a list of actions with deadlines and responsibilities. In July, our QbD assistant started work. During the first few months, the focus was on procedures and manuals. We fine-tuned the procedures for risk management, supplier qualification and customer qualification, among other things. We now manage manuals via a digital document management system. This means that the whole process from creation to approval, revision and version management is perfectly under control.’
Maintenance and risk-based calibration
‘We reviewed the manuals of many pieces of equipment,’ Leen Van de Water continues. ‘We used to plan preventative maintenance and calibration activities at fixed intervals. Today, the inspection programme has been set up in terms of risk. We mapped the risk variables. As a result, we know exactly when inspection is required. This also allows us to optimise maintenance costs.’
From validation master plan to building plan
Together with QbD, Pannoc drew up a validation master plan. This comprises a guide and an action plan for all qualifications, validations and revalidations. The scope is wide: from equipment to analyses, methods, software and even buildings.
‘The quality and safety of products and raw materials are co-determined by factors such as ambient temperature and the chance of switching or cross-contamination,’ Leen Van de Water explains. ‘Some evaluations have resulted in strategic decisions. The storage of drugs and distribution to pharmacies has since been outsourced. The freed-up space made a major restructure possible. QbD set up user requirements, formulated recommendations for improvement in function of GMP and drew up a warehouse plan. Soon, we will extend the warehouse with additional receiving and dispatch bays. Optimisation plans are also being drawn up for the production areas.’
Successful balancing act
‘These are a major investments for a small SME, but they fit in perfectly with Pannoc’s ambitious growth plan,’ Leen Van de Water stresses. ‘They underline our positioning as a reliable contract manufacturer and help us in the search for new markets for our drugs. Management is in full support of the initiative.’
‘Quality and safety require fairly substantial efforts by pharmaceutical SMEs. Therefore, cost effectiveness is vital. QbD directed us to training grants. The action plan and milestones are totally geared to budgetary capabilities. And yet, this is not an approach of an off-the-shelf quality system. Pharmaceutical companies differ greatly from each other. Procedures are almost never interchangeable. Our quality system has to support regulation, take into account an SME budget, whilst also being tailor-made for us. A balancing act QbD performs with verve.’