Issue link: https://www.e-digitaleditions.com/i/1481708
52 Pharmaceutical Technology ® Trends in Formulation 2022 eBook PharmTech.com NASTASSIA - STOCK.ADOBE.COM L aying the foundation stones for creating the right environment to be successful in solid dosage forms can sometimes come down to literally laying down the right brick and mortar building foundations and walls. Pharmaceutical Technology discussed trends and op- portunities with experts for good manufacturing practice (GMP) guidance for manufacturing, test- ing, and quality assurance of products. This built in minimum quality management system is custodial to assure manufactured drug products are safe, both the end user, and also for those working to produce them. In the background it is useful to note that the pharmaceutical community is approaching harmo- nization, but key differences remain. Pharmaceutical companies must be cognizant of this if they plan to sell their products globally. From a qualit y, regulator y, and facilities stand- point, what priorities need to be established to achieve optimal design for a new or existing good manufactur- ing practice (GMP) facility, and ensure consistent qual- ity of the end product? Richard Anderson cleanroom specialist, of WHP Engineering diplomatically asserts it "depends on a detailed understanding of every stage of the process. WHP's 'inside out architecture' is based on sizing of rooms, room adjacencies, set down areas, warehouse spaces, and packing rooms, in order to achieve the best layout and eliminate bottlenecks. Once we have the layout, we can work out the classifi- cation of cleanrooms, air flow patterns, and pressures. We then look to protect the person, product, and envi- ronment, and to maximize energy efficiency and sus- tainability." So, in the descending order of priorities, at least from an engineering company's perspective, the space itself, and the structure comes first. This makes even more sense when Anderson continues, "In general, manufacturers will continue to produce their specific product under licence using the same facility and equipment until the licence expires. Only when they need to bring new products to market, will they Building GMPs for Solid Dosage Chris Spivey, editorial director Creating building blocks for good manufacturing practices is essential.