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50 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Quality M any new biological entities use unique processing f lows and steps that can require non-traditional thinking about process validation. Large-molecule drug products and attendant manufacturing pro- cesses often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule phar- maceutical products. In fact, it has been said that for biotechnology products, "The product is the process." Traditional small-molecule drug products have well-defined chemical structures and can be analyzed to ensure conformance to specifications. Biopharmaceu- ticals are often complex molecules, or mixtures of molecules, pro- duced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore, the manu- facturing and purification processes become critically important in ensuring the "sameness," quality, efficacy, and safety of these products. Process validation is documented process understanding and con- trol that begins when it is determined that a cell, molecule, or com- pound may have clinical significance and ends when the product is no longer viable in the marketplace. Each product and process may have different validation formats and structures and may not fit the traditional validation models. Validation requires careful thought and planning. It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of "qualifications" such as design (DQ), installation (IQ), operational (OQ), and performance qualification (PQ) studies. It is not hiring a validation company to develop the protocols, perform the studies, and write the reports. Understanding Validation and Technical Transfer Russell E. Madsen Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies. Russell E. Madsen is president of The Williamsburg Group, LLC, providing pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence, and regulatory liaison. ETIAMMOS/SHUTTERSTOCK.COM