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Quality Figure 1: Process definition applicable to pharmaceutical and biopharmaceutical validation. 52 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m "Process" defined Process has been defined in a number of ways. One dictionary definition is "a particular method of doing something, generally involving a number of steps or operations" (15). Another definition is "a series of ac- tions that you take to achieve a result" (16). However, these definitions do not adequately consider the factors inf luencing the operations, actions, and steps that constitute a process. Those factors in- clude the processing system itself, the inputs that drive the system, and the system outputs. Scherkenbach, a student of W. Edwards Deming, defines process broadly yet concisely. "In its sim- plest form, a process is a blending or a transforma- tion of inputs such as people, materials, equipment, methods, and environment into outcomes. Some of these inputs do the transforming and some of them are transformed" (17). This definition con- siders important process inf luences lacking in dic- tionary definitions. The keys to the effectiveness of this definition are the identified inf luences on the inputs and outputs. Those inf luences must be defined, evaluated, and controlled to ensure the process performs as intended. Figure 1, based on Scherkenbach's work, presents a process definition applicable to pharmaceutical process becomes the input to an- other, or multiple process outputs may serve as in- puts to another. For example, a drug substance is an input to a process that produces a drug product, along with other components that result from other processes. And the drug substance itself is likely the result of multiple process inputs and outputs. "Validation" defined Validation of pharmaceutical processes was codi- fied in the mid-1970s. That does not mean that earlier pharmaceutical processes were not vali- dated. Pharmaceutical manufacturers had quality control programs that ensured the robustness of their manufacturing processes and the quality of the pharmaceuticals they produced. However, the scope of those programs depended on individual manufacturers resulting in variable effectiveness. Codification of validation expectations and re- quirements was intended to reduce that variability. The 1978 CGMP regulations (4) discussed valida- tion in terms of automatic, mechanical, and electronic equipment (21 CFR § 211.68), validation of supplier's test results for components, drug product containers, and closures (21 CFR § 211.84(d)(2)), and validation of any sterilization process (21 CFR § 211.113). However, the word validation was not explicitly defined. ALL FIGURES ARE COURTESY OF THE AUTHOR and biopharmaceutical validation. Specifically, a process is inputs operating through a processing system to produce outputs. The inputs and outputs are influenced by people, material, equipment, procedures, and the environment in which they operate. Processes may be discrete or linked so that the output of one