Issue link: https://www.e-digitaleditions.com/i/1052795
40 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m Raw Materials Testing materials list. When these changes occur, it is im- portant for biomanufacturers to test the raw ma- terials. It is a good idea to have a solid baseline of information and, if necessary, bridge the gap between old and new suppliers of raw materials. Comparison studies are helpful in these situa- tions. Using reliable, consistent methods will allow trending analysis and a proper 'apples-to-apples' comparison of raw material test results. Browne (Almac): All manufacturers must show that they understand the critical material attributes of their raw materials and which of those affect vari- ability as well as how to control variability. They must show that appropriate analytical methods are used to characterize raw materials. Analytical best practices PharmTech: What analytical best practices are cur- rently implemented in the lab to ensure the quality and purity of raw materials to be used in biologic production? Foehr (Pacific BioLabs): In order to ensure quality of raw materials, it is important to use qualified or validated methods and rigorous quality control (QC)/quality assurance (QA) review. United States Pharmacopeia or European Pharmacopoeia mono- graphs are a good place to start when testing for identity or potency of common raw materials used in biomanufacturing. Established labs follow in-house generated stan- dard operating procedures for common procedures (pH, appearance, UV/VIS, osmolality, etc.) to as- sess raw material quality attributes. When doing so, testing labs should use qualified instrumenta- tion and good documentation practices, and they should have an independent QA review. For more complex assays, it is recommended to have state-of-the-art instrumentation (high-per- formance liquid chromatography, gas chromatog- raphy, liquid chromatography-mass spectrometry) and highly trained personnel. Browne (Almac): It is essential that supplier certifi- cates of analysis are provided, but also that the raw material is tested and verified in a good manufac- turing practices laboratory with associated control and procedures. Tests must include, at minimum, testing for identity. Bulpin (MilliporeSigma): Applying the same prin- ciples and technologies used to test critical quality attributes of final drug products for raw materi- als ensures they meet the standards needed for the production of biologics. Real-time inventory tracking and access to raw-material testing data also provide the transparency needed to identify and resolve issues almost instantly. Analytical advances PharmTech: Have there been advances recently in either analytical equipment, technique, methodol- ogy, or approach for testing raw materials? Browne (Almac): Testing raw materials is a routine requirement; therefore, fingerprint technology in- "However, sometimes different vendors are used, products are discontinued and supply chains are disrupted, or lower- cost substitutes are introduced to the raw materials list." —Foehr, Pacific BioLabs