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62 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Quality often left out of the validation equation. How often following some deviation or FDA 483 observation is the first impulse to blame an operator for the occur- rence and the proposed corrective action to retrain the individual? Sometimes this is justified, but often it is not. Sometimes the error belongs inherently to the process and its variability (i.e., normal varia- tion). Retraining operators to "correct" this type of process is a fool's errand. However, sometimes personnel are the cause of process deviations due to inadequate training or performance. In those in- stances, correctly retraining people in how to do the job, but more importantly teaching them why it is important to do it in a certain way, can improve the process in question. Do not fail to consider people when designing a process validation study. Look at the overall process and its parts. Deter- mine CQAs and perform appropriate risk analyses, not only with respect to the process, but for the pa- tient who might use the product. Ishikawa diagrams and failure modes and effects analyses are helpful in visualizing the process and determining the process attributes that must be controlled. No matter what type of product, the stage of de- velopment or manufacture, or the form the valida- tion studies take, if there is documentation support- ing answers to all of the questions about a process that begins with who, what, when, where, why, and how, that process may be considered to be validated. If not, there is more work to be done. References 1. FDA, Drugs; Current Good Manufacturing Practice in Manufac- ture, Processing, Packing, or Holding. In 21 CFR 133, 28 Federal Register 6385, 1963. 2. B. R. Matthews, PDA J. Pharm. Sci. Technol. 56 (3), 137-149 (2002). 3. FDA, Current Good Manufacturing Practice in the Manufacture, Processing, Packing, or Holding of Large Volume Parenterals for Human Use. In 21 CFR 212, 41 Federal Register 22208, 1976. 4. FDA, Current Good Manufacturing Practice for Finished Phar- maceuticals, In 21 CFR 211, 43 Federal Register 45077, 1978. 5. FDA, Guideline on General Principles of Process Validation (CDER, Rockville, Maryland, 1987). 6. FDA, Guidance for Industry, Process Validation: General Princi- ples and Practices, Draft Guidance (CDER, Rockville, Maryland, 2008). 7. FDA, Guidance for Industry, Process Validation: General Princi- ples and Practices (CDER, Rockville, Maryland, 2011). 8. ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, Geneva, Switzer- land, 1999). 9. ICH, Q7 Good Manufacturing Practice Guide for Active Pharma- ceutical Ingredients (ICH, Geneva, Switzerland, 2000). 10. ICH, Q8(R2) Pharmaceutical Development Revision 2 (Step 4 version)(ICH, Geneva, Switzerland, 2009). 11. ICH, Q9 Quality Risk Management (Step 4 version) (ICH, Ge- neva, Switzerland, 2005). 12. ICH, Q10 Pharmaceutical Quality System (Step 4 version) (ICH, Geneva, Switzerland, 2008). 13. ICH, Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (Step 4 version) (ICH, Geneva, Switzerland, 2012). 14. ASTM, E 2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufac- turing Systems and Equipment (ASTM International: West Con- shohocken, PA, 2007). 15. M. Agnes and D.B. Guralnik, Eds., Webster's New World College Dictionary, Fourth Edition ed. (Wiley Publishing, Inc., Cleve- land, Ohio, 2007). 16. Cambridge Dictionary, https://dictionary.cambridge.org/diction- ary/english/process (accessed March 10, 2018). 17. W. W. Scherkenbach, The Deming Route to Quality and Produc- tivity Road Maps and Roadblocks, p. 145 (CEEPress Books, George Washington University: Washington, D.C., 1986). 18. EC, Consultation Document Good Manufacturing Practice for Advanced Therapy Medicinal Products (European Commission, 2015), http://ec.europa.eu/health/files/advtherapies/2015_pc/ publ_cons_doc_2015.pdf. 19. FDA, Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy (CBER, Rockville, MD, 1998). 20. W. Matzmorr, BioPharm International, 29 (4), 46-48 (2016). 21. W. E., Deming, Out of the Crisis, p 507 (Massachusetts Institute of Technology: Cambridge, Mass., 1986). PT Avista ........................................................................................................47 Daiichi Jitsugyo America, Inc. ................................................................55 ILC Dover LP ...............................................................................................9 Lonza ........................................................................................................25 Patheon ....................................................................................................19 Pyramid Laboratories ............................................................................. 11 TOMI/SteraMist ........................................................................................39 Veltek Associates ......................................................................................3 Ad Index COMPANY PAGE