Friday, 29 March 2013

THE REGULATORY BASIS FOR PROCESS VALIDATION


The concept of process validation from its beginnings in the  early  1970s  through  the  regulatory  aspects associated  with  current  good  manufacturing  practice (cGMP)  regulations  and  the  application  thereof  to various  analytical,  quality  assurance,  pilot  plant, production, and  sterile product and  solid dosage  forms considerations.  In  the  early  1990s,  the  concept  of preapproval inspection (PAI) was born and had as one of its  basic  tenets  the  assurance  that  approved  validation protocols and schedules were being generated and that comprehensive  development,  scale-up,  and  biobatch and  commercial batch  validation data were  required  in order to achieve a successful regulatory PAI audit. There are  several  important  reasons  for  validating  a  product and/or process.  First, manufacturers are required by law  to conform to cGMP regulations. Second, good business  dictates  that  a  manufacturer  avoids  the  possibility  of  rejected  or  recalled  batches.  Third,  validation  helps  to  ensure  product uniformity,  reproducibility,  and quality.  Although  the  original  focus  of  validation  was  directed  towards prescription drugs,  the FDA Modernization Act  of  1997  expanded  the  agency’s  authority  to  inspect  establishments  manufacturing  over-the-counter  (OTC)  drugs  to  ensure  compliance  with  cGMP.  Once  the  concept of being able to predict process performance to  meet  user  requirements  evolved,  FDA  regulatory  officials  established  that  there  was  a  legal  basis  for  requiring process validation. The ultimate legal authority
is  Section  501(a)(2)(B)  of  the  FD&C  Act,  which  states  that a drug  is deemed to be adulterated  if the methods  used  in,  or  the  facilities  or  controls  used  for,  its  manufacture,  processing,  packing,  or  holding  do  not  conform  to  or  were  not  operated  or  administrated  in  conformity  with  cGMP.  The  cGMP  regulations  for  finished  pharmaceuticals,  21  CFR  210  and  211,  were  promulgated  to  enforce  the  requirements  of  the  act.  FDA has  the authority and  responsibility  to  inspect and  evaluate  process  validation  performed  by  manufacturers.  The  cGMP  regulations  for  validating  pharmaceutical  (drug) manufacturing  require  that  drug  products be produced with  a high degree of  assurance  of  meeting  all  the  attributes  they  are  intended  to  possess

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