This paper discussed the requirement of GMP that manufacturer identifies what validation work is needed to prove control of the critical aspects of their particular operations. The legal requirement for all regulatory guidelines is that any system or process can only be regarded as validated if it is in full compliances with GMPs. It is important to remember that c-GMP are simply the best manufacturing practices industries can follow to produce product safely and efficiently while ensuring the highest possible quality. Furthermore elaboration of relationship between validation and GMP a major challenge in the pharmaceutical industry is to know where to apply GMP controls because if they are applied inappropriately, GMP tends to lock in practices and create barriers to effective changes. Validation is never to be restricted because they provide guidance in establishing and maintaining best possible manufacturing operations. Validation is a substantive discipline, requires by law; failure to comply is prosecutable as a criminal act in some countries.
Loading....