When drafting the verification protocol, i noticed and wondering about this topic:
What is the main difference between verification and validation of cleaning procedures? When is the verification needed, Needed prior to validation ?
Is Verifications executed in development phase only to test the cleaning procedures? how many runs need to perform? is one enough?
validation is for consistency of cleaning procedures effectiveness? and should be 3 runs?
Looking for help. please let me know your thoughts
Is cleaning verification applicable for commercial facility
FOLLOWING STEPS INVOLVE IN SOP FOR CLEANING VALIDATION LIFE CYCLE
Title: SOP for cleaning validation life cycle
Step No.
steps involve in SOP
Responsibility
Development of new product
FNDD
confirmation for manufacturing of new product in shared facility with PDE approach
FNDD
Identification of product soil nature
FNDD
cleaning process design/development for new product (QBD)
FNDD
define cleaning process CPP and CQA
FNDD
cleaning analytical method development
FNDD/ARDL
cleaning process optimization for confirm define CPP and CQA considering commercial facility
FNDD/PRODUCTION/IPQA
TT of CPP, CQA of cleaning process like product TT
FNDD/QA
Addition of new product in cleaning matrix
QA
selection of worst case molecule based on product soil nature and PDE value
QA/PRODUCTION
calculation of MACO considering PDE
QA
cleaning validation for worst case molecule
QA/PRODUCTION/QC
cleaning verification if not worst case molecule
QA/PRODUCTION/QC
Establish and implementation of cleaning process
PRODUCTION
Frequency of cleaning verification
(yearly 3 batches considered having hard product soil nature with applying lowest MACO)
QA/PRODUCTION
cleaning process capability calculation (cpk)
QA/PRODUCTION