Line Clearance
What is Line Clearance :
Line clearance is a process that provides a high
degree of confidence or assurance that the said line or area is free from any
unwanted residue or leftover of previous processing before proceeding with the
next process. Quality assurance has to provide Line clearance before the start
of any activity whether it is batch to batch change over and Product to product
change over.
Criteria of Batch to batch change over :
Change over from one batch to another batch of the
same product and same Strength or increasing in strength provided the
excipients are the same.
Cleaning between batches of the same product but in
ascending or increasing strength.
Criteria of Product to Product change over :
- Change over from one
product to another product.
- Change over from one
product to the same product with descending or decreasing strength.
- Change over between
batches/products with different colors Flavour / Excipients.
- Change over after post
maintenance or when the next product is not known (as
applicable).
- Continuously running
one batch for a longer period of time.
- Area or Equipment is
kept ideal for more period of time.
Line clearance should be carried out at change over by Manufacturing, Packaging, Raw Material Store, Packing Material Store, etc independently for the stages where final dosage form & intermediates are formed, handled and processed.
