Friday, November 19, 2010
Checklist after line clearance
1.0 Purpose : To provide instructions for clearance by QA after cleaning of equipment by production department.
2.0 Objective : To provide a documented procedure for clearance after cleaning of equipment by production.
3.0 Scope : This procedure is applicable for QA clearance at batch to batch and after product change over, cleaning of equipment by production department.
4.0 Responsibility :
· Primary : Chemist, Officer of respective department.
· Overall Responsibility : Respective department Head.
· Upon intimation from Production department, QA persons has to do following steps for clearance: -
· Inspect the area for cleanliness.
· The area must be clean.
· There must not be any traces of previous stage material.
· There must not be found spillages of cleaning washes
· There must not be observed dust.
· There must not be excess tools / equipment as they can affect smooth functioning.
· Inspect the equipment for cleanliness & absence of previous product / material.
· Check the status label of equipment.
· Check the cleaning procedure and cleaning record.
· Check the Environmental parameters like pressure differential, relative humidity, temperature etc are in limit and recorded is respective logbooks.
· Inform to Engineering dept. if any discrepancy is observed.
· Check the equipment uses logbook.
· Based on above observations QA will sign on document and status label for cleaning clearance.
6.0 Reference Document : Not applicable
7.0 Abbreviations :
· QA = Quality Assurance department
· SOP = Standard Operating Procedure
· QC = Quality Control
8.0 Copies to Distribution Sites.