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.
5.0       Procedure:
·        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.
·        QA
·        Production 

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