1.0 PURPOSE:
2.0 SCOPE:
This SOP for handling of materials in quarantine is applicable for Production Department at (Company name).
3.0 RESPONSIBILITY:
3.1 Production personnel / operator is responsible for performing the activity.
3.2 Production Officer / Executive is responsible for the execution of the procedure and to confirm the procedure.
3.3 Head-Production is responsible to ensure the compliance of the procedure.
4.0 DEFINITION:
5.0 PROCEDURE:
5.1 After completion of any process clean the outer surface of Conta bin/IPC bin or HDPE/SS containers/crates with dry lint free cloth and then transfer the Conta bin/IPC bin or HDPE/SS containers/crates lined with double poly bags to respective quarantine area with duly signed “IN PROCESS LABEL / BULK FINISHED LABEL / STATUS LABEL.
5.2 Ensure that materials are kept batch wise and product wise.
5.3 Weigh and record the same in respective quarantine log book.
5.4 After getting approval from QC, Quality assurance personnel shall stick the approved label over the container (Applicable for semi-finished or finished products).
5.5 Record the temperature and relative humidity twice in a day in the respective log book.
5.6 On holidays and weekly off temperature and relative humidity for quarantine area will be recorded on next working day.
5.7 Issuance of material to be recorded in the respective quarantine log book.
5.8 Lock the quarantine room at the end of the operation.
(Note: Quarantine to be opened and closed by operator and production staff only.)
6.0 ABBREVIATIONS:
SOP : Standard Operating Procedure
HDPE : High Density Poly ethylene
IPC : In Process Container
SS : Stainless Steel
QC : Quality control
7.0 REFERENCE:
8.0 ENCLOSURES:
Also read: SOP for Handling of Alarms for Critical Equipments.
Also read: SOP for Critical Area Practices.