SOP ON IMPACT ASSESSMENT FOR EQUIPMENT /SYSTEM
OBJECTIVE: To assess the impact of process variables on quality of product prior to carrying out process validation.
SCOPE: This SOP is applicable for different stages of manufacturing for product to be validated.
RESPONSIBILITY:
It is the responsibility of operator and production supervisors to follow the procedure as prescribed in this SOP during maintaining Equipment Usage logbook.
Officer/Supervisor or designee of IPQA is responsible for the line clearance and verification of the related documents along with ensuring the compliance of SOP.
Manager/Executive or designee of Production department is responsible for giving the training on regarding tasks and review the related records.
IPQA shall be responsible for verification of activity.
ACCOUNTABILITY:
Head of the Production Department. & Head QA
PRECAUTIONS, SAFETY & EHS
Never change the location while the particle counter is in operation.
Keep the particle counter in dry place & clean place.
Chemist/operator should follow all instructions of clean room behavior during operation of particle counter in filling room.
Cleaning shall be avoided during monitoring of particle count.
PROCEDURE:
Concern user department shall fill the request for issuance of Sequential logbook of Equipment on every financial year and also when logbook is filled and received new logbook for usage record.
Concerned Departments should have Sequential Logbook for Equipment/Machine.
Details of operation, cleaning, preventive maintenance and breakdown shall be recorded in respective sequential logbook.
Preparation, issuance, distribution & retrieval of sequential logbook shall be controlled through QA Department.
On starting of every fiscal year, QA shall issue sequential logbook for every equipment to respective department upon receiving requisition for Sequential Logbook for Equipment / Machine.
Filled logbook shall be submitted to QA department.
If additional logbook is required then concerned department shall raise the requisition for extra logbook.
After QA Head approval, QA personnel shall issue the new logbook to the concerned department.
DISTRIBUTION
The SOP shall be distributed to respective department by QA. The QA department shall
Authorize for the distribution of SOP and shall sign for “Issued by:” Follow the distribution of SOP as per following:
Master Copy – QA Department
Control Copy – User Department (Production, IPQA)
Display Copy – Production
The Revised SOP shall be distributed only after retrieval of superseded SOP.