Sr.

Job Title Document to be review & to be provide

No
Guide for different type of Deviation
Deviation SOP Deviation format Training
handling
Guide for different type of Change Control
Change Control SOP Change control format Training
Handling
Guide for different type of CAPA Handling
CAPA SOP CAPA format Training
guidance
Guide for different type of Market
1. QMS Market Compliance SOP Market Compliance Format Training
Compliance Handling
Training SOP Training Management Training NA

Vendor Qualification SOP Vendor Qualification format Training NA

Self-inspection SOP Self-inspection format Training Compliance

One Equipment & one product risk
2 Risk Assessment SOP Risk Management format Training assessment to be provide for guidance
purpose
Protocol & Report 2 No. Product protocol & report to be
3 Process Validation SOP Training
Hold time study report provided for Execution
Protocol & Report 2 No. Product protocol & report to be
4 Cleaning Validation SOP Training
Hold time study report provided for Execution
Critical Equipment IQ ,OQ & PQ protocol &
5 Equipment Qualification SOP Protocol & Report Training
report to be provide for execution
2 No. Area protocol & Report to be
6 Temperature & Distribution Study SOP Protocol & Report Training
provide for Execution
Critical area Qualification protocol &
7 Area Qualification SOP Protocol & Report Training
report to be provide for execution

8 Standard Operating Procedure SOP General SOP to be provide as per requirement