SOP for Handling of Change Control
1. OBJECTIVE
1.1. Change control is a quality tool and a management to maintain and keep the records of all changes as a history. Changes can be related to facility, documentation, system, equipment, instrument, procedure, layouts and products etc.
1.2. To lay down a procedure to describe the handling ...
SOP for Data Integrity
1. Objective
1.1. To lay down a procedure for data integrity as part of quality management system.
1.2. To establish guidelines and procedures to ensure data integrity in regulatory activities.
1.3. To prevent unauthorized access, loss, alteration, or falsification of data throughout the regulatory processes, ...
Preventive Maintenance of Autoclave
1.0 OBJECTIVE
1.1 To describe a procedure for the preventive maintenance of autoclave.
2.0 SCOPE
2.1 This procedure applies to the Engineering department.
3.0 RESPONSIBILITY
3.1 Engineering
4.0 ACCOUNTABILITY
4.1 Plant Head
5.0 REFERENCE
5.1 In-house.
6.0 PROCEDURE
6.1 Procedure for mechanical work:
6.1.1 ...
SOP for Calibration Procedure of Pressure Gauge
1.0 OBJECTIVE
1.1 To describe a procedure for the calibration of pressure gauge.
2.0 SCOPE
2.1 This procedure applies to the Engineering department.
3.0 RESPONSIBILITY
3.1 Engineering
4.0 ACCOUNTABILITY
4.1 Plant head
5.0 REFERENCE
5.1 In-house.
6.0 PROCEDURE
6.1 Close the line in which Pressure Gauge ...
Operation of Boiler SOP
1.0 OBJECTIVE: To lay down a procedure for Operation of Boiler.
2.0 SCOPE: This SOP is applicable for Operation of Boiler at ………….
3.0 RESPONSIBILITY: Officer / Executive – Engineering
4.0 ACCOUNTABILITY: Head – Engineering
5.0 DEFINITION: Not Applicable
6.0 PROCEDURE:
6.1 PRE STARTUP CHECKS:
6.1.1 ...
SOP for Civil Work Permit
1.0 OBJECTIVE: To lay down a procedure for Civil Work Permit.
2.0 SCOPE: This SOP is applicable for Civil Work Permit for any maintenance in the plant premises.
3.0 RESPONSIBILITY: Officer / Executive – EHS
4.0 ACCOUNTABILITY: Head – EHS
5.0 ABBREVIATIONS:
SOP Standard Operating Procedure
No. ...
SOP for Hot Work Permit
1.0 OBJECTIVE: To lay down a procedure for Hot Work Permit.
2.0 SCOPE: This SOP is applicable for the requirement of Hot Work Permit whenever Welding, Cutting, Burning, Drilling, Soldering or any other open flame work is carried out at ……………..
3.0 RESPONSIBILITY: Officer / Executive – ...
SOP for Gas cylinder handling
OBJECTIVE: To establish a standard procedure for handling of gas cylinder.
SCOPE This SOP is applicable for (Company Name).
RESPONSIBILITY
3.1 Operator shall be responsible to follow the procedure strictly.
3.2 Supervisor shall be responsible to ensure that the SOP is followed properly.
ACCOUNTABILITY
Head ...
SOP for General Care of Facilities
OBJECTIVE
To establish and define methods to be used in the care of facilities to ensure compliance with GMP.
SCOPE
This SOP shall be applicable for all Departments.
ASSOCIATED DOCUMENTS
Not applicable.
RESPONSIBILITY/ACCOUNTABILITY
4.1 All employees shall be responsible for the care of the facilities.
4.2 Head ...
Vendor Audit
1.0 OBJECTIVE
To provide a procedure to evaluate a potential new source or to monitor ongoing quality on a routine basis for existing vendors.
2.0 SCOPE
This SOP shall be applicable to all vendors manufacturing raw & packaging materials supply to the BPL.
3.0 ASSOCIATED DOCUMENTS
Not applicable.
4.0 ...

