Procedure for Opening and Closing of production area

 In this post Standard Operating Procedure of Procedure for Opening and Closing of production area in Pharmaceuticals is describe.

 1.0 OBJECTIVE:

To lay down the procedure for Opening and Closing of production area.

2.0 SCOPE:

This procedure is applicable to Opening and Closing of production area.

3.0 RESPONSIBILITY:

Officer /Executive/ Manager

Head Production: To ensure execution & compliance.

4.0 PROCEDURE:

4.1 Opening of Department:

4.1.1 Collect the individual department key from security gate by duly signature for receiving the key.

4.1.2 Keys are collected by respective department Officer/Executive/ Manager.

4.1.3 Open the department with the help of keys and collect the different cubicle keys from the key box and open the cubicle.

4.1.4 After opening the cubicle keep the key in the key box in office / IPQA office.

4.1.5 Switch on the light and inform the engineering department to switch on the utilities of the respective area.

4.2 Closing of Department:

4.2.1 Ensure all scrap/waste has removed from the individual area

4.2.2 Ensure the IPC and container is properly closed.

4.2.3 Ensure the valves of all utility line exist in the respective area are closed.

4.2.4 Switch off the machine/computer system /instrument/Balances etc. in respective area.

4.2.5 Ensure proper closing of any solvent/ink bottles.

4.2.6 Ensure the area is cleaned before closing.

4.2.7 Ensure all the in-process materials are properly covered and labeled, equipments and area are also properly labeled.

4.2.8 Switch off the light of the respective area.

4.2.9 Lock the door of respective area.

4.2.10 Keep the key of the area in the key box of the respective sections.

4.2.11 Switch of the light of the Office and lock the door of department.

4.2.12  Handover the key to the security gate with duly signed from deposit of the key.

5.0 ANNEXURE (S):

Nil

6.0 REFERENCE (S):

SOP: Preparation, approval, distribution control, revision and destruction of Standard Operating

Procedure (SOP).

7.0 ABBREVIATION (S) /DEFINITION (S):

AHU: Air Handling Unit.

IPQA: In-process Quality Assurance.