SOP for Safety in Quality Control
1.0 OBJECTIVE: To lay down a procedure to provide safety guidelines while working in Quality control department .
2.0 SCOPE: This SOP shall be applicable for all persons working in Quality Control Laboratory.
3.0 RESPONSIBILITY– All Quality Control Personnel’s
4.0 ACCOUNTABILITY – Manager ...
User Requirement Specification (URS)
The following points must be included in URS:
=>> Name of the user department.
=>> Location
=>> Machine/equipment/software name.
=>> Purpose of the machine/ equipment/ software.
=>> Other areas of impact (AHU, movement, and space).
=>> Parameters to be considered for the URS.
=>> Model making Name with ...
Good Practices of Air Handling Unit (AHU)
=>> AHU system should be designed as per requirement in new schedule ‘M’ or such other guidelines.
=>> Installation of window A/C without any air filtration and pressure design is not satisfactory.
=>> AHU should be fabricated and installed according to design qualification, and its record should ...
SOP for Action Plan during Emergency
1.0 OBJECTIVE: To lay down a procedure for Action Plan during Emergency.
2.0 SCOPE: This SOP is applicable for action to be taken incase of Emergency in all areas at …………..
3.0 RESPONSIBILITY: Officer / Executive of Concerned Department
4.0 ACCOUNTABILITY:Head of Concerned Department
5.0 ABBREVIATIONS:
SOP ...
SOP for Operation and Cleaning of Lift
1.0 OBJECTIVE: To lay down a procedure for Operation and Cleaning of Lift.
2.0 SCOPE: This Procedure is Applicable to Operation & Cleaning of Lift (Make: Omega) in Administration Block used for Man Movement at ………
3.0 RESPONSIBILITY: Officer / Executive Personnel & Administration / HR
4.0 ...
Types of Air Lock System
Cascade Airlock:
These airlocks are very common having a higher pressure on one side and lower pressure on another side. This prevents to enter dust and contaminants from outside to airlock and from airlock to inner side.
Bubble Airlock:
These types of airlocks have a higher pressure inside the airlock ...
What are the contents of Annual product quality review (APQR)?
1. Introduction
2. Number of Intermediates and APIs batches produced.
3. Review of out put for all Isolated Intermediates and Finished Products.
4. Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products.
5. Summary of changes made during the year with respect ...
What is the formals for calculating number of air changes in an area?
Number of air changes/hour in an area is =Total Room Airflow in CFM x 60 / Total Volume of room in cubic feet
ACH = CFMx60/Room Volume
Example: Say the volume of the room is 1,200 cubic feet, and the volume of air the HVAC system is going to supply is 200 CFM. Thus, ACH = 200×60/1,200 = 10. This ...
What is the difference between a dynamic pass box and a static pass box?
Dynamic Pass Box is equipped with a suction HEPA filter of around 0.3 microns.
A static pass box doesn’t have a filter.
1. Dynamic Pass Box:
A dynamic pass box is equipped with HEPA/ULPA filters and operates with air circulation to prevent contamination during the transfer of materials between ...
How does an Air Handling Unit (AHU) work in the Pharmaceutical Industry?
An AHU plays a critical role in maintaining cleanroom conditions, controlling particulate contamination, and ensuring compliance with regulatory requirements (USFDA, EU GMP)
1. Air Intake and Pre-Filtration
Fresh air Intake: The AHU draws in fresh air and passes it through pre-filters (10-micron filters) ...
