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SOP for Operation of RMG
Purpose: To lay down operating procedure for the operation of RMG.
Scope: This procedure is applicable to ………………
Responsibility: Production Chemist
Pre-operating Check: Ensure that the line clearance is done
Equipment used: RMG (400 liters GMP)
Operating Procedure:
1. ...
SOP for Operation of Soft Water Plant
Purpose: To lay down operating procedure for operation of Soft Water plant.
Scope: This procedure is applicable to ……………
Responsibility: Production Chemist
To supervise the activity
Equipment used: Softener (Indion NGS – 3B)
Operating procedure:
1. Check the cleaning ...
SOP for Regeneration of Demineralized Water Plant
Purpose: To lay down operating procedure for regeneration of demineralized water plant.
Scope: This procedure is applicable for …………….
Responsibility: Production Chemist
To supervise the activity
EQUIPMENTS USED:
1. Portable Deioniser
a) For anions & cations (Model ...
SOP for Regeneration of Soft Water Plant
Purpose: To lay down operating procedure for regeneration of soft water plant.
Scope: This procedure is applicable to ………………..
Responsibility: Production Chemist
To supervise the activity
Equipment used: Softener (Indion NGS – 3B)
Regeneration procedure:
Brine ...
SOP for Entry exit Procedure in Pharma
1.0 Purposes: 1.1 Lay down the standard operating procedure for the entry-exit procedure in pharmaceuticals.
2.0 scope: 2.1 This SOP applies to all personnel, including visitors entering or leaving the production area of the main plant.
3.0 Responsibility: 3.1 All personnel entering and leaving the production ...
Main Components of GMP
GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products.
There are several guidelines for good manufacturing practices worldwide like WHO , FDA and EU. These guidelines have recommendations for almost ...
GxP’s in Pharmaceutical Industry
1. Good Manufacturing Practice (GMP)
GMP ensures that pharmaceutical products are consistently produced and controlled according to quality standards. This includes guidelines for facilities, equipment, personnel, documentation, and processes.
2. Good Laboratory Practice (GLP)
GLP ensures the reliability ...
SOP for Noise Level Measurement
OBJECTIVE:
2.1 The Objective of this SOP is to describe the procedure for Noise level measurement.
SCOPE:
3.1 This SOP is to describe the procedure for Noise level measurement.
RESPONSIBILITY:
4.1 The Maintenance Engineer shall be:
4.1.1 Responsible for checking the noise level measurement.
4.1.2 Responsible ...
Conductivity test in the Pharmaceutical Industry
In the pharmaceutical industry, water conductivity is a measurement of the amount of dissolved ions in a water sample, and is used to determine the purity of water.
Using a conductivity meter to measure the conductivity of water sample. The meter applies a voltage across two electrodes immersed in the ...
SOP for Integrity Testing of HEPA Filter
OBJECTIVE: The Objective of this SOP is:
1 To describe the procedure for integrity testing of High Efficiency Particulate Air (HEPA) filters being used in Clean Room, De-pyrogenating Tunnel, Laminar Air Flow (LAF) unit and supply/exhaust air unit connected to the critical processes (wherever installed).
2 ...

