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 ...

SOP for Operation of Chiller Plant

OBJECTIVE The Objective of this SOP is to describe the procedure for operation of Chiller plant & Monitor the Performance of the Chiller plant. SCOPE This SOP is applicable for the operation of Chiller plant. Installed in Utility at RESPONSIBILITY 1 The Plant Operator shall be responsible for: 1.1 ...

SOP for Verification of Stainless Steel Quality

OBJECTIVE: To describe the procedure for checking the quality of Stainless Steel (SS). SCOPE: This SOP is applicable for the checking the quality of Stainless Steel (SS) installed RESPONSIBILITY: 1 The Maintenance Engineer shall be: 1.1 Responsible for procedure for the checking the quality of SS. ACCOUNTABILITY: ...

SOP for Air Flow Pattern Checking

OBJECTIVE: The Objective of this SOP is to describe the procedure for Airflow pattern checking. SCOPE: This SOP is applicable for the describe the procedure for Airflow pattern checking 4.0 RESPONSIBILITY: 4.1 The Maintenance Engineer shall be responsible: 4.1.1 For Airflow pattern checking. 4.1.2 For ...

SOP for Calibration of Hour Meter

OBJECTIVE: The purpose of this SOP is: To describe the procedure for Calibration Of Hour Meter being used in various departments. SCOPE: This SOP is applicable for the calibration of Hour meter installed in manufacturing & other Facilities of RESPONSIBILITY: 1 The Maintenance Engineer shall be: 1.1 ...

What is a GxP?

GxP is a set of regulations and quality guidelines formulated to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. GxP is a general abbreviation for the “good practice” quality ...
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