Sunday, October 21, 2018

Review, Storage, Retrieve and Disposal of Executed Batch Documents

Objective To lay down the procedure for Review, Storage, Retrieval and disposal of Executed Batch documents. Scope This SOP covers the procedures for Review, Storage, Retrieval and...

What is Calibration, Verification and Validation in pharmaceuticals?

In pharmaceutical industries these three terms are commonly used. Sometimes there is a confusion between these terms. Here I would like to explain these...

Quality Audit: Introduction, Types and Procedure

Auditing in simple terms could be defined as inspection of a process or a system to make sure that it complies with the requirements...

DCGI Makes LSSDC Certification Compulsory For All Pharma Manufacturing Jobs From 2018

India’s government has launched a certification programme aimed at tightening up quality standards in its domestic drug industry. Drug manufacture have comply their...

URS (User Requirement Specification) Sterile API Facility

 USER REQUIREMENT SPECIFICATION                    STERILE API FACILITY 1.0 Introduction  1.1 Scope of the Project:                                                           The project envisages setting up of a Greenfield Sterile API manufacturing facility and...

SOP On Facility Designing and Qualification

1.0 Objective To define the Standard Operating Procedure for Facility Designing and Qualification. 2.0 Scope 2.1 This SOP is applicable for pharmaceutical Facilities. 2.1.1 When designing new facility. 2.1.2...

Qualification of Water System

Earlier pharmaceutical industries used to rely on one time procedures that had a severe impact on the formulations resulting in product recalls often and...

SOP on Quality Risk Management

1.0 Objective To describe the procedure for management of risks, arising from different operations, activities and discrepancies. 2.0 Scope This Standard Operating Procedure is applicable for the...