Quality Assurance

1.0 Objective To lay down a procedure for the Corrective and Preventive Action so as to eliminate the causes of potential non-conformities and /or encountered...

CALIBRATION VALIDATION Calibration is a demonstration that, a particular Instrument or device produces results with in specified limits by comparisons with those produced by a reference or traceable...

 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...

1.0 Objective:  To lay down a procedure for house keeping personnel movement 2.0 Scope:  This SOP is applicable to house keeping personnel for guiding them concerning their...

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...

Blow-Fill-Seal (BFS) technology was developed in the early 1960s and was initially used for filling many liquid product categories, for example, nonsterile medical devices,...

1.0 Objective: To lay down a procedure for the status labeling system and its control. 2.0 Scope: This Standard Operating Procedure is applicable for identification...

1.0 Objective To lay down a procedure for sampling of Wash Water of equipments. 2.0 Scope This Standard Operating Procedure is applicable for formulation plant. 3.0 Responsibility 3.1    Executive/...

In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of...

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and...