Saturday, December 14, 2019

SOP on Electronic Data Backup Management System

1.0 Objective To lay down a procedure for electronic data backup management system. 2.0 Scope This standard operating procedure is applicable at IT department of pharmaceutical company. 3.0...

VMP (Validation Master Plan) Preparation Guideline in Pharmaceuticals

Validation Master Plan VMP is a roadmap of validation activity like facility qualification and also define system and area to be validated. VMP justifies the...

Untouched area of Data Integrity in Pharmaceutical Industry

Now a days the topic "Data integrity and non compliance" is the hot topics. Lots of references available online that deals with the Data...

Corrective and Preventive Actions…Basic approach

Corrective and Preventive Actions CAPA is a fundamental management tool that should be used in every quality system.  This program provides a simple step by...

Sampling of Inprocess Materials and Finished Products

1.0 Objective To lay down a procedure for Sampling of Inprocess materials and Finished products. 2.0 Scope This standard operating procedure is applicable to pharmaceutical formulation plant...

Bowl Fill Seal (BFS) Technology in pharmaceutical for sterile Preparation

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,...