Development and Validation of Calculation Data Sheets to Ensure the Accuracy and Security of Pharmaceutical Data Through Qa Procedures (Qaps)

Abstract

Introduction: Quality stands as an essential prerequisite in the evaluation of any product and especially true for pharmaceuticals, for stringent standards of quality during their manufacturing process. In this consideration, the Food and Drug Administration introduced good manufacturing practices (GMP) and viewed validation as an integral part of cGMP. Validation studies have been conducted for a long time in industries. In recent times to better the quality of pharmaceutical products, industries emphasize quality assurance programs.

Objectives: This research has introduced a simplified and efficient method for validating Excel spreadsheets. The sheets are designed to fulfil the regulatory requirement, easy to use and developed itself by the users to assure the accuracy, integrity and quality of their data. This sheet should be validated and strictly follow the GMP and FDA 21 CFR part 11 regulations.

Methods: All the sheets are designed in Excel- 2013 following the regulatory requirements. The data is collected from the analytical laboratories following the standard procedures to perform the test.

Results: The sheets should validate and every action should be documented and all the sheets are assured to present the quality data with complete maintenance of the security, accuracy and integrity of the data. By following these principles, it is possible to fully validate and implement a standard spreadsheet in very less time.

Conclusions: The sheets provide the accuracy maintenance of data and calculations in order to protect the data from any unauthorised access. The good documentation and manufacturing practices alongwith the regulatory authorities made it important for getting regulatory compliance. Validation of process, equipment plays important role in assuring the quality of product while the excel sheets ensure the data integrity and protection from any modification. Therefore it necessary to validate the excel sheets as per the reference documents and to assure quality of the data.