V Model Validation Process-in the Pharmaceutical Industry - FDA Perspective

Summary
The objective of this paper is share Conceptual clarity while working on Life science SAP projects ( End to end, Solution Rollout, Development & Support etc) and try to take best practices out of this to other domain projects. To bring the importance of Validation, Compliance from Quality System point of view.
Author: Girish Deshpande
Company: Satyam Computer Services Ltd
Created on: 30 December 2008
Author Bio
Girish Deshpande has worked in leading Automobile manufacturing for eight years in area of Quality Assurance and has extensively worked as Senior Consultant in Quality Management, Plant Maintenance, and Document Management System for global clients in Pharmaceuticals giants in Europe, Steel Manufacturing units, Beverage bottler in China from eight years. The aim of this paper is to share V model & validation in Pharma from FDA point of view.
Table of Contents
Introduction ........................................................................................................................................................ 3
GxP Overview .................................................................................................................................................... 3
Key Regulatory Bodies................................................................................................................................... 3
What is CSV (Computer System Validation)................................................................................................... 4
V Model Concept ............................................................................................................................................ 6
Validation Process ......................................................................................................................................... 6
Document Tractability .................................................................................................................................... 7
Conclusion ......................................................................................................................................................... 7
Related Content ................................................................................................................................................. 7
Disclaimer and Liability Notice .........................................................................................................Introduction
The primary aim of this article is to share key concepts while one work with Life science SAP projects in particular to Pharmaceutical, Beverage, and Health care domain. Under stand and implement universally formed model while executing projects. Following are key theme
 GxP overview
 Know Important Regulatory bodies
 V model
 Importance of Validation
 Document Tractability
As most of you know that entire Pharmaceutical Industry (Finished goods, Intermediate products, Drugs & Substance manufacturing) deals with human & animal life, saving human. The pharmaceutical industry undertakes the development, production and supply of pharmaceutical products needed to save lives, prevent disease and otherwise assist in maintaining quality of life.
This industry is governed by Regulatory authorities and lot of emphasis on documentation. There is huge Research & Development investment with long lead time for product to come into market for commercial purpose once regulatory approvals are in place.
GxP Overview
The term GxP means GMP ( Good Manufacturing Practices) „x‟ includes
 GCP ( Good Clinical Practices )
 GLP ( Good Laboratory Practices )
 GDP ( Good Distribution Practices )
The pharmaceutical industry is regulated industry means pharmaceutical. Preparations must be safe and effective for patients & the general public. It must protect consumer. Adhere to GxP for compliance & Proof that any systems and activities are “fit for purpose”.
In nutshell the GMP covers all business functions which are closely associated with business process in major category People who follow certain Processes to make required Products with the help of administrative, Quality, regulatory Procedures & related paper work.
Key Regulatory Bodies
In major continents across globe, we have International reputed agencies who has worldwide presence who acts as Regulated bodies for Pharmaceuticals industry
 Food & Drug Admirations (FDA) –Relevant for US Market mainly
 European Medicines Evaluation Agency (EMEA) –For European Region
 Drug Controller General of India –For IndiaWhat is CSV (Computer System Validation)
 Computerized system validation (CSV) is the documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
 The validation process begins with the system proposal / requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.
 System definition artifacts that reflect these requirements can include, but are not limited to, the following:
o User Requirements Specification: What the system needs to do for its user(s)?
o Functional Requirements Specification: How each feature of the system functions?
o Design Requirements Specification: How each feature of the system is built?
o Hardware Requirements Specification: Minimum hardware required to support the system.
FDA Definition: “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” (Source: FDA Guidelines on General Principles of Process Validation, 1987)
Significance of CSV
Main business reason behind CSV is to deliver as per requirements and to have minimum maintenance cost for a computer system. Documentation is one of the most important requirements of CSV. It is important for Pharma Systems to be CSV compliant to:
 Minimize regulatory actions.
 Maintain positive relationship with regulatory bodies.
 Expediting submissions to FDA / other regulatory and faster approvals by FDA.
 Avoiding product recalls and negative publicity.
Key FAD Regulations applicable for SAP Projects
Following are key FDA Regulations which are closely related with SAP Software development cycle.
CFR : Code of Federal Regulations ,Title 21 mainly deals with Food & Drugs published by US FDA
 21 CFR Part 11 ( Electronic Records, Electronic Signature )*
 21 CFR Part 210 (Current GMP in Manufacturing, processing, packaging)
 21 CFR Part 211(Current GMP for finished pharmaceuticals)
* The 11 th sub part is related with all kinds of electronic records & Signature for software project
Refer website for country specific regulatory bodies mentioned in reference...................Audit trail of changes
 What type of changes ( Creation, Modification, deletion )
 What record was & what it is now
 Who did it ( Unique identities)
 When it was done
Electronic Signature
 Irrevocable legal signature
 2 Elements ( User ID and Password)
 Password not viewable ( even by system administration )
Access Control
 User Profile
 Password
 Password encryption
Main Benefits of 21 CFR Part 11 are
 Increased speed of information exchange
 Cost savings
 Reduced data entry and errors
 Improved process control
 More efficient data transmission to FDA for review and approvals