Document Change Control

Change Control goes to the core of pharmaceutical operations.  Most FDA 483 observations are written to cite a lack of control of the plant.  If change control is weak, the plant is out of control.  What changes are worth spending a lot of time effecting and what changes can be made effective by an individual acting in accordance with their assigned duties?  This is the question that compliance and regulatory people have pondered for a long time.  The cost implications can not be underestimated by simply stating that all changes are critical and therefore need to have a lot of paper work to effect and ever increasing costs to maintain the status of the change control.

Our Approach

Determination of Criticality and Complexity

Determination of criticality and complexity is essential to assessing the appropriate level of change control.  A matrix system for determination of the appropriate change control level is a useful tool for making this assessment.  The first matrix is the criticality determination.  If the assessment of the effort results in any one the four major categories on the left placing the effort into the high or very high columns then the entire effort is placed in this level of criticality or complexity.

 

LIFE CYCLE PHASES

(Lower Level Procedures will be more specific.)

Level 1

Validation or Change

Level 2

Validation or Change

Level 3

Validation or Change

Level 4

Validation or Change

PROJECT TEAM

Project Leader

Project Leader selects team

Project Leader

Validation Engineer

Other team members as needed

Project Leader

Validation Engineer

Cross-functional Reps.

DEVELOPMENT & DESIGN

(Document design)

Design Notes

Formal Requirements

Feasibility Study

Formal Requirements

Feasibility Study

Design Review

Formal Requirements

Feasibility Study

Failure Analysis

Design Review

IMPLEMENTATION

FABRICATION/CODE

(Documents needed to maintain the system)

Drawings

Documented Code

Drawings

Documented Code

 

Drawings

Documented Code Connectivity Diagrams

Drawings

Documented Code

Connectivity Diagrams

TESTING / QUALIFICATION

Test Report

Test Plan written by Project Team

Test Results

Test Plan written by Project Team & Approval by Approval Authority

Test Results

Qualification Protocol written by Project Team & Approval Authority

Qualification Protocol Report

APPROVAL AUTHORITY

Area Manager

Cross-Functional Group designed to sign for that type of validation

Cross-Functional Group designed to sign for that of validation Includes Quality & Technical Services, R&D, Process Engineering

Cross-Functional Managerial Group designated for that type of validation

Includes Quality & Technical Services, R&D, Process Engineering

The following is a schematic representation of the change control scope.  The results of the criticality and complexity matrices leads to the appropriate change control or validation effort described in the previous table.  The results are determined as follows:

Change Control Chart

Copyright 2013 The Pivotal Point Group, LLC