Quality Assurance

Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries

G Welty

• Publisher: Woodhead Publishing
• Year: 2013
• Print ISBN:
  9781907568367
• eBook ISBN:
  9781908818621
• Topic: Medicine
• Subtopic: Pharmacology

Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort. - Presents a comprehensive view of the field of quality assurance - An approach grounded in direct experience - Uses diagrams and figures to clarify analytical points

Part I

A systematic approach to problem solving

Introduction

This book has three parts. Part I establishes the framework for what follows. It considers how a systematic approach to problem solving can lead to continuous improvement of program and process in the life sciences industry. Program improvement carries its own consequences. Controlled change, a crucial aspect of program improvement in regulated industry, results in the revision of controlled documents - standard operating procedures (SOPs). These revisions in turn require training of all employees impacted by the change.

Part II provides an overview of the development of several kinds of GXP training modules. Part III addresses the implementation, assessment, record-keeping, and evaluation of those training modules.

Chapter 1 involves the identification and analysis of a problem that is the occasion for an organization’s response and remediation. Several groups of stakeholders are identified – operational employees, quality unit auditors, regulatory investigators, health care providers, and customers. Certain kinds of observations tend to be associated with each of these stakeholders: escalated events tend to be associated with employees, internal audits with auditors, non-compliance observations with regulatory investigators, adverse events with health care providers, and customer quality complaints with patients. These observations initiate an investigation and revising process that varies in emphasis but that has an underlying logic.

Chapter 2 discusses the organizational response to observations of deviations. Observations are either escalated, or they are triaged (especially if they relate to non-GMP issues). If an observation is escalated, it can become the basis of an investigation and root cause analysis (RCA). At the conclusion of the investigation, remediation can be proposed in the form of corrective action and preventive action (CAPA), and may ultimately lead to the revision of one (or more) SOPs. Next, the processes of investigation and RCAs were addressed.

Chapter 3 considers how remediation involves the updating of operational procedures. Revisions that add value to a procedure can contribute to best practices. Revisions that do not add value are wasteful, and from a regulatory standpoint also suggest that a process is not in control. Given the ubiquitous changes in technology, procedures must be appropriately versioned up. The key word here is “appropriate.” In order to ensure that the revision is appropriate, the SOP should be subjected to a critical review. Newly written procedures can also be subjected to critical review.

There is a range of approaches to critical review of procedures, in terms of increasing credibility of the review findings. It is management’s prerogative to weigh the benefits of increasing credibility against the costs of increasing rigor of the approach. This cost/benefit analysis must be informed by an assessment of the degree of change that is involved in the revision, as well as a risk analysis of the change. This leads to the consideration of the place that the critical review of procedures holds in a value-adding approach to program design and management.

The preceding chapter established the central role of a SOP in the regulated process. The first part of Chapter 4 presents a template for the development of a SOP, including the relation of a process map (flowchart) to the SOP. The second part illustrates the completion of that template with a cleaning and sanitizing procedure. This will also involve a review of the process of cleaning and sanitizing of facilities for GMP compliance.

In sum, a diligent approach to revision promotes the continuous improvement of the program and its process, as well as the development of program staff.

1

Framework for continuous improvement

Abstract:

This chapter considers occasions that lead to the continuous improvement of manufacturing processes and programs in the life sciences industry, and to the revision of SOPs. Several groups of stakeholders in the sphere of FDA-regulated industry are identified. Each of these groups tends to be associated with particular kinds of observations, observations of various deviations from the anticipated manufacturing process and product. These observations initiate an investigation and revising process that varies in emphasis but that has an underlying logic. An observation is typically escalated, triaged, and can become the basis of an investigation and RCA. At the conclusion of the investigation, programmatic remediation can be proposed in the form of corrective actions and preventive actions, and may ultimately lead to the revision of a procedure. A diligent approach to revision promotes the continuous improvement of the manufacturing process.

Key words

adverse event

change control

controlled document

corrective action

customer quality complaint

deviation investigation

good management practice

management notification

Notice of Event

preventive action

regulatory inspection

SISPQ

standard operating procedure

stakeholders

1.1 Introduction

There are events and situations that – when observed and acted upon – initiate the revision of processes and procedures addressed by good manufacturing practices (GMPs) in a regulated industry such as that covered by the US Food and Drug Administration (FDA) or other global regulatory agencies. These events and situations can lead to two kinds of revision of GMP processes. They can be either reactive interventions such as corrective actions, or proactive interventions such as preventive actions. An example of a proactive intervention would be the organization’s response to tracking and trending data that suggest critical action points will soon be exceeded. Another e...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of figures
• List of tables
• List of abbreviations
• About the author
• Acknowledgments
• Part I: A systematic approach to problem solving
• Part II: Designing and developing training materials
• Part III: Using the training materials
• Index