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

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

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

valutazioni:
5/5 (1 valutazione)
Lunghezza:
447 pagine
Pubblicato:
Jun 30, 2013
ISBN:
9781908818621
Formato:
Libro

Descrizione

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
Pubblicato:
Jun 30, 2013
ISBN:
9781908818621
Formato:
Libro

Informazioni sull'autore

Gordon Welty is currently Lecturer in Social Science at Adelphi University, USA . He has extensive professional experience in program development and the management of organizational change. He gained his doctorate from the University of Pittsburgh, USA , and was named Professor Emeritus at Wright State University in 1998. Welty was recruited to develop, rollout, and manage the GMP Trainthe-Trainer program as corrective action/ preventive action (CAPA) for Schering-Plough’s consent decree in 2003. His writings have appeared in such scholarly publications as the Academy of Management Journal, International Sociological Review, Journal of GXP Compliance, and Metroeconomica, as well as a number of anthologies. He was the recipient of the Institute of Validation Technology’s “Author of the Year” Award in 2008, 2009 and 2010.


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  • 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.

  • The first is an observation made by an employee that requires notification to management of a business risk or quality risk. The second is an observation made by an auditor during an internal quality audit.

  • That procedure stipulated that for proposed changes to be implemented, an operational SOP had to be appropriately requested, processed, and approved.

  • Some remediation implicates the revision of a standard operation procedure (SOP); other remediation does not.

  • SOPs are not set in stone, once and forever.

Anteprima del libro

Quality Assurance - G Welty

remaining.

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 example of proactive intervention would be an organization’s response to a close call, where a deviation did not actually occur.

In either case, reactive or proactive intervention, systematic pursuit of revision leads to continuous improvements.

Events and situations do not generate the intervention by themselves. The key terms here are when observed and acted upon, focusing attention on the major groups of stakeholders that can initiate the chain of events leading to the change. The persons occupying each of these stakeholder roles must first observe, then act, to occasion the intervention.

There are five major groups of these stakeholders. These five groups make up a map of the overall sphere of the regulated life sciences industry. Each represents a different facet of regulated industry, including the following:

1. operational staff and their supervisors;

2. quality unit auditors;

3. regulatory investigators;

4. health care providers;

5. patients and other health care consumers.

In brief, operational staff manufacture the regulated product, be it a drug, medical device, nutritional supplement, etc. The quality auditors function independently to monitor the activities of operational staff as well as the quality attributes – the Safety, Identity, Strength, Purity, and Quality (SISPQ) of the product. Agency investigators in turn regulate the activities of both operational and quality staff. Health care providers prescribe the product, and patients utilize the product.

Any member of these groups can make an observation that may bring about an investigation and RCA. Consider several illustrative observations:

 A forklift operator raised the forks too high and damaged a fire sprinkler head. The water was under high pressure and it not only flooded the area but cascaded down to the floor below, threatening to inundate production areas. After an engineer shut off the water supply, operational staff escalated this event to management.

 The quality unit of a FDA regulated blood center reported an increase in the number of BacT Positive samples, which might be indicative of contamination with tuberculosis bacteria. The samples turned positive over the weekend. An investigation was initiated.

 FDA 483 Observation to Genzyme dated 13 November 2009, for example, pointed out that Genzyme’s:

…Investigation AIR 1517 dated 21 June 2007 was opened because HEPA filters in the filling suite failed routine recertification. The investigation found metal particles embedded in several of the HEPA filters. However, no route [sic] cause was determined for the source of the metal contamination found in these filters.¹

 FDA MAUDE AE Report on Genzyme Biosurgerys Synvisc Injection dated 4 August 2008: The [health care provider] assessed the relationship of the events – swelling both knees and right knee effusion – to synvisc as probable. He assessed the relationship of the event – allergic reaction to synvisc – as likely.²

 McNeil Consumer Healthcare recalled bottles of Tylenol eight-hour caplets after some consumers complained of a musty or moldy odor in the product.³

The outcome of an investigation can be followed by the development and execution of corrective actions and preventive actions (CAPA). The logic of this investigative and revising process may be more or less explicit in the various regulated industries, but the underlying logic is the same.

Briefly put, a CAPA can identify several kinds of remediation for a given observation. Some remediation implicates the revision of a standard operation procedure (SOP); other remediation does not. This chapter focuses on the range of intervention and remediation, giving special attention to those that lead to the revision of procedures.

Following an initial section of this chapter that addresses the function of SOPs and the revision of life-cycle documents, the second section discusses the routine review of procedures. This set of routine practices should be juxtaposed to the set of exceptional practices. Thus routine practices can be taken as a baseline for the exceptional practices that are addressed in the remainder of this chapter. The third section addresses the two kinds of internally-based observations that can initiate an intervention and thereby the revision of SOPs: employee notification to supervision and quality (internal) audits. The fourth section discusses the three types of externally-based observations that may initiate an intervention and thereby the revision of a SOP: regulatory inspections, adverse event (AE) reporting, and customer quality

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