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PQRI Case Study (8): Internal GMP Audit Program

The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.

An integral part of an effective quality system in a cGMP-compliant pharmaceutical manufacturing operation is a formal self-assessment process. This is commonly accomplished by performing periodic internal audits of site operations (e.g., quality, manufacturing, engineering, logistics) and associated systems with potential cGMP impact.

The overall administration of the internal audit program is the responsibility of the quality control unit. The quality control unit is responsible to assess site operations and associated systems in order to identify the focus, frequency and resources to support the internal audits as well as to determine the effectiveness of the conducted audits. Audits are typically conducted according to a predetermined schedule and on a regular basis.

This case study on internal GMP audits is the last of eight in a series put together by the Product Quality Research Institute Manufacturing Technical Committee (PQRI-MTC) risk-management working group. The series is meant to advance the understanding and application of the International Conference on Harmonization (ICH) Q9 Quality Risk Management guideline by providing actual examples of risk-management assessments used by the bio/pharmaceutical industry. The introductory article and first case study, on defining design space, appeared in the July 2011 issue of Pharmaceutical Technology (1). Subsequent case studies in the series (8 in total) can be viewed online at PharmTech.com/pqristudies .

In the current case study, the manufacturing site is a diverse drug-product facility. Ideally, the site would be able to perform internal audits of all site operations and systems within a given calendar year. Given the breadth and scope of operations and available support resources, it will be difficult to conduct an internal audit to all operations and systems within that timeframe. One potential approach to administer an effective internal audit system is to maintain a listing of site operations that are subject to internal audit and determine audit frequency based upon the criticality of the operation. The site maintains a list of current operations and also periodically reviews and understands the performance of these operations and associated systems. As a result, facility management recognizes that there are certain internal systems that could benefit from additional focus and enhancement. Site management wants to ensure that resources are applied to those operations having the highest potential for GMP impact and proposes use of quality risk management (QRM) as a tool to effectively apply resources and schedule and conduct internal audits at their site.

The risk question and assessment method

The risk question developed for the subject case study was: What is the optimal internal audit schedule to ensure that those operations and associated systems with the greatest potential impact on product quality and, therefore, potentially the patient, are audited on a more frequent interval than those determined to be less critical?

An internal audit is a diverse activity with more qualitative characteristics than quantitative ones. Therefore, the selected risk-assessment tool will produce a qualitative description of risk (e.g., high, medium, or low). An additional objective of the selected tool is to assist in the organization of data as the assessment moves to the next stage of the process. The developed list of site operations and associated systems ensures identification of the potential risks. As a result, a complex risk-assessment tool is not required. A simple tool that allows for qualitative analysis and evaluation is sufficient.

The risk methodology selected for the subject case study was: risk ranking and filtering.

Risk identification and analysis

As partially shown in Table I, the site has prepared a master list identifying all operations and associated systems which have potential impact on product quality.

Table 1: Risk-evaluation score.

The risk-analysis stage of the QRM process estimates the potential harm(s) associated with each potential risks. The analysis may be qualitative or quantitative in nature, or a combination of the two. The risk score in the current case study will be determined by combining the probability or likelihood of a problem in a given site operation and the outcome, or potential undesired consequences, if a problem were found in the operation. A numerical value of 1, 2, or 3 is assigned to correspond with a low, medium, or high risk-analysis determination, respectively. The risk-evaluation score is calculated as follows:

(Probability Score × Outcome Score) = Risk Evaluation Score

The probability and outcome scores and subsequent risk-evaluation scores for the selected operations are presented in Table I. If desired, for this application, the risk ranking and filtering tool may be modified to include consideration of the length of time since the last audit was performed. To include this element in the risk-evaluation process, the formula for determining the risk-evaluation score is modified to include the time since the last audit as follows:

(Probability Score x Outcome Score) + (Years since last audit) = Risk Evaluation Score

As a result of the executed QRM evaluation, the site is now able to better prioritize resource utilization to focus auditing efforts on those areas with the highest risk scores.

Risk control and documentation

In the current case study, risk is reduced by identifying site operations above a specific threshold score from the risk ranking, and scheduling internal audits for those operations. Inherent risk will be accepted for those site operations which are below that threshold. For those operations, an internal audit will be deferred until audits have been completed for those operations with a higher risk ranking.

Communication of the utilized QRM process should include all key stakeholders of the affected departments throughout the department to ensure organizational buy-in and support. The output of QRM process, the audit schedule, and associated risk analysis justifying the approach, should be documented and endorsed by the site quality unit and effectively communicated to stakeholders.

Risk review

In the case study presented, it may be convenient to review the risk-assessment process and assumptions as the annual schedule is developed. During this activity, the site will confirm that included operations/systems are still in use, remove those that are not and add any new operations/systems to the process. Examples of changes that may potentially impact risk of site operational systems include: changes to control systems, changes to equipment and processes, changes in suppliers/contractors, and organizational restructuring.

Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray,* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.

*To whom all correspondence should be addressed, at [email protected]

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Quality Risk Management Principles and Industry Case Studies

The Pharmaceutical Quality Research Institute Manufacturing Technology Committee (PQRI-MTC) commissioned a Risk Management working group to assemble industry case studies for the purpose of advancing the understanding and application of ICH Q9. The working group was comprised of eight representatives from industry and US-FDA with risk management experience and expertise. This paper represents the outcome of the Risk Management Working Group and provides a summary of common risk management principles and best practices, several working tools to foster consistency around the use of ICH Q9 in day- to-day risk management decision-making, and a series of examples of risk management applications currently in use by major pharmaceutical firms.

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case study rmwg-01 internal gmp audit program (3)

• Case Study RMWG-01 Internal GMP Audit Program (3)

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 Manufacturing Technology Committee  – Risk Management Working Group Risk Management Case Studies  

Case Study Title: Internal GMP Audit Program Case No. RMWG-01 

GMP SystemImpacted:

Introduction /Background

An integral part of an effective Quality System in a cGMP-compliantpharmaceutical manufacturing operation is a formal self-assessment process. This is commonly accomplished byperforming periodic internal audits of site operations (Quality,Manufacturing, Engineering, Logistics, etc.) and associated systemswith potential cGMP impact.

The overall administration of the internal audit program is the

responsibility of the quality control unit. The quality control unit isresponsible to assess site operations and associated systems inorder to identify the focus, frequency and resources to support theinternal audits as well as to determine the effectiveness of theconducted audits. Audits are typically conducted according to apre-determined schedule and are conducted on a regularlyscheduled basis.

In the current case study, the manufacturing site is a diverse drugproduct facility. Ideally, the site would be able to perform internalaudits to all site operations and systems within a given calendaryear. Given the breadth and scope of operations and availablesupport resources, it will be difficult to conduct an internal audit toall operations and systems within that time frame. One potentialapproach to administer an effective internal audit system is tomaintain a listing of site operations that are subject to internal auditand determine audit frequency based upon the criticality of theoperation. The site maintains a list of current operations and alsoperiodically reviews and understands the performance of theseoperations and associated systems. As a result, facilitymanagement recognizes that there are certain internal systems thatcould benefit from additional focus and enhancement. Sitemanagement wants to ensure that resources are applied to thoseoperations having the highest potential for GMP impact andproposes use of Quality Risk Management (QRM) as a tool toeffectively apply resources and schedule the conduct internal audits

at their site.

Defining the RiskQuestion The risk question developed for the subject case study is:

What is the optimal internal audit schedule to ensure that those operations and associated systems with the greatest potential impact on product quality and, therefore, potentially the patient, are audited on a more frequent interval than those determined to be less critical? 

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Case Study: Internal GMP Auditing (Study # RMWG-01)

Page 2 of 3

Selecting a RiskAssessmentMethod

An internal audit is a diverse activity with more qualitativecharacteristics than quantitative ones. Therefore, the selected riskassessment tool will produce a qualitative description of risk (e.g.High, Medium or Low). An additional objective of the selected toolis to assist in the organization of data as the assessment moves to

the next stage of the process. The developed list of site operationsand associated systems ensures identification of the potential risks. As a result, a complex risk assessment tool is not required. Asimple tool that allows for qualitative analysis and evaluation issufficient.

The risk methodology selected for the subject case study is:

Risk Ranking and Filtering

Risk Assessment(RiskIdentification,

Analysis andEvaluation)

Risk Identification -

As partially shown in Table 1 below, the site has prepared a masterlist identifying all operations and associated systems which have

potential impact on product quality.

Risk Analysis and Evaluation -

The Risk Analysis stage of the QRM process estimates the potentialharm(s) associated with each potential risks. The analysis may bequalitative or quantitative in nature, or a combination of the two.The risk score in the current case study will be determined bycombining the probability or likelihood of a problem in a given siteoperation and the outcome, or potential undesired consequences, ifa problem were found in the operation. A numerical value of 1, 2, or3 is assigned to correspond with a Low, Medium, or High riskanalysis determination respectively. The Risk Evaluation Score is

calculated as follows:(Probability Score x Outcome Score) = Risk Evaluation Score 

The Probability and Outcome Scores and subsequent RiskEvaluation Scores for the selected operations are presented inTable 1.

Master List of Site OperationsRisk Identification   Risk Analysis  

Risk  Evaluation  

Area Subject Probability Outcome Score

Maintenance Med (2) Med (2) Med (4)Engineering

Calibration Med (2) High (3) High (6)

Human Resources Training Med (2) Med (2) Med (4)

Production High (3) High (3) High (9)

Labeling/Label Control High (3) High (3) High (9)

Packaging High (3) High (3) High (9)

Manufacturing

Production Control Labs High (3) High (3) High (9)

Vendor/SupplierQualification

Med (2) Med (2) Med (4)Logistics

Warehouse Med (2) Med (2) Med (4)

Regulatory Regulatory Low (1) High (3) Low (3)

Batch Release Med (2) High (3) High (6)

Change Control Low (1) High (3) Low (3)

QC Labs Med (2) High (3) High (6)

Complaints Low (1) High (3) Low (3)

Quality Operations

Validation Med (2) Med (2) Med (4)

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Page 3 of 3

If desired, for this application, the Risk Ranking and Filtering toolmay be easily modified to include consideration of the length of timesince the last audit was performed. In order to include this elementin the Risk Evaluation process, the formula for determining the RiskEvaluation score is modified to include the time since the last audit

as follows:

(Probability Score x Outcome Score) + (Years since last audit) = Risk Evaluation Score 

As a result of the executed QRM evaluation, the site is now able tobetter prioritize resource utilization to focus auditing efforts on thoseareas with the highest risk scores.

Risk Control In the current case study, risk is reduced by identifying siteoperations above a specific threshold score from the risk ranking,and scheduling internal audits for those operations. Inherent risk

will be accepted for those site operations which are below thatthreshold. For those operations, an internal audit will be deferreduntil audits have been completed for those operations with a higherrisk ranking.

RiskDocumentationand Control

Communication of the utilized QRM process should include all keystakeholders of the affected departments throughout thedepartment in order to ensure organizational buy-in and support.The output of QRM process, the audit schedule and associated riskanalysis justifying the approach, should be documented andendorsed by the site quality unit and effectively communicated tostakeholders.

Risk Review In the case study presented, it may be convenient to review the riskassessment process and assumptions as the annual schedule isdeveloped. During this activity, the site will confirm that includedoperations/systems are still in use, remove those that are not andadd any new operations/systems to the process. Examples ofchanges that may potentially impact risk of site operational systemsinclude: changes to control systems, changes to equipment andprocesses, changes in suppliers/contractors, organizationalrestructuring, etc.

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