VAL 160 Periodic Review of Systems and Processes Sample

Standard Operating Procedure
Title: Periodic Review of Systems And Processes
4.5.4 Periodic reviews shall be conducted within the time interval not to exceed 5 years.
4.5.5 In the absence of a risk-based schedule, the periodic review shall default to no
more than 2 years.
4.5.6 Periodic review of validated process is not required as the evaluation of deviations,
changes and process trends is covered and combined with the Annual Product Records
Review.
4.5.7 The results of the periodic review shall be documented, reviewed and approved by
the site validation committee.
4.5.8 The review may result in the need for additional studies (e.g. supplemental
validation or revalidation).
4.5.9 For processes with systems with lower risk, a periodic review with evidence that
the process or system is consistently producing product meeting its specifications fulfils
the need for revalidation.
4.5.10 For system that has not been impact assessed, its impact will be assessed to
determine whether the system is a direct impact, indirect or non-impact system prior to
periodic review.
5.0 PROCEDURE
5.1 Periodic Review of System
A system’s first periodic review will cover the time period from the completion of the
system’s most recent full validation to the review date. Subsequent reviews then cover
the time period since the completion of the most recent periodic review.
During the periodic review, the following will be evaluated:

 Review of system description, including complete listing of critical subsystems /
components (e.g. equipment, hardware, software).
 Review of the cumulative and/or repetitive effect of all changes (e.g. Change
Controls) to include an assessment of whether further action is warranted.
 Review of all deviations (e.g. Deviations, Incidents) including frequency and

reasons, to determine whether there is a trend away form the qualified state.
 Review of appropriate maintenance and calibration records (as applicable) to

determine whether the system has been properly maintained.
 Review performance trending, if applicable (e.g. system logs).
 Review system against applicable regulatory, GMP and Site requirements

established since the last periodic review or qualification.
5.2 Periodic Review Report
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Standard Operating Procedure
Title: Periodic Review of Systems And Processes
The criticality of a system is a quantitative measure of the severity of the impact of an

adverse GMP / product quality event occurring in the system that would affect GMP
regulatory compliance and/or the critical quality attributes of any relevant products.
When assessing the criticality of a system, the system impact on product quality may
include:
5.4.1.1 Direct product contact.
5.4.1.2 Production of any excipient or ingredient.
5.4.1.3 Cleaning, sanitisation or sterilisation.
5.4.1.4 Preservation of products status.
5.4.1.5 Generation of data / records used to reject or accept product.
5.4.1.6 Control of a process without independent verification.
Based on this assessment, the criticality level of the system may be defined:
Low – minor negative impact, no direct effect on patient, no long-term GMP

regulatory compliance effect.
Medium – moderate impact, possible long-term effect on patient, short to medium

term GMP regulatory compliance impact.
High – very significant impact, direct and immediate effect on patient, long term
GMP regulatory compliance effect.
5.4.2 Probability of an Adverse GMP / Product Quality Event

The probability is a measure of the probability of an adverse GMP / product quality
event occurring. This should take into account the complexity of the system, its
robustness and its frequency of use. The probability should be assigned based on an
estimate of how often an adverse event would expect to occur, as below:
Low – one adverse GMP / product quality event in 10,000 operations
Medium – one adverse GMP / product quality event in 1000 operations.
High – one adverse GMP / product quality event in 100 operations.
5.4.3 Probability of Detection

The probability of detection is an indication of how likely it is that an adverse GMP /
product quality event would be detected. For example, routine calibration may
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Standard Operating Procedure

Title: Periodic Review of Systems And Processes

During the periodic review, the following will be evaluated:

 Review of all deviations (e.g. Deviations, Incidents) including frequency and

 Review of appropriate maintenance and calibration records (as applicable) to

 Review performance trending, if applicable (e.g. system logs).

 Review system against applicable regulatory, GMP and Site requirements

5.2 Periodic Review Report

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The criticality of a system is a quantitative measure of the severity of the impact of an

Low – minor negative impact, no direct effect on patient, no long-term GMP

Medium – moderate impact, possible long-term effect on patient, short to medium

5.4.2 Probability of an Adverse GMP / Product Quality Event

Low – one adverse GMP / product quality event in 10,000 operations

Medium – one adverse GMP / product quality event in 1000 operations.

High – one adverse GMP / product quality event in 100 operations.

5.4.3 Probability of Detection

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