What were the changes?

In 2021, ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016) was updated, to become ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification, Mapping and Monitoring (Second Edition, 2021). The addition of “Commissioning and Qualification” to the title reflects the additional focus that these activities receive in the Second Edition, with content changes being made to adapt to the changing industry and to better align with other ISPE guides.

Commissioning and qualification, ISPE rules in the 2021 update including for temperature mapping and periodic reviews.

The most significant content changes were:

Improvements to the commissioning and qualification activities, resulting in more efficient processes, and
Determining the periodic review frequency based on consideration of the risk associated with use of the controlled-temperature chamber, with key risk factors being the risk of failure to maintain uniform temperature, and the criticality of material being stored.

Guidance for Efficient Commissioning and Qualification

Although the original Good Practice Guide contained a sufficient level of detail to enable the successful execution of commissioning and qualification, and it identified the general applicability of a risk-based approach to verification, the instructions essentially prescribed the testing to include as part of the commissioning and qualification exercise, with little guidance on how to structure and approach the exercise.

There was an opportunity to provide guidance that would result in more efficient commissioning and qualification.

The updated Good Practice Guide defines a commissioning and qualification process that is designed to be efficient yet still compliant. In terms of presentation, the process is described in a very detailed, clear and logical order. Furthermore, the updated Good Practice Guide presents commissioning and qualification within the same overall process, which is useful to illustrate the progression from commissioning to qualification.

Comparing the two editions of the Good Practice Guide, the most notable modification to the commissioning and qualification process (itself) relates to its thoroughness. The revised process relies on clearly defining/describing and documenting all aspects of the process upfront and throughout the process. The Second Edition places emphasis on the importance of planning and establishing the foundations, which is aligned with ISPE Baseline Guide: Commissioning and Qualification (Second Edition).

With this level of detail, organization, and preparation, the commissioning and qualification process is more time-efficient and more cost-effective. A carefully planned process can create efficiencies in the overall commissioning and qualification effort by:

Targeting effort on relevant, value-adding work and avoiding work that is not beneficial to the overall qualification process,
Eliminating on-the-fly decision-making and the resulting potential for efforts to be wasted, duplicated or performed under time pressure (as can occur if the approach to qualification changes partway through the project), and
Reducing the potential for creating and closing non-compliances that arise from ill-considered testing activities.

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Periodic Review Frequency

Prior to the Second Edition, only a limited amount of information on how to determine the periodic review frequency was provided in the Good Practice Guide. The original version of the Good Practice Guide simply recommended using a risk assessment to determine the periodic review frequency. Although this guidance was sound, the effectiveness of its implementation depended on the capabilities of the user, and its outcome had the potential to vary from case to case.

In the Second Edition of the Good Practice Guide, the process for determining the periodic review frequency is clearly defined. Periodic review frequency is determined based on two primary risk factors:

The material being stored, and
The storage temperature conditions

For risk assessment in accordance with the Second Edition:

Stored materials are classified into three categories:

Category 1 (Most critical, e.g. Active Pharmaceutical Ingredients, drug product, stability samples),
Category 2, and
Category 3 (Least critical, e.g. supplies and reagents for environmental monitoring, media)

Temperature conditions are also classified into three categories based on risk fluctuations:

High risk (e.g. a refrigerated storage facility directly exposed to extreme temperature fluctuations),
Medium Risk
Low Risk (e.g. an ambient warehouse enclosed within a facility controlled to moderate temperature fluctuations)

Classification and assessment of these risk factors, in accordance with the guidance provided in the Second Edition, determines if there is a:

High risk of failure (“failure” meaning that the temperature within the storage space is inappropriate and causes a quality issue),
Medium risk of failure, or
Low risk of failure.

The frequency of review is based on the risk assigned, with high risk requiring more frequent review.

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By providing additional guidance on assessing the risk of using the temperature-controlled chamber for storing the material, the Second Edition helps to ensure:

That the periodic review frequency does not result in an excessive burden for planning and executing periodic reviews,
While maintaining appropriate control of the quality risk.

Furthermore, across the industry as a whole, the more well-defined risk assessment process has the potential to result in a more uniform approach for determining the periodic review frequency.

Other Changes

In addition to the significant changes discussed above, other changes introduced in the Second Edition include:

Expansion of freezer types to include ultra-low (temperature) freezers, and duration of storage needs,
Discussion on how materials of construction may impact cold rooms,
Descriptions of GxP storage facilities and warehouses,
Enhanced descriptions of monitoring systems,
A high-level overview of decommissioning a unit, and
Considerations for using ocean reefers (air-conditioned transportable containers).

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How can PharmOut help?

PharmOut can help you with commissioning, qualification, temperature mapping and monitoring. PharmOut can provide the equipment, assist with protocol development, execution, data analysis, reporting, project management and anything in between. PharmOut also has a set of controlled space design templates and Validation Protocols, i.e., IQ, OQ, and PQ templates for sale.