Which guidelines are relevant to your temperature mapping study working in pharma?

Estimated reading time: 4 minutes

This article aims to inform about the principles that need to be applied when conducting temperature mapping studies of facilities and equipment used in the pharmaceutical field.

In the article, we go through:

• WHO guidelines
• ISPE guidelines
• Guidelines from other agencies
• References

1. Introduction

For the conduction of temperature mapping studies, your quality representative needs to follow the internal, external, and international guidelines that are set by the government and organizations.

These guidelines aim to unify the practices followed by an organization’s representatives in order to provide coherent services and products.

Also read: Regulations, standards, and guidelines – is there a difference?

2. Temperature mapping guidelines for GMP

The World Health Organization (WHO) and The International Society for Pharmaceutical Engineering (ISPE) offer guidelines that give a satisfactory overview of how a temperature mapping study should be conducted in order for a storage area to be conformed with Good Manufacturing Practices.

WHO guidelines are available to the public for free whereas ISPE guides require purchase.

Also read: Key guidelines and compliance regulations of temperature mapping

2.1. World Health Organization

The World Health Organization or WHO consists of 194 member states that follow and comply with the health recommendations of the organization.

WHO has defined the principles required for the storage and transportation of Time and Temperature Sensitive Pharmaceutical Products or TTSPPs, based on international regulations and best practices, in WHO Technical Report Series, No. 961, Annex 9 (2011): Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products.

In regards to the temperature mapping studies of TTSPPs, WHO has issued two additional supplements on Annex 9, Section 4.7: Qualification of temperature-controlled stores, listed below:

• WHO Technical Report Series, No. 992, Annex 5, Supplement 7 (2015), Qualification of temperature-controlled storage areas: Supplement 7 lays out the requirements a controlled-temperature facility or unit needs to follow prior to its use. The report acts as a guide on how to perform the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) that need to be conducted before the use of the unit.

• WHO Technical Report Series, No. 992, Annex 5, Supplement 8 (2015): Temperature mapping of storage areas: Supplement 8 states the purpose of the temperature mapping study and counsels on how to execute a temperature mapping in a temperature-controlled area. It gives information on the positioning of mapping sensors, on the acceptance criteria that need to be followed, the structure of the mapping report, and the way data should be analyzed.

2.2. The International Society for Pharmaceutical Engineering

The International Society for Pharmaceutical Engineering or ISPE provides guidance on good practices for the mapping of controlled temperature storage areas used to store medicinal products and which operate under the current GMP.

Among others, the ISPE practices offer advice on:

• the monitoring of the storage areas
• the frequency of temperature mapping studies
• the location and number of mapping sensors needed for temperature mapping

They also elaborate on the recording intervals for temperature mapping as well as on different rationales that the sensor numbers and locations are based on.

ISPE Good Practice Guide:

• Cold Chain Management (2011).
• [Controlled Temperature Chambers (Second edition – 2021): Commissioning and Qualification, Mapping and Monitoring].(https://ispe.org/publications/guidance-documents/ispe-good-practice-guide-controlled-temperature-chambers-2nd-edition)

2.3. Other agencies

The guidance and regulatory documents are revised continuously, therefore it is important to keep informed of the changes.

Besides WHO and ISPE, which are considered the global standards, other agencies and groups contribute to the regulatory standards. The agencies are based in various regions, as different countries have distinct requirements.

3. References

United States Pharmacopeial Convention:

• USP Chapter 1118 Monitoring Devices – Time, Temperature, and Humidity

Parenteral Drug Association:

• PDA Technical Report No. 52 (2011) – Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain

European Commission:

• EC Guidelines on Good Distribution Practice:

1. Commission guideline 2013/C 343/01 on Good Distribution Practice of Medicinal -Products for Human Use (2013)
2. Commission guideline 2015/C 95/01 on principles of Good Distribution Practice for active substances for medicinal products for human use

• Eudralex Volume 4: Good Manufacturing Practice (GMP) guidelines – Medicinal Products for Human and Veterinary Use
• Eudralex Volume 4 Annex 11 (2011): Computerized Systems
• Eudralex Volume 4 Annex 15 (2015): Qualification and Validation

Pharmaceutical Convention Inspection and Pharmaceutical Inspection Cooperation Scheme:

• PIC/S Validation Master Plan (2007): Installation and Operational Qualification, Non Sterile Process Validation, Cleaning Validation
• PIC/S Guide To Good Manufacturing Practice For Medicinal Products (2023):

1. GMP Guide Part I (2023)
2. GMP Guide Part II (2023)

Health Canada:

• GUI 0069: Guidelines for Temperature Control of Drug Products During Storage and Transportation (2020)

Saudi Food & Drug Authority:

• SFDA Guidance ver. 2.0 (2013): Guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

U.S. Food and Drug Administration (FDA) – Code of Federal Regulations

• Title 21: Food and Drugs (last amended 25 of April 2022)

1. 21 CFR 820.150: Storage
2. 21 CFR Part 210: Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
3. 21 CFR Part 211: Current Good Manufacturing Practice For Finished Pharmaceuticals
4. 21 CFR Part 820: Quality System Regulation
5. 21 CFR Part 600: Biological Products: General
6. 21 CFR Part 111: Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
7. 21 CFR Part 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES. Tip! Learn more about 21 CFR Part 11 in temperature compliance here.
8. 21 CFR 211.46: Ventilation, air filtration, air heating and cooling.
9. 21 CFR Part 211.68: Automatic, mechanical, and electronic equipment.
10. 21 CFR 211.142: Warehousing procedures.
11. 21 CFR Part 211.194: Laboratory records.

• Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations (2006)

• Pharmaceutical CGMPs for the 21st Century (2004): A Risk-Based Approach

International Conference on Harmonization (ICH):

ICH Quality Guidelines:

1. ICH Q8 – Pharmaceutical Development (2006)
2. ICH Q9 – Quality Risk Management (2006)
3. ICH Appendix 2.4 Human and Organizational Errors and Criticality of Records
4. ICH Q10 Pharmaceutical Quality System (2009)
5. ICH Q11

International Society of Pharmaceutical Engineering (ISPE):

ISPE GAMP 5 Guide (2008):A Risk-Based Approach to Compliant GxP Computerized Systems

World Health Organization (WHO):

• WHO Technical Report Series 908 (2003): TRS 908 – 37th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
• ASTM E2500 Standard Guide (2020 Edition): Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

International Organization for Standardization (ISO):

• ISO/IEC 17025:2017: General Requirements for the Competence of Testing and Calibration Laboratories
• ISO 10012:2003: Measurement Management Systems
• ISO 14971:2019: Medical Devices – Application of Risk Management to medical devices