GMP warehouse mapping: step-by-step guidelines for validating life science storage facilities
Good manufacturing practice (GMP) regulators in the United States, Canada, European Union, Japan, Australia and China have sharpened their focus on warehouse storage and distribution practices.
Driving this trend is a shift in regulatory thinking from quality-by-test to quality-by-design systems, an with emphasis on level of risk to product quality and patient safety. Other drivers include greater demand for storage facilities due to globalisation of manufacturing, an increase in temperature-sensitive biopharmaceuticals and changes in technology.
Regulators in these countries require ‘mapping’ the temperature and relative humidity profiles of warehouses for environmentally sensitive life science products. This step-by-step guide describes how to map a warehouse to comply with internationally recognised GMPs, including many that have been published or revised recently. This guide, intended for use by any organisation involved in the storage and distribution of products sensitive to temperature and humidity in a GMP-compliant environment, draws on Vaisala’s extensive customer experience throughout North America and Europe. Vaisala solutions are used in over 150 countries worldwide.
Step by step — good practices for warehouse mapping studies
Vaisala recommends a nine-point process for successful mapping of a warehouse or other regulated storage space.
These nine steps will help you design and execute a successful mapping plan. They will ensure that you take into consideration the most important elements of validation, especially understanding where temperature and humidity pose risks to product quality. Following these steps will go a long way in demonstrating to a regulatory inspector that your company is GMP compliant.
Step 1: Create a validation plan
The validation plan, or validation master plan, is the document used to specify the company’s decisions about qualifying every aspect of the facility, equipment and processes to maintain a GMP-compliant environment. The plan should take a risk-based approach, with a rationale based on verifiable data. The plan should focus on where environmentally sensitive products and materials will be stored and whether environmental controls can meet specified storage requirements. The plan is also a starting point for regulators to evaluate the rationale for the company’s goals and methods.
Step 2: Identify areas at risk
To map a warehouse or storage space, you first must identify areas where product quality may be at risk because of unacceptable variations in temperature and humidity. Many factors affect the control or variability of your space. (Because relative humidity is dependent on temperature, variations in temperature will affect humidity as well.)
Step 3: Develop protocol information
Once you’ve identified areas of risk, develop a protocol for the mapping study that describes the following, with justifications for each decision.
Step 4: Determine sensor distribution
How many sensors will you need to map a particular space? Where will you put them? There are no simple answers. Sensor distribution must be adequate to assess temperature uniformity. Good practice means that you use a sufficient number of sensors to understand your environment, especially areas where risk is greatest. You’ll need to place sensors in a uniform pattern in all three dimensions of the space — top to bottom, left to right and front to back. Add additional sensors where you suspect cool or warm areas exist, as well as near the control sensors and monitoring sensors. Placement of temperature and relative humidity sensors is a function of the risks identified in Step 2.
Step 5: Select suitable technology
Use equipment designed for mapping. Software that accompanies the sensors is used to set up the equipment and download data. Software should produce tabular and graphical reports that meet all requirements of 21 CFR Part 11 and comparable international standards, such as European Commission Annex 11 and those contained in European Union GMP Volume 4.
Step 6: Set up mapping equipment
After you’ve identified risk areas and determined sensor distribution, it’s time to set up mapping equipment and conduct a test of the storage space. The purpose of this initial test is to determine where variable conditions exist, and where temperature and humidity are uniform and suitable for product storage.
Step 7: Conduct a test and review data
You’ll need to establish the reporting information you’ll use to evaluate the test. When the test is complete, the software will read the secure files from the data loggers, show recorded data, perform calculations and graph the results selected for a mapping study report.
Step 8: Make modifications
Use the results from the initial test to identify locations where the product may be exposed to unacceptable conditions. Then make adjustments — for example, to the storage racks or HVAC system — to correct this variation, or simply decide where products will not be stored. For example, many warehouses have a mezzanine level designated off limits for raw materials or finished goods because HVAC controls are ineffective there. Name and describe these locations and modify the validation plan. Also, modify your validation protocol in light of the results from your initial mapping test.
Step 9: Document and schedule the mapping study
After you adjust for environmental variability in the warehouse, it’s time to conduct and document a mapping study for approval.
Download the white paper and read more about step-by-step practices at https://bit.ly/36qEgFz.
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