Warehouse
of
Mapping
Presented By
Md. Al-Amin
Officer, Engineering Department,
Renata Limited.
Basic
Mapping: Documented measurement of the temperature and/or relative humidity
distribution within a storage area, including identification of hot and cold spots.
Data loggers : Data loggers are electronic devices which automatically monitor and record
environmental parameters over time. The data logger contains a sensor to receive the
information and a computer chip to store it.
Storage temperature: The temperature range listed on the Time and temperature-sensitive
pharmaceutical product (TTSPP) label, and within the regulatory filings, for long-term
storage.
Step by Step - Good Practices for Warehouse Mapping
Create a Develop
Identify areas
Validation protocol
at risk
Plan Information
Determine Conduct test
Select suitable
Data Logger and review
technology
distribution data
Make Schedule
modifications mapping study
Create a Validation Plan
The validation plan should Contains:
• Validation objectives.
• Identify roles and responsibilities of quality, metrology, and other working groups in
the process.
• Identify validation activities.
• Develop documentation and procedures, including the company’s response if a
temperature or humidity excursion occurs.
• Determine a validation schedule.
• Specify the management approval process.
• Create change control protocols.
*Regulatory Note: GMPs require maintaining temperature and humidity within storage
recommendations printed on product labels or provided by raw-material suppliers. These
recommendations are derived from known chemical properties and stability testing.
Identify areas at risk
• Volume of space: A large warehouse has different control burdens than
a small storage area, with greater demands on the HVAC system and the
potential for greater variations in temperature and humidity at various
locations.
• The capacity of diffusers or fans to adequately circulate air.
• Temperature gradients between the floor and warmer air near the
ceiling.
• Locations near sources of heat or cold, such as the roof and exterior
walls, windows, and loading docks.
• High-traffic areas where product or equipment is moved often.
• Seasonal temperature changes or unusual weather events.
Develop protocol information….
A detailed and comprehensive protocol should be prepared, reviewed and
approved before the mapping exercise begins.
The mapping protocol should contain the following sections:
a. Approval page and change control history
b. Acronyms and glossary
c. Description and rationale
d. Scope
e. Objectives
f. Methodology
g. Annexes as needed, including templates for the mapping report.
Develop protocol information
Required Information's to Prepared a Mapping protocol:
• Survey the site: Conduct a site survey of the area(s) to be mapped. Measure length,
width and height.
• Types of data to be generated – for example, temperature, relative humidity, and
measurement intervals.
• Number of Data Loggers to be used.
• Schematic or diagram of Data Logger locations.
• Load conditions, Mapping Duration.
• Calibration requirements of the data loggers.
• Acceptable limits for temperature or relative humidity excursions.
• Reporting requirements.
Regulatory Note: Once you develop a protocol, follow it consistently. If the protocol
changes, document the reasons.
Select Suitable Technology
Some Requirements of a suitable Technology:
• Software should produce tabular and graphical reports that meet all
requirements of 21 CFR Part 11 and comparable international standards.
• Minimum sources of error – that is, low measurement uncertainty.
• High accuracy in the measurement range.
• Long-term stability, particularly for relative humidity.
• Traceable calibration performed within the measurement range.
***All Data loggers must have a NIST-traceable 3-point calibration completed and valid
(within the current year), and have an error of not more than ±0.5°C at each calibration
point.
Determine Data Logger distribution…
• How many Data Loggers will you need to map a
particular space?
• Where will you put them?
Data Logger distribution must be adequate to assess temperature
uniformity. Good practice means that you use a sufficient number of
Data Loggers to understand your environment, especially areas where
risk is greatest.
Determine Data Logger distribution…
Focus on the site survey to mark the required locations of the Data
Logger.
Length and width:
Data Logger should be arranged in a grid fashion along the width and
length of the area so that the area is reasonably covered, with Data
Loggers located every 5–10 meters.
The chosen Data Logger grid should take account of:
• The layout of the area
• Where products are placed.
The positions of Data Loggers should coincide with locations where
TTSPPs are actually stored or planned to be stored.
Determine Data Logger distribution
Height: At each point on the grid, arrange Data Loggers vertically as
follows:
• If the ceiling height is 3.6 metres or less, position Data Loggers
directly above one another at high, medium and low level (e.g. one
EDLM at floor level, one at 1.2 metres and one EDLM at 3.0 metres.)
• If the ceiling height is greater than 3.6 metres, Data Loggers can be
arranged in vertical arrays at the bottom, middle (multiple) and
top of the space.
For instance, for a storage area 6 metres in height, Data Loggers can be positioned
in each grid location at heights of 0.3 metres, 1.8 metres, 3.6 metres and 5.4 metres.
5 ~10 5 ~10
5.4 metre P4 metre P8 metre P12
P3 5 ~10
metre P7 P11
5 ~10
3.6 metre metre
P2 5 ~10 P6
metre P10
1.8 metre 5 ~10
metre
P1 5 ~10 P5 5 ~10 P9
metre
0.3 metre metre
Floor
Sample Diagram For Data Logger Positioning
(*Considering Ceiling Height is 6 metre)
0
5~1
m
5~10 metre
Conduct test & Review Data...
Set up mapping equipment:
• Equipment has been calibrated.
• Equipment has been validated.
• Ensure mapping software access has been secured and authenticated.
• Ensure the warehouse area and data logger locations are accurately described.
• Regular sample intervals have been determined.
• Study duration has been determined.
• Temperature & %RH Lower and Upper Limit have been determined.
• Data loggers link to an audit trail file for traceability.
• Data loggers are functional and positioned in defined locations.
*Data logger Should Set up in the warehouse Before 02 hours of Study Start for
stabilization.
Conduct test & Review Data
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.
• Summary, Graph & Raw data with times and dates.
• Calculated values such as minimum, maximum, average & MKT.
• Calibration information of data Loggers.
• Date and time of the test.
• Space for review and approval signatures on printed reports.
If all Data within Acceptance Limit, identify Hot and Cold Spot & mark those points for routine
monitoring. If Data is out of Limit then need to identify the cause for Modification.
A graphical overview can help identify high-risk locations, especially where problems may occur
sporadically. For example, a temperature spike may be linked to a time when loading doors were open.
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.
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.
Regulatory Note: Modifications to a newly commissioned warehouse don’t need to
appear in the inspection record. But once your company approves a validation
master plan, then the plan must document all subsequent changes.
Schedule the mapping study
How long should mapping last?
As with your initial mapping test, there’s no fast rule. Your protocol may support a
single long study, or a series of shorter studies. Either way, it’s important to measure
the environment during a range of different work activities in the warehouse, such
as loading, moving product, and periods such as weekends when little activity might
occur. So It is Justified to Mapping the warehouse for 07days.
How often should you map a Warehouse?
Some protocols call for mapping every three months while others can justify
mapping yearly or even less frequently. The validation master plan should anticipate
variables that can change storage conditions after completion of a warehouse
qualification.
Summary
The keys to a successful warehouse mapping study include creating a validation
plan and protocol.
Document changes to the plan and protocol.
Identify areas of risk in your warehouse to determine the distribution of Data
Loggers and duration of the mapping.
Select reliable technology suitable to the task.
Modify your storage space to ensure you are mapping a controlled environment.
Schedule mapping studies to account for changes in the warehouse environment.
Keep records in a manner that they are secure and accessible.
Document that your protocol was followed consistently, and re-evaluate your
procedures periodically.
Regulations and guidance
Warehouse mapping regulations require documented evidence
that an environment is in a state of control and suitable for the
products stored there. Regulatory agencies and independent
organizations also issue nonbinding guidance documents that
can provide greater detail than regulations in applying current
regulations.
Links to resources
World Health Organization:
• WHO Technical Report Series, No. 961, 2011. Annex 9: Model guidance for the storage and
transport of time- and temperature-sensitive pharmaceutical products.
United States Pharmacopeia:
• USP Chapter 1079 Good Storage and Distribution Practices for Drug Products
International Society of Pharmaceutical Engineering:
• ISPE Good Practice Guide – Controlled Temperature Chamber Mapping and Monitoring
Parenteral Drug Association:
• PDA Technical Report No. 52 – Guidance for Good Distribution Practices for the Pharmaceutical
Supply Chain
European Commission:
• EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme:
• PIC/S GMP Guide Part I: Guide to GMP for Medicinal Products Section 3.19
• PIC/S GMP Guide Part II: Guide to GMP for Medicinal Products Sections 7.42
Thank You
