Warehouse climatic mapping is required whenever regulatory controlled product is stored either between processes or as a finished product in the warehouse. There is a cGMP requirement that the warehouse storage conditions must be validated. This is to verify that where storage conditions have been specified; they are complied with, and where they are not specified; to ensure that the storage conditions will not cause irreparable damage to the product or the product packaging or any appended documentation. Where there are no conditions specified then best practice must be followed and best practices are available in guidance documents from regulatory authorities world-wide. These should be discussed and a documented justification for the values adopted included in the Validation Plan.
Validation of these storage climatic conditions must verify that all shelf and free standing areas where product is to be stored; must remain within the temperature and humidity levels specified in the storage specifications for the product. These storage conditions must be maintained regardless of seasonal variations in the local ambient weather system. Where these are extreme it may require the validation task to be run continuously through theses seasons or simply repeated during their occurrence. This matter should be discussed and a documented justification included in the Validation Plan.
For many years warehouse climatic mapping tasks involved running hundreds' of metres of sensor cable and weaving in out shelving, across access passages and generally making life difficult for the often exasperated warehouse staff. Now; using wireless individual data loggers the task has become a lot less intrusive, individual data logger sensors can be attached to shelving support structure (using adhesive tape), so keeping them clear from the routine product movement that the shelves are subjected to. In fact the sensors can be installed discretely in a matter of minutes and left unattended for the complete duration of the mapping exercise.
The number of; and location of; individual data logger sensors required for successful warehouse climatic mapping is governed by several factors, disruptive air flow entering or leaving the storage area, distribution of conditioned air inlet and exhausts, open doorways and or windows and generally the environmental insulation to walls and ceilings. A typical layout for 1000 square metre warehouse climatic mapping with shelves stacked 4 metres high; good general wall and roof insulation; no open doorways or windows and evenly spaced-out condition-air inlets and exhausts, could be one sensor in each corner of the storage area, and one midway along each wall, with one in the centre. This means nine sensors would be placed on the lowest storage shelf, then nine on the middle shelf and finally nine on the top shelf. Smaller rooms could be scaled similarly, with one sensor in each corner and one high layer and one lower layer, giving a total in a smaller room of eight sensors. If there are disruptive influences to the general air in /out flows or to the location of the conditioned air inlet and or exhausts then these location would have to be altered and would possibly have to be establish by conducting preliminary warehouse climatic mapping air flow studies. However when the position and number of sensors has been agreed, the justification for your choice must be documented in the Validation Plan. Are you beginning to see just how important the Validation Plan is?
As stated above the advent of the low priced accurate data logger has changed the task of climatic mapping large buildings and warehouses. We now use these data loggers for all large temperature and humidity mapping tasks. It has cut the cost dramatically. It has also simplified the task considerable and changed the task from one that had to be carefully planned and integrated to cause minimal disruption, to one that now goes barely noticed.Data logger Specifications.
As stated above the advent of the low priced accurate data logger has changed the task of climatic mapping large buildings and warehouses. We now use these data loggers for all large temperature and humidity mapping tasks. It has cut the cost dramatically. It has also simplified the task considerable and changed the task from one that had to be carefully planned and integrated to cause minimal disruption, to one that now goes barely noticed.
The specification of the data loggers we use is given below:
Storage Capacity 16,382 Temp and Humidity Readings
(32,764 Total Readings/Samples) Humidity
Measurements Range: 0 to 100% RH
Accuracy: ±3.0%RH Overall (20 to 80% RH)
Internal Resolution: 0.5 %RH
Long Term Stability: 0.5 % RH per Year Temperature Measurements Range: -35°C to 80°C (-31°F to 176°F)
Repeatability: ±0.1°C (±0.2°F)
Accuracy: ±0.5°C (±1°F) Overall
Internal Resolution: ±1.1°C (±2°F) Overall Dew Point Accuracy
(25°C, 40-100%RH) ±1.1°C (±2°F)
We supply these data loggers in multiples of five. Each multiple is supplied with its own DVD containing a copy of the associated software.
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your Risk Mitigation in Validation template.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.
Validation, Risk & Requirements Plan (VrrP) is one document designed
specifically to replace three. The contents of the three original documents
were completely revised and edited into a more compact and interactive
format. Resulting in the document becoming notably easier to use and
quicker to review and amend. This new format will make a very significant
difference to the man hours required to produce and execute these
documents. There will also be a very noticeable reduction in the time
required for the reviewing and approving tasks. This new document titled
the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q
Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation costs without sacrificing regulatory compliance.
4Q Equipment Validation Protocol (4Q-Equip) has been designed
specifically to replace four standard protocols. By taking the
contents of the four protocol and carefully weaving them into one notably easy
to use protocol, we have made a significant advance in the task of streamlining
validation documentation by reducing protocol numbers by close to 75%.
The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now
compliments our equally new VrrP Protocol. By integrating the old style
DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in
the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word.