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Cold Chain Compliance.
June 04, 2014
GMP Transgressions and Citations.
When the market is lean there should be even more reasons for ensuring your company’s GMP compliance is being diligently applied and rigorously managed. This is not the best time to be presented with citations for breaches in your regulatory compliance obligations; nor is it a good time to be facing any product recall issues. Yet; currently, these problems actually appear almost endemic throughout our industry. These regulatory lapses can debilitate a company and possibly result in a reduction in end user confidence in using or specifying company products.
So now is the time to ensure that those validation protocols and plans are comprehensive, precise and regulatory compliant.
Where can this confidence in your GMP come from? Quite simply it comes from the proper and diligent use of the three top level validation documents; User Requirements Specification (URS), Design Specification (DS) and the Design Qualification (DQ).
The URS, has detailed the actual needs of the end user, in functionality, training, documentation, engineering drawings and support.
The DS, is a detailed design put forward (either from an in-house resource or from a vendor) which will satisfy all the requirements detailed in the URS.
The DQ, must verify that the DS will in fact satisfy the URS.
This is the level that all aspects of design, installation, operation, maintenance, documentation, training, calibration, cleaning and installation, are challenged at. The satisfactory execution of the DQ confirms that this DS satisfies all applicable requirements as detailed in the URS, cGMP and the Health and Safety regulations. It also documents the fact that all supporting requirements have been reviewed and the review has been approved by management.
At this stage the Validation Plan can be completed (it may have started earlier, but cannot be completed until the DQ has become an approved document).
The VP scope can now be detailed and, responsibilities and methodologies can be detailed. Having fully detailed the support documentation (FAT, drawing, specifications, calibration certification) in the URS, the IQ and OQ will flow quite easily.
The documentation dovetails together and actually presents you with a simple (at each stage), logical, traceable and cost effective validation methodology that now must be rigorously applied and managed.
Simple to use and highly cost effective when used.
Any vaccine that has not been stored at a temperature of 2-8ºC as per its licensing conditions is no longer a licensed product
The Problem Requires Immediate Attention
The Regulators Are adamant Compliance is Essential.
The Patient Must Come First.
Where there is any doubt that cold chain has not been maintained, medications should not be used.
Cold Chain Validation
Cold Chain Validation requires the verification that the internal temperature throughout any transportation container, used to distribute temperature sensitive cGMP regulated product; is maintained within the acceptable temperature range mandated for the product being transported. Further to this; documented evidence of such conformance must be produced. Documented proof of conformance may be produced using two sampling data loggers to record actual container temperatures at predetermined intervals. Both the actual location of the loggers and sampling time intervals must be established through trials and then validated.
Uniformity of temperature throughout the container and the location of the history generating loggers must be both established and documented during the execution of a temperature mapping exercise. The number and location of single channel data loggers required for successful temperature mapping of a cold chain warehouse is dictated by several factors. Disruptive air flows entering or leaving the storage area, distribution of conditioned air inlet and exhausts, open doors and or windows and generally the environmental insulation of the ceiling and walls.
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