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Transgressions & Citations.
June 04, 2014
Good Day

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.

 URS – DQ – VP – VRA – IQ – OQ – PQ

 Simple to use and highly cost effective when used.



Comments that are now in every day use throughout the industry:-

Any vaccine that has not been stored at a temperature of 2-8ºC as per its licensing conditions is no longer a licensed product.

Where there is any doubt that cold chain has not been maintained, medications should not be used.

Cold Chain Temperature Fluctionations.

 According to a recent study conducted by the U.K. based Medicines and Healthcare Products Regulatory Agency (MHRA), a staggering 43% of critical and major product deficiencies are related to ineffective temperature control and monitoring during storage and transportation.

Similarly the World Health Organization (WHO) recently maintained that 25% of all vaccine products arrive at their final destination in a degraded state. Given the high cost of conducting global clinical trials and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain - transportation and logistics providers included − conform to GxP guidelines and immediately activate procedures to attain Cold Chain Validation compliance.

  1. WHO’s “Good distribution practices for pharmaceutical products” and “Guide to good storage practices for pharmaceuticals”
  1. FDA’s “cGMP / 21 CFR 211”
  1. U.S. Pharmacopeia (USP) <1079> “Good Storage and Shipping Practices”
  1. Canada’s “Guidelines for Temperature Control of Drug Products during Storage and Transportation”
  1. Ireland’s “Guide to control and monitoring of storage and transportation temperature conditions for medicinal products and active substances”
  1. EU’s “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” (94/C 63/03)

It is anticipated that these finding will move all things to do with - product quality in transit - to the top of visiting regulators inspection lists. The obvious priority being the thermal validation of transit containers - be they demountable or integral to a motor vehicle.

Validation of these containers and or vehicles is not difficult and can be tackled (using our fully detailed documents) by most technicians and or laboratory assistants.

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