The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
It is the equivalent of the TGA (Therapeutic Goods Administration) here in Australia. Both administer compliance matters in Good Manufacturing and Distribution Practice (GMDP) in manufacturing facilities.
The GMDP Inspectorate of the MHRA recently published a presentation document on their (2015) inspection deficiency data trends. This document is a gathering of the data that describes deficiencies of facilities inspected based on the GMDP Guidelines:
The data is (among other things) available to allow stakeholders to perform their own assessment against the common or typically observed deficiency findings, as part of a continuous improvement approach of self-inspection.
The trend identifies the overall number of deficiencies identified in facilities by the MHRA and the impact and frequency of those issues, presented as being either:
(ii) Major or
With reference here to PIC/S PE 009 Chapter 3 (Premises and Equipment), it is comforting that no “Critical” facility deficiencies were observed. This would indicate the general appropriateness of the design of manufacturing facilities.
However, a relatively large number of “Major” and “Other” deficiencies are generally observed. In turn, this tends to indicate a large number of ‘detail’ or ‘focus’ issues associated with facilities.
Most of those issues were identified with the following clauses of PIC/S PE 009:
Clause 3.19 re Design or adaptation of storage areas to ensure good storage conditions
Clause 3.34 re Design, location and maintenance of manufacturing equipment
Clause 3.41 re Calibration of equipment
Some examples of those deficiencies are cited as follows:
- The configuration of the drug storage room had changed with no assessment of the potential impact on the validity of the temperature mapping of the area
- QC sampling of chemicals was performed in the material airlock in the pilot rooms. Room usage was not recorded and there was no record that the room was clean and clear prior to use
- QS sampling of packaging materials was not performed in a dedicated are in the Goods-in area
- Area of the facility and equipment were in poor state of repair, e.g. damaged filter panel covers in the drying tunnel and damaged vents
- The rubber seal within the dispensing equipment showed evidence of deterioration and shedding
These examples suggest that the issues that appear to be important with respect to “Premises and Equipment” are more likely to be ongoing, associated with managing (any) changes in facility design.
This would, in turn, suggest the suitability of process architects adopt a more ‘holistic’ approach to facility design, rather than a ‘snapshot’ in time, being one that considers the design lifecycle use of the building with respect to the facility master plan.
In turn, designs that are modular or flexible in the practices of good pharmaceutical facility design would be favoured from this perspective, with an organic capability to ‘focus’ a building for change – this can best allow for incremental changes (within an overall approach). This is invariably associated with parallel schedules of maintenance with respect to the building services.
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