GMP Compliance Strategy

Resource efficiency in pharmaceutical manufacturing – where do I start?

You have a great idea to save water and energy in the facility. The engineering changes required for capturing savings in your ‘resource efficiency’ project may be straightforward; but if the changes will impact a GMP system, the effort becomes more complex (and may have a large financial impact). This may result in the generation/revision of a number of documents, and require qualification and validation work before the system is released for site use again, even for a simple engineering change to improve manufacturing and operational efficency.

So how can you ensure resource efficiency in pharmaceutical manufacturing?

Ensuring resource efficiency takes thoughtful data analysis, planning, and monitoring after implementation.

Start by taking a more holistic approach and look at utility usage across the whole site:

  1. Gather data and compare it against metered usage
  2. Present a pie chart to senior management of where water, electricity or gas is consumed
  3. Identify resource efficiency opportunities (ideas to reduce utility consumption).
  4. Classify and document these opportunities according to the following classifications:
    • No GMP impact (e.g. re-using clean waste water from RO system in a non-GMP application). These changes can be made using Good Engineering Practices.
    • Indirect GMP impact (e.g. reducing air change rates in CNC rooms).
      • These changes will require an assessment of the risk to product by the proposed change, and the changes to systems may be controlled via the sites’ Change Control system.
      • Any work carried out would require commissioning, qualification and validation, as well as potential changes to the ongoing monitoring of the utility.
    • Direct GMP impact (e.g. energy efficient WFI still).
      • These changes will require planning (VMP), risk assessment, protocols, reports, site impact assessments as well as other controls.
  5. Seek approval for opportunities with no GMP impact
  6. Review business case for standalone implementation of indirect or direct GMP impact in view of the risk assessment to product.

Analyse the Business Case for your Resource Efficiency Project

If a standalone project business case does not stack up then consider incorporating the opportunity into another related project.

For example, there may be a project upgrade to improve a system.

  • The project requires significant qualification and validation effort, but piggy-backing your ideas early on in the project will save extra qualification and validation time/cost/resources later.
  • To ensure your ideas are flagged, make resource efficiency as part of the URS or capital approval process.
  • Hence, the project business case may be related to quality or productivity with the side benefit of reducing utility costs.

An example is reducing water usage in automated clean in place (CIP) system. Large centralised CIP systems require significant volumes of water, hot water (energy) and chemicals as well as generating waste water. Cleaning processes may sometimes uses more energy and water than is required to ensure that equipment is sufficiently cleaned.

ICH Q10 encourages continuous improvement and innovation

ICH Q10 (Section 1.5.3) encourages continuous improvement through process improvements and innovation. Therefore when reviewing your CIP methodology, identify potential efficiency gains that may result in:

  • Quicker cleaning times, hence less downtime
  • Lower volumes of cleaning solution if used, and hence less waste

Examples of potential resource utilisation improvements include re-using final rinse water, ending final rinse when effluent conductivity is achieved and using UV to control the contaminants in recirculating cleaning solution. A recent example used inline UV to reduce cleaning cycle times by 40% resulting in a return on investment of less than 2 months1.

As each site is unique then so each solution will be unique.

Resources and further reading for Resource Efficiency in Pharmaceutical Manufacturing

1Jonathan Roy, Process Analytical Technology, Examples and Business Case Development, ISPE, June 17, 2009