Lean Qualification and Validation: Change management during lifecycle of facilities, utilities and equipment

A practical guide to lean commissioning, qualification and validation

The Lean Qualification and Validation (LQV) workstream has published the first in a proposed series of practical guides to support the wider implementation of a lean, scientific and risk-based approach to commissioning, qualification and validation (CQV) of equipment and facilities.

The regulatory-intensive nature of the biopharmaceutical industry means that companies spend a significant amount of time and effort demonstrating to inspectors that what they set out to do is what they actually did – and equipment and facilities are no exception.

However, the variable adoption across the industry of a risk-based approach has resulted in many inefficiencies, which prove both time-consuming and expensive.

Removing inefficiencies

While there is an excessive amount of high-level guidance in this area, it is not aimed specifically at the biopharmaceutical industry, leaving companies without a clear path to implementation of CQV.

Following an inspirational mini-sprint day, the workstream formulated a vision to produce short, sharp best practice guides to the existing standards, rather than writing yet more rules. While, through doing this, the team hopes to improve demonstration of compliance and remove redundant, non-value adding activities – thereby saving time and money – it also realizes that, “If we do this right, we can get product to market quicker” said Julian Goy from BioPhorum.

The first guide – Change Management for System Lifecycle – was born out of a flowchart depicting a proposed change control management strategy, with the idea being to stimulate discussion within member companies, confirm where accountabilities and responsibilities lie within their own organizations and also identify any changes that need to be made.

“The best practice guide promotes a lean approach, both in terms of change lifecycle duration and personnel investment, which will deliver a compliant, timely and cost-effective change management process,” said John Murphy, Associate Director Engineering at Merck MSD who sees the value of the guide as being threefold: “1) for a mature company to confirm alignment with best practice change management; 2) to use as a playbook for a mature company recalibrating its change management process to ensure alignment with best practices; and 3) to use as an initial template for the generation of a best practice change management process at a start-up company.”

Change control

Primarily, the guide is about “removing the risk of inefficiencies brought about by a lack of clarity in respect to roles”, added BioPhorum’s Julian Goy.

Whether building a new facility or updating an existing one, there is often an overlap of responsibilities between the Engineering and Quality teams. The guide seeks to clarify the handoff between the project and operational phases by defining the responsibilities of key stakeholders. It also proposes involving the Quality Unit earlier should a change impact a critical attribute, i.e. one affecting safety, strength, purity and quality or regulatory filing – for example, a change to a cleanroom grade classification.