Phorum

Drug Substance

Creating a lean approach to qualification and validation

A practical guide to lean CQV

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 hoped to improve demonstration of compliance and remove redundant, non-value adding activities – thereby saving time and money – it also realized 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.

So far,10 member companies have pledged their support to the proposals.

 

What’s next?

 At a meeting in November, the team will discuss its vision for a User Requirement Specification (URS) document of the future, with a view to publishing a paper. Supply partners will also be invited to help with this simplification objective.

The URS has been identified as the start point for many of the frustrations experienced by biomanufacturers and supply partners alike. Currently, companies write URS documents in different ways, which creates issues for suppliers. The real risk with this, however, is what goes in the URS defines what must be qualified and validated for the rest of the life of that product – so, something written incorrectly or unnecessarily into the document can echo 15 or 20 years down the line.

LQV’s war on qualification and validation inefficiency has begun.

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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