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Managing the change control process for GxP compliance

shutterstock_image (8)Change control in life science development is critical to ensuring the ultimate safety of end users. And having a formal process in place to capture, approve and track all change requests is a major part of GxP compliance.

 

Change control is a feature of all of the different GxP (best practice guidelines) from GLP (Good Laboratory Practice) through GMP (good manufacturing Practice) to  GDP (Good Distribution Practice).  It is referenced by the FDA, the MHRA and the WHO as a central method by which dangerous mistakes can be averted and consequent harm to consumers can be prevented. 

What is change control and why is it important?

An effective change control process in life science development ensures that each alteration proposed to a product (and the way it is handled throughout its life cycle ) is adequately defined, reviewed and approved before it is implemented. 

Ensuring review by qualified stakeholders from all relevant departments, as well as proper tracking of each request should prevent:

  • Vital changes being ignored
  • Unnecessary changes being made - causing needless expense and disruption
  • Unauthorised changes being made that leave no documentary evidence
  • Changes being implemented that do not answer the specific problem identified
  • Changes that may cause unintended consequences for other parts of the production system/product 

But the change request process in some organisations is still carried out in manual ways. There may be formal meetings that take place with a change control group that are intended to ensure nothing slips through the net, but issues may still be raised by paper document or email.  They may not immediately trigger automated workflows and they can end up getting lost or delayed in the system as a result.

Ultimately, this can result in serious inefficiencies, inadequate evidence for compliance and breaches of safety that could endanger human life.

Automate steps for change control sequences

An eQMS (Electronic Quality Management System) can be harnessed to develop flows which answer specific compliance and commercial needs, ensuring each part of a required process is triggered automatically.  With an automated workflow each request can be reviewed by the right people at the right time, and every part of the review/approval process can be documented for future audit. 

Mapping a seven step change control process

With the right eQMS, forms can be set up in the system that capture all required information (including groups of documents that need to be completed) ready for review.  A sequence, like the one below triggered by emails sent from a central platform (with associated reminders and alerts) will ensure that nothing is forgotten and the process is continually being moved forward.

1. Change requests formally identified

Issue raised as part of CAPA procedures or as a ticketed item within the quality team

2.Change request submitted by QA team

Change request triaged and prioritised for action - expedited in an emergency - shared as formal request amongst key stakeholders.

Depending on the regulation and your business needs this should include a formal CR form including;

  • Description of request - a description of what the objective of the change is
  • Reason for the request - why it is necessary
  • Conditions of success - what will success look like?
  • Required timescale for work
  • Deadline for response - with sequence of automated reminders to ensure prompt response
  • Expected value - description of the value to business

3. Change request reviewed by stakeholders

 Key stakeholders review document within the eQMS and submit feedback

4. Risk assessment undertaken - and changes recommended/mandated

Quality team review feedback -  potential changes specified and documented, risks of suggested changes outlined, resubmitted to group with associated documentation to support case.  This might include:

  • Proposed solution
  • Proposed timeline
  • Impact assessment of making/not making the proposed change
  • A required time frame for response

5. Approval given/denied

Formal permission to proceed is given by stakeholders - with e-signatures to prove acceptance

6. Change implemented

Enters workflow for actioning, based on priority

7. Post change review and reporting

A formal workflow is triggered to assess the success/impact of any change made after a specified time has elapsed. Results are shared among the group to feed into programme of continuous improvement

A flexible eQMS solution helps you set up different change control processes to answer different needs

In life science regulation GxP guidelines call on developers and product managers to have documented and fail-safe procedures for ensuring change requests are captured and tracked.  The FDA states that life science developers must have procedures for “…managing change to prevent unintended consequences.”

Change control requirements for medical device companies are specified in FDA's 21 CFR part 820 which requires that manufacturers establish written change control procedures that describe company-approved processes.  These include:

Part 820.30 (design changes)

820.40 (document changes)

820.70 (production and process changes).

And it’s not just in development but throughout the whole product lifecycle.  The EU’s GMP Guidelines defines their requirements for “change control” as:

“A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or process”

When you’re developing an eQMS you should consider how the system could be used to oversee change control in other areas like manufacturing equipment and premises, as well as the design steps that you need to take as part of the development process.

Conclusion

Your change control process is vital for ensuring that the right product decisions are taken throughout the entire lifecycle of a project.  It is a way of achieving the highest quality products that are safe to consume and efficient to manufacture.

As teams and premises are more and more widely dispersed around the world there is a greater need for electronic systems that automate these crucial processes.  These are the tools that can minimise the risk of omissions and mistakes leading to future product failure. 

At the same time, the ability to document and track all the measures you have undertaken to control change within a single platform, will allow you to demonstrate GxP compliance to the regulators in the most efficient way possible.

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