So, you’re working for an exciting brand-new start-up. It’s getting to the pointy end – you understand all your processes, but you need to have these documented and in place to control and direct your regulated activities, ready for your initial regulatory inspection. Or perhaps your business is evolving – you need to incorporate regulation-driven changes into existing processes ready for when your new regulated products become authorised. This blog will outline various approaches that can be implemented for setting up your Quality Management System (QMS).
Where do you start?
All seasoned pharma professionals know that to get anything done in the industry, you have to raise a change control. But hang on, what if you haven’t got a change process yet? Or a document control procedure for that matter?
You still need to make sure that your approach:
- Ensures your compliance with your applicable regulations
- Is thorough and manages both quality and business risks
- Is robust enough to withstand interrogation by a regulator
The TGA have a comprehensive list of those documents they expect to see in place at the point of inspection. It’s important to note that regulators are reasonable in their approach and expectations when inspecting new or changed systems with their focus being on your demonstration of control.
You might be asked whether or not they have yet been implemented and you may be justified in saying no for some of them and argue that processes such as product quality reviews will be implemented after a year of manufacture.
On the other hand, for business reasons, some processes may need to be implemented well ahead of receiving your licence. e.g. supplier qualification. Change control may also fall in this category if you choose to use it as part of your project management framework.
How do you choose the right approach of implementing a QMS?
Unlike many processes within the therapeutic goods industry, assuming that you can meet the above and are happy to defend your approach in front of an inspector, there are several ways you could approach implementing your new QMS.
The approach that you choose to take might depend on your team’s level of previous experience and comfort in this Quality field, the business’s risk appetite and the available timeframe.
Each of these options presents its own risks, benefits, and disadvantages which you should assess according to the needs of your business.
|1. Direct Implementation|
|Identify, plan and prepare all your QMS documents|
Implement them simultaneously with a supporting document to describe you approach e.g. Quality Plan – see option 5
|Documents must be implemented before the process can be undertaken – the long development time may impact early processes such as supplier qualification, or equipment management and validation||Quick implementation||Laborious development|
A high knowledge level is required early in the project – appropriate staff should be in place
|2. Stepwise implementation|
|Implement your document control suite first, followed by risk assessment and change control. You may also choose to implement your Quality Manual and describe how processes will be managed as a ”halfway house” to full process implementation|
Subsequent implementation can be managed via the change control procedure.
Carefully consider which documents will be needed next, particularly to support those that are now in place e.g. training, record management, deviations
|Incorrect assessment of implementation requirements and order may impact business||Thorough|
Assured compliance with plenty of opportunities for continuous improvement
|3. Uncontrolled change management process|
|Use an unimplemented but compliant change process||Need a robust defence in front of an inspector|
Inadequate change control management could mean that risks are not fully identified
|Follows industry-standard and defendable change process||High knowledge level is required with the appropriately knowledgeable staff in place|
|4. Retrospective change control|
|Identify, plan and prepare all your QMS documents|
Implement them as and when they are completed/needed
Once the QMS is complete, raise and document the QMS implementation with a change control
|Requires significant expertise|
May be unpopular with regulators
|Allow early processes (validation, supplier qualification) to be undertaken in a controlled manner|
Allows documents changes to be made before the change control without onerous/ unnecessary paperwork
|The change control record must be complete before the initial inspection|
|5. Quality project plan|
|Create a project plan outside of the QMS which documents how you will control the implementation and might include:
• Risk assessments
• Change control approach
• Process map (for the full QMS as well as each process)
• Assign responsibilities
• Implementation plan and timeline
• Phased document release|
It might be called a Quality project plan, validation master plan, project change control, project quality manual – the content is more important than the title
|Limited||A thorough approach for large and complex implementations||Needs an experienced project management Quality professional to appropriately control and document the process|
Managing changes throughout the project
Inevitably there are going to be changes to the approach or execution of a QMS project along the way. You may also need to remedy the findings from your initial inspection. How you control, record and approve these changes will depend on the approach that you’ve decided to take but, needless to say, they must be recorded and justified.
Key take-home message
This conversation is set to be ongoing. Regardless of the approach you choose, it’s essential that you’re able to justify it in front of managers and inspectors alike and demonstrate that you have appropriate control over your QMS.
Further reading about QMS and document writing
PharmOut has a number of other blogs to help you make the best of your QMS:
- GMP Documentation – Top Tips for Writing User-friendly GMP Documents
- Technical writing is a science, not an art
- Plan your route: The role of process mapping in SOP writing (COMING SOON!)
- Getting the best from your experts: SME engagement (COMING SOON!
- Form design: It’s all about the white space
- Form use: The right way to fill in a form
Support from PharmOut
PharmOut can offer document writing assistance, ongoing advice, mentoring and/or support as you develop and implement your PQS at your site; we have a team of experienced GMP technical writers who can help.
Or if you’d like some training, please visit our website:
Technical Writing Training Courses
ISO 13485 – Quality Management Systems for Medical Devices