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8 GMP principles for med tech developers to live by

Med tech

Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and other regulated items are consistently manufactured according to quality standards. In doing so they can protect your products from failing, your customers from potential harm and your business from commercial damage.

Focusing on the core principles of GMP (as specified by the FDA and others) will help you drive consistency in:

  • Your day to day operations
  • The way you prepare use and maintain equipment/facilities
  • Your organisational structure as a whole

And a digital quality management system (eQMS) can make these principles simply ‘the way you do things.'

8 principles of GMP - embodied in an eQMS

1. Be clear about roles and responsibilities

Everyone involved in making a product must have clear roles and responsibilities so that tasks have owners and the chain of accountability is established throughout the organisation. A graphical QMS can help visualise these relationships and accountabilities so that everyone can see exactly how the business is organised and what is required of them to achieve desired results.

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2. Train and develop your staff

Employees should be trained to follow procedures and their performance must be assessed. Training methods must be periodically reviewed so that manufacturers know they remain effective in keeping workers properly competent in what they do. Effective training and knowledge sharing can be powered by an eQMS that is a single source of truth for your entire organisation.

3. Maintain your facilities and equipment

There should be fully documented instructions for calibrating equipment so that they always work as intended. The design of the whole facility must take requirements for ongoing maintenance and recalibration of machinery into account. Equipment should be continuously validated and calibrated to ensure they are fit for purpose and producing consistent results. Your eQMS should be capable of documenting and illustrating these requirements for your workers and should help you formally record and track the effects of any changes you make.

4. Write great SOPs and follow them

GMP is about establishing ‘how your business does things’ - so routine tasks can be carried out in the same way every time with the same predictable results. The FDA are generally not prescriptive about the particular steps that must be observed in your SOPs, only that your organisation must record and adhere to them. This, of course, means making them as accessible and understandable as possible to the people who need to follow them.

Documenting the way you do things with clarity and economy is essential if you want people to understand and absorb SOPs efficiently. A graphical QMS showing SOPs as interactive flow diagrams within a process-driven extranet can make them an essential resource for training and reference in your company.

5. Keep and retain records

‘If it’s not written down, it didn’t happen’

In the GMP guidelines ‘documents’ and ‘records’ are regarded as two different things.

Documents outline procedures or instructions for carrying out key operations in your plant (e.g. SOPs). Records, on the other hand, are used to show that your operations have been carried out in compliance with GMP.

Your Quality Management System should not only show your workers the SOPs they must follow, but should also ensure that they are keeping a record when these activities are done, as well as storing them for future auditing purposes.

Required GMP records include:

  • product master records
  • batch or manufacturing records
  • material / component control records
  • personnel records
  • training records
  • equipment logs
  • cleaning logs

Your eQMS can help your workers with this record-keeping. For example, using electronic signatures to confirm when required actions have been completed in a process and by whom.

Record keeping supports the full traceability of a production process, allowing:

  • The cause of nonconformances to be traced throughout a production process
  • Help you trace the individuals who were responsible for errors to improve training
  • Preventative or corrective actions can be implemented and then tracked and measured over time

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6. Validate

It’s not enough just to install state of the art equipment and establish processes that reflect the latest thinking in achieving manufacturing efficacy and accuracy. GMP requires you to prove through testing and documentation that your equipment and procedures are always doing what they are supposed to. This is the validation process:

"Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."

Validation is typically done in a three step proces documented in a Master Validation Plan:

  1. Installation Qualification (IQ) verifies equipment is installed correctly
  2. Operational Qualification, (OQ), verifies that the equipment operates as it should
  3. Performance Qualification, (PQ), verifies that product can be consistently be produced to specification.

Validation is all about establishing that you are in control of the tools and processes you use to create your end product. When anything changes in these tools or processes you need to re-validate to ensure they are still producing the same results.

The right eQMS can automate these validation processes, notifying workers when they need to undertake and follow up on these activities as part of standard change control procedures.

7. Be available for inspection and audit

Good Manufacturing Practice ensures that you are following procedures to achieve expected outcomes, and that you are also recording evidence you have done so. The right eQMS makes this evidence available for digital audit on demand and stores it for as long as the law requires.

8. Design quality into the whole product lifecycle

GMP recognises that you can’t retrospectively test quality ‘into’ products. In a pharma production line it is not possible to check every pill contains the right percentage of ingredients or has not been subject to contamination. Likewise, you can’t dismantle every medical device you produce to prove it has been assembled correctly.

Instead, the aim of GMP and other associated GXP (best practices) - including GCP (clinical practice), GDP (Good Distribution Practice) - is to develop processes to ensure you always do things in a uniform way to achieve consistent quality in end products.

Because it’s that consistency that will guarantee the efficacy and ultimate safety of the product for the end-user.

Taken as a whole, GXP requirements give confidence that everyone in the supply and distribution chain are controlling the way they work in order to protect customers from using products that are unsafe, damaged, contaminated or ineffective.

And ultimately it is your Quality Management System which will help you design, define and implement those GXP within your business.

Conclusion

Adopting the right eQMS will help you establish and maintain GMP throughout your operations:

  • Graphically document the way you work
  • Make processes and procedures accessible to workers
  • Implement robust change control procedures to guard against unexpected failure
  • Validate all your processes and equipment
  • Demonstrate to regulators that you have done all of the above

Using the right digital tools will help you live out the principles of GMP in everything you do. They will help make best practice your default setting; and the way all your workers approach their tasks.

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