Good Manufacturing Processes (GMP)
For Project Managers & Project Engineers
Part 1: Qualification and Validations
When I think about aspects of project delivery that engineering and project managers don’t seem to plan well, my mind jumps straight to qualification and validation. I was made think about this recently while traveling on holidays in the South Island. While hiking in a remote area of the country, I surprisingly had the opportunity to have a great discussion, with a specialist in the field of validation and qualification. We discussed the highs and lows of this topic, specifically with regards to the field of engineering. I was thinking about writing on the topic of Good Manufacturing Processes and sharing war stories on this subject gave me the inspiration to write this piece. I would like to use it to illustrate the importance of validation and qualification.
Fortunately, in this case, our war stories were relatively tame. Whereas, within the engineering profession, there is a long history of horror stories from exploding or imploding equipment, hazardous products or by products to hazardous leaks. Indeed, its often these times that makes you question why you would want to be an engineer. Some of these disasters, I believe, could have been avoided with a better validation or commissioning plan.
It was intriguing to discuss the approaches taken by different companies and individuals, other than the ones I have experienced to date. Through my experience, I have seen a spectrum of project managers and project engineers address validation in Europe, Australia and New Zealand. Some project managers and project engineers are of the opinion a one-page document related to this topic is one page too many. Others view the documentation and procedure as more important than the project and installation itself. I personally believe a good validation procedure holds incredible value for a company, above and beyond regulatory requirements, to deliver a successful project. From a project manager or project engineer perspective, when the correct procedures are in place, it can act as a great way to focus the mind and generate a road map to completing end user and client orientated projects.
In essence, a good validation masterplan plan is that road map. When I was talking about this document to the specialist, I couldn’t help but think about a previous project I have worked on. A client was considering the best method to validate their process. The discussion started around Installation Qualification (IQ) and Operational Qualification (OQ). My first thoughts were “Are we jumping way ahead? What does the validation master plan say?”. A good Validation Master Plan (VMP) is the high-level guidance on how to deliver equipment or a process which has the quality of the end user as the highest priority. You would imagine for client centric companies; the importance of this document would be a no brainer. Surprisingly in some cases and industries this is not the case.
On a side note, one thing I really like about the New Zealand regulatory bodies, is the ease of accessibility to information. For example, in the pharmaceutical sector, the GMP documentation is freely available (See PIC/S GMP Guide referenced below). It’s a great start for a project manager or engineer trying to get access to the basic requirements. Not only that, it helps detail what certain documents should contain, like how the VMP should also cover the validation policy for the company, the organisation structure for the company, details of the site facilities, equipment, systems, status, change control and deviation management protocols, guidance on developing acceptance criteria, references to active standards/SOP’s/quality documents and finally the qualification and validation strategy. Essentially the cornerstone of a company’s validation process.
Thinking back on the client I was mentioning earlier, with the information documented in the VMP it should have been an easy step to find the appropriate validation protocols specifying the critical systems, attributes, parameters and acceptance criteria. These protocols should have been formulated from international standards, pharmacopeia or other equivalent, internals standards/specification or industry best practices. The requirements and number of tests will be dependant on the industry and sector. Based on the protocol information, the client could start formulating the required documentation to qualify the system (URS – User requirements specification, DQ – Design Qualification, FAT/SAT, IQ – Installation Qualification, OQ – Operational Qualification and PQ- Performance Qualification…. all the other acronyms).
From a project management perspective, each one has a logical step in the of delivery a project. The URS states what the process, system, and equipment should do and specifies the quality requirements for the system, an ideal partner for a scope document. The DQ will confirm that the design complies with the quality requirements of the system. The IQ ensures it has been installed correctly, as per the design. The OQ ensures that it is operating per the design and the PQ ensures it is performing as per the URS during the trials.
When illustrating the sequence, process validation is the next step. This will verify that the process and quality parameters can be consistently met by the process. Other validation exercises required are packaging validation, test method validation and cleaning validation. At this point, it’s also worth mentioning another key element, the qualification of utilities will also most likely be required. Identifying the impact of these activities early in the process is critical for successful delivery.
Project managers may ask, “Why do I need to know this information?”. Its simple. It is impossible to plan and budget for the impact of validation activity, if you don’t know why or how it is being completed.
Other key points that project managers and project engineers should consider when installing a system that needs to be validated:
- Plan your project with validation heavily integrated. Do not see it as an add see it as supplementing the quality of the final delivered project.
- Engage the quality/validation team when planning the schedule for the projects as sampling and document review can take a significant amount of time and can lead to project overrun.
- Work with the quality/validation team to ensure the boundaries of the system being qualified early. This will limit crossover and additional work.
- Start the process at day one with a strong document management system in place. Maintain it throughout the process to ensure information is always to hand when validation/qualification is being carried out.
- Appreciate that consultants may not be thinking about system validation. If discussed earlier, deliverables can be fashioned to better match validation outputs.
- Similarly, contractors may not be thinking about system validation. If discussed earlier, handover docs can be fashioned to better match validation outputs.
- Understand the deviation process. Things will not always go to plan. Understanding the deviation limits and how to handle them. This can reduce the requirements for requalification. This will reduce additional cost and time delays to a project.
- Understand the market, product, product risks and regulatory requirements to manufacture the product. Ensure the protocols are appropriate for the market and not over the top relative to the requirements. This is a quick way to lose money with unnecessary documentation and manpower.
- Understand what you are trying to achieve. The documents are the output/proof but not the reason for doing it. Validation is demonstrating what you have installed, is fit for purpose and operating as required. If the validation is difficult, then consider, was the correct item installed or the right procedures followed?
On a final note, I believe validation to be a way for a client to say to the world and more importantly the regulatory bodies, here is what we do, this is how we do it, this is how we can do it repeatedly and with the safety of the end user as the priority. It is worth the time and effort, in the long term to invest in validation and quality to protect the long-term interests of the company.
This is a high-level piece on this extremely complex topic and one I can talk at length, on the many factors involved. I am available at www.bpm.org.nz if you’d like to chat through any problems or questions relating to this topic and offer advise as required. If you found this article helpful, then I welcome the sharing of it to help your colleagues.
· PHARMACEUTICAL INSPECTION CONVENTION,
· PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME,
· PE009-14 (Part II), 1 July 2017, “GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II”