The real and clear explanation of Qualification and Validation, and more importantly, how to do it properly.
#1: Introduction
The excitement of a shiny new piece of equipment or the eagerness to make a new procedure live can be overshadowed by the impending doom that is qualification and Validation. Its a vital piece of documentation that we know we need, but why is it so overwhelming?
As someone with little previous experience within the pharmaceutical industry I often struggled to get my head around what Qualification and Validation meant, and more importantly, when to use which one. Those of you that work within quality departments will relate to the frustrated googling, trying to narrow down your search to something more relevant. The problem is clear, there is so much about Qualification and Validation that is not pharmaceutical specific, and it adds to the confusion for us.
You do not need to look any further, below I detail definitions, examples, and some helpful tips that we use here at Modus Consultancy.
#2: Qualification or Validation
To become confident in Qualification, you need to understand what it means in simple terms.
Qualification is the description and understanding of what the piece of equipment can do. I tend to remember it as the specification. You'd be looking at areas such as accuracy of results, equipment data, what the equipment is sold for doing. Qualification in this context is not to be confused with the Qualification of your customer and Suppliers. For an example, you qualify the cold room/ Fridge can be set at the temperature you require for the storage of medicine products.
Validation on the other hand is the proof of repeatable, continuous, accurate data. The Equipment's performance is repeatable and in turn, reliable. For example, the cold room/fridge can maintain the same temperature. You can also Validate a process, such as Transportation, a delivery route, a recall procedure, or a change control procedure. Temperature mapping is a form of validation, you validate your warehouse.
#3: So, how do I Qualify and Validate?
To build your qualification documentation up, more is better. Your aim is to collect as much information as possible, and, learn. There is so many sneaky things manufacturers hide within information leaflets that can really help your own company out. It's not a crafty trick to have a better understand of the equipment and procedures you run within your business. It may seem like a chore, but Qualifying and Validating is there to help you.
Your Quality management system may include a Qualification and Validation Report. I'd advise you include the User Requirement Specification (URS) and the Functional Qualification Statement (FQS) within your report. The URS is where the required results, performance and characteristics are outlined. The FQS is where justification for why proposed function of facilities/systems are suitable.
In your Validation protocol, you should also make note to cover:
Installation Qualification (IQ): The Equipment/ facility has been installed as per manufacturer.
Operational Qualification (OQ): The Equipment/ facility perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): The Equipment/ facility can perform effectively and be replicated, based on the approved specification highlighted in the IQ and OQ.
Utilising these will help break down your report and make sure the questions that need to be asked are also being answered.
The way this data is collect is Equipment/process specific. A controlled test to show a representative performance would be a strong start, followed by a wider, more abnormal range of conditions to provide insurance. An example for this is to expose Temperature Controlled Cool-boxes to a prolonged external cold temperature . Whilst it is unlikely to be left in -10 degrees for 10 hours, having the validation to support an incident may be useful. A rabbit hole to go down, but you may consider using a temperature chamber; they also need validating!
#4: Quick Descriptions
Qualification – The action of proving equipment works correctly and to specification.
Validation – The action of proving a result of performance is repeatable.
User Requirement Specification - Characteristics, required results.
Functional Qualification Statement - Suitability
Installation Qualification (IQ): The Equipment/ facility has been installed as per manufacturer.
Operational Qualification (OQ): The Equipment/ facility perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ): The Equipment/ facility can perform effectively and be replicated, based on the approved specification highlighted in the IQ and OQ
The MHRA and its approach
Over the last few years we've noticed a huge increase on focus of validation and qualification during inspections. They are usual key points within the Manufacturing side of things, however that has seemed to have bled into the Wholesale side if the Industry. The MHRA's stance is that if you have not validated or qualified your process/equipment, then in essence you cannot trust anything produced. Their view is not to be discarded as harsh; how do you know that anything you do is right? Are we meant to trust that what we have in our warehouse works 100% accurately, just because we bought everything within it brand new & with warranty?
I don't think we'd be overreactive to suggest that validation and qualification is becoming one of the most vital piece of documentation, but often the least focused on.
Reading
The Green Guide - Chapter 3 Premises and Equipment. Page 89 onwards.
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