What Does ‘Fit for Purpose’ Mean for Pharmacy Equipment?

 When choosing pharmacy equipment, you will often come across the phrase “fit for purpose”.

The General Pharmaceutical Council (GPhC) requires equipment and facilities used to provide pharmacy services to be safe and fit for purpose. They should also be obtained from reputable sources, stored securely, protected from unauthorised access and appropriately maintained.

That makes being fit for purpose about much more than whether a piece of equipment works. You need to consider what it will be used for, its specification, accuracy, condition and any requirements applying to that task.

Start With What the Equipment Needs to Do

A piece of equipment can work perfectly but still be unsuitable for a particular task.

A large cylinder may be perfectly capable of holding a small quantity of liquid. However, its graduation intervals may not provide the resolution required for accurately measuring that volume.

The same principle applies throughout a healthcare setting.

A refrigerator used to store temperature-sensitive medicines must be capable of maintaining the required storage conditions. Temperature monitoring equipment needs sufficient accuracy for its intended application. And equipment used to provide clinical services needs to be suitable for that service.

The GPhC provides a useful real-world example. One pharmacy highlighted for good practice maintained different measuring cylinders, separate measures for methadone, calibrated clinical equipment and monitored refrigeration. This allowed equipment to be matched to the task rather than treated as interchangeable.

Check Which Requirements Apply

There is no single standard covering every item of pharmacy equipment.

Requirements depend on what the equipment is, what you are using it for, and in some cases which medicines are involved.

Relevant considerations include legislation, GPhC standards, MHRA guidance, British or international standards and manufacturer specifications.

The Misuse of Drugs (Safe Custody) Regulations 1973 set specific requirements for the storage of relevant controlled drugs. Subject to the provisions and exemptions within the regulations, controlled drugs covered by the requirements must be kept in suitable locked storage designed to prevent unauthorised access.

The regulations also contain structural requirements for applicable safes and cabinets, including their construction, locks and secure fixing.

Accuracy Matters With Measuring Equipment

Accuracy becomes particularly important when equipment is used for measurement.

GPhC guidance for pharmacies preparing unlicensed medicines states that specialist equipment should be designed for its intended purpose. It should also be of a sufficiently high specification and accuracy, where applicable, to produce a safe, high-quality product.

Examples include equipment for measuring weight and volume.

With a measuring cylinder, for example, you need to consider its capacity, graduations and tolerance. A cylinder designed for much larger volumes may have graduation intervals that are inappropriate for measuring a small quantity.

The condition of the equipment matters too. Clear graduations are essential for taking readings, while chipped or cracked glassware should not remain in use.

What Makes a Pharmacy Fridge Fit for Purpose?

Refrigeration provides another useful example because the equipment needs to perform consistently, not simply become cold.

Start with the medicines being stored and their specified storage conditions. The refrigerator needs to maintain the appropriate environment for that stock.

But the fridge itself is only one part of the process.

Its usable capacity should be appropriate for the stock being stored. There needs to be sufficient airflow around medicines, while the refrigerator also requires appropriate ventilation in its location.

Temperature monitoring then provides evidence of the conditions inside it.

When choosing pharmacy fridges, it therefore makes sense to look at the complete application.

Choosing Temperature Monitoring Equipment

The most sophisticated monitoring system is not automatically the most appropriate. Instead, consider what you need the equipment to monitor and how the information will be used.

Relevant factors can include measurement range, accuracy, calibration, recording intervals and probe positioning.

You might also consider whether you need alerts when temperatures move outside specified limits and how easily historical records can be retrieved.

For electronic monitoring systems, think about the practical side too. Staff need to understand the equipment and know what action to take when an alert occurs.

Collecting temperature information has limited value if nobody reviews or acts on it.

Controlled Drug Storage Needs Particular Consideration

Controlled drug storage requirements include detailed provisions covering the construction and security of the safes and cabinets a controlled drug is stored in. The 1973 regulations also specify secure fixing requirements for cabinets subject to Schedule 2.

Home Office security guidance additionally considers the amount and type of controlled drug stock when looking at appropriate safes and cabinets.

Capacity therefore deserves consideration alongside physical security. A cabinet might meet the necessary construction requirements but become impractical if the amount of stock regularly stored exceeds its useful capacity.

Consider your current stock as well as likely future requirements.

Position, installation and control of access also form part of the wider storage arrangement.

Can Staff Use the Equipment Properly?

Think about how equipment fits into everyday workflow.

Are the controls straightforward? Can displays and graduations be read clearly? Is the equipment positioned where staff can use it correctly? And have the people using it received appropriate training?

The right capacity matters too.

Equipment that is unnecessarily large, small or difficult to handle can make a routine task more complicated than it needs to be.

Equipment Needs to Remain Fit for Purpose

The GPhC requires pharmacy equipment to be appropriately maintained. Its inspection material also gives examples of pharmacies using servicing, calibration checks and maintenance records to demonstrate that equipment remains suitable.

Different equipment will require different approaches.

Manufacturer recommendations should help determine the appropriate maintenance requirements and intervals.

For specialist equipment used when preparing unlicensed medicines, GPhC guidance specifically recommends maintaining appropriate validation and calibration records.

When Should You Review Pharmacy Equipment?

Regular reviews form part of the process.

A change in services may mean equipment that was previously adequate is no longer suitable. Increased stock levels can change refrigeration or controlled drug storage requirements. And new procedures may require different measuring or monitoring equipment.

Other reasons for a review include repeated faults, physical damage, unreliable readings or changes to relevant requirements.

Manufacturer recommendations may also identify servicing, calibration or replacement intervals.

Five Questions to Ask About Your Pharmacy Equipment

When purchasing or reviewing equipment, these five questions provide a useful starting point:

• What will you use it for? Start with the task rather than the product.
• Which requirements apply? Check relevant legislation, professional standards, guidance and product specifications.
• Does its specification suit the task? Consider capacity, accuracy, operating range and other relevant characteristics.
• Can your team use it correctly? Think about training, accessibility and how the equipment fits into existing processes.
• Can you demonstrate that it remains suitable? Consider servicing, calibration, maintenance records and routine checks where appropriate.

Choosing Pharmacy Equipment That Is Fit for Purpose

“Fit for purpose” is not a label attached to a product.

Equipment needs to be appropriate for the particular task, meet relevant requirements and continue performing as intended throughout its working life.

That might mean selecting a measuring cylinder with appropriate graduations, refrigeration capable of maintaining the required storage conditions or secure storage that meets the requirements applying to controlled drugs.

It also means looking after that equipment once it enters the pharmacy.

By considering specification, use, maintenance and regulatory requirements together, you can choose pharmacy equipment that works effectively within your dispensary and continues to support safe pharmacy services.

Denward has extensive experience in helping clients select the right product for their specific needs. By taking the time to understand the intended application, operational requirements and any relevant regulatory considerations, our knowledgeable team can offer practical guidance and recommend equipment that is genuinely fit for purpose.