Introduction
Stability storage is undertaken on a variety of pharmaceutical products including tablets, capsules, liquids, creams, gels and a variety of medical devices. As part of the stability storage trial, products are stored in equipment to replicate various environmental conditions, and at various time points, those products are subject to a variety of analytical tests to ensure that the Active Pharmaceutical Ingredients (API) are still effective and the product or packaging have not deteriorated, being subjected to those environmental conditions over time.
Stability storage trial data is used to support getting the product to market and, by their very nature, these trials can be up to 36 months in duration, sometimes longer of up to 5 years! It is therefore imperative that the equipment used is a good quality and fit for purpose.
The importance of maintaining equipment
Safety
Surely the most important reason why equipment should be regularly serviced and maintained is for safety of staff. Companies have a legal responsibility to ensure the welfare and safety of staff and ensuring equipment is serviced and maintained is one part of this, to reduce the risk of electrical faults, potential fire and any mechanical failure which could cause injury.
Delays to market
Stability data is required to evidence that drug products are safe and effective and can be signed off by the Medicines & Healthcare products Regulatory Agency (MHRA). Should equipment fail, and the operating set point of the room go out of specification as defined in the International Council for Harmonisation (ICH) guidelines, the effect can cause huge delays in being allowed to launch a product to market. The worse-case scenario maybe that a trail may have to be re-started which can add years to a product launch.
Financial
Of course, an extension in getting the product to launch may have huge financial impacts. The costs associated in the research and development of pharmaceutical products is significant. Pharmaceutical companies need a return on their investment and failures in getting the product to market only delays this.
What to look for in an outsourcing partner
More and more companies are choosing to concentrate on core business activities which allows the company to concentrate and focus upon revenue generating activities such as research and development and contract manufacturing.
Quality Systems / accreditations
Having a suitable Quality Management System (QMS) is an absolute must in the pharmaceutical world and, is paramount in having the ability in providing data to the MHRA for product approval. When choosing which company to service and validate your equipment, you must ensure that they have the suitable quality systems in place and are IS0 9001:2015 accredited.
Also ask to see what documentation they have for their service visit reports, the Preventative Maintenance Inspection (PMI) report and the validation protocols which they undertake.
Expertise
Trusting a company to look after your critical equipment is an important decision. You must feel comfortable and confident in your service provider that they have the right level of skill, knowledge and professionalism to carry out their duties.
A company looking to engage a service partner should thoroughly check which other companies they work with. Can they offer clients that would recommend them? Have they got a credible name in the market? What is their reputation like?
Call out response
Another factor to consider is what is the response time for a company to attend site? Do they have an appropriate amount of service engineers to have suitable coverage? Do they have an on-call duty engineer who can attend out-side of normal business hours and provide cover at weekends and bank holidays. Do they have a service desk which can ‘triage’ the initial fault?
These are all relevant factors which need to be considered when choosing an outsourcing partner.
Original Equipment Manufacturer
Ideally the service provider should be the company that installed the original stability equipment. They should be better placed to have detailed knowledge of the equipment, how it operates, and how to achieve optimum performance. They will also have mechanical and electrical design details/ design and drawings as well as access to a database with the original parts. All of which is critical for ensuring equipment is kept in peak performance.
All though the points above are not an exhaustive list, they do give companies something to think about upon deciding on choosing who will be their service provide for maintenance of equipment.
If you would like to learn more about how Source BioScience can assist you with your service requirements, then please do get in touch stability.storage@astoriom.com or telephone:
Telephone
UK:+44 (0) 1706 716710
Ireland:+353(0)51338435
US: +1 (562)-944-446
