Outsourcing Stability Studies: Choosing the Right Partner

Introduction

Stability storage is a key process in bringing a pharmaceutical product to market. Fundamentally, the objective of stability storage trials is to determine and substantiate the shelf life of the product and packaging, and to verify that the API’S (active pharmaceutical ingredients) do not deteriorate over time, given those environmental conditions. 

Why outsource?

A growing number of pharmaceutical companies are choosing to outsource stability storage trials, rather than undertaking them in-house, for a variety of reasons. 

• CAPEX vs. OPEX

By its very nature, stability storage equipment (albeit cabinets, reach in rooms or walk-in rooms) can be a sizeable investment, not only in the units themselves, but in all the other associated costs, such as monitoring systems, annual service and validation plans.

Stability equipment can be large and so laboratory refurbishment / new build / extensions are sometimes required, so this can all factor into the decision of whether to outsource stability storage trials, which can be more financially beneficial. More and more companies are choosing to outsource storage and pay a monthly storage fee, and ‘pay for what you use’ so to speak.

Depending on the internal systems within the company finance teams, it can often be easier and quicker to raise OPEX rather than CAPEX, which can all cause delays of setting products down on store and getting product to market. 

• Physical Space

Stability storage equipment can be sizeable, especially allowing for large walk-in rooms and their associated chillers. Many companies do not have the physical space to accommodate such equipment without the requirement for laboratory refurbishments / extensions so choose to outsource their stability trials. 

• On-going management

Stability equipment must be managed and maintained to safeguard against equipment failure and therefore the associated headaches and documentation which can occur should a piece of equipment go out of specification.

The Laboratory/Stability Manager will usually be responsible for organising annual service and validation activities, ensuring daily, weekly, and monthly checks and procedures are undertaken, data monitoring is backed up and working correctly, ensuring stock inventory is up to date, co-ordinating stability set downs and pulls for analytical and microbiology testing and perhaps being called out at one o’clock in the morning when things have gone wrong! By outsourcing stability studies to a trusted partner, all off those headaches, worries and hassles and taken away! 

• Focus on core activities

More and more companies choose to outsource non-core business activities. This allows the company to concentrate on revenue generating activities such as Research and Development and contract manufacturing. 

• Speed

When speed is of the essence…when things ‘just happen’ and product needs to be placed on store, it can be a lot a quicker to simply send out samples to an established storage partner. 

What to look for in an outsourcing partner

Once a company has decided that they want to find an outsourcing stability storage partner, although this is not an exhaustive list, they should consider the following points: – 

• Quality systems / accreditations

Quality is at the heart of the pharmaceutical world and this is reflected in all activities of drug development, manufacture, storage, and testing. An outsourcing partner should demonstrate that they have the appropriate QMS (Quality Management System) in place, to manage documentation, CAPA’s, deviations, non-conformances and to track relevant Standard Operating Procedures.

This should be evidenced and shown at a formal audit at the providers site, where they can demonstrate how they operate a stability storage facility.

They should be asked what quality standards they work to, such as ISO 9001: 2015 and whether they adhere and operate to cGMP. 

• Data logging monitoring facilities

Having data to support stability storage is a key necessity in bringing product to market. An outsourcing partner must be asked what monitoring systems it has in place? Whether those systems are 21-part CFR part 11 compliant? How is data kept and stored? How is that data backed up? 

• Equipment management & maintenance

Another determining factor which is paramount when choosing an outsourcing partner is considering their infrastructure. As a company, you need to have complete trust and confidence in your outsourcing partner and that they have the necessary structures in place.

Such considerations should include:

Service and validation

Does the provider have well maintained, serviced, and validated equipment? Is this documented? How often are they serviced? How is the equipment log kept up to date? How are the rooms validated? Can the outsourcing partner demonstrate how the equipment is validated and show you this? 

On-call duty engineers

What provisions does the storage provider have in place should the equipment fail/go out of specification, out of hours. Does the provider have staff on call to respond to such occurrences from a technical point of view but also from a stability GMP point of view? 

Critical/spare parts

As an extension from the point above, does the storage provider keep spare parts on site so any equipment failures can be easily rectified to reduce out of specification times and occurrences. 

Back-up generator

Does the service provider have a back-up power supply in case of mains failure? What would happen if a freak accident occurred and the site lost its power? How would the equipment be maintained? This is a consideration for the equipment and the monitoring system. 

Controlled access & CCTV

How does the service provider ensure that only authorised personnel have access to the stability suite or the rooms themselves? How is this safe guarded? What security measures are in place?               

• LIMS system

A storage outsourcing partner should be able to demonstrate a suitable LIMS (Laboratory Information Management System) which can fully track storage samples from receipt of product, to return. The software needs to be fit for purpose and be able to detail such as:

1. Product
2. Conditions
3. Quantities
4. Duration
5. Return dates
6. Other relevant study information 

• Staffing and training

Questions should be asked of the outsourcing partner as to how staff training is undertaken, reviewed, and monitored, to ensure that all SOP (Standard Operating Procedures) are being followed. 

• Proven track record

A company’s trading history can give a great deal of confidence to a company if they are looking to secure an outsourcing partner. Can the accounts be checked to see if they are of good standing?

Can the outsourcing partner provide clients who would recommend them? Have they a credible name in the market? What is their reputation like?

All though the above points are not an exhaustive list, they are very worthwhile points to explore when considering who you would like your outsourcing partner to be.

To find out more register for our free on-demand webinar here ‘A guide to outsourced stability storage’ or contact us today at stability.experts@sourcebioscience.com