Outsourcing should be considered in small and large organisation where where an expert third party is more effective and economical. The alternative is to employ and train in-house experts or retrain existing team members. Quality Expertise can be sought in diverse areas such as Contract Responsible Person, or Qualified Person, Supplier/Customer qualification and approval, GDP /GMP compliance auditing, Data logger calibration, Warehouse Mapping, Transport Qualification/ Validation and Pharmacovigilance. A robust Technical Agreement should be drawn up between the contract giver and contract acceptor to detail who is responsible for what , the key performance indicators that the contract giver will monitor. The TA should be reviewed annually to ensure that it is still fit for purpose. Often by outsourcing overheads are reduced, expertise drives better regulatory compliance, contractors automatically focus on keeping up with the ever-changing GDP & GMP guidelines. This allows the management to focus on commercial aspects of their business.
Where do you start when trying to find an suitable partner?
Firstly qualify what it is you want to outsource?
Set yourself a budget ?
Take a look at the companies or people providing the service, start by looking on line.
Devise a list of questions you may wish to ask them via e mail or telephone , however face to face is better if possible as you can watch their body language and drill down further into areas depending on the initial answers/
Questions you may wish to ask ….
- Do they have a Quality Manual ? Quality Management System ?
- How big is the Team, what qualifications do they have and how do they keep up to date?
- Do they have sufficient equipment of their own, which is maintained and checked in a way that meets GMP requirements?
- Are they resourced to be responsive to fluctuating workloads at their customers’ operations and their own companies?
- If you are outsourcing your calibration, you may wish to ask if the contract acceptor is fully accredited to calibrate your data loggers or equipment ? Also by which recognised authority?
- Do they offer a range of services, allowing customers to source more than one activity from the same supplier? Such as GDP compliance audit , training, Quality Management System development or review?
- Do they meet all your qualified requirements, and within your budget?
- Do they have a template TA they use ? This is often useful to use as a starting block along with your own TA or qualification to build a mutually agreed robust TA.
- Can they provide two recent references ?
- What evidence can they provide to support their competence ?
The right partner will provide vital cost effective support to help maintain GMDP standards. Experience is the key it takes time and money to gain and maintain, a contract RP is often better placed to keep their skills and knowledge up to date as they often work with many different businesses, can share best practice and industry insight and experience many more inspections which is very useful when improving a company’s compliance or preparing them for their next inspection.
If you would like to outsource any of your activities and would like to discuss your requirements contact Pharmacy Consulting Limited and ask for one of their RPs
Written by Jackie Peck