TAs – when do we need them in place and who with and what should be in them?
PCL have been reviewing a few TAs over the last few weeks and we have put a few tips and hints together. If you only follow GDP or GMP; the principals are the same.
If you are a manufacturer and comply with GMP, then you need to have a contractual agreement in place with everyone you contract services with for example:
- Manufacturing Facilities
- IT providers
- Test laboratories
- Any contract pickers , packers , storage , labellers , or re-labellers
- Logistics providers
- Pest control
- Cleaning companies
The contract giver is effectively the “Owner “of the agreement, and product.
The contract acceptor is the contracted service provider and does not own the product and is responsible for the delegated activities in the agreement/ or contract. But remember that a contract acceptor cannot agree to manufacture for instance under non-cGMP conditions!
Both the FDA and the EU in the revised cGMP chapter 7: Outsourced Activities also identifies ultimate accountability as lying with FDA’s product “Owner “or “Contract Giver “.
“The Contract Giver is ultimately responsible …….” (EU, Health and Consumers Directorate –General, Good Manufacturing Practice for Medical Products for Human Use, Chapter 7: Outsourced Activities, June 2012, 7.4, p.1.)
If a small pharma company outsources their manufacture they are still liable for the review and release of their finished product and the EU allows this to be carried out by a contract Independent QP. Currently the FDA do not allow this independent QP option. But the key thing in the EU is that the contract giver cannot outsource both the manufacture and the finished product release to the same contract facility.
Some useful tips
- Commercial and Quality agreements should not be in the same agreement
- They should be mutually agreed , signed and dated
- They will be inspected by the competent authority
- Keep them to the point and easy to understand – try to avoid jargon
- Use simple tables to clarify and delegate the responsibility
- Keep a spreadsheet with useful data such as when the agreement is due to expire so that it can be re-negotiated in time
- Audit before you sign an agreement with the service acceptor. The audit should always look for risks in their processes, traceability, processes and their control, Training records, sampling, purchasing.
- Try where possible to adopt the terms and procedures of the contract acceptor to minimise the inherent risks of misinterpretation, error and deviations.
The contract giver must ensure that the contract acceptor has sufficient controls in place to ensure that the contracted activity is carried out in a safe and effective way incorporating risk management principals.
The TA or QA must include
- Scope /Purpose
- Effective, review and termination dates
- Clear responsibilities of both contract giver and acceptor
- Provision for dispute resolution
- How it will be reviewed risk assessed and changed ( deviations , CAPA, people involved and how they will manage the process)
- How the records required will be kept and secured and ensure traceability is achieved.
- Contract givers must have access to the contract acceptors site to audit and ensure that the activities outsourced are being carried in accordance with the TA/QA and the current legislation.
- The contract acceptor must inform the contract giver if they are outsourcing any of their agreed services in advance.
Take time to perfect your TAs /QAs and review them in a timely manner to ensure that they are still fit for purpose.
Go on, read yours this week…….make sure you are inspection ready.