If on notification of a forthcoming inspection by the authorities or a customer audit you find to your horror that
- the last internal audit was 2 years ago, even though you had specified a regular annual cycle?
- the contract for the definition of pharmaceutical responsibilities with a new manufacturer has still not been formulated, even though the first production batch is already in storage with you in-house?
- your raw materials supplier has made changes in his materials again without informing you, although you have wanted for a long time to conclude a supplier’s agreement with him and to carry out an audit on his premises?
- the last important notice of amendment has been due for six months already?
- when could you possibly find time to do all that?
- who in your company could deal properly and effectively with these problems without leaving a gap in-house?
- how can you retain an overview?
Experts called in on a temporary basis can help you and make sure the legal requirements and customer’s needs are met by e.g.
- drawing up your quality management system with you
- providing guidance for self-inspection and for continuous improvement
- adapting and improving your quality management with you
- auditing suppliers and contract manufacturers
- acting as your internal auditor
Experts can be called in on a temporary basis at short notice to relieve the burden on your in-house staff. And you determine the precise scope of the expert’s temporary assignment for a definitive period and a clearly defined project. That saves costs.
But the implementation and use of the quality management system remains in your hands. These are things which an outside expert cannot do for you.