Instrumentation, continuity of equipment service contracts
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We have just taken over an Instrumentation service contract for a GMP/GLP account. Are there MHRA regulations regarding service contracts and their continuity?
The take over process has been quite short so we may not have 100% of contracts in place at go-live date.
If the equipment is still maintained to a compliant schedule and within its service level there should be no issue?
GMP Committee response
Chapter 7 of Part 1 of the EU GMPs gives some general guidance with regards to contracted out activities and the requirements for contracts. While it is expected that any such contracts, laying out the terms and conditions of service provision are in place before any work is conducted an interim temporary arrangement within the (GMP) contract giver’s quality system, using for example, a deviation, could act as a bridge.