'Don't Highlight Too Many Things That Are Wrong'!!

A blue chip pharmaceutical company awarded a significant project to a major engineering supplier, to build a new facility. The pharmaceutical company concerned stipulated that the personnel working on the validation aspect of the project, on behalf of the engineering supplier, had to be PAYE personnel, directly employed by the supplier.

Unbeknown to the pharmaceutical company and ZES, the main engineering supplier sub-contracted out CSV work, in part, to ZES. The lead engineering supplier concerned claimed all their staff working on the project were PAYE personnel. ZES weren’t, in common with many of the engineering suppliers to the project!!

During the project, the ZES consultant was asked by the pharmaceutical client about their employment status with the lead engineering supplier. ZES were released from the contract, by the lead engineering supplier, for ‘making the client aware that ZES are Sub-Contractors’.

In the opinion of ZES, if suppliers are unable to operate with the utmost integrity, they should not be operating in the life science sector. In the experience of ZES, pharmaceutical manufacturers are not being told the truth by a significant number of their suppliers, and suppliers are relying on the client not having the technical expertise in-house.

During the same project the ZES consultant was asked to review an autoclave URS, which had been reviewed by the lead engineering supplier ‘PAYE’ personnel on 7 occasions previously. The autoclave was to sterilise the final product before product release and injection into the patient.

The ZES consultant was told by the lead engineering supplier ‘PAYE’ personnel ‘Don't highlight too many things that are wrong’. The ZES consultant ignored this request and highlighted a number of fundamental issues he felt were appropriate for the intended use of the autoclave.

Numerous fundamental issues were found within the URS by the ZES Consultant. One of these is quoted below:

‘Following the reset of an emergency stop, the autoclave shall restart and finish the current cycle.'

It was pointed out by the ZES consultant that following the reset of an emergency stop, any autoclave should safely return to room pressure and the cycle should be rejected. There should also be a requirement that emergency stops are logged and printed as part of the cycle data printout.

ZES decided that this was the final time ZES worked via a third party engineering suppler on a project for the life science industry. ZES are here to ensure a quality product which protects the pharmaceutical manufacturer and its patients.