Commissioning is a program characterised by check ups, functional tests, training, documentation collection and verification, and equipment commissioning.
The customer will be supported during the construction and commissioning phase, when suppliers are required to guarantee that all the installations, systems and equipment have been designed and installed correctly, that they operate according to customer requirements and are furnished with complete documentation.
“Good documentation constitutes an essential part of the Quality Assurance System. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. Specifications, manufacturing formulae and instructions, procedures, and records must be free from errors and available in writing. The legibility of documents is of paramount importance”.
(EU GMP, Chapter 4, “Documentation”)
The 1MP service will provide the package of documents to create a proper QMS including SOPs, SMF, VMP and templates for the job descriptions and organisation chart. The following activities will be performed in this phase: