Handover is carried out according to workplace procedures 5 Hand over the production 5.1 process Handover production team is made of process and related 5.2 equipment status at completion of handover The appropriate shutdown procedure is identified 6 Shut down the process 6.1 The process is shut down according to workplace procedures 6.2 Maintenance requirements are identified and reported according to 6.3 workplace reporting requirements Checks on yields, and reconciliation of quantities performed according 6.4 to workplace procedures. Yields and quantities performed outside acceptable limits are identified 6.5 and rectified or reported cGMP 6.6 Workplace records are maintained according to and workplace requirements. REQUIRED SKILLS AND KNOWLEDGE This describes the essential skills and knowledge and their level, required for this unit. Required Skills: access workplace information to identify processing requirements select, fit and use personal protective clothing and/or equipment confirm supply of necessary materials and services handle and store materials and products in a manner that prevents contamination and mix-ups perform area and/or line clearances identify pre-start checks, such as: inspecting equipment condition to identify any of wear selecting appropriate settings and/or related parameters confirming that equipment is clean and ready for use ensuring any scheduled maintenance has been carried out confirm equipment is operating correctly
5 Hand over the production process 5.1 Handover is carried out according to workplace procedures 5.2 Handover production team is made of process and related equipment status at completion of handover 6 Shut down the process 6.1 The appropriate shutdown procedure is identified 6.2 The process is shut down according to workplace procedures 6.3 Maintenance requirements are identified and reported according to workplace reporting requirements 6.4 Checks on yields, and reconciliation of quantities performed according to workplace procedures. 6.5 Yields and quantities performed outside acceptable limits are identified and rectified or reported 6.6 Workplace records are maintained according to cGMP and workplace requirements. REQUIRED SKILLS AND KNOWLEDGE This describes the essential skills and knowledge and their level, required for this unit. Required Skills: access workplace information to identify processing requirements select, fit and use personal protective clothing and/or equipment confirm supply of necessary materials and services handle and store materials and products in a manner that prevents contamination and mix-ups perform area and/or line clearances identify pre-start checks, such as: inspecting equipment condition to identify any of wear selecting appropriate settings and/or related parameters confirming that equipment is clean and ready for use ensuring any scheduled maintenance has been carried out confirm equipment is operating correctly
curr22450VIC%20PHARMANFPRINCIPLES.docx