Section A: Copyright and course classification information Copyright owner of the course Copyright of this course is held by the Department of Education and Training, Victoria © State of Victoria (Department of Education and Training) 2017. Address Executive Director Industry Engagement and VET Systems Higher Education and Skills Department of Education and Training PO Box 4367 Melbourne, Victoria, 3001 Organisational Contact: Manager: Training Products Unit Higher Education and Skills Telephone: (03) 9637 3092 Email: Day to day contact: Curriculum Maintenance Manager Service - General Manufacturing Chisholm Institute 2 New Holland Drive Cranbourne VIC 3977 PO Box 684 Dandenong VIC 3175 T +61 3 9238 8448 Email: Type of submission This course is submitted for accreditation. Copyright acknowledgement Copyright of this material is reserved to the Crown in the right of the State of Victoria. © of Victoria (Department of Education and Training) 2017 Copyright of the following unit of competency from nationally endorsed training packages is administered by the Commonwealth of Australia and can be accessed from Training.gov at Imported unit: FDFOHS1001A Work safely from the FDF10 Food Processing Training Package. Licensing and franchise Copyright of this material is reserved to the Crown in the right of the State of Victoria. © State of Victoria (Department of Education and Training) 2017 This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Australia licence ().
manufacturing biological or biotechnology pharmaceuticals manufacturing veterinary pharmaceuticals manufacturing complementary medicines including herbals and medicinal preparing or liquid dose sterile or non-sterile operations API manufacture finished dose manufacture quality Control warehousing inspection, labelling and packing including repacking Australian and other applicable regulatory frameworks might include: National Medicines Policy Therapeutic Goods Act Therapeutic Regulations Manufacturing Principles Therapeutic Goods Orders Pharmacopeias Code of cGMP other TGA guidelines relevant to product and market legislation relating to environmental manufacturing, Occupational Health & Safety US Food, Drug & Cosmetic Act and associated Codes of Federal Regulations and guidance European Directives and legislation of EU member states applicable to pharmaceutical manufacturing Global harmonization might include: PIC/S background and guidance ICH background and guidance Current Good Manufacturing Practice (cGMP) compliance includes: conformance to site-wide manufacturing quality systems for ensuring that products are consistently produced and controlled according to quality standards cGMP requirements might include: adherence to specific Quality, Quality Assurance, Quality Control, Quality Risk Management procedures
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
EVIDENCE GUIDE The evidence provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package. Overview of Assessment The assessment environment provides access to documentation related to controlled environments together with a range of activities typical of commercial manufacturing operations, and that meet the requirements of the Australian Code of current GMP. Critical aspects for assessment and evidence required to demonstrate competency in this unit To demonstrate competence in this unit, a candidate must provide evidence of the application of their knowledge to: describe the characteristics of controlled environments, describe the operating parameters of controlled environments, follow pre-entry requirements, follow required work practices appropriate to controlled environments, follow exit procedures Context of and specific resources for assessment Assessors must be satisfied that the person can consistently perform the unit including all elements and performance criteria, and can demonstrate the required skills and knowledge. Resources for assessment include: a range of relevant exercises, case studies and/or other practical and knowledge assessment, and/or access to an appropriate range of relevant operational situations gowning/degowning procedures and related advice on equipment operation, including advice on safe work practices and environmental requirements personal protective clothing and equipment information relating to the design, operation, testing and monitoring of Air Handling Units / Heating Ventilations and Air Conditioning (HVAC) information relating to the regulatory and management issues associated with controlled environments, relevant to work responsibilities examples of data collection forms and information recording systems, requirements, procedures and examples of data.