zip TGA cGMP Human Blood and Tissues

A zip file containing >200 QMS templates relevant to the Therapeutic Goods Administration standards for Good Manufacturing Practice (Human Blood and Tissues)

Non-Conformance Management

This SOP describes the procedures and responsibilities for the management of non-conformances and deviations (planned and unplanned). It relates to non-conforming products, materials, processes, procedures (documentation), environment, facility and equipment.

Emergency and Evacuation Plan

This SOP outlines the procedure to follow in an emergency situation. It should include details of how to protect any manufacturing that is in process at the time of an evacuation.

Equipment Register

This register lists all the equipment in a facility including critical equipment.

Risk Management Procedures

This procedure describes the identification of potential risk and risk factors that may impact on the quality and safety of processes and product(s). The impact assessments and calculations form the basis of a risk mitigation (minimisation) plan used to proactively reduce significant risk to an acceptable level where possible. ¬†Occupational Health and Safety and business […]

Environmental Monitoring Procedure

This document describes the environmental monitoring program for the clean areas of the manufacturing facility. It includes surveillance of temperature, relative humidity and air pressure, microbial contamination and particulate air matter.

Cleanroom Cleaning Procedure

The purpose of this SOP is to outline the procedures and materials used in the routine cleaning of cleanrooms and associated clean areas within the facility.

Organisation Document

Description of the organisation, the staff, management processes and organisation chart.