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Guidelines for Emergency Use Authorization of Medical Products  

MedicinesBiologicalsMedical Devices | Ghana

These guidelines publish the regulatory requirements for authorizing the emergency use of a Medical Product (Allopathic Medicines, Biological Medicinal Products and Medical Devices) during a declared public health emergency. Such emergencies shall include, but not limited to, a heightened risk of affliction or attack on the life, health, safety and security of the general public or any incident with a significant potential to affect national security.

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GMP Clearance Code Tables Guidance: Manufacturing Steps  

BiologicalsMedicinesHerbal Cosmetic Nutra | Australia

This guidance aims to:
• Provide a list of common manufacturing steps that validate within the various TGA product registration/listing systems
• Provide an interpretation for the common manufacturing steps from a GMP clearance perspective
• Provide clarification around common manufacturing step group terms and the individual manufacturing steps associated with each group which validate in the product registration/listing systems
• Reduce validation errors experienced within the product registration and listing systems

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Site Master File for Source Plasma Establishments  

Biologicals | PIC/S

The Site Master File for Source Plasma Establishments (SMF – SPE) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant terminology can be found there. It is based on the information given in the PIC/S document PE 008.

The SMF – SPE should be completed by the manufacturer. In case of more than on choosing the correct boxes should be marked and missing entries should be filled in. Hand-written entries must be easily legible (use printed / block letters). Numerical data should refer to a calendar year.

In order to provide actual information the SMF – SPE should be completed not earlier than approximately six (6) weeks prior to the inspection

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Site Master File for Plasma Warehouses  

Biologicals | PIC/S

The Site Master File for Plasma warehouses (SMF – PW) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant
terminology can be found there. It is based on the information given in the PIC/S document PE 008.

The SMF – PW should be completed by the manufacturer. In case of more than on choosing the correct boxes should be marked and missing entries should be filled in. Hand-written entries must be easily legible (use printed / block letters). Numerical data should refer to a calendar year.

In order to provide actual information the SMF – PW should be completed not earlier than approximately six (6) weeks prior to the inspection

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