To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product. Achieving this standard requires that a number of procedures are…
The TGA recently announced an update to the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been implemented, taking effect on 30 June 2022. The URTPG: instructs sponsors about how to efficiently and effectively remove marketed therapeutic products that pose a potential risk to users from the distribution chain outlines a consistent approach for undertaking…
Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials. The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or processed (e.g. prion diseases). Transmissible Spongiform Encephalopathy (TSE) is a prion disease that can affect…
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others with respect to audit deficiencies? Audit Deficiencies Reported by the TGA The Australian Therapeutic Goods Administration…
To start understanding mRNA vaccines we need to begin with talking about viruses. Although viruses fall under the field of microbiology, they are not considered as true living organisms in the conventional sense, as they cannot exist without a living host cell. Our school Biology textbooks define living things as displaying seven characteristics: Respiration Movement…
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