This section is for manufacturers of blood, blood components and HPCs. You should also see Manufacturing basics and Manufacturing inspections which include information for manufacturers of all types of therapeutic goods.
Legislation and codes of practice
- Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
Applies to blood, human tissues and human cellular therapy products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance - S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites
Circumstances when manufacturing licence may cover two or more manufacturing sites
Guidelines and standards
- Current standards applicable to TGA-licensed HPC manufacturers
Clarification about product standards that apply to haematopoietic progenitor cells - Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
Describes the scope, detail and depth of information required for Technical Master Files to demonstrate the safety and quality of blood, blood components and haematopoietic progenitor cells
Licence guidance
Licence and overseas GMP certification applications
- Good Manufacturing Practice decision tree
This decision tree can help you in determining if GMP licencing or certification is required - Australian manufacturing licences and overseas GMP certification: a step-by-step guide
Guidance for applicants for manufacturing licences, and sponsors and manufacturers of goods manufactured overseas that require inspection for GMP certification - Declaration of intent to supply the Australian market
A declaration of intent to supply is required for GMP certification applications in certain circumstances. Where supply of the product has not commenced by the time a reinspection is due, we may decide to not conduct an inspection. This may lead to the lapse of the GMP clearance. - Requesting variations to your manufacturing licence: a step-by-step guide
Guidance for applicants for variations to a manufacturing licence which is in force for an Australian manufacturing site, under section 40B of the Therapeutic Goods Act 1989 - Transfer of a manufacturing licence
Guidance for Australian manufacturers who wish to transfer a manufacturing licence to another entity
Responsibilities
- Sponsor responsibilities related to GMP clearance and certification
Guidance for sponsors of medicines manufactured overseas - Responsibilities of manufacturers of medicines and biologicals
Manufacturers of medicines, APIs, biologicals, blood and blood components and haematopoietic progenitor cells have responsibilities in relation to: during manufacture, informing the TGA, licence-specific responsibilities and GMP inspections.
Revoking manufacturing licences
- Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence
Manufacturers can request revocation or suspension of their manufacturing licence or the TGA can initiate revocation or suspension - Revoking manufacturing licences for not paying the annual charge
We can revoke a manufacturing licence if the annual charge is not paid on time
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