Manufacturing biologicals

This section is for manufacturers of biologicals. You should also see Manufacturing basics and Manufacturing inspections, which include information for manufacturers of all types of therapeutic goods.

Manufacturing principles

Different manufacturing principles apply to different kinds of biologicals.

• Biologicals that comprise, contain or are derived from human cells and tissues, or are specified as a biological by the Secretary, must comply with the Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products.
• Biologicals that comprise or contain live animal cells, tissues or organs must comply with the PIC/S guide to GMP, except for annexes 4, 5, 14 and 16 (the same manufacturing principles that apply to medicines)

Guidelines

• Australian regulatory guidelines for biologicals (ARGB)
  Information for manufacturers, sponsors, health professionals and the general public on the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals')
• Manufacturing FMT products
  Information for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products

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
• S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites
  Circumstances when manufacturing licence may cover two or more manufacturing sites
• 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 (HPCs) 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