How do I get a GMP manufacturing licence in Australia?

Obtaining a GMP manufacturing licence in Australia requires more than submitting an application to the Therapeutic Goods Administration (TGA). An Australian manufacturing site must demonstrate that its facilities, equipment, personnel, quality systems, documentation and manufacturing practices comply with the applicable regulatory requirements for the therapeutic goods it intends to manufacture.

For medicines, active pharmaceutical ingredients and other relevant therapeutic goods, the licensing process is designed to establish that the manufacturer can consistently operate in accordance with the applicable GMP requirements. The TGA states that Australian manufacturers of medicines, APIs and biologicals must apply for a manufacturing licence for the Australian manufacturing site.

The practical process therefore starts well before the application is lodged. A manufacturer needs to understand the scope of manufacture, establish the required quality system, prepare supporting documentation and ensure that the site can demonstrate effective implementation during inspection.

Determine Whether a TGA Manufacturing Licence Is Required

The first step is determining whether the proposed activity constitutes manufacture requiring a TGA licence.

Australian legislation requires manufacturers of therapeutic goods for human use to hold a manufacturing licence or, where applicable, a conformity assessment certificate, unless an exemption applies. The TGA provides a GMP application decision tree to assist manufacturers in determining the appropriate regulatory pathway.

The answer depends on the type of therapeutic good, the manufacturing activity being performed and the applicable legislative requirements. Consequently, a manufacturer should establish the regulatory scope before developing an application around assumptions about its operations.

For an Australian manufacturing site, the relevant pathway is generally a TGA manufacturing licence where the activities fall within the licensing requirements. Overseas manufacturers supplying products to Australia follow a different GMP certification or clearance framework.

Define the Manufacturing Scope

A GMP licence is not simply an approval of a building. The licence identifies the manufacturing site and the types of products and manufacturing steps authorised. A Schedule of Conditions generally accompanies the licence and can include conditions specific to the licensed operations.

Defining the intended scope accurately is therefore critical.

The manufacturer needs to identify the products, manufacturing operations and activities that it intends to have covered. The TGA states that the inspection is limited to the scope described in the application.

This makes scope definition an important early activity. An application that does not accurately describe the intended operations can create unnecessary complications during inspection or leave activities outside the proposed licence scope.

Establish the Applicable GMP Requirements

The next stage is understanding the GMP requirements applicable to the products and processes.

For medicinal products, Australia currently applies the PIC/S Guide to GMP PE009-17, subject to the Australian implementation provisions. The current requirements took effect from 1 September 2025, with specific transitional arrangements associated with changes to Annex 1 for sterile manufacture.

The applicable GMP framework addresses areas including pharmaceutical quality systems, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints, deviations, corrective and preventive actions, validation and other aspects of pharmaceutical manufacturing.

The precise requirements relevant to a particular site depend on its manufacturing activities. A sterile facility, for example, will have requirements that differ in important respects from those applicable to a non-sterile manufacturing operation.

Perform a GMP Gap Assessment

Before submitting an application, a structured GMP gap assessment can identify where the site does not yet meet the applicable requirements.

The assessment should examine both documented systems and actual implementation. Typical areas include the pharmaceutical quality system, organisational responsibilities, personnel training, premises, equipment qualification, utilities, materials management, production controls, laboratory controls, validation, data integrity, deviation management, CAPA, change control, supplier oversight and batch documentation.

A useful assessment does not simply generate a list of missing procedures. It evaluates whether the quality system operates effectively and whether objective evidence exists to demonstrate that it does.

This distinction becomes particularly important during inspection. TGA inspectors review the quality management system, manufacturing areas and personnel and seek evidence demonstrating compliance with the relevant GMP standards.

Build and Implement the Quality System

A manufacturer needs an operational quality system capable of supporting GMP activities.

This generally includes controlled procedures and records governing activities such as document management, training, deviations, CAPA, change control, complaints, recalls, supplier qualification, quality risk management, validation and batch release.

However, implementation matters as much as documentation.

A procedure that exists only as an approved document does not demonstrate effective GMP control. Personnel need to understand their responsibilities, records need to show that procedures are being followed, and quality decisions need to be appropriately documented.

The objective is therefore to establish a system that functions in routine operations before the inspection takes place.

Prepare the Facility and Equipment

The physical manufacturing environment must support the proposed GMP operations.

Depending on the manufacturing process, this can include appropriate premises, controlled areas, equipment, utilities, material flows, personnel flows, cleaning systems, environmental controls and storage arrangements.

Equipment and systems may also require qualification or validation appropriate to their intended use. The manufacturer should be able to demonstrate that critical equipment and processes are suitable for the activities being performed.

Inspection readiness consequently involves more than making the facility appear orderly. The underlying systems, records and controls need to demonstrate that the manufacturing operation is capable of consistently producing therapeutic goods of the required quality.

Prepare the Application

Once the manufacturing site and quality systems are sufficiently developed, the manufacturer can prepare the TGA application.

The TGA application process includes becoming a TGA client, compiling documentation, completing the relevant statutory declaration, submitting the application and paying the applicable fee.

The application should accurately reflect the proposed manufacturing activities. The TGA specifically advises applicants to ensure that the manufacturing scope identified in the application fully reflects the activities they want licensed.

The application becomes effective once the required supporting documentation has been supplied and the relevant application fee has been paid. TGA then reviews the application and determines whether an inspection is required.

Prepare for the TGA Inspection

For applications requiring inspection, preparation should focus on demonstrating actual GMP implementation.

TGA inspections examine relevant facilities, processes, equipment, staff, training and quality management systems. Inspectors assess compliance against the applicable manufacturing principles and the scope of the application.

During an inspection, personnel may be asked to explain procedures, demonstrate processes and provide supporting records. Inspectors can identify deficiencies and request additional evidence.

A typical inspection includes an opening meeting, review of the quality system and manufacturing operations, discussions with personnel, and a closing meeting during which identified deficiencies are discussed. TGA states that inspection duration depends on the complexity of the manufacturing operation, with inspections commonly taking between one and five working days.

Inspection readiness therefore means being able to demonstrate that the system works in practice.

Address GMP Deficiencies

If deficiencies are identified, the manufacturer must address them through appropriate corrective actions and provide the required responses and evidence.

The TGA's licensing process includes post-inspection review, addressing deficiencies, assessment of responses and inspection closeout before the licensing decision is finalised.

Corrective actions should address the underlying issue rather than simply treating the immediate observation. Where appropriate, the manufacturer may need to determine the root cause, assess the extent of the issue, implement corrective action and establish measures to prevent recurrence.

The quality and completeness of these responses can therefore be an important component of the overall licensing process.

Licence Grant and Ongoing GMP Compliance

Successful completion of the licensing process results in a TGA Licence to Manufacture covering the authorised site and manufacturing activities. The licence remains in force unless it is revoked or suspended, and the TGA publishes a list of licensed Australian manufacturers.

Obtaining the licence does not conclude GMP responsibilities. Manufacturers remain subject to ongoing regulatory oversight and must maintain compliance with the applicable requirements.

Changes to manufacturing operations, premises, processes or licence conditions may require notification, variation or other regulatory action depending on the nature of the change. Follow-up inspections can also form part of the ongoing regulatory framework.

Manufacturers must also ensure that they do not commence manufacturing therapeutic goods for supply to Australia before the required licence or certification has been granted, unless an applicable prior approval or exemption applies.

How Quality Systems Now Supports GMP Licensing

The most effective licensing programs treat the TGA application as the final stage of a broader GMP implementation project rather than as the starting point.

Quality Systems Now supports manufacturers through the practical stages required to establish inspection readiness. This can include assessing the existing quality system against applicable GMP requirements, identifying gaps, developing and implementing controlled documentation, establishing quality processes, reviewing manufacturing and laboratory controls, and preparing personnel for regulatory inspection.

The emphasis is on building systems that can operate effectively in routine manufacturing rather than creating documentation solely for the purpose of an inspection.

For a new Australian manufacturing site, the licensing pathway can therefore be understood as a progression: determine whether a licence is required, define the manufacturing scope, establish the applicable GMP framework, assess and close compliance gaps, implement the quality system, prepare the facility and supporting evidence, submit the application, undergo inspection where required, address deficiencies and maintain compliance after the licence is granted.

The TGA licence is ultimately evidence that the manufacturing site has met the applicable regulatory requirements for the authorised scope. The underlying objective is the sustained operation of a manufacturing system in which quality is controlled and demonstrated throughout the manufacturing process.