TGA Compliance verification

• GMP Audit
• GXP Audit
• Third Party / Vendor Audit
• Pre-Health Authorities Mock Audit
• Warning Letter Lifting
• Post Inspection Remediation
• Import Alert Lifting
• Quality Systems Development
• Computer System Validation
• Merger and Acquisition Consulting Services
• GMP Retainership on Hourly Basis
• Quality, GMP and Technical Trainings
• Engineering Services
• SOP Review and Writing
• Upgradation of Domestic Site to Regulatory
• Brazil GMP
• TGA Compliance Verification
• Brazil REBLAS / EQFAR Certification

TGA Compliance verification

A Deep Dive into Regulatory and GMP Verification for Overseas Manufacturers

In the Australian pharmaceutical and therapeutic goods landscape, compliance with the Therapeutic Goods Administration (TGA) regulatory framework is not just a box to tick—it is a foundational requirement for ensuring public safety, product quality, and effective market access. For sponsors and manufacturers, particularly those operating outside Australia, navigating the intricacies of TGA’s GMP (Good Manufacturing Practice) Clearance process is essential for legally supplying medicinal products in the country.

Importance of TGA Compliance

• Under the Therapeutic Goods Act 1989, any medicine or active pharmaceutical ingredient (API) manufactured overseas must be proven to meet acceptable standards of manufacturing and quality control before it can be included in the Australian Register of Therapeutic Goods (ARTG) and sold in Australia.
• This requirement applies to both registered and listed medicines and ensures that foreign facilities match the manufacturing rigour expected of Australian license holders.
• The TGA’s core objective is the assurance of safety, quality, and efficacy for all therapeutic goods consumed in Australia. Thus, overseas manufacturers must undergo a GMP Clearance process to demonstrate that their operations align with internationally accepted GMP standards.

Pathways to TGA GMP Clearance The TGA provides three key pathways for overseas GMP clearance:

1. Mutual Recognition Agreements (MRAs)
These apply when an overseas manufacturer has already been inspected and certified by a regulatory authority with which Australia holds a Mutual Recognition Agreement. Examples include authorities in the EU, Canada, Singapore, and Switzerland. MRA-based applications are usually faster (TGA target: 15 working days) and less documentation-intensive.

2. Compliance Verification (CV)
CV is the most commonly used pathway and involves a detailed assessment of inspection reports issued by a recognized overseas regulator (e.g., US FDA, Health Canada, MHRA). The sponsor must submit comprehensive documentation, such as Site Master Files, GMP agreements, inspection reports, Product Quality Reviews, and Validation Master Plans. CV timelines vary by product risk, typically taking 30 to 90 working days.

TGA On-site Audit

When MRA or CV evidence is inadequate or unavailable, the TGA may perform its own inspection of the overseas manufacturing facility. This is resource-intensive and costly but ensures full visibility and verification of GMP practices.

Regardless of the pathway, GMP Clearance must be renewed periodically, and sponsors are responsible for initiating renewal applications three months before the clearance expires.

Responsibilities of Australian Sponsors

Sponsors, as the legal bridge between manufacturers and the Australian market, hold the burden of proof and compliance. Their responsibilities include:

• Providing and maintaining up-to-date GMP evidence for all overseas manufacturing sites.
• Monitoring regulatory actions or inspection outcomes that may affect manufacturing sites.
• Notifying TGA promptly about any significant changes in scope, manufacturing processes, or facility ownership.
• Submitting variation applications to amend GMP Clearances where necessary.
• Establishing formal GMP contracts with manufacturers and their subcontractors.

Failure to uphold these duties can result in application rejection, clearance suspension, or withdrawal of product listings from the ARTG.

 Documentary Evidence and Best Practices

When applying via the CV pathway, sponsors must compile an evidence package tailored to the manufacturing activity and product type. This may include:

• A recent GMP certificate from a recognized authority.
• Inspection reports not older than three years.
• Site Master File and Quality Manual.
• GMP Agreements with direct manufacturers.
• Release procedures and testing protocols.
• Product Quality Reviews for sterile or biotech products.

Sponsors must ensure that all documentation is in English, current, and accurately reflects the manufacturing site’s scope and compliance level. Submitting outdated or ambiguous evidence is a common cause for clearance delays or denials.

Strategic Considerations for Overseas Manufacturers

If you’re an overseas manufacturer seeking to enter the Australian market, preparation is key:

• Align your internal GMP standards with PIC/S guidelines adopted by the TGA.
• Maintain open communication with your Australian sponsor regarding inspection outcomes or regulatory issues.
• Invest in proper documentation systems that can promptly support CV or MRA applications.
• Understand that the TGA may audit your site even if CV or MRA documentation has been provided, especially if risk signals are identified.

How Masuu Global Solutions Can Help

Achieving TGA compliance can be daunting—but it doesn’t have to be. At Masuu Global Solutions, we specialize in supporting overseas manufacturers and Australian sponsors through every step of the GMP clearance journey.

Our expert consultants provide:

• End-to-end guidance for CV and MRA submissions.
• Preparation and review of inspection documentation and site files.
• Audit readiness assessments and mock inspections.
• Direct liaison with TGA to resolve issues swiftly and efficiently.

Whether you’re navigating your first clearance or managing complex renewals, Masuu Global Solutions ensures you stay ahead of compliance challenges—so you can focus on delivering quality therapeutic goods to the Australian market.