TGA manufacturing Licensing (PIC/S)
In the rapidly evolving pharmaceutical industry, obtaining TGA (Therapeutic Goods Administration) licence is of utmost importance for gaining access to the Australian market and adhering to the country’s regulatory standards. Medicinal products, including listed products (AUST L) supplied in Australia must be manufactured at TGA licensed facility that meets the PIC/S standard for Good Manufacturing Practice (GMP). Whether you are currently manufacturing non-therapeutic products and looking to expanding into producing therapeutic products or you intend to start from ground up, R2 Pharma Solutions and their GMP experts can provide comprehensive solution.
R2 Pharma Solutions are GMP consultants and has expertise to implement a complete Pharmaceutical Quality System (PQS) for a manufacturing facility.
Our TGA and GMP experts in Good Manufacturing Practice (GMP) can assist with manufacturing setup for any product types including sterile injectables and hazardous medicines.
R2 Pharma Solutions can assist with complete implementation of following Quality Management Systems.
- TGA Manufacturing license (PIC/S) for sterile and non-sterile medicines
- ISO 9001 Quality Management System
- ISO 13485/MDSAP for Medical Devices
- Australian Pesticide and Veterinary Medicine Authority (APVMA) GMP Code
- Compounding labs, pharmacy facilities, research facilities and micro/analytical labs.
Comprehensive TGA License Solutions
Our GMP consultants experienced with the PIC/S GMP can assist with obtaining TGA manufacturing License. We can also assist with design of the facility. Depending on what stage your project is at, our GMP consultants can come in and assist with project management and designing a plan for implementing the right QMS for obtaining TGA manufacturing License.
PQS Documentations is our expertise including validations, risk managements, change management systems, corrective actions etc. We can design appropriate training management plan for all personnel.
We provide on-going ad hoc services and training if needed even after the issuing of TGA License.
Benefits of Choosing R2 Pharma Solutions
Following are some ways we define the TGA manufacturing license services we provide
Green Field Project (New Projects)
This is our one stop shop service, where we start from ground up or an empty warehouse. Product scope includes Master Plan, Architectural and Structural Designing, Detailed Electrical Design, Designing for Utilities System, Fire Fighting and Safety System, Piping Engineering, Process Automation Design, Procurement assistance and Co-ordination with site contractor
Brown Field Projects (Upgrades)
This is suitable for businesses currently manufacturing non-therapeutic products or non-TGA products and intend to achieve TGA manufacturing license. Our TGA consultants will provide scope that includes gap assessment to consider the additional steps needed to achieve TGA license. Estimate and scope of work is then prepared for the client. This is also suitable for compounding pharmacies intending to achieve TGA licensing.
Quality Management Systems (QMS)
This is often combined with Green Field Project and Brown Filed Projects, but can also be provided own it own for businesses that already have facility design in place. Our TGA consultants will provide documentation assistance to implement full QMS including Validation protocols and assisting with validating necessary equipment or processes.
Ad Hoc services (Value added)
This is our ongoing assistance with the maintenance of the QMS or providing vendor audits, internal audits, mock audits etc. We provide total training for GMP / GLP/GWP/GEP/ VALIDATION /STABILITY/ DOCUMENTATIONS.
FAQs
To obtain a Therapeutic Goods Administration (TGA) license in Australia, you generally need to meet the requirements specific to the type of therapeutic goods you intend to manufacture, import, export, or supply. The TGA regulates a wide range of therapeutic goods, including medicines, medical devices, biologicals, and blood products. You must consider type of products you intend to manufacture, appoint a qualified personnel, ensure facility is in compliance with PIC/s requirement and be ready for TGA audit inspection.
TGA manufacturing license consulting services, such as those offered by R2 Pharma Solutions, provide valuable expertise and guidance throughout the entire TGA license journey. These services can benefit your business in several ways:
- Expert Guidance: TGA consultants offer comprehensive support, from the initial gap assessment, design phase to implementation and training.
- Time and Resource Savings: Consultants streamline the license acquisition and PIC/S alignment processes, saving your business valuable time and resources.
- Access to Industry Knowledge: TGA consultants have access to a network of regulatory experts and stay updated with the latest industry knowledge, giving your business a competitive edge.
Absolutely! A TGA license consultant, like those at R2 Pharma Solutions, can provide invaluable assistance with the preparation and submission of license applications. They have expertise in compiling the required technical dossiers and supporting documentation.
Yes, our TGA license consultants are well-versed in quality management systems and documentation requirements. They can offer guidance on establishing and maintaining quality management systems that comply with TGA regulations. We provide comprehensive documentation service that is targeted towards your process. We do not stop at developing templates only, we will assist in populating the documents specific to your processes. We will provide the necessary training and can participate in the TGA audit as well.