SeerPharma Blog

TGA GMP License Assistance for a New GMP Facility

May 11, 2017
by SeerPharma

SeerPharma has commenced work assisting a firm looking to manufacture and supply multivitamin tablets to China and Australia. Our team has been engaged to help obtain a TGA GMP license by ensuring that the manufacturer has a suitable Quality Management System and will also
help ensure that the facility and equipment the firm plans on using is validated.

Bringing over 30 years of experience to the fore, SeerPharma will provide the following range of solutions to help the client obtain their TGA license:

1. Quality System Documentation

SeerPharma will provide a set of quality system documentation templates that will be customised and
finalised by the client’s Quality personnel. SeerPharma will assist with the customisation to ensure the
right balance between regulatory compliance and operational efficiency. The documents will address
the high-level Quality System policies and procedures.

2. Operational Documentation

SeerPharma will map the process and identify all procedures and records needed to fulfil the GMP requirements. SeerPharma will provide templates as part of the Document Control system.

3. Validation Master Planning

SeerPharma will prepare a risk-based Validation Master Plan (VMP) identifying all the validation work
associated with the facility and equipment. It will include a process risk assessment which will contribute to the development of work instructions and batch records.

4. Validation Protocol and Report Documentation

SeerPharma will prepare IQ, OQ, PQ and PV protocols, supervise the client executing the validation,
review the data and write the validation reports for:

  • Facility Qualification
  • Equipment Qualification
  • Water System Qualification
  • Process Validation

5. Training

SeerPharma will provide formal training and coaching as required for:

  • Each Quality System element; e.g. Corrective and Preventive Action (CAPA), change management
  • Risk Management
  • General GMP training and the TGA-regulated environment

6. Mock TGA Inspection

Finally, SeerPharma will perform a mock audit of the complete operation in preparation for the TGA
inspection.

Contact us should you require any assistance with obtaining a GMP license for your facility from the US FDA, EU EMA, TGA or other PIC/S member regulatory body.

This post comes from our April 2017 Journal.  You may also be interested in:

Click here to see all SeerPharma Journal content

Filed Under: TGA GMP License, New GMP Facility