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good manufacturing practice

As an operator of a Therapeutics Goods Administration (TGA) licensed manufacturing facility, The Herbal Extract Company of Australia agrees to uphold the principles of GMP as outlined in ‘The Australian Code of GMP for Medicinal Products’. This means we must ensure that the practitioner only liquid herbal extracts we manufacture are fit for their intended use, and do not place patients at risk due to inadequate safety, quality or efficacy. In order to do this and ensure continued compliance with the requirements of the TGA, we have designed and implemented a comprehensive system of Quality Assurance (QA), incorporating GMP and thus Quality Control (QC). This comprehensive system of Quality Assurance is fully documented, with its effectiveness routinely monitored by the TGA and ourselves, through regular audits.

Ensuring safety, quality and efficacy

  • All manufacturing processes are clearly defined
  • Critical steps in the manufacturing process are validated
  • Operators are trained to carry out procedures correctly
  • Comprehensive records are made during the manufacturing process which demonstrate that all necessary steps were performed
  • Batch records are retained to enable the complete history of a batch to be retraced
  • All necessary requirements for GMP are provided including:

A TGA audit focuses on the following aspects of GMP:

  • Personnel (qualifications and training)
  • Premises
  • Maintenance of buildings and grounds
  • Storage of starting materials and finished product
  • Equipment maintenance and cleaning
  • Production and in-process controls
  • Quality control
  • Raw material sampling and identification
  • Sanitation and hygiene of personnel and manufacturing premises
  • Documentation (batch records)
  • Validation and revalidation programs
  • Calibration of measuring instruments or systems
  • Recall procedures
  • Complaints management
  • Label control
  • Release for sale controls
  • Results of previous audits (internal and external) and any corrective action taken

When purchasing a liquid herbal extract from The Herbal Extract Company of Australia, you can be certain it is both safe for your patient and of the highest quality.