Quality Control Specifics  

What is G.M.P.?
Good Manufacturing Practice is licensed by the Australian Federal Government. It is a standard of manufacturing set in accordance with the guide-lines of the Standard of Overseas Manufacturers; which must be reached before a license to manufacture therapeutic goods can be obtained. This is an involved and expensive procedure which is audited each year.

G.M.P. Procedures:

  • Quarantine all incoming starting materials for therapeutic goods
  • Current certificate of analysis presented for each batch.

  • Set specification for each oil.
  • Testing, standard comparisons and documentation of all material prior to release into the production area.
  • Manufacturing area must be clean, hygienic, contamination-free environment with micro-biologically filtered      air.
  • Each batch of oil bottled must have a distinct and separate batch number.
  • Elaborate batch records, reconciliation's and documentation must be completed for oils, bottles, labels and      any other starting materials.
  • Samples of each batch to be kept for up to two years.
  • Procedure and records for stability testing of samples.
  • Rejection, complaints and recall procedures and documentation must exist.

  • What is T.G.A.?
    This is the Therapeutic Goods Act of 1989 which aims to promote the development of a national system of controls relating to the quality, safety, efficacy and timely availability of Therapeutic Goods used in Australia or exported from Australia. All manufacturers selling Therapeutic Goods to the public must hold this license.

    T.G.A. Procedures
    In order to hold a TGA license all therapeutic products must be listed or registered on the Australian Register of Therapeutic Goods.
  • The products must display their AUST L or AUST R number on the primary packaging
  • Detailed and accurate labeling must be approved by the TGA to show: the common name, botanical      species and plant part.
  • The batch numbers and expiry date. Dosages and directions must be on the primary pack or insert
  • Storage conditions
  • Cautions
  • Strict advertising codes must be adhered to for any promotional and advertising material displayed to the      public.
  • Annual license fee and listing fee for each product.

  • What is a Certificate of Analysis?
    A certificate of analysis is a document certified by a manufacturer of therapeutic goods as a truthful statement of tests and test results for an individual, manufactured batch of a particular product.

    The certificate should identify at least:
  • The primary manufacturer
  • The product
  • The date of the certificate and date of testing
  • The batch of the product
  • The tests and test results
  • The acceptable test specifications. (These are the limits or range of results to which the batch must comply).
  • The signature of the appropriate company official.

  • See also:
    Our Commitment to Quality
    Company Profile

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