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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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