manuf twg cm sampling 131217
Technical guidance on the
interpretation of manufacturing
standards
Sampling and testing of complementary
medicines
Technical working group on complementary
medicines
Version 1.1, July 2013
Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)
•
The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical
devices.
•
The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk
management approach designed to ensure therapeutic goods supplied in Australia
meet acceptable standards of quality, safety and efficacy (performance), when
necessary.
•
The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with
the use of medicines and medical devices.
•
The TGA relies on the public, healthcare professionals and industry to report problems
with medicines or medical devices. TGA investigates reports received by it to
determine any necessary regulatory action.
•
To report a problem with a medicine or medical device, please see the information on
the TGA website .
Copyright
© Commonwealth of Australia 2013
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal
use or, if you are part of an organisation, for internal use within your organisation, but only if you or your
organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all
disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or
allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any
part of this work in any way (electronic or otherwise) without first being given specific written permission from the
Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA
Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to
.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 2 of 13
Therapeutic Goods Administration
Version history
Version
Description of change
Author
Effective date
V1.0
Original publication
Office of Manufacturing
Quality
12/05/2009
V1.1
Template update
Office of Manufacturing
Quality
01/07/2013
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 3 of 13
Therapeutic Goods Administration
Contents
Technical working groups
5
About this guidance
5
Disclaimer ______________________________________________________________________ 5
Further information __________________________________________________________ 5
Purpose__________________________________________________________________________ 6
Scope _____________________________________________________________________________ 6
Glossary _________________________________________________________________________ 6
Intermediate product ______________________________________________________________________ 6
Bulk product ________________________________________________________________________________ 6
Finished product ___________________________________________________________________________ 6
Certificate of Analysis (C of A) ____________________________________________________________ 7
Sampling
7
Testing
8
Further items for clarification
10
Extension of assigned expiry date for raw materials__________________ 10
Extension of assigned expiry date for bulk and finished goods _____ 10
Premixes ______________________________________________________________________ 11
Preservatives in raw materials ___________________________________________ 11
Herbs and herbal extracts _________________________________________________ 11
Multi herb materials _____________________________________________________________________ 11
Rotational testing ____________________________________________________________ 11
Starting material grade _____________________________________________________ 11
References
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
12
Page 4 of 13
Therapeutic Goods Administration
Technical working groups
Technical Working Groups have been established by the TGA’s OMQ to bring together
manufacturing technical expertise from industry and the regulator to address the
standards for the application of Manufacturing Standards.
The aim of the Technical Working Groups is to:
•
Establish a formal and transparent forum for industry and the regulator to work
cohesively in order to provide advice on the application of manufacturing standards.
•
Improve and foster industry implementation of manufacturing standards, and enhance
regulatory audit consistency in the application of manufacturing standards.
•
Identify and discuss key areas of concern, and address emerging issues relevant to the
interpretation and application of manufacturing standards.
•
Develop specific guidance documents as appropriate.
Guidance documents are not intended to establish a minimum standard of practice
for audit purposes. Guidance documents are not enforceable.
About this guidance
This Guidance is not mandatory or enforceable under law. It is not intended to be
restrictive. It describes a way that a manufacturer may use to demonstrate compliance
with the relevant Code of GMP or QMS Standard.
Disclaimer
This document is provided for guidance only and has been developed on the basis of
current knowledge of the subject matter. It should not be relied upon to address every
aspect of the relevant legislation. Please also refer to the Therapeutic Goods Act, and the
Therapeutic Goods Regulations, 1990 for legislative requirements and the relevant Code of
GMP or Quality Management System Standard for technical requirements.
Further information
The Office of Manufacturing Quality of the Therapeutic Goods Administration (TGA) can be
contacted by:
Email:
•
General & Australian manufacturing enquiries: gmp@tga.gov.au
•
Overseas manufacturing enquiries: gmpclearance@tga.gov.au
Phone:
•
02 6232 8156
•
1800 446 443 (free call)
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 5 of 13
Therapeutic Goods Administration
•
Users who are deaf or have a hearing or speech impairment can call through the
National Relay Service:
–
TTY or computer with modem users phone 1800 555 677 then ask for
1800 020 653
–
Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for
1800 020 653
Fax:
•
02 6232 8426
Post:
•
Office of Manufacturing Quality, TGA, PO Box 100, Woden ACT 2606, Australia
Website:
•
Purpose
This guidance is intended to clarify the interpretation of the Australian Code of GMP for
Medicinal Products in relation to the sampling and testing of complementary medicines.
It covers the sampling and testing requirements for raw materials used in the manufacture
of complementary medicines and complementary medicines, whether in the form of
intermediate, bulk or finished products.
It also describes a plan for reduced sampling and testing once an approved supplier has
been qualified.
Scope
This guidance is relevant to complementary medicines.
Glossary
Intermediate product
Partly processed material which must undergo further manufacturing steps before it
becomes a bulk product.
Bulk product
Any product that has completed all processing steps up to, but not including, final
packaging.
Finished product
Any medicinal product which has undergone all stages of production including packaging
in the final container.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 6 of 13
Therapeutic Goods Administration
Certificate of Analysis (C of A)
A certificate issued by the manufacturer of the product reporting the test results obtained
for the specified lot(s) of product supplied.
Sampling
Table of sampling criteria and qualifications
Criteria – Pre qualification
Post qualification
Excipents – Raw materials
Guideline currently allows √n +1
Apply √n +1 or reduced sampling plan if
material is from a site that manufactures only
one product, eliminating product mix-up
possibilities. Further reduced sampling or
alternative sampling plans may be justified.
Actives – Raw materials
All containers to be sampled
Intermediate product
All intermediate products must be sourced from
manufacturers that are either TGA licensed or
have a TGA GMP clearance. All containers to be
sampled, with the exception of solid dosage
forms transported for coating.
Apply √n +1 or reduced sampling plan
Apply √ n+1 or reduced sampling plan.
Bulk product
All bulk products, including solid dosage forms
transported for coating, must be sourced from
manufacturers that are either TGA licensed or
have a TGA GMP clearance. As such, prequalification does not apply.
Container must have some form of integrity
sealing; otherwise sample every container.
Containers should be numbered and the
quantity reconciled.
If integrity seals are intact, sample 1 container
from each pallet or the √n +1 of all containers,
whichever is less.
If integrity seals are compromised on any
container then an investigation should be
documented by the Quality Unit.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 7 of 13
Therapeutic Goods Administration
Criteria – Pre qualification
Post qualification
Finished product
If testing occurs on the finished pack for release
purposes, samples must be taken throughout
the run and be representative of the entire
batch.
Additional sampling of finished packs is not
required by the sponsor if retention samples are
held by the contract manufacturer.
Sufficient retention samples should be held to
allow two times full testing of the product.
Testing
Table of testing requirements
Table of testing requirements
Raw materials
Excipients:
Identity testing performed individually on all
sampled containers, each delivery.
Composite of all samples for other tests.
Critical tests on composite samples on all
deliveries. Assay may / may not be considered
critical. Moisture may be critical depending on
the raw material risk analysis and finished
product it’s used in.
All other tests can be rotated.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 8 of 13
Therapeutic Goods Administration
Table of testing requirements
Actives:
Identity testing performed individually on all
sampled containers, each delivery.
Composite all samples for other tests.
Critical tests on composite samples on all
deliveries. Assay considered critical if part of
release specification.
Minerals should not be excluded from critical
assay. Moisture and related substances may be
critical depending on the raw material.
All other tests may be rotated.
Intermediate product
Sufficient testing should be conducted to ensure
quality of the product.
Bulk product
Single Active products
Sufficient testing, including active ingredient
assay where possible and Uniformity of Content
testing (if required), should be conducted to the
quality of the product.
Customers can accept C of A from TGA licensed
or GMP clearance issued manufacturers without
further testing if the following issues are
addressed:
Verification of supply chain (may be included in
supplier qualification).
Examination of packaging for integrity of seal.
Individual samples visually inspected.
Visual comparison of bulk materials against an
internal reference standard for identification
purposes.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 9 of 13
Therapeutic Goods Administration
Table of testing requirements
Multi Active products
Sufficient testing should be conducted to ensure
the quality of the product. Reduced and/or
rotational testing may be used where justified.
Customers can accept C of A from TGA licensed
or GMP clearance issued manufacturers without
further testing if the following issues are
addressed:
Verification of supply chain (may be included in
supplier qualification).
Examination of packaging for integrity of seal.
Individual samples visually inspected.
Visual comparison of bulk materials for
identification purposes.
Finished product
If testing occurring at this stage, same protocol
to be followed as for bulk product.
No need for repeat chemical testing if already
performed on bulk product.
Micro testing on finished pack for liquids and
semi solids if applicable.
Further items for clarification
Extension of assigned expiry date for raw materials
Extensions of assigned expiry date are permitted up to the manufacturer’s recommended
expiry date. Extensions beyond the manufacturer’s recommended expiry date require data
(e.g. assay and impurity testing) clearly justifying the extension.
Extension of assigned expiry date for bulk and finished
goods
Extensions of assigned expiry date are permitted provided data (e.g. stability data) is
available supporting the extension. Extension beyond 5 years from original date of
manufacture is not permitted. Any extension to the expiry date of the finished goods must
be based on stability data.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 10 of 13
Therapeutic Goods Administration
Premixes
Multi active ingredients eg vitamin premixes: Test all ingredients where possible.
Preservatives in raw materials
Testing of preservatives not required
Herbs and herbal extracts
Identification testing is critical. Active component testing is critical if component reported
on label. Microbiological testing as required. Heavy metals tested on a rotational basis. C of
A result acceptable for other criteria, including pesticides and residual solvents (where
relevant).
If herbal extracts are sourced from a manufacturer that is either TGA licensed or has a TGA
GMP clearance then extracts can be accepted on a C of A without further testing if the
following issues are addressed:
•
Verification of supply chain (may be included in supplier qualification).
•
Examination of packaging for integrity of seal.
Multi herb materials
Must be able to uniquely identify each herb in the material. If multi herb materials are
sourced from a manufacturer that is either TGA licensed or has a GMP clearance then multi
herb materials can be accepted on a C of A without further testing.
Rotational testing
May be implemented once supplier qualified. Any rejected material relating to quality
issue from supplier, should result in reverting status back to non-qualified.
Rotational testing is considered to follow the process below:
•
Perform critical tests on each delivery plus one non critical test
•
Non critical test are rotated. It is expected that all test are to be done and none are
skipped without adequate justification.
Starting material grade
It is expected that starting materials will comply with the applicable pharmacopoeial
requirements as specified in the Therapeutic Goods Act.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 11 of 13
Therapeutic Goods Administration
References
•
PIC/S Guide to Good Manufacturing Practice for Medicinal Products – 15 January 2009,
including Annexes
•
TGO 69 – General Requirements for Labels for Medicines
•
TGO 78 – General Requirements for Tablets and Capsules
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 12 of 13
Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference/Publication #R13/525421
interpretation of manufacturing
standards
Sampling and testing of complementary
medicines
Technical working group on complementary
medicines
Version 1.1, July 2013
Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)
•
The Therapeutic Goods Administration (TGA) is part of the Australian Government
Department of Health, and is responsible for regulating medicines and medical
devices.
•
The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk
management approach designed to ensure therapeutic goods supplied in Australia
meet acceptable standards of quality, safety and efficacy (performance), when
necessary.
•
The work of the TGA is based on applying scientific and clinical expertise to decisionmaking, to ensure that the benefits to consumers outweigh any risks associated with
the use of medicines and medical devices.
•
The TGA relies on the public, healthcare professionals and industry to report problems
with medicines or medical devices. TGA investigates reports received by it to
determine any necessary regulatory action.
•
To report a problem with a medicine or medical device, please see the information on
the TGA website .
Copyright
© Commonwealth of Australia 2013
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal
use or, if you are part of an organisation, for internal use within your organisation, but only if you or your
organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all
disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or
allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any
part of this work in any way (electronic or otherwise) without first being given specific written permission from the
Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA
Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to
.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 2 of 13
Therapeutic Goods Administration
Version history
Version
Description of change
Author
Effective date
V1.0
Original publication
Office of Manufacturing
Quality
12/05/2009
V1.1
Template update
Office of Manufacturing
Quality
01/07/2013
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 3 of 13
Therapeutic Goods Administration
Contents
Technical working groups
5
About this guidance
5
Disclaimer ______________________________________________________________________ 5
Further information __________________________________________________________ 5
Purpose__________________________________________________________________________ 6
Scope _____________________________________________________________________________ 6
Glossary _________________________________________________________________________ 6
Intermediate product ______________________________________________________________________ 6
Bulk product ________________________________________________________________________________ 6
Finished product ___________________________________________________________________________ 6
Certificate of Analysis (C of A) ____________________________________________________________ 7
Sampling
7
Testing
8
Further items for clarification
10
Extension of assigned expiry date for raw materials__________________ 10
Extension of assigned expiry date for bulk and finished goods _____ 10
Premixes ______________________________________________________________________ 11
Preservatives in raw materials ___________________________________________ 11
Herbs and herbal extracts _________________________________________________ 11
Multi herb materials _____________________________________________________________________ 11
Rotational testing ____________________________________________________________ 11
Starting material grade _____________________________________________________ 11
References
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
12
Page 4 of 13
Therapeutic Goods Administration
Technical working groups
Technical Working Groups have been established by the TGA’s OMQ to bring together
manufacturing technical expertise from industry and the regulator to address the
standards for the application of Manufacturing Standards.
The aim of the Technical Working Groups is to:
•
Establish a formal and transparent forum for industry and the regulator to work
cohesively in order to provide advice on the application of manufacturing standards.
•
Improve and foster industry implementation of manufacturing standards, and enhance
regulatory audit consistency in the application of manufacturing standards.
•
Identify and discuss key areas of concern, and address emerging issues relevant to the
interpretation and application of manufacturing standards.
•
Develop specific guidance documents as appropriate.
Guidance documents are not intended to establish a minimum standard of practice
for audit purposes. Guidance documents are not enforceable.
About this guidance
This Guidance is not mandatory or enforceable under law. It is not intended to be
restrictive. It describes a way that a manufacturer may use to demonstrate compliance
with the relevant Code of GMP or QMS Standard.
Disclaimer
This document is provided for guidance only and has been developed on the basis of
current knowledge of the subject matter. It should not be relied upon to address every
aspect of the relevant legislation. Please also refer to the Therapeutic Goods Act, and the
Therapeutic Goods Regulations, 1990 for legislative requirements and the relevant Code of
GMP or Quality Management System Standard for technical requirements.
Further information
The Office of Manufacturing Quality of the Therapeutic Goods Administration (TGA) can be
contacted by:
Email:
•
General & Australian manufacturing enquiries: gmp@tga.gov.au
•
Overseas manufacturing enquiries: gmpclearance@tga.gov.au
Phone:
•
02 6232 8156
•
1800 446 443 (free call)
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 5 of 13
Therapeutic Goods Administration
•
Users who are deaf or have a hearing or speech impairment can call through the
National Relay Service:
–
TTY or computer with modem users phone 1800 555 677 then ask for
1800 020 653
–
Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for
1800 020 653
Fax:
•
02 6232 8426
Post:
•
Office of Manufacturing Quality, TGA, PO Box 100, Woden ACT 2606, Australia
Website:
•
Purpose
This guidance is intended to clarify the interpretation of the Australian Code of GMP for
Medicinal Products in relation to the sampling and testing of complementary medicines.
It covers the sampling and testing requirements for raw materials used in the manufacture
of complementary medicines and complementary medicines, whether in the form of
intermediate, bulk or finished products.
It also describes a plan for reduced sampling and testing once an approved supplier has
been qualified.
Scope
This guidance is relevant to complementary medicines.
Glossary
Intermediate product
Partly processed material which must undergo further manufacturing steps before it
becomes a bulk product.
Bulk product
Any product that has completed all processing steps up to, but not including, final
packaging.
Finished product
Any medicinal product which has undergone all stages of production including packaging
in the final container.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 6 of 13
Therapeutic Goods Administration
Certificate of Analysis (C of A)
A certificate issued by the manufacturer of the product reporting the test results obtained
for the specified lot(s) of product supplied.
Sampling
Table of sampling criteria and qualifications
Criteria – Pre qualification
Post qualification
Excipents – Raw materials
Guideline currently allows √n +1
Apply √n +1 or reduced sampling plan if
material is from a site that manufactures only
one product, eliminating product mix-up
possibilities. Further reduced sampling or
alternative sampling plans may be justified.
Actives – Raw materials
All containers to be sampled
Intermediate product
All intermediate products must be sourced from
manufacturers that are either TGA licensed or
have a TGA GMP clearance. All containers to be
sampled, with the exception of solid dosage
forms transported for coating.
Apply √n +1 or reduced sampling plan
Apply √ n+1 or reduced sampling plan.
Bulk product
All bulk products, including solid dosage forms
transported for coating, must be sourced from
manufacturers that are either TGA licensed or
have a TGA GMP clearance. As such, prequalification does not apply.
Container must have some form of integrity
sealing; otherwise sample every container.
Containers should be numbered and the
quantity reconciled.
If integrity seals are intact, sample 1 container
from each pallet or the √n +1 of all containers,
whichever is less.
If integrity seals are compromised on any
container then an investigation should be
documented by the Quality Unit.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 7 of 13
Therapeutic Goods Administration
Criteria – Pre qualification
Post qualification
Finished product
If testing occurs on the finished pack for release
purposes, samples must be taken throughout
the run and be representative of the entire
batch.
Additional sampling of finished packs is not
required by the sponsor if retention samples are
held by the contract manufacturer.
Sufficient retention samples should be held to
allow two times full testing of the product.
Testing
Table of testing requirements
Table of testing requirements
Raw materials
Excipients:
Identity testing performed individually on all
sampled containers, each delivery.
Composite of all samples for other tests.
Critical tests on composite samples on all
deliveries. Assay may / may not be considered
critical. Moisture may be critical depending on
the raw material risk analysis and finished
product it’s used in.
All other tests can be rotated.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 8 of 13
Therapeutic Goods Administration
Table of testing requirements
Actives:
Identity testing performed individually on all
sampled containers, each delivery.
Composite all samples for other tests.
Critical tests on composite samples on all
deliveries. Assay considered critical if part of
release specification.
Minerals should not be excluded from critical
assay. Moisture and related substances may be
critical depending on the raw material.
All other tests may be rotated.
Intermediate product
Sufficient testing should be conducted to ensure
quality of the product.
Bulk product
Single Active products
Sufficient testing, including active ingredient
assay where possible and Uniformity of Content
testing (if required), should be conducted to the
quality of the product.
Customers can accept C of A from TGA licensed
or GMP clearance issued manufacturers without
further testing if the following issues are
addressed:
Verification of supply chain (may be included in
supplier qualification).
Examination of packaging for integrity of seal.
Individual samples visually inspected.
Visual comparison of bulk materials against an
internal reference standard for identification
purposes.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 9 of 13
Therapeutic Goods Administration
Table of testing requirements
Multi Active products
Sufficient testing should be conducted to ensure
the quality of the product. Reduced and/or
rotational testing may be used where justified.
Customers can accept C of A from TGA licensed
or GMP clearance issued manufacturers without
further testing if the following issues are
addressed:
Verification of supply chain (may be included in
supplier qualification).
Examination of packaging for integrity of seal.
Individual samples visually inspected.
Visual comparison of bulk materials for
identification purposes.
Finished product
If testing occurring at this stage, same protocol
to be followed as for bulk product.
No need for repeat chemical testing if already
performed on bulk product.
Micro testing on finished pack for liquids and
semi solids if applicable.
Further items for clarification
Extension of assigned expiry date for raw materials
Extensions of assigned expiry date are permitted up to the manufacturer’s recommended
expiry date. Extensions beyond the manufacturer’s recommended expiry date require data
(e.g. assay and impurity testing) clearly justifying the extension.
Extension of assigned expiry date for bulk and finished
goods
Extensions of assigned expiry date are permitted provided data (e.g. stability data) is
available supporting the extension. Extension beyond 5 years from original date of
manufacture is not permitted. Any extension to the expiry date of the finished goods must
be based on stability data.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 10 of 13
Therapeutic Goods Administration
Premixes
Multi active ingredients eg vitamin premixes: Test all ingredients where possible.
Preservatives in raw materials
Testing of preservatives not required
Herbs and herbal extracts
Identification testing is critical. Active component testing is critical if component reported
on label. Microbiological testing as required. Heavy metals tested on a rotational basis. C of
A result acceptable for other criteria, including pesticides and residual solvents (where
relevant).
If herbal extracts are sourced from a manufacturer that is either TGA licensed or has a TGA
GMP clearance then extracts can be accepted on a C of A without further testing if the
following issues are addressed:
•
Verification of supply chain (may be included in supplier qualification).
•
Examination of packaging for integrity of seal.
Multi herb materials
Must be able to uniquely identify each herb in the material. If multi herb materials are
sourced from a manufacturer that is either TGA licensed or has a GMP clearance then multi
herb materials can be accepted on a C of A without further testing.
Rotational testing
May be implemented once supplier qualified. Any rejected material relating to quality
issue from supplier, should result in reverting status back to non-qualified.
Rotational testing is considered to follow the process below:
•
Perform critical tests on each delivery plus one non critical test
•
Non critical test are rotated. It is expected that all test are to be done and none are
skipped without adequate justification.
Starting material grade
It is expected that starting materials will comply with the applicable pharmacopoeial
requirements as specified in the Therapeutic Goods Act.
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 11 of 13
Therapeutic Goods Administration
References
•
PIC/S Guide to Good Manufacturing Practice for Medicinal Products – 15 January 2009,
including Annexes
•
TGO 69 – General Requirements for Labels for Medicines
•
TGO 78 – General Requirements for Tablets and Capsules
Technical guidance on the interpretation of the manufacturing standards: Sampling and testing of
complementary medicines
V1.1 July 2013
Page 12 of 13
Therapeutic Goods Administration
PO Box 100 Woden ACT 2606 Australia
Email: info@tga.gov.au Phone: 1800 020 653 Fax: 02 6232 8605
http://www.tga.gov.au
Reference/Publication #R13/525421