Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 1999 (Cth)

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Manufacturing Principles)

Determination No 1 of 1999

MP1/1999

I, TERENCE SLATER, delegate of the Minister for Health and Aged Care for the purpose of section 36 of the Therapeutic Goods Act 1989 and acting under subsection 36(1) of that Act, determine the following principles to be observed in the manufacture of all therapeutic goods for use in humans.

Dated 22^nd July 1999                 Signed T SLATER

Delegate of the Minister for Health and Aged Care

Citation

1. This Determination may be cited as the Therapeutic Goods (Manufacturing
            Principles) Determination No 1 of 1999.

   
   

Commencement

2.         This Determination commences on the date of gazettal.

[Note: see Acts Interpretation Act 1901, s.46A and s.48.]

Revocation

3.         This Determination revokes the previous Therapeutic Goods (Manufacturing 
         Principles) Determination number 3 of 1998 and all previous Determinations 
         made under subsection 36(1).

Interpretation

4.         In this Determination, unless the contrary intention appears:

“the Act” means the Therapeutic Goods Act 1989;

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”Blood” means human donor blood collected for a number of purposes including plasma separation required to be licensed under Part 4 of the Act, where the plasma may be used for a number of purposes including the manufacture of further blood components required to be licensed under Part 4 of the Act;

“Blood and Blood Components Code of GMP” means Sections 1-10, inclusive, and including the “Glossary” and “Corrigendum to clause 227” to, the document entitled “The Australian Code of Good Manufacturing Practice for Therapeutic Goods – Blood and Blood Components” published by the Commonwealth Department of Human Services and Health¹;

“EN 46001” means the document entitled EN 46001:1996 “Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001”; published by the European Standards Committee (CEN) Central Secretariat¹;

“EN 46002 means the document entitled EN 46002:1996 “Quality systems – Medical devices - Particular requirements for the application of EN ISO 9002”; published by the European Standards Committee (CEN) Central Secretariat¹;

“EN 566” means the document entitled EN 556: 1994 “Sterilization of medical devices – requirements for medical devices to be labelled ‘Sterile’”, published by the European Standards Committee (CEN) Central Secretariat¹;

“Human Tissues Code of GMP” means Sections 1-10, inclusive, the “Glossary” and

“Corrigendum to clause 706” to, the document entitled the “Code of Good Manufacturing Practice for Therapeutic Goods – Human Tissues” published by the Commonwealth Department of Human Services and Health, September 1995¹;

“Investigational Medicinal Products Code of GMP” means Clauses 1 to 53 inclusive, and the “Glossary” to the document entitled Annex 13 “Good Manufacturing Practice for Investigational Medicinal Products” of Volume 4 “Good manufacturing practices” of the Rules Governing Medicinal Products in the European Union, 1997 Edition published by the European Commission Directorate General III – Industry, Pharmaceuticals and Cosmetics Unit¹.

“ISO 9001” or “EN ISO 9001” means the document entitled AS/NZS ISO 9001:1994 “Quality systems – Model for quality assurance in design; development, production, installation and servicing”; published by Standards Australia¹;

“ISO 9002” or “EN ISO 9002” means the document entitled AS/NZS ISO 9002:1994 “Quality systems – Model for quality assurance in production, installation and servicing”’ published by Standards Australia¹;

“ISO 13485” means the document entitled ISO 13485 “Quality Systems – Medical devices – Particular requirements for the application of ISO 9001”; published by the International Standards Organisation¹;

“ISO 13488” means the document entitles ISO 13488 “Quality Systems - Medical devices – Particular requirements for the application of ISO 9002”; published by the International Standards Organisation¹;

1. See NOTES on last page

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“Medicinal Gases Code of GMP” means Chapters 1-6 inclusive of the document entitled “The Australian Code of Good Manufacturing Practice for Therapeutic  Goods  - Medicinal Gases”, published by the Commonwealth Department of Health, Housing and Community Services in July 1992¹;

“Medicinal Code of GMP” means:

Part 1, being Chapters 1 to 9 inclusive, and the “Glossary” to, the document
     entitled the “Australian Code of Good Manufacturing Practice for Therapeutic
     Goods – Medicinal Products”, published by the Commonwealth Department of
     Community Services and Health in August 1990¹; and

     the document entitled Annex 1 “Manufacture of Sterile Medicinal Products” of
     Volume 4 “Good manufacturing practices” of the Rules Governing Medicinal
     Products in the European Union, 1997 Edition, published by the European
     Commission Directorate General III –  Industry, Pharmaceuticals and Cosmetics 
     Unit¹.

“Plasma” means plasma, separated from human donor blood, intended for a number of purposes including the production of further blood components required to be licensed under Part 4 of the Act;

“Sunscreen Code of GMP” means Chapters 1 to 9 inclusive, and the “Glossary” to, the document entitled “Australian Code of Good Manufacturing Practice for Therapeutic Goods – Sunscreen Products” published by the Commonwealth Department of Human Services and Health in February 1994¹; and

“Sunscreen Products” means those goods described under Item 7, Schedule 4 (Part 1)  of the Therapeutic Goods Regulations.

Compliance with a Quality Assurance System

5.         Therapeutic goods must be manufactured in compliance with an approved
            Quality Assurance System as follows:

(1)   Blood collection and plasma separation must be in compliance with the Blood
             and Blood Components Code of GMP;

(2)   Drugs (including products derived from plasma but excluding sunscreen
             products, medicinal gases and investigational medicinal products) must be
             manufactured in compliance with the Medicinal Code of GMP;

(3)   Human tissues must be manufactured in compliance with the Human Tissues
            Code of GMP;

(4)   Investigational medicinal products must be manufactured in compliance with
             the  Investigational Medicinal Productions Code of GMP;

1. See NOTES on last page

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(5)   Therapeutic devices:

 (i)   If the therapeutic devices are required to be listed on the Australian Register

 of  Therapeutic Goods, they must be manufactured in compliance (a) with
               either EN 46001 or EN 46002, or (b) with either ISO 13485 or ISO 13488;
               or

(ii)  If the therapeutic devices are required to be registered on the Australian
               Register of Therapeutic Goods, they must be manufactured in compliance
               with either EN 46001 or ISO 13485; and

(iii)  If the therapeutic devices are labelled “Sterile”, they must also be
               manufactured in compliance with EN 556.

(6)   Medicinal gases must be manufactured in compliance with the Medicinal
            Gases Code of GMP;

(7)   Sunscreen products must be manufactured in compliance with the Sunscreen
             Code of GMP; and

(8)   If the therapeutic goods to be manufactured are of a type for which there is no
            quality assurance system specified above, the manufacturer must use a system
            that incorporates the principles of section 4 of ISO 9001.

(9)   Any blood processing plant:

(a)  that is used to process plasma collected from donors in Australia; and

(b)  that processes plasma described in paragraph (a) above for products that are
               or will be used in Australia (“the Australian product”)

shall not be used to process any plasma collected from any source outside of
        Australia (“the foreign source”) unless, in relation to that particular source:

(c)  a plasma master file, prepared in accordance with the requirements of the
              Committee for Proprietary Medicinal Products Guidelines entitled
              “Contribution to Part II of the Dossier for the Application for Marketing

Authorisation – Control of Starting Materials for the Production of Blood

Derivatives (reference CPMP 111/5272/94)” has been submitted to the

Secretary by the licensee of the relevant blood processing plant; and

(d)  the Secretary has advised the licensee of that plant, based upon the plasma

master file referred to in paragraph (c) above and having taken into account

the plant’s processes, that the plasma from the foreign source will not
               contaminate the Australian product with any blood borne pathogens.

NOTES

1.     At the time of gazettal of this Determination:

1.1.   the Blood and Blood Components Code of GMP, the Human Tissues Code of GMP, the

Medicinal Gases Code of GMP, the Medicinal Code of GMP and the Sunscreen Code of GMP

were available from the Therapeutic Goods Administration;

1.2.   EN 46001, EN46002, EN556, AS/NZS ISO9001, AS/NZS ISO9002, ISO 13485 and

ISO 13488 were available from Standards Australia; and

1.3.   the Investigational Medicinal Products Code of GMP (Annex 13 “Good Manufacturing

Practice for the Investigational Medicinal Products” of Volume 4 “Good manufacturing practices”

page 4 of 5

      of the Rules governing Medicinal Products in the European union) was available from the

European Commission Directorate General III – Industry, Pharmaceuticals and Cosmetics

Unit;

2.   This Determination changes the publisher of the European Standards from the British Standards

Institute to Comité Européen de Normalisation CEN (European Standards Committee); and

3.   Addresses and links for sources of documents current at the time of gazettal are provided for

Information only, as follows:

3.1.   The European Commission Directorate General III – Industry, Pharmaceuticals and Cosmetics

Unit, RP11, 4150, rue de la Loi, B-1049, Brussels, Belgium, on the Internet at

3.2   CEN - Comité Européen de Normalisation CEN (European Standards Committee), Central

Secretariat, 36, rue de Stassart, B-1050 Brussels Belgium Fax: [phone], on the

           Internet at or Email [email protected];

3.3    Standards Australia, phone [phone] (8.00am – 8.00pm Eastern Time Mon-Fri), Fax

      1300 65 49 49, Email [email protected], address mail to Standards Australia, PO Box

1055, Strathfield, NSW 2135, on the Internet at < and

3.4    The Therapeutic Goods Administration PO Box 100 Woden ACT 2606, phone [phone],

(or GMP Audit and Licensing Section 02 6232 8629 fax [phone]) on the Internet at     
   < 5 of 5