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GMP clearance for overseas manufacturers

16 May 2011

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Appendix A - Glossary of terms

This appendix contains interpretations of terms used in this document.

Terms that appear in the Therapeutic Goods Administration Act 1989 or the Therapeutic Goods Administration Regulations 1990 may be described slightly differently (for example, to expand or narrow a definition) in Orders made under the Act.

Term Interpretation
the Act The Therapeutic Goods Act 1989
Active Pharmaceutical Ingredient (API): Therapeutically active component in the final formulation of therapeutic goods.
ARTG Australian Register of Therapeutic Goods
Audit "Audit" and "inspection" are used interchangeably, meaning when the GMP Compliance of a facility is assessed at the overseas site either by TGA auditors or by inspectors of another competent authority recognised by the TGA as meeting an equivalent standard.
Authorised person A person recognised by the TGA as having the necessary background and experience to undertake particular functions.
Batch (or lot)

A defined quantity of starting material, packaging material or product processed in one process or series of processes such that it could be expected to be homogeneous.

Note: To complete certain stages of manufacture, it may be necessary to divide a batch into a number of sub-batches which are later brought together to form a final homogeneous batch. In the case of continuous manufacture, the batch must correspond to a defined fraction of the production, characterised by its intended homogeneity.

For the control of the finished product, a batch of a medicinal product comprises all the units of a pharmaceutical form which are made from the same initial mass of material and have undergone a single series of manufacturing operations or a single sterilisation operation or, in the case of a continuous production process, all the units manufactured in a given period of time.

Batch number (or lot number) A distinctive combination of numbers and/or letters which identifies a specific batch.
Bulk product Any product which has completed all processing stages up to, but not including, final packaging.
Codes of GMP (GMP) Principles and practices to be followed in the manufacture of therapeutic goods to provide assurance of product quality and compliance with product registration or listing in the Register.
Compliance Verification An assessment based on the evaluation of prior evidence by a competent authority recognised by the TGA. This assessment is performed by considering documents provided by other regulators, the sponsor and the manufacturer to verify the manufacturer's compliance with GMP.
Contract manufacture Any part of the manufacturing process of therapeutic goods that is carried out by a person other than the sponsor on a contract basis (including principal manufacturers and other (sub) manufacturers).
Dosage form The pharmaceutical form in which a product is presented for therapeutic administration, for example, tablet, cream. A list of dosage forms and their definitions for the purpose of recording information in the ARTG database is included in the TGA Approved Terminology for Medicines.
eBS TGA's online business system - eBusiness System.
Finished Product A medicinal product which has undergone all stages of production, including packaging in its final container.
GMP Certificate A document issued by an authorised regulatory body certifying compliance of the manufacturer to the applicable GMP standard.
GMP Clearance The approval of GMP documentary evidence as demonstrating that a manufacturer is of an acceptable GMP standard.
GMP contract or agreement A GMP agreement is a written contract covering the manufacture and any technical arrangements made in connection with it.
Inspection See "Audit" above.
Listed medicines See definition in section 3(1) of the Act. Listed goods are entered on the ARTG based on approved ingredients, low level claims and certification by the sponsor of the evidence to support their application. Listed goods are not evaluated by the TGA prior to inclusion on the ARTG.
Manufacture See definition in section 3(1) of the Act. Any step in the manufacture of therapeutic goods, including production, labelling, packaging, sterilisation, quality control, release, storage and distribution of medicinal products and the related controls.
Manufacturer The person which manufactures therapeutic goods ie produces the product, or engages in any part of the process of producing the product or of bringing the product to its final state, including engaging in the processing, assembling, packaging, labelling, storage, sterilising, testing or releasing for supply of the product or of any component of ingredient of the product as part of that process.
Manufacturer Information System The section of the e-Business Service website that holds information regarding GMP licences, clearances and certificates.
Manufacturing site See definition in section 3(1) of the Act. Means premises:
(a) that is for use in the manufacture of a particular kind of therapeutic goods; and
(b) in relation to which the same person/s have control of the management of the production of those goods and the procedures for quality control.
Manufacturing Principles The principles of therapeutic goods manufacture as defined in section 36 of the Act. For medicines these principles are defined to be those described in the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
Marketing authorisation

Compliance with regulatory requirements specified on the ARTG and imposed under the Act, and any other requirements imposed by a relevant delegate of the Secretary of the Department of Health and Ageing upon the listing or registration of the product.

Examples of regulatory requirements include the following: compliance with registered formulations, special storage and transportation conditions, shelf life, labelling, batch release testing requirements, etc.

Medicine See definition in section 3(1) of the Act. Therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal (previously referred to as a drug).
Medicinal products Any medicine or similar product intended for human use, which is subject to control under health legislation in the manufacturing or importing country.
MRA Mutual Recognition Agreement
MRA regulator A regulator who is recognized by other partners to a Mutual Recognition Agreement.
Overseas manufacturer Manufacturer with manufacturing premises or testing laboratory located outside Australia.
Premixes Also known as 'advanced intermediates' are APIs that have been partially formulated, for example pellets prior to encapsulation.

All operations, including filling and labelling, which a bulk product has to undergo in order to become a finished product.

Note: Sterile filling would not normally be regarded as part of packaging, the bulk product being the filled, but not finally packaged, primary containers.

Procedures Description of the processes to be carried out, including the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of medicinal products.
Production All processes involved in the preparation of medicinal products, from receipt of materials, through processing and packaging, to completion as a finished product.
Product Quality Review (PQR) Also known as Annual Product Reviews. An annual review of the batches made of a product with the intention of highlighting any significant batch-to-batch trends or need for process improvements. See PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-8 part 1, section 1.4).
Qualification Action of proving that any equipment works correctly and actually leads to the expected results. The word "validation" is sometimes used to incorporate the concept of qualification.
Quality Management Systems (QMS) The systems employed by a manufacturer to manage their documentation and practices
Release for Supply That step of manufacture in which an authorised person certifies that a production batch has been produced and controlled in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products following review of all pertinent information to allow supply to the market.
Site Master File The Site Master File is prepared by the manufacturer and contains specific information about the quality assurance, the production and/or quality control of pharmaceutical manufacturing processes carried out at the named site and any closely integrated processes at adjacent and nearby buildings. If only part of a pharmaceutical process is carried out on the site, a Site Master File need only describe those processes, e.g. analysis, packaging, etc.
Sponsor Defined in section 3(1) of the Act as
A person who exports, or arranges the exportation of, the goods from Australia or a person who imports, or arranges the importation of, the goods into Australia or a person who, in Australia, manufactures the goods, or arranges for another person to manufacture the goods, for supply (whether in Australia or elsewhere) but does not include a person who: exports, imports or manufactures the goods or arranges the exportation, importation or manufacture of the goods on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.
TGA on-site audit An audit carried out by the TGA at the facility of the manufacturer.
Validation Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results.

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