SERVICE

HEALTH --- The Best Gift for Your Family, Friends and Yourself. ORGANIC NATURE provides varied Vitamins & Minerals, Herbal Extracts, Essential Fatty Acids, Beehive, Specialised Formulae, Functional Food and Skin & Body Care Products. Best Quality You can rely on. We invite you to become a part of the ORGANIC NATURE family of customers and experience a more affordable way to good health.

Links:

Australian TGA

PIC/S

HealthInsite

Complementary Healthcare Council

Sue Akeroyd & Assoc.
Regulatory Consultants

Australian Made

World Health Organisation

ORGANIC NATURE

PRODUCTS

Own Brand :

Customers are required to prepare the following documents prior to any product packaging commencing.	HCL will provide the following:
1. The ARTG Listing Record (Marketing Authorisation)	6. Confidentiality Agreement
2. Finished Product Specification	7. GMP Agreement
3. Certificate of Analysis	8. Product Packaging Specification
4. Product Stability Testing	9. Packaging Materials
5. Product labels	10. Batch Documents
	11. Samples

1. The ARTG Listing Record (Also known as the Marketing Authorization)

This document is the approval or authorisation given to the sponsor by the TGA to supply a therapeutic good in Australia. The marketing authorisation includes the formulation listed on the Australian Register of Therapeutic Goods (ARTG) (for listed products) and shelf life conditions together with any other conditions of listing or registration.

Most healthcare products must be included on the Australian Register of Therapeutic Goods (ARTG). An AUST R or AUST L number on a label shows that the healthcare product has been included on the ARTG. The Therapeutic Goods Administration (TGA) is the part of the Australian Government Department of Health and Ageing responsible for ensuring that healthcare products available in Australia are of an acceptable standard. Consumers expect that the healthcare products they purchase are safe, effective and of high quality.

An AUST R number shows that a product has been assessed for safety, quality and effectiveness. AUST L numbers are given to lower risk products used for minor health complaints or health maintenance.

HCL Manufacturers Pty Ltd must be included in this document.

2. Finished Product Specification

The Product Specification combines information with starting material specifications and relevant standards, acceptable formatting for formulation ingredients, overages, test methods & expiry/release limits, packaging specification, microbiologic testing etc.

HCL Authorised person in releasing the product for supply will need the document provided by the sponsor to ensure that manufacturing formula and specification are consistent with the entry in the ARTG.

BACK TO THE TOP

3. Certificate of Analysis

The Certificate of Analysis (CofA) is the documented evidence of the quality control testing carried out on the medicines. It gives the details about its quality and compliance to specifications and is a document relating specifically to the result of testing a representative sample drawn from the specific batch or lot of material it is purported to represent.

1. The Customer must provide to HCL the product’s CofA as prepared and signed by the Manufacturer of the product . The CofA will support the manufacture of the Starting Material (Bulk product) to be used in the packaging. This document will provide details of the Supplier’s Batch Number and Date of Manufacture, together with details of the manufactured product.

HCL will cross link the Supplier Batch Number with the HCL Batch Number on the Batch Documents.

4. Product Stability Testing

Stability testing ensures the product is of acceptable quality throughout its entire storage period. In order to do this, it is necessary to monitor compliance of the product with a suitable quality specification throughout the shelf life. It is not acceptable to only test at the time of expiry, for example, on a retention sample (even though the results of this type of testing may provide useful information about the overall stability of the product).

Most often, the content of active ingredients and/or components and relevant physical properties of the product are monitored during storage under defined conditions using methods capable of detecting deterioration or degradation.

The sponsor of the goods is responsible for these matters. The sponsor must ensure that stability data exists to support the shelf life. The shelf life must be based on scientific data. TGA may check the data through the usual regulatory mechanisms.

The Customer must provide to HCL certification that the product’s shelf life is supported by appropriate stability testing data. This information will be used to confirm the Expiry Date to be printed on the product label/carton.

5. Product Labels

Product labels / unit cartons provide information to help consumers select products that are suitable for consumers and understand how to use products correctly. The labels also include information in correct storage conditions, precautions or warnings, as well as contact details for the sponsor or supplier of the product.

The Customer must provide all product labels/ unit cartons to be used, in sufficient quantities to complete the packaging by HCL, and must leave sufficient space on the label / unit carton for HCL to print the Batch No. and Expiry Date.

Label Specification

to fit HCL's labelling machine:

Roll direction

Supply Roll: 12" (304mm) maximum diameter on 3" (76mm) core.

BACK TO THE TOP

HCL will provide the document template for items 6, 7 and 8 below.

These documents represent the formalities that need to be completed by the Customer,

for both Regulatory and Operational purposes.

6. Confidentiality Agreement:

We require our Customers to sign a Confidentiality Agreement to protect the all intellectual property issues and other information that may pass between the Customer and HCL.

This Agreement is to be signed by HCL and the Customer.

7. GMP Agreement:

Customers are required to sign a Good Manufacturing Practice Agreement. This GMPAgreement defines the responsibilities and obligations of HCL and the Customer in relation to Code of Good Manufacturing Practice and other quality assurance issues in respect to the supply of bulk materials, packaging materials, release for supply of the packed product and delivery of the customer’s products.

This Agreement is to be signed by HCL and the Customer.

8. Product Packaging Specification

The Customer is required to complete this Specification including all packaging components, assembly method and delivery. This document provides all of the packaging requirements in respect to the Customer’s product, in order that HCL will correctly package the according to the Customer’s instructions.

BACK TO THE TOP

9. Packaging Materials

Supply of the packaging materials such as bottles, caps, silica gel sachets/canisters, sliver wool, Induction seal, labels, unit cartons, leaflet, safety seals, shrink wrapping film, outer shipper, shipper labels will be customers' responsibility. HCL do however offer to provide the packaging materials on customers' behalf should this option is preferred.

HCL will use the information on the Product Packaging Specification to purchase the correct packaging materials that meet your product requirements.

10. Batch Document

HCL will provide to the Customer a complete set of Batch Documents with a signed release for supply of the product , for record purposes.

The Batch Documents provide complete details of the product packaging – such as Pre- packaging Checklist, in-process testing, label reconciliation, total quantity of packed product and Document Check for release for supply, with appropriate HCL signatures.

11. Samples

A reference sample is a sample for the purpose of future analysis, which could refer to starting materials, packaging materials or finished products.

A retention sample is a sample representing the batch of finished product as distributed.

Items from the stability program cannot be used as retention samples.

For multipack products, it is not necessary the complete multipacks need to be retained as samples. The requirement is that the amount of retention samples is sufficient to carry out analytical work during the entire shelf life of the product.

BACK TO THE TOP

[ Home ]

Send mail to with questions or comments about this web site (www.hclm.com.au). Last modified: May 25, 2011 Copyright 2000 © produced by HCL Manufacturers Pty Ltd. Unit 2/ 69 Selhurst St. COOPERS PLAINS QLD 4108, Australia ABN : 68 088 074 686