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HCL offers Australian GMP contract pharmaceutical packaging services and assists you with the filling and packaging of Capsules (hardshell and softgel), tablets and powder.
Commonly packaged container types/styles range from Plastic or Glass bottles/ jars (made of glass, HDPE to PET) and Blister Packing (Alu foil and PVC/PE/PVDC film). Batch sizes range from the hundreds of units to thousands of units.
HCL also offersProduct security packaging processes including induction sealing, Fuji sealing,
tamper-tell packagingand security-tag labelling.
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), claims, warnings 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 added as a manufacturer on the sponsor's ARTG Listing.
The Product Specification combines information with starting material specifications and relevant standards, acceptable formatting for formulation ingredients, overages, test methods & expiry/release limits, packagingspecification, 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.
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.
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.
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 documented evidence 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.
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 provides all product labels/ unit cartons to be used, in sufficient quantities to complete the packaging by HCL, and is noted to leave sufficient space on the label / unit carton for HCL to print the Batch No. and Expiry Date.
HCL may 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 regulatory orproduction purposes.
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.
Customers are required to sign a Good Manufacturing Practice Agreement. This GMP Agreement defines the responsibilities and obligations of HCL and the Customer in relation to the 2009 PIC/S code of Good Manufacturing Practice and other quality assurance issues in respect to the PQR 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.
The Customer is required to complete this Packaging 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 according to the Customer's instructions.
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 will however offer to provide generic packaging materials on customers' behalf should this option is available.
HCL will use the information on the Product Packaging Specification to purchase the correct packaging materials that meet your product requirements.
HCL will provide to the Customer a complete set of Batch Documents with a signed release for supply of the products, 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.
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. HCL may keep a number of retention samples during production according to customer requirement.
For multipack products, it is not necessary the complete multipacks 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.