Regulatory Compliance

Maverick Biosciences is committed to providing Animalogicals to the global life sciences industry that achieve, maintain and exceed the customer's expectation. We are committed to the continual improvement of our systems to preserve, and increase customer satisfaction.

To implement this policy, Maverick Biosciences has established an effective Quality System, planned and executed in conjunction with other management functions, such that quality is an integral part of business strategy.

Maverick Biosciences recognizes that success in its business is based on;

• Quality of data.
• Validation of processes.
• Quality documentation

Maverick supplies materials in complete compliance with our clients' requirements of compliance with ISO 22442 -1, -2, -3.

Our Quality Systems Manual establishes and documents all those processes Maverick Biosciences uses to maintain or exceed customer requirements. We have in place a system of documented procedures for maintaining the standard set by the company. We recognize the role that our raw material providers, remote and on site production teams and subcontractors play in achieving desired results and recognize that we must ensure proper control over outsourced processes. We have in place a series of Standard Operating Procedures to give guidance to these entities.

Training documentation is established by the Quality Department, in conjunction with the Production Department. Ongoing periodic audit of training documentation pertaining to production is carried out by Quality.

The training procedure is broken into 3 parts. These parts are:

1.    Induction - All personnel that commence employment with Maverick Biosciences will undergo an induction. This induction will consist of the following:
a.    Information about the processing site.
b.    Relevant Processing Site Contractor information.
c.    Maverick Safety Procedures.

2.    Training - Training will be carried out be employees qualified and trained as "Trained trainers". All employees being trained will be given copies of the relevant Standard Operating Procedures for the process that is being carried out. The employee will read through the SOPs and be given time to comprehend them.
a.    The employee will sit with the trainer and go through the SOPs one at a time ensuring that the employee fully understands the process.
b.    The employee is observed performing the task to ensure that they understand what they have to do and how they are to do it.
c.    There is a question and answer section where questions relevant to the process are to be asked to ensure the process is fully understood.

3.    Assessment - Each employee being trained will be assessed according to their knowledge of the documentation and their ability to perform the task required

Training Documentation

• Training documentation will be filled out throughout the process, and kept on record.
• Training documentation will commence being filled out after the SOPs have been read through with the employee.
• As part of training the employee will undertake physical observation of the procedures they are undertaking to ensure compliance with training needs. Outputs of this process are recorded as part of the training documentation

Our Standard Operating Procedures contain the following information:

• Purpose - States the purpose of the procedure.
• Scope - States who is covered by the SOP
• Responsibilities - States who is responsible for the SOP being followed
• Materials - States what materials are needed for the SOP
• Notes(optional) - States any extra or important information that may be needed to allow the procedure to be carried out properly
• Safety - States any safety requirement that need to be known by the person performing the procedure
• Procedure - Outlines the steps necessary to form the procedure correctly

Specifications are developed for all products and are numbered uniquely and one copy will be kept in the production area and another copy will be kept on record in the office. When necessary the customer specification will be used.

The specification will contain the following information:

• Description of product required including state, colour etc.
• Species of origin
• Age of animals processed
• Necessary dimensions
• Packing materials and instructions
• Labeling materials and Instructions
• Storage conditions
• Additional requirements as necessary - may contain photographs

Maverick operates with a Corrective/Preventative action process and utilises the following to stimulate action:

• Internal audits.
• External audits.
• Monitoring.
• Non Conformance Reports.
• Customer complaints.

Age verification

Is carried out in Australia and New Zealand via the Dentition method. Slaughterhouses operate a "mouthing" station and then stamp the carcase according to the number of  Permanent Incisors evident upon inspection. Selection of eviscerated materials is governed by a visual correlation of the dentition stamp on the carcass at the time of retrieval/selection from the viscera table.

Likewise the same dentition stamp is referenced when procuring materials from the carcass subsequent to evisceration.

Traceability

Source materials can be produced whilst maintaining complete traceability. Bovine materials are packaged as per client specifications with animals routinely traceable by "lot or batch" and traceable back to farm of origin/birth utilising radio frequency identification (RFID) tagging systems.

Complete paper trails also exist to ensure traceability and to capture supporting information regarding the veterinary treatments the animals have been subjected to in their lives and that withholding periods of treatments have/have not been complied with.  The capture of agronomical chemical usage relevance to the location of the grazing animals and their feedstuffs is also captured to ensure safety within the food chain and that withholding periods have/have not been adhered too.

Porcine animals are tagged or tattooed at birth and this individual number is then utilised throughout the paper trial (that again monitors veterinary chemical usage, and feedstuff consumption). During the evisceration and carcase preparation process the tattoo evident on the animal is typed into a computerised system that then has the ID tattoo written into a bar-coded carcass tag to allow subsequent traceability when the animal departs the slaughter floor.

Ante & Post Mortem Inspection - Bovine and Porcine
Ante and post mortem inspection is carried out at all Australian and New Zealand export registered slaughterhouses, by qualified government employed veterinarian officers.

A link so as to review the details of the inspection process is attached FYR:

http://www.publish.csiro.au/Books/download.cfm?ID=5553

Maverick Biosciences is committed to providing Animalogicals to the global life sciences industry that achieve, maintain and exceed the customer's expectation.