Testing, Consulting, Auditing & Training Services
Text Box: Testing, Consulting, Auditing & Training Services

Text Box: COMPANY PROFILE Biotest Laboratories P/L was established in 1989 to provide expert laboratory testing and technical consultation services in Brisbane Management staff at Biotest have significant and directly relevant experience as professional microbiologists and chemists and are committed to providing high quality and meaningful scientific services. This is reflected in the establishment and certification of a quality system based on ISO 9000. SERVICES Key areas of service include:- Analytical Testing - Biotest provides expert microbiological, chemical and physical testing services to the biotechnology, biopharmaceurical and pharmaceutical, veterinary, medical device, cosmetic, food and water industries. Methods include BP, USP and EU pharmacopoeia and Australian Standard methods for foods. A dedicated 1000 m2 laboratory facility in Underwood, Brisbane, holds significant licences and registrations relevant to the provision of testing services. The laboratory operates a cGMP and GLP compliant quality system accredited to ISO 17025. The laboratory is NATA accredited and is TGA and APVMA licensed (microbiology and chemistry) for the testing of human therapeutic goods and veterinary products. The laboratory is also AQIS approved for inspection of imported foods. Consulting - Biotest's consulting expertise and broad industry experience covers many disciplines. Consultants hold significant qualifications combined with practical industry experience. Services include technical management and operations improvement through the provision of documentation, implementation and training, auditing and verification services relevant to medical device, pharmaceutical, veterinary and food industries. Auditing - Our Technical Director, Mr Greg Taylor is an APVMA approved GMP auditor, qualified external quality system auditor (ISO 9000) and a Senior Food Safety Auditor. Biotest staff are trained quality system auditors with significant practical experience in assessing the compliance and effectiveness of quality systems. Training - Biotest staff have certificate IV qualifications in Work place training and competency assessment. Biotest have practical experience in the delivery of workplace training including aseptic manufacture, operation of HEPA filter workstations and clean rooms. Clean room Manufacture - Specialist clean room and HEPA filtered production area support research and development trials, product packaging and sterilisation for products requiring clean room conditions, stringent controls and technical monitoring. Laboratory Products - Biotest manufacture and supply a specialist range of laboratory and medical products. These include laboratory diagnostics, LABag liquid media and Biotest Dipslide products. Biotest's products are represented directly, via agents and under tender/contract. Biotest Solutions for Science

 
Text Box: Testing, Consulting, Auditing & Training Services

CONSULTING SERVICES

 

 

Biotest's consultants have had prior employment in industry as senior managers or technical leaders in their field of expertise.  With this experience our consultants are aware of the practical aspects aimed at the implementation of cost effective solutions, not simply theory.

 

Biotest has established a scientific consultancy Biotest Consulting Services P/L, providing cGMP / GLP, Food Safety, Scientific, Environmental, Occupational Health and Quality Assurance consultants to a broad range of industries, manufacturers and government organisations.  Detailed resumes of our senior consultants are available upon request.  Services offered extend from identification (needs analysis), documentation, implementation, training, auditing and verification to product research, manufacturing practices and product performance.  Areas of expertise include regulation and standards compliance, GMP and quality standards, food safety, HACCP analysis, sanitation performance, medical device sterilisation protocols/validations, product and process audits, environment monitoring, indoor air quality investigations and expert witness.

 

The management experience of our consultants allows the group to provide project management and review / audit functions for technical projects and groups.  Examples of consultancies supporting the services provided include:-

 

Biopharmaceutical –  Stability Protocol Development

 

 Pharmaceutical - Cleaning Validations / Product Specifications / Process Control 

 

  Services provided include:

· cGMP & GLP Training

· Material and Manufacturing process specifications, manufacturing SOP's

· Systems control and auditing

· Aseptic Manufacture protocol development and validation.

· Clean room operation and maintenance,

· Contract sterilisation validation - EU code GMP,  BS, EN  & ISO standards

· Product stability indicating profile, stability protocol

 

 

  Food Service - Food Safety and Risk assessment / HACCP analysis, system implementation and audit

 

  Services include:       

· Risk assessment, identification of product safety and quality issues and manufacturing deficiencies.

· HACCP analysis, identification of Control points, action limits.

· Implementation of HACCP plan and supplier QA .

· HACCP audit

· Product description and specification development.

· Sanitation/Hygiene performance evaluation

· Capturing of HACCP in a Quality System to ISO 9002

· Preparation of standard operating procedures

· Staff hygiene training / HACCP team training

 

 

Biotest Consulting provides cost effective Solutions for Science

 

MELBOURNE

 

BIOTEST CONSULTING SERVICES PTY. LTD.

26 Mitchell Crt NORTH CROYDON  VIC 3136

Telephone: 61 3 9723 1300

Facsimile: 61 3 9723 6713

Email: biotestv@biotestlab.com.au

 

BRISBANE

 

BIOTEST LABORATORIES PTY. LTD.

2 Darnick St UNDERWOOD  QLD  4119

Telephone: 61 7 3841 2232

Facsimile: 61 7 3841 2241

Email: biotestq@biotestlab.com.au