New Wayz has a broad client base in which the dominant proportion is repeat clients, in many cases over many years and for many projects. Our clients demand quality design, quality documentation and project delivery. |
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New Facilities
Biotechnology Manufacturing
Retained as Production/Project Engineers for upgrade of a multi-national biotechnology company's manufacturing facility. Responsibilities included provision of assistance to local management and projects teams on facility, plant and equipment installation, operation, commissioning and validation as well as upgrade of quality systems to compliance with FDA CGMP for Medical Devices and IVD's.
Bakery Factory Refurbishment
Retained as Project Managers to relocate and reconfigure manufacturing facilities for one of the largest commercial bakeries in New Zealand. The project included planning for reconfiguration of existing site services and new facility arrangement including HACCP studies for licence purposes.
Pharmaceutical Distribution Centre
Relocation of a multi-national pharmaceutical warehousing operation. New Wayz was engaged to select the green field site, prepare the; design brief, budget costing, project justification and consultant briefs. Assisted with the selection of property developers and acted as Project Manager for construction and relocation.
Assisted in the implementation of site quality management procedures and training of newly appointed Quality Assurance Manager, Quality Assessment Coordinator and staff.
Pharmaceutical Dry Powder Inhalations Facility
Core member of the project team to construct a green field facility to manufacture Pharmaceutical Dry Powder Inhalation products. Specific responsibilities included preparation of scope and design documentation, tender documentation and equipment specifications. Role as Project Leader for the team to commission and validate the facility, primarily involved with facility and equipment qualification and process validation.
Strategic Planning & Business Development
Business Continuity Planning
New Wayz developed and maintained the Business Continuity Plan for a multi-national pharmaceutical company's sites including corporate, marketing and distribution functions. The project included revision of customer complaint, product recall and regulatory reporting procedures. Separate simulations of incidents for senior management were conducted on two sites.
Business Planning - Pharmaceuticals
New Wayz were retained to assist a multi-national pharmaceutical company on benchmarking studies for individual companies and processes for the purpose of development of strategic sourcing strategy and rationalisation of manufacturing facilities.
Dietary Supplement - New Venture
New Wayz acted on behalf of a NZ company wishing to contract manufacture and package a vitamin product to MoH/TGA codes of GMP. We sourced and assessed contract manufacturers and packers, negotiated initial commercial terms and recommended preferred contractors.
Factory Closure and Asset Disposal
New Wayz was responsible for the disposal of properties, plant and equipment from sites in Palmerston North and Auckland following restructuring of a major pharmaceutical company's manufacturing and distribution divisions. The process included assessment of local companies to undertake ongoing manufacture and packaging of liquid and tablet products for supply to the local market, assisting with commercial arrangements for the selected companies and assuring ongoing product quality standards.
Waste Management
New Wayz were retained to advise a client on technical and business aspects of a new venture of separate contaminants from stored solvent wastes to allow recycling and disposal. We also sought resource consent under the RMA, advised on processing alternatives, and prepared feasibility reports and budget costings for application to Technology NZ for funding.
GMP Compliance & Licencing
Biotechnology - New Venture
Retained by a start-up company to advise on cGMP aspects of new veterinary product development through field trials and regulatory approval. Acted as Project Manager for development of facilities and quality systems for trial and production plant. Performed the role of "Principal Technician" for the commercialisation phase of the project.
Cosmetic Products Manufacturing
New Wayz recommended and assisted with implementation of improvements to facilities, regulatory affairs practice and quality systems to achieve compliance to Australian TGA standards for a manufacturer and packer of cosmetic products.
Dietary Supplement Manufacture/Packaging
New Wayz has been retained on an ongoing basis to oversee completion of licensing for a number of companies in this sector. We have prepared scope of work assessments to recommend improvements to and facilitated provision of, facilities and quality systems to permit licensing to New Zealand and Australian Therapeutic Goods Codes of GMP.
Pharmaceutical Warehousing
New Wayz was retained to assist with development of quality systems and facilities to permit wholesale of medicines under Section 29 of the NZ Medicines Regulations 1984.
Equipment Design
Lyophilization (Freeze Dry) Installation
New Wayz were retained by a multi-national client for a project to develop large scale freeze drying capabilities for a product finishing process. We advised on facility layout and were responsible for process design, procurement of equipment, installation commissioning and validation for the process.
Pharmaceutical Facility - HVAC
New Wayz acted as consultant mechanical services engineer for the design, installation, and commissioning of heating ventilating and air conditioning services to a contract pharmaceutical manufacturers new facilities.
Purified Water Systems
Acted as project engineer for the design, commissioning and qualification for a number of purified water plants to comply with BP/EP pharmacopoeial standards, including a large volume fully automated plant including ozone disinfected bore water supply with UV sanitisation. The same role included a project to install, commission and qualify Water for Injection and Clean Steam plant to USP standards.
Veterinary Product Packaging Line
New Wayz formed a consortium to provide a turn-key upgrade to sanitary packaging facilities for a multi-national biotechnology company involved in filling and packaging of sterile animal vaccines. New Wayz acted as Project Manager for the consortium and provided validation support to the principal for the project.
Process Development & Improvements
Aerosol Analysis
Designed, coded, implemented and maintained software to automate preparation and analysis of aerosol samples (Total Dose, Dose per Actuation, Deposition) by computer-spectrophotometric methods. Analysis turn-around time was reduced by a factor of 70%.
Capsule Manufacturing
Acted as project manager for a generic pharmaceutical manufacturing company for the product development of two capsule products, through concept to introduction to production.
Clean Liquids Filling and Packaging Process Improvement
Asked to study a pharmaceutical process for a multi-national manufacturer and recommended changes to improve performance. Suggested engineering operational enhancements saw throughput increased by 43% and reject rate reduced from 8% to 2%. Operational cost savings achieved were approximately $5,000 per batch.
Dry Powder Inhalations Productivity Improvements
Conducted a process capability study to enhance performance of an automated filling and packaging line. Results of the study permitted fill weight controls to be introduced which saw throughput time/batch improved by 40% and yields increased by 7%. Predictive process performance measures were able to be implemented.
Tablet Analysis
Designed, coded, implemented and maintained software to automate average weight and co-efficient of variation analysis for tablet analysis on an automated tabletting line. Analysis time was reduced by a factor of 60% and potential for rejects was significantly reduced due to timely reporting of in-process analysis.
Tablet Manufacturing
Managed the upgrade of a modern flexible manufacturing facility for tablets, including preparation of the design brief, budget costing, and project justification. During the project, acted as project engineer, engaged consultants, contractors and managed the upgrade, overseeing pilot scale trials, preparation of operating procedures and validation.
Quality Management Systems
Engineering & Technical Services
Designed and implemented a quality management system for a multi-national client's Engineering and Technical Services Department including project management, validation and qualification policies and procedures in compliance with regulatory requirements. An external audit ranked these procedures highly and they were used as a model for international operations.
Product Development
New Wayz was retained to implement product development procedures for the formulation of new materials and processing methods in the plastics industry. The system was designed to consider commercial, quality and safety requirements in development of specialised new products and materials for this market.
Third Party Auditing
New Wayz were engaged by a multi-national biotechnology company to audit contract freeze drying of client supplied raw material to general cGMP. Freeze dried product is post processed by the client for sale internationally.
Waste Management
New Wayz implemented a waste management plan for a pharmaceutical company which assured security and was in regulatory and GMP compliance and within the framework of statutory requirements. The system was highly praised in a third party audit.
Computerised Manufacturing Systems (CMS)
Calibration & Maintenance Management System
Managed a project to develop and install an upgrade to a computerised preventative maintenance programme to manage calibration and product critical maintenance activities within a multi-national pharmaceutical company. The completed system was commended during a technical compliance audit, and used as a benchmark for similar operations within the group.
Computerised Building Management System
New Wayz were retained to specify, commission and validate computerised building and energy management systems and support systems for a pharmaceutical tablet manufacturing facility. We specified control logic and point detail, assessed and selected suppliers and managed the installation to allow validation to GMP standards.
Software Application Management
Contracted to design, prepare and maintain user guide and system reference documentation both in print and HTML formats for a multi-national company designing and selling utility company customer management and billing software. On-line documentation was also provided for maintenance of a customer support intranet and standard operating procedure web pages.
Master Documentation Control System
Responsible for the design and implementation of an upgrade to a master documentation management system for batch control, tracking of batch status, control of master manufacturing and packaging instructions and batch sentencing in a pharmaceutical facility. Subsequent to implementation and audit the system was used as model for other systems and software improvements for critical document control.
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