Situation: Bioprocessing company wanted an evaluation of the Quality Management System and targeted training for key staff in pharmaceutical GMP as it related to their process.
Process: Conducted a review of the production process against the current documentation and identified gaps. Provided a group training session to highlight where the Company’s products fit within the pharmaceutical industry. Conducted one-on-one training for key Production and QC staff using a HACCP (Hazard Analysis and Critical Control Points) format and risk assessment as it relates to the production process steps.
Situation: An International Vaccine network supported by the Bill Gates Foundation, requires the development and delivery of WHO/PICs/FDA quality systems and GMPs across their network in Asia. The purpose of the training is to improve quality standards of vaccine manufacturers in developing countries.
Process: CBE developed specific multiple training programs based on case work and workshops in the areas of Quality Systems, Validation, Aseptic Processing, Cleaning, Environmental Monitoring and Sterilisation. As part of the program CBE consultants were also invited to provide a one day GMP gap assessment of vaccine manufacturers in China and Vietnam.
Situation: An international biotechnology company’s strategic plan was to rapidly expand their product portfolio into international markets. They underwent a GMP licensing audit from TGA which identified some significant gaps to PICs/EMA/FDA standards. The firm engaged CBE to assist them in identifying and closing the gaps, and to prepare for re-inspection.
Process: A team of CBE experts in Quality Systems, Quality Control, GMP, Validation, Manufacturing and Pharmaceutical Engineering visited the site on 3 occasions over a four month period and conducted a full gap analysis to international standards. Working closely with senior management the team (a) prepared a systematic and detailed corrective action plan for TGA (Phase 1) and (b) provided a comprehensive improvement plan for implementation over the following 12 months (Phase 2). In addition CBE identified that the site needed to plan and implement a GMP audit preparedness program to successfully manage future audit outcomes.
Situation: A regional Pharmaceutical Manufacturers Association provides ongoing professional development training for its membership. The association requested CBE to develop rolling three day workshops and presentations to industry professionals. The course had to be practical, hands on and filled with industry case studies.
Process: A regional Pharmaceutical Manufacturers Association provides ongoing professional development training for its membership. The association requested CBE to develop rolling three day workshops and presentations to industry professionals. The course had to be practical, hands on and filled with industry case studies.
Situation: An Asian start up company with a young enthusiastic team required training program to ensure that staff were familiar and up to date with current EU/FDA/TGA quality standards particularly in the area of aseptic processing. Additionally management wanted their team to be well informed on viral inactivation / removal processes and the regulatory requirements with respect to process validation for viral clearance steps. Finally, as tangential flow flitration technology is extensively used in their processes they required a course on process optimisation of this technology.
Process: A comprehensive program was developed and delivered over 2 days covering Sterilization Theory and GMP requirements (particularly steam sterilization); Aseptic processing and media fill validation and Sterile filter validation and control, Testing (QC) Programs for biological products; Viral Inactivation technologies and validation; Tangential Flow Filtration Technologies and process optimization.
Situation: Chemotherapy compounding facility has their newly built facility rejected by the state authority due to concerns about the facility design, equipment and production processes.
Process: The process involved providing engineering and quality expertise to lead a risk assessment process across the facility, equipment and production. The risk assessment identified a range of deficiencies. These risks were mitigated through a series of facility modifications, qualification work on the equipment and some internal changes to the aseptic practices.
Situation: A hospital had recently built a new compounding pharmacy and had concerns about the quality of the finishes and whether the design met the current and proposed Australian standards.
Process: A site visit by a CBE engineer assessed the facility and found a range of problems from poor finish details through to inappropriately located supply HEPA filters. A comprehensive report was prepared that outlined the issues found, provided references where they did not meet the required standards and categorized the issues into high, medium and low criticality.
Situation: A Hong Kong based manufacturer has invested in a substantial upgrade of their non-sterile manufacturing facility to meet current and future PICs requirements. The client had not undertaken a project of this nature before and looked to CBE to provide technical expertise and support across Quality Management, Validation, Training and eQMS implementation.
Process: CBE conducted a gap analysis and formed a small project team with cross–functional skills to support the site in execution of the plan. This involved a complete re-structure of the QMS, transition to an affordable eQMS, development of a validation master plan based on risk analysis, and preparation of PQ, PV and cleaning validation protocols. The project also involved mentoring site management and supporting them in facilitating a regulatory audit.
Situation: Private Equity company considering investing in a biopharmaceutical business in China wanted more information on risks, product portolio and strength of R&D program.
Process: The process involved leading the equity team in a series of meetings addressing and testing assumptions presented by the company to the team. The process included several site visits and was supported by an interpreter provided by a CBE affiliate company based in China.
A comprehensive report was prepared summarizing
Situation: An international company having options to invest in multiple countries was seeking government funding as an incentive to invest.
Process: With a qualified economist a detailed paper was prepared outlining the magnitude of investment, the flow on benefits and technology platform that the investment would create. The paper demonstrated significant return on investment to government in future years. The paper was presented to multiple government departments.
Situation: A Startup biotechnology company acquired intellectual property and required a comprehensive manufacturing strategy to minimise time to market. The strategy included ensuring product specifications and process controls were in place to demonstrate the scaled up manufacturing process resulted in product equivalent to product used in clinical trials.
Process: Gathered a team with the relevant skills and reviewed the pilot scale process to determine requirements for scaled up manufacture. Put in place protocols and additional testing required to demonstrate product equivalence with clinical trial material. Identified a suitable manufacturing partner with the relevant regulatory approvals and entered into in-principle discussions.
Situation: Pharmaceutical CMO experienced downturn in annual revenue and was looking for opportunities to increase competitiveness across operations, including quality and technical functions, without compromising quality standards. Target of $3M pa savings.
Process: Conducted a review of current operations using DMAIC (Define, Measure, Analyse, Improve and Control) process. Led a cross functional team through an exercise to re-define key quality indicators and performance measures for quality and technical functions to enable further improvements to efficiency and effectiveness.
Led a cross functional team through a successful change process resulting in:
Situation: A leading, global Biopharmaceutical company has an ambitious project timeline to implement a new SAP ERP system in line with its international practices which involves switching from another ERP environment. Business activities include data readiness and pre / post load data verification, review of procedures & training material, defect resolution and readying the Business to successfully move to the new ERP system – on schedule with minimal interruption to manufacturing schedules.
Process: The process involved CBE providing an experienced Manufacturing Executive to lead the business team delegates from all key areas including Finance, Sales & Distribution and Manufacturing Operations for a period of 8 months. This period included the critical phases of deployment and post go-live “hypercare”. The process required constant interaction with the Project Leadership Team, Business Streams, Data Migration Team and Senior Site Management Team. This SAP implementation was one of the most complex implementations attempted by this Biopharmaceutical manufacturer.
Situation: A Government Human Blood Collection and Processing Business has misalignment between its donor collection schedules and customer order dispatch schedules. The Production Services Manager asks the Testing Manager to extend the Laboratory Testing hours to include nightshift hours in order to solve the problem. Is this the best way?
Process: The process involved bringing together representatives from the Testing, Distribution, Processing and Collection Teams to analyse if there was a suitable alternative to adding an expensive nightshift, yet ensuring the right quantities of fresh components were available to replenish the metropolitan hospitals inventory in the early evening. Together the existing process was mapped and potential solutions discussed.