Quality Assurance

Processes have been constructed utilizing the embedded principal of “Quality by Design”.

The Quality Assurance Department encompasses all planned and systematic actions, within the framework of the supporting Quality System, that are molded to ensure that the finished products have been manufactured, packaged, and tested in accordance with their assigned specification, assessment criteria, and/or market authorization requirements.  Further, Senior Management supports and focuses on the safety of the product throughout all stages of materials acquisition, manufacturing, packaging, assaying, warehousing, and shipping.

 The following are a few additional subject areas for Quality Assurance staff:

a)      cGMP / GMP

    • Places, People, Processes, and Products – functional and operational awareness, modified from ideas present by E.J. McCarthy
    • Plan-Do-Check-Act – popularized by W.E. Deming but originally accredited to W.A. Shewhart
    • Customer Complaint Program – a robust internal procedure that records product and service defects, thereafter offering a plan for correction
    • Change Control – a hallmark of modern process management where decisions are planned and authorization recorded
    • Risk Management – a set of assessment tools are used to prioritize what resources are needed, where they are need, and the establishment of a plan to mitigate the inherent risks of a product or process
    • Pharmacovigilance and Recall – the ability to detect, assess, and report adverse pharmacological events and, when required, to coordinate with relevant government agencies to complete product recalls in order to maintain confidence for the safety of consumer products
    • Internal Audits – following a self-assessment process, internal quality system issues are identified, assessed, and an action plan established that instructs what type of follow-up would be required in determining that the identified issue has been fixed
    • Third Party Audits – various clients as well as government officials from Canada, the US FDA, Taiwan, and other nations, have all visited the facility
    • process driven – the totality of the actions from (and the results of) following standardized procedures, policies, and protocols

b)      Documentation

    • Standard Operating Procedures – these are corporate documents that have been constructed to fulfill the ICH definition for being “detailed, written instructions to achieve uniformity of the performance of a specific function”
    • policies, including Quality, Halal, Environmental, and Workplace Safety – these are written commitments, endorsed by senior management, and encouraged as corporate culture
    • approval of Validation Protocols (specifically, cleaning and process) – these are detailed documents that explain how the manufacturing design space is to be constructed within the operational limits of the equipment and product
    • approval of Master Batch Records for Manufacturing and Packaging – these documents represent stable instructions that explain what tools and machine settings are needed to consistently build and package a finished product
    • approval for labels, packaging materials, product inserts, and related advertisements or handouts – a required control step to aid in finding and eliminating errors that would otherwise become part of the printed material of the finished product
    • approval for Product Release – one of the last quality assessment steps that is required to be completed before shipment of the finished product can be authorized
    • OOS Investigations – working with laboratory staff to investigate, record, and determine a course of action after initial assay results were found to be not compliant with specification
    • Deviation Investigation Reports – for use with the Batch Manufacturing and Packaging records, these investigative reports document and explain events or incidents that occurred during the construction of the product that were beyond what was initially planned
    • Root Cause Analysis – a quality investigative tool that is used to systematically determine sequential fault events
    • Annual Product Reviews – a legal requirement in many countries, these reports summarize data in order to assess the ongoing consistency of manufacturing and packaging processes by identifying longer term trends
    • Corrective and Preventative Action – a tool for ensuring consistency of processes and product with a view of initiating actions to prevent a reoccurrence of an identified deficiency
    • Archiving – the long term storage and security of documents (and related records) to maintain ongoing legal and contractual obligations

c)      Technical Assistance

    • provide recommendation for corrective actions – as part of the continuous improvement idea, suggestions can be made that lead to a betterment of established process
    • technology transfer – the establishment of the rules governing how information, knowledge, skills, samples, product formulations, customized manufacturing equipment, or other intellectual property is to be transferred, disseminated, or used between subcontractors, the client, and Viva
    • equipment verification (specifically, IQ, OQ, and PQ) – as part of an ongoing internal program, the building’s utilities, the manufacturing and packaging equipment, along with the laboratory equipment, all need to be periodically serviced, performance verified, and results documented
    • process optimization – this involves working collaboratively with Production, Research and Development, and Laboratory staff to improve the overall efficiency of a process
                         

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