Quality Assurance

Inno Biologics is committed to ensure product quality by implementing a reliable and efficient support system mainly in several important areas such as plant facility, utility and equipment, material management, production activities, packaging and labelling control, laboratory and quality management systems. Every system will be consistently monitored and reviewed for compliance and effectiveness based on regulatory (NPCB, FDA, EMEA) and cGMP (PIC/S, EU, ICH Q7A) requirements.

Qualified and well-trained personnel will coordinate and conduct quality audits, initiate corrective and preventive actions, when necessary, and perform product quality reviews on a regular basis for continual improvement purposes. Any process changes or deviations will be strictly controlled, thoroughly investigated and comprehensively documented where justification and verification are required before implementing the new process into practice.

Our quality service is also extended towards providing an efficient Supply Chain Quality Control (SCQC) management system. This concept is introduced to ensure smooth running of goods-supply-delivery-chain exercise consistent with product requirements and customer expectations.

Quality Control

Inno Biologics' QC laboratory unit is divided into four separate components which are Protein Analysis for biochemical testing, Microbiology, Raw Material and In-process Quality Control (IQPC). QC testing programme is based on QC Inspection Plan, established from the Product Development (PD) research unit, regulatory requirements and recognized resources.

QC analytical procedures and specifications are developed from validated methods, established pharmacopies and other approved references. QC and IPQC test results will determine whether products are within the approved and registered specifications.

Environmental, utilities and personnel monitoring are also part of the QC responsibilities. We have built a complete and sophisticated facility, supported by qualified laboratory equipments, robust analytical methods and trained analysts for various testing activities.

Outsourcing

QA will ensure the reliability and quality of the outsourced third party principals by initiating a qualification audit programme. Performance of the selected and approved parties will be continuously monitored through audits on their quality management system and inspections to their premises on a regular basis.