Quality Management for products/services of Company
At Inno Bio Ventures Sdn.Bhd., we deal with diversified businesses, viz. recombinant – monoclonal antibodies, cell therapies including adult stem cells and services like, contract research, contract manufacturing and training etc. In order to become a world-class enterprise, the quality system under the supervision of Vice President – Q.M.R.A. was established, based on innovation, operational excellence and customer intimacy. Our accomplishments include establishment of Quality Management Systems(QMS), based on PIC/S cGMP guidelines. The Nilai cGMP facility has undergone National Pharmaceutical Control Bureau (NPCB) pre- audit in January 2009. And now it is proposed to undergo final GMP inspection for obtaining manufacturing, distribution and marketing licenses for recombinant monoclonal antibody products.
The primary objective of the QMS at Inno Biologics, is to provide timely support to our Biomanufacturing division for proper validation, control of documents and quality control.
Scope of QMS:-
- To validate the Biomanufacturing department and QC areas of Inno Biologics to ensure that products are manufactured, and tested under cGMP/GLP environment.
- To provide timely QC support to the Biomanufacturing section in terms of testing and qualifying the RM/PM, in-process and finished product analysis.
- To ensure that only calibrated and validated euipment and instruments are used for manufacturing and testing.
Our Quality Management System covers:
- The design and maintenance of buildings, equipment and premises.
- The quality, suitability and functionality of raw and processing materials, including donor selection and screening.
- The development of, and conformance to appropriate procedures (cGMP; GLP; cGTP) and /or specifications for labelling, handling, packaging, storage and distribution.
- Infection controls, including sourcing controls and inactivation methods.
- Control of product design and validation of manufacturing processes to ensure that product meets identified requirements for clinical performance.
- Validation and documentation of procedures for tissue culture (e.g. manipulation, expansion, storage, transport and clinical use).
- Quality control testing and inspection by Biomanufacturing department and prior to release, including control of test equipment, to ensure that batches of product meet specified design requirements.
- Training of staff and their qualification for specific activities.
- Product identification and trace ability between raw materials and distribution records.
- Post marketing surveillance, including monitoring of clinical performance and effectiveness (eg.infection, morphology, function, proliferation, persistence, immunotoxicity, efficacy) and corrective or preventive actions.
- The management system, including independent responsibility for Biomanufacturing department and quality, internal quality audits and management review of the quality system.
- Systems to minimise cross-contamination, including contamination from Biomanufacturing department staff.
- Preparation of regulatory dossiers for registration of the products in different countries.
- Carrying out stability studies on the API.
- Attending to customer complaints and carrying out failure investigations.