Quality Control & Assurance CVs in Kenya

a) (i) the release of a medicinal product with appropriate quality indicators is achieved through the development, planning, implementation, maintenance and continuous improvement of the system; b) (ii) knowledge about the medicinal product and its production process is applied throughout all stages of the life cycle; c) (iii) medicinal products are developed and researched taking into account the requirements of these Rules; d) (iv) production and inspection operations are defined and comply with the requirements of these Rules; e) (v) the responsibilities and duties of personnel are clearly defined; f) (vi) arrangements are in place to ensure the production, supply and use of appropriate raw materials and packaging materials, and arrangements are in place to select and control suppliers and to verify that each shipment is made through an approved supply chain; g) (vii) processes are in place to ensure that outsourced activities are managed (outsourced management); h) (viii) a continuous controlled state is established and maintained through the development and use of effective monitorin Quality Control & Assurance CVs in Kenya g and control systems in relation to the effectiveness of the process and the quality of the medicinal product; i) (ix) the results of drug and process monitoring are taken into account in batch release, in the investigation of deviations and for taking preventive measures to avoid potential deviations; j) (x) necessary control of intermediate products, control during production and validation is carried out; k) (xi) continual improvement is made through the implementation of improvements based on up-to-date process and product knowledge; l) (xii) measures are taken for a prospective assessment of the planned changes and their approval prior to implementation, subject to notification and agreement with the authorized federal executive body, if required; m) (xiii) post-implementation changes are assessed to confirm that the goal of the changes has been achieved and that this has not negatively affected product quality; o) (xiv) An appropriate level of root cause analysis is applied during the investigation of deviations, including assumptions of product defect and other problems. Causes can be identified using quality risk management principles. In the event that the true cause of the nonconformity cannot be determined, the most likely cause must be established. Where human error is suspected or identified as a cause, the cause must be proven to ensure that there are no existing process, procedural or system errors or problems. Based on the results of the investigation, appropriate corrective and (or) preventive actions are determined and taken. The effectiveness of such actions should be checked and evaluated by the manufacturer in accordance with the principles of quality risk management; n) (xv) the introduction of medicinal products into civil circulation before the issuance of a release by an authorized person is not allowed. The authorized person certifies that each batch of the medicinal product has been produced and controlled in accordance with the requirements of the registration dossier and these Rules; https://jiji.co.ke/quality-control-and-assurance-cvs