These are the fundamentals (shorthand) linked to their original structure.
6 Make sure you have an inclusive QMS in place
7 1. Confirm you have the right people, right number, right training. 2. Confirm your roles and responsibilities are clearly defined. Make sure the information flow is also defined and that accountability lines are clear. 3. Confirm that the right people have the right level of authority. 4. Monitor the training, the impact of training and the overall impact on manufacturing practice. 5. Confirm that you have a robust strategu for hygiene deployment, implementation, monitoring and intervention.
8 1. Demonstrate that your premises are fit for purpose. 2. The processes behind the use of premises and equipment are geared at minimising error, easy cleaning and avoiding (cross) contamination. 3. Ensure all key equipment has its own validation protocols
9 1 Documentation is available on specs, manufacturing procedures, records, impact, interventions and impact of interventions, history track record. 2. Data snapshots are properly calibrated.
10 1. Procedures are in clear, resourcing processes are identified, process controls are demponstrably embedded. 2. Handling protocols are secure to avoid mix ups. 3. Change validation process are in place for each product. Processes are made out of critical phases, each is independently validated. 4. All steps of validation are documented.
11 1. Quality control is led by qualified personnel, is independent of production and has access to necessary examination tools. 2. Quality includes imported products or products fulfilled by outside agencies. 3. Product release depends on final product and all processes which led to the product. 4. Samples of each batch of finished medicinal product are retained as a physical history.
12 1. All contracted out processes regulated by contractual agreements . 2. Roles and responsibilities clearly defined in contract. 3. Sub-contracting tightly regulated. 4. quality systems which are integrated in overall QMS.
13 1 Clear complaints and recall process in place. Recall linked to Article 123 of Directive 2001/83/EC. 2. Tight documentation system re complaints and recalls in place. 3. procedure for the rapid unblinding of blinded products.
14 Self-inspect, seek out lack of conformity, intervene and monitor.
15 Label to provide narrative of the product.