1. Quality is the responsibility of all persons involved in manufacturing.
3. The system for managing quality encompasses the organizational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the APIs meet the specifications for quality and purity. All quality related activities are defined and documented.
5. The persons authorized to release intermediates and APIs are specified.
7. Any deviation from established procedures are documented and explained. Critical deviations are investigated, and the investigation and its conclusions are documented.
9. Procedures exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.).
Quality Risk Management
2. The quality risk management system ensures that:
- the level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk
1. The quality units should be involved in all quality-related matters.
3. The main responsibilities of the independent quality units are described in writing and include but not necessarily be limited to:
3.2. QC has a system to release or reject raw materials, intermediates, packaging and labelling materials;
3.4. QC ensures that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates
3.6. QA makes sure that critical deviations are registered, investigated and resolved;
3.8. QA approves all procedures impacting the quality of intermediates or APIs;
3.10. QA approves changes that potentially impact intermediate or API quality;
3.12. QA makes sure that quality related complaints are investigated and resolved;
3.14. QA and QC perform product quality reviews
The responsibility for production activities is described in writing, and includes but not necessarily be limited to:
2. Producing APIs and, intermediates according to pre-approved instructions;
4. Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded;
6. Making sure that the necessary calibrations are performed and records kept;
8. Making sure that validation protocols and reports are reviewed and approved by QA
10. Making sure that new and/or modified facilities and equipment are qualified.
1. In order to verify compliance with the principles of GMP for APIs, regular internal audits are performed in accordance with an approved schedule.
Product Quality Review
verifying the consistency of the process. Such reviews are normally conducted and
- A review of in-process control and API test results;
- A review of all critical deviations or non-conformances and related investigations;
- A review of results of the stability monitoring program;
- A review of adequacy of corrective actions.
Head of QA Department:
Dr. S. Todorov, MD
Date: 10.05 .2017
In case of a serious quality complaint about medicinal products manufactured by BB NCIPD Ltd. we can be contacted at phone +359 2 4160354.
Copyright © 2003-2017 BB - NCIPD Ltd.
Created by: i-Sol Ltd.