QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
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This document discusses change control in the pharmaceutical industry. It begins by defining change control as a formal system to review proposed or actual changes that could affect facilities, systems, equipment, or processes. The functions of change control are then outlined as identifying, reviewing, approving, validating, analyzing, and monitoring changes. The areas of change that would require control are described, including manufacturing, quality control, research and development, engineering, and marketing. Finally, the document states that written procedures and documentation like standard operating procedures and change control forms are necessary parts of the change control system.
QUALITY MANAGEMNT SYSTEMS: Change Control (CC)
- 2. QUALITYMANAGEMENTSYSTEMS Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur
- 3. TREY research CHA NGE CO NTR OL LEARNINGOBJECTIVES After completing this presentation, you will be able to understand: Introduction to Change Control. Definition of Change Control. Function of Change Control. Area of Change. Written Procedures and Documentation. 3
- 5. TREY research 5 CHANGE CONTROL In pharmaceutical industry change control is an important part of quality assurance. The changes proposed and made in any procedure or process should be reviewed, established, documented and approved by the concerned authorities. Change control is the system to implement this approved change to confirm the regulatory requirements.
- 6. TREY research 6 CHANGE CONTROL: Definition Change control can be defined as; “A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of - facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state”. (EU GMP Guidelines, Annexure 15)
- 7. TREY research 7 CHANGE CONTROL: Function Any change in manufacturing process, equipment, materials used that may cause alteration in product quality should be validated. The main functions of change control are: 1. Identification of the changes made. 2. Review of the change. 3. Approval of the change. 4. Validating the changes which can alter the product quality, regulatory or GMP requirements. 5. Analysis of the change and monitoring of the impact of change.
- 8. TREY research 8 CHANGE CONTROL: Area of Change 1. Manufacture: Following changes are concerned: • Raw materials • Equipments • Process/parameters • Testing/validation procedures • Packaging materials • Cleaning process
- 9. TREY research 9 CHANGE CONTROL: Area of Change 2. Quality control and quality assurance: Following changes are considered: • Quality testing parameters • Sampling size • Validation process • Specifications of raw materials, intermediates and final product • Documentation • Standard operating procedures (SOPs)
- 10. TREY research 10 CHANGE CONTROL: Area of Change 3. Research and development: It includes the change in; • Manufacturing process (any addition OR elimination of steps) • Raw materials (any addition OR omission of the product) • Specifications of raw materials, intermediates and final product • Quantitative aspects of raw materials and finished products • Manufacturing conditions and storage conditions • Testing/validation procedures
- 11. TREY research 11 CHANGE CONTROL: Area of Change 4. Engineering: It includes the following changes in: • Equipment used • Validation of the equipment • Parts of equipment • Working and design layout • Software/ Hardware or Change in any program 5. Marketing.
- 12. TREY research 12 CHANGE CONTROL: Written Procedures and Documentation Procedures in writing should be kept at the proper place to describe the changes made related to the materials, equipment and method of manufacturing or testing conditions or any other change that can affect the quality of the product. Standard operating procedure (SOP) and records of change control documents are required for the documentation.
- 13. TREY research 13 CHANGE CONTROL: Written Procedures and Documentation Change Control Form (CCF) is an important documentation part of change control. It contains the form related to initiate department for the proposed change, proposed change details, comments from QA Head, category of the changes, supportive documents, management review form and assessment of CCF.
- 14. TREY research 14 CHANGE CONTROL: Written Procedures and Documentation Change Control Form (CCF)
- 16. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory) DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.) AJAY81AJAY@GMAIL.COM WHATSAPP: 9782226444 Tobecontinued...