Change Control Flow Chart with example in English and Hindi
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4 سال پیش
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This video is about Change
This video is about Change Control Flow Chart with example in English and Hindi
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WHAT IS CHANGE CONTROL?
DEFINITIONS
PIC/S document PI 006-2:
“Written procedures should be in place to describe the actions to be taken if a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications.
PIC/S document PI 006, section 6.7.1
“Change control is an important element in any Quality Assurance system. Written procedures should be in place to describe the actions to be taken if a change is proposed to a product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or support system operation.”
CATEGORY OF CHANGE CONTROL
Minor – may or may not impact product quality.
E.g: Replacement of apparatus part of the same design
Major – impact on product quality.
E.g: Change in the product composition.
DOCUMENTATION
“All changes should be formally requested, documented and accepted by representatives of Production, QC/QA, R&D, Engineering and Regulatory Affairs as appropriate. The likely impact (risk assessment) of the change on the product should be evaluated and the need for, and the extent of Re-validation discussed. The change control system should ensure that all notified or requested changes are satisfactorily investigated, documented and authorised.” (PIC/S document PI 006, section 6.7.2) “
All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for, and the extent of, re-qualification and re-validation should be determined.” (Annex 15, no. 44)
#PharmaGyan
Hello, Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
Visit our website for more stuffs like guidelines, jobs, vacancies, SOPs, Protocols, etc.
Link is : https://sites.google.com/view/pharmagyan
Let's Checkout Our Other Videos
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WHAT IS CHANGE CONTROL?
DEFINITIONS
PIC/S document PI 006-2:
“Written procedures should be in place to describe the actions to be taken if a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducibility of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications.
PIC/S document PI 006, section 6.7.1
“Change control is an important element in any Quality Assurance system. Written procedures should be in place to describe the actions to be taken if a change is proposed to a product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or support system operation.”
CATEGORY OF CHANGE CONTROL
Minor – may or may not impact product quality.
E.g: Replacement of apparatus part of the same design
Major – impact on product quality.
E.g: Change in the product composition.
DOCUMENTATION
“All changes should be formally requested, documented and accepted by representatives of Production, QC/QA, R&D, Engineering and Regulatory Affairs as appropriate. The likely impact (risk assessment) of the change on the product should be evaluated and the need for, and the extent of Re-validation discussed. The change control system should ensure that all notified or requested changes are satisfactorily investigated, documented and authorised.” (PIC/S document PI 006, section 6.7.2) “
All changes that may affect product quality or reproducibility of the process should be formally requested, documented and accepted. The likely impact of the change of facilities, systems and equipment on the product should be evaluated, including risk analysis. The need for, and the extent of, re-qualification and re-validation should be determined.” (Annex 15, no. 44)
#PharmaGyan
Hello, Friends welcome to my channel "PharmaGyan" Learn about Pharmacy, Pharmaceutical companies, regulatory guidelines, Documentation procedures, SOPs, How to videos on various operating procedures, Quality Assurance, Quality control, R&D, Pharmaceutical validation and qualification guidelines and procedures etc.
4 سال پیش
در تاریخ 1399/11/15 منتشر شده
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