際際滷shows by User: RavichandraNadagouda / http://www.slideshare.net/images/logo.gif 際際滷shows by User: RavichandraNadagouda / Tue, 26 Oct 2021 14:46:31 GMT 際際滷Share feed for 際際滷shows by User: RavichandraNadagouda Cleaning validation /slideshow/cleaning-validation-250532151/250532151 cleaningvalidationautosavedautosavedautosaved-211026144632
It is process of Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results. Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations 1. Cross contamination with active ingredients Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated. In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern. 2. Contamination with unintended materials or compounds While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment. ]]>
It is process of Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results. Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations 1. Cross contamination with active ingredients Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated. In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern. 2. Contamination with unintended materials or compounds While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment. ]]> Tue, 26 Oct 2021 14:46:31 GMT /slideshow/cleaning-validation-250532151/250532151 RavichandraNadagouda@slideshare.net(RavichandraNadagouda) Cleaning validation RavichandraNadagouda It is process of Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results. Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations 1. Cross contamination with active ingredients Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated. In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern. 2. Contamination with unintended materials or compounds While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/cleaningvalidationautosavedautosavedautosaved-211026144632-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> It is process of Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results. Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits. The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations 1. Cross contamination with active ingredients Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated. In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern. 2. Contamination with unintended materials or compounds While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment&#39;s provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
Cleaning validation from RavichandraNadagouda
]]> 20446 0 https://cdn.slidesharecdn.com/ss_thumbnails/cleaningvalidationautosavedautosavedautosaved-211026144632-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 Packaging material vendor audit /RavichandraNadagouda/packaging-material-vendor-audit packagingmaterialvendoraudit-211018135906
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendors quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world. Reason why organizations use audits is to reduce cost and improve quality control The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks. In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes. To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier. According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations. After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer. ]]>
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendors quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world. Reason why organizations use audits is to reduce cost and improve quality control The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks. In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes. To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier. According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations. After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer. ]]> Mon, 18 Oct 2021 13:59:05 GMT /RavichandraNadagouda/packaging-material-vendor-audit RavichandraNadagouda@slideshare.net(RavichandraNadagouda) Packaging material vendor audit RavichandraNadagouda A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendors quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world. Reason why organizations use audits is to reduce cost and improve quality control The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks. In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes. To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier. According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations. After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/packagingmaterialvendoraudit-211018135906-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendors quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world. Reason why organizations use audits is to reduce cost and improve quality control The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks. In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes. To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier. According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations. After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Packaging material vendor audit from RavichandraNadagouda
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Medical device packaging science]]>
Medical device packaging science]]> Sat, 24 Jul 2021 04:10:38 GMT /slideshow/medical-device-packaging-249846731/249846731 RavichandraNadagouda@slideshare.net(RavichandraNadagouda) paharmaceutical packaging Medical device Packaging types of medical device packaging primary and secondary packaging RavichandraNadagouda Medical device packaging science <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/packagingsemi-210724041038-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Medical device packaging science
paharmaceutical packaging Medical device Packaging types of medical device packaging primary and secondary packaging from RavichandraNadagouda
]]> 6377 0 https://cdn.slidesharecdn.com/ss_thumbnails/packagingsemi-210724041038-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://public.slidesharecdn.com/v2/images/profile-picture.png https://cdn.slidesharecdn.com/ss_thumbnails/cleaningvalidationautosavedautosavedautosaved-211026144632-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/cleaning-validation-250532151/250532151 Cleaning validation https://cdn.slidesharecdn.com/ss_thumbnails/packagingmaterialvendoraudit-211018135906-thumbnail.jpg?width=320&height=320&fit=bounds RavichandraNadagouda/packaging-material-vendor-audit Packaging material ven... https://cdn.slidesharecdn.com/ss_thumbnails/packagingsemi-210724041038-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/medical-device-packaging-249846731/249846731 paharmaceutical packag...