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Validation & Quality Blogging Insights | qualification/validation & quality related topics for the pharmaceutical & biopharmaceutical industries

"If you have knowledge, let others light their candles with it" ˜Winston Churchill This blog is for novice and experienced professionals in the bio/pharmaceutical industries with an interest in current Good Manufacturing Practices (cGMPs) and its applications. It is intended to provide basic theory and application of cGMP topics and be a valuable resource to…

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Validation & Quality Blogging Insights | qualification/validation & quality related topics for the pharmaceutical & biopharmaceutical industries | validationquality.wordpress.com Reviews

https://validationquality.wordpress.com

"If you have knowledge, let others light their candles with it" ˜Winston Churchill This blog is for novice and experienced professionals in the bio/pharmaceutical industries with an interest in current Good Manufacturing Practices (cGMPs) and its applications. It is intended to provide basic theory and application of cGMP topics and be a valuable resource to…

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Resource Links | Validation & Quality Blogging Insights

https://validationquality.wordpress.com/resource-links

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. The following is an ongoing listing of selected web sites on topics presented in Validation and Quality Blogging Insights. These web sites provide additional information on current Good Manufacturing Practice regulations and its principles and applications in the Pharmaceutical and Biopharmaceutical industries. The Office of Compliance, Division of Manufac...

2

To Clean Or Not To Clean—An Audit Case of Misinterpreting the Good Manufacturing Practices | Validation & Quality Blogging Insights

https://validationquality.wordpress.com/2012/08/11/to-clean-or-not-to-clean-an-audit-case-of-misinterpreting-the-good-manufacturing-practices

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. To Clean Or Not To Clean An Audit Case of Misinterpreting the Good Manufacturing Practices. August 11, 2012. Is the auditee’s response deemed acceptable? Should the auditor close out this observation? Minimum CGMP Regulatory Requirements. Assessment of Audit Response. The auditee failed to maintain cleaning records for the washing area of the laboratory so...

3

The Responsibilities and Failures of the Quality Unit | Validation & Quality Blogging Insights

https://validationquality.wordpress.com/2012/09/02/the-responsibilities-and-failures-of-the-quality-unit

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. The Responsibilities and Failures of the Quality Unit. September 2, 2012. English: US Government instruction manual on Quality Systems; free content. http:/ www.fda.gov/CbER/gdlns/qualsystem1.gif. The responsibilities of the Quality Control Unit are specified in 21 CFR 211.22. [Ref. # 3]. Specifically, the QCU shall have:. Responsibilities and procedures a...

4

Canadian GMP Regulations Applicable to Procedures | Validation & Quality Blogging Insights

https://validationquality.wordpress.com/2012/06/18/canadian-gmp-regulations-applicable-to-procedures

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. Canadian GMP Regulations Applicable to Procedures. June 18, 2012. A key element for Good Manufacturing Practices. GMPs) is approved procedures. May be used to supplement product-specific master and batch production documents”. Following SOPs ensures that drugs are consistently produced and controlled in such a way to meet the quality standards ap...The Can...

5

A Quality Journey through ASQ Certification | Validation & Quality Blogging Insights

https://validationquality.wordpress.com/2011/02/23/a-quality-journey-through-asq-certification

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. A Quality Journey through ASQ Certification. February 23, 2011. While in college I learned about the American Society for Quality Control (ASQC), now known as the American Society for Quality (ASQ), and its certifications programs, particularly the Certified Quality Auditor (CQA). Pharmaceutical GMP Professional Certification. Leave a Reply Cancel reply.

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Validation & Quality Blogging Insights | qualification/validation & quality related topics for the pharmaceutical & biopharmaceutical industries

Validation and Quality Blogging Insights. Qualification/validation and quality related topics for the pharmaceutical and biopharmaceutical industries. 8220;If you have knowledge, let others light their candles with it” Winston Churchill. Moreover, this blog provides useful information on processes and systems associated with qualification and validation in the pharmaceutical and biotech industries. Subjects addressed include manufacturing and packaging processes; cleaning processes; analytical method...

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