realmofquality.blogspot.com
Realm of Quality -: MHRA Publishes OOS FAQs
http://realmofquality.blogspot.com/2012/05/mhra-publishes-oos-faqs.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Thursday, May 24, 2012. MHRA Publishes OOS FAQs. FDAs guidance on Out-of-specifications (OOS) is well known. Now Guidance from the MHRA on how to handle out-of-specification results during laboratory analysis is - on the contrary - pretty unknown although an own webpage on the MHRA website is dedicated to the OOS topic. To read and download the guidance.
realmofquality.blogspot.com
Realm of Quality -: CDSCO Website in its improved version with inclusion of Industry Guidance Documents
http://realmofquality.blogspot.com/2010/08/cdsco-website-in-its-improved-version.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Saturday, August 28, 2010. CDSCO Website in its improved version with inclusion of Industry Guidance Documents. CDSCO website in new avatar. Since my last visit to the website, may be at a gap of a year, I realise, CDSCO has included various multidisciplinary topics. Navigation is made easy and search relatively better. To reach the website, click here.
realmofquality.blogspot.com
Realm of Quality -: Time, Money...and Quality.
http://realmofquality.blogspot.com/2013/01/time-moneyand-quality.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Thursday, January 3, 2013. Time, Money.and Quality. Time, money and Quality.what will you choose? January 14, 2013 at 10:44 AM. Definitely Quality. It will automatically take care of Time and Money. Subscribe to: Post Comments (Atom). This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 India License.
realmofquality.blogspot.com
Realm of Quality -: Excipients to get Certification standards
http://realmofquality.blogspot.com/2011/10/excipients-got-certification-standards.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Monday, October 31, 2011. Excipients to get Certification standards. The Excipients finally have come inside the auditing ring. The much awaited standards for auditing Excipients. Product portfolio to influences Excipients role. Also the price rise among Excipients and cut throat competition compels their manufacturers to invent niche processes in shortest p...
realmofquality.blogspot.com
Realm of Quality -: EU GMP Guide: New Requirements added for Batch Certification
http://realmofquality.blogspot.com/2011/08/in-part-iii-of-eu-gmp-guide-document-on.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Tuesday, August 30, 2011. EU GMP Guide: New Requirements added for Batch Certification. Where applicable this batch certificate shall also be used for non-finished medicinal products such as intermediates, bulk or partially packed products. To download the full document. Subscribe to: Post Comments (Atom). Blogs and weblinks I visit.
realmofquality.blogspot.com
Realm of Quality -: Revision of Isopropylbenzene status from Class 3 to Class 2
http://realmofquality.blogspot.com/2010/09/revision-of-isopropylbenzene-status.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Friday, September 3, 2010. Revision of Isopropylbenzene status from Class 3 to Class 2. Keyoor has forwarded an interesting information. The jumping of chemicals from one list to another will continue. The information says that ICH is revising the status of Isopropylbenzene to Class 2 from existing Class 3! Subscribe to: Post Comments (Atom). This work is li...
realmofquality.blogspot.com
Realm of Quality -: Template for API Quality Agreement
http://realmofquality.blogspot.com/2010/09/template-for-api-quality-agreement.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Wednesday, September 29, 2010. Template for API Quality Agreement. For more information and downloading of the template, click here. Subscribe to: Post Comments (Atom). This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 2.5 India License. Profiel to know more on my profession, activities and networking.
realmofquality.blogspot.com
Realm of Quality -: SMEs likely to play important role in pharma growth story: report
http://realmofquality.blogspot.com/2013/09/smes-likely-to-play-important-role-in.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Tuesday, September 10, 2013. SMEs likely to play important role in pharma growth story: report. SMEs likely to play important role in pharma growth story: report. December 8, 2014 at 12:32 PM. I was looking for blogs related of who-gmp certification india. Then i found this blog, this is really nice and interested to read. Subscribe to: Post Comments (Atom).
realmofquality.blogspot.com
Realm of Quality -: What is AIP ?
http://realmofquality.blogspot.com/2010/07/what-is-aip.html
Realm of Quality -. Viewpoint on - GMPs, - Pharmaceutical Manufacturing Systems Management, -Regulatory Compliance and related Corporate Strategies. Sunday, July 18, 2010. AIP is Application Integrity Policy. The policy focuses on the integrity of data and information in applications submitted for Agency (FDA) review and approval. The AIP described Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability.
