regimeofquality.blogspot.com

Regime Of Quality

Saturday, April 14, 2012. Significant Changes in HPLC System Suitability: New USP Provisions Planned. A revision of General Chapter. On Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution. On the co...

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Saturday, April 14, 2012. Significant Changes in HPLC System Suitability: New USP Provisions Planned. A revision of General Chapter. On Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution. On the co...

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Regime Of Quality | regimeofquality.blogspot.com Reviews

https://regimeofquality.blogspot.com

Saturday, April 14, 2012. Significant Changes in HPLC System Suitability: New USP Provisions Planned. A revision of General Chapter. On Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution. On the co...

INTERNAL PAGES

regimeofquality.blogspot.com

1

Regime Of Quality: Regulators are sharing more and more information through the agreements between them

http://regimeofquality.blogspot.com/2010/10/regulators-are-sharing-more-and-more.html

Sunday, October 10, 2010. Regulators are sharing more and more information through the agreements between them. As per the two recently signed confidentiality agreements we can know how the regulators are thinking on the future aspects. In both agreements, the partners have provided assurance that they can effectively protect this non-public information. To read the agreements between agencies write to me i will be sending you the same agreements. Subscribe to: Post Comments (Atom).

2

Regime Of Quality: Draft Guidance for Qualifying Drug-Development Tools by USFDA

http://regimeofquality.blogspot.com/2010/11/draft-guidance-for-qualifying-drug.html

Monday, November 1, 2010. Draft Guidance for Qualifying Drug-Development Tools by USFDA. The US FDA issued draft guidance on the Qualification Process for Drug Development Tools.As per the document drug-development tools (DDTs) include biomarkers and patient-reported outcome instruments, among other things. The draft guidance also offers a mechanism for formal review by CDER to qualify the DDT. Subscribe to: Post Comments (Atom). DCGI becoming more and more vigilent and making th. To Subscribe click here.

3

Regime Of Quality: 10/3/10 - 10/10/10

http://regimeofquality.blogspot.com/2010_10_03_archive.html

Friday, October 8, 2010. Recall statement of USP 33–NF 28 check out on USP web site. Check the site mentioned for details. Http:/ www.usp.org/USPNF/recallStatement.html. Wednesday, October 6, 2010. The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way. The structure of this GPG follows, as far as this is possible, the structure of the operation-related GAMP5 appendices. This is pasted from GMP Compliance website. Tuesday, October 5, 2010. Subscribe to: Posts (Atom).

4

Regime Of Quality: FDA Publishes Revised Process - Validation Guidance

http://regimeofquality.blogspot.com/2011/01/fda-publishes-revised-process.html

Friday, January 28, 2011. FDA Publishes Revised Process - Validation Guidance. Guidance on Process validation is published by the USFDA which was awaited for quite a long time i.e from May 1987 and the draft from November 2008.The newly published guidance revises and replaces the 1987 guidance with the title "Guideline on General Principles of Process Validation". This guidance describes process validation activities in three stages. This stage has two elements: (1) design of the facility and qualificati...

5

Regime Of Quality: 10/17/10 - 10/24/10

http://regimeofquality.blogspot.com/2010_10_17_archive.html

Tuesday, October 19, 2010. Chinese State Food and Drug Administration Proposed Route of Registration for APIs, Excipients and Auxiliary Materials. 183; The drug product manufacturer is the entity responsible for the quality of component materials used in the drug. 183; Scope covers drugs registered for sale in China, apparently not APIs or excipients which are made for export only. 183; Clinical investigational materials are not addressed in this document. Subscribe to: Posts (Atom).

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regimeofquality.blogspot.com

Regime Of Quality

Saturday, April 14, 2012. Significant Changes in HPLC System Suitability: New USP Provisions Planned. A revision of General Chapter. On Chromatography is proposed in the Pharmacopeial Forum (volume 38, edition 2). This new chapter has a major impact on system suitability tests (SST). In the current USP 35, adjustments in the mobile phase in gradient conditions are not recommended. Now, adjustments should be possible but as they may cause changes in selectivity, they should be made with caution. On the co...

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