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EMA:Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on …

‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1) – Draft

Original Link: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/08/

WC500170476.pdf
Adobe Acrobat Document 125.8 KB

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Stability Program for Pharmaceuticals Products
September 2013
Presented for US Pharmacopeia
234842849-2013-09-18-USP-Stability-1-Reg
Adobe Acrobat Document 1.3 MB

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MRLs for active substances and excipients
Presented by: Isaura Duarte Head of Animal and Public Health
MRLs for active substances and excipient
Adobe Acrobat Document 558.2 KB

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Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms
Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development – April 2012
214616069-Qbd-h-FDA-Ir-08oct13.pdf
Adobe Acrobat Document 1.5 MB

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USP Excipients Standards Setting Process
USP Stakeholder Forum Meeting 1 – June 7, 2013
Catherine S. Meehan – Senior Director USP Convention
3b-excipient-standard-setting-process-20
Adobe Acrobat Document 553.5 KB

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The regulation of pharmaceutical excipients.
Vikrant Saluja*, Bhupinder Singh Sekhon
Faculty of Pharmaceutical Sciences, PCTE Group of Institutes, Ludhiana, India-142021
Received: April 29, 2013; Accepted: August 22, 2013 Review Paper
213-1403-1-PB.pdf
Adobe Acrobat Document 280.9 KB

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Addressing specific regulatory excipients requirements in the marketing authorization
Dr. Philipp Hebestreit – Global Regulatory Affairs – BASF
PharmSciFair Nice, June 11th, 2009
Specific_regulatory_requ_PH.pdf
Adobe Acrobat Document 168.8 KB

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Regulatory challenges are hindering the use of novel excipients
Kate Denton – Regulatory Affairs Manager – Novozymes Biopharma
Reprint from Pharmaceutical Technology Europe – Issue June 2010
KDEN_PTEJuly2010.pdf
Adobe Acrobat Document 608.0 KB

Articles

European Union Introduces GMPs for Excipients

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Nov 1, 2013 By: Sean Milmo BioPharm International Volume 26, Issue 11, pp. 12-13