ISPE Comments on Regulations

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ISPE comments on proposed regulations and guidance that affect the bio/pharmaceutical industry. Comments are solicited from ISPE Communities of Practice (COPs), Committees, Councils, Task Teams, and Members-at-large. Below is a list of items on which the Society has submitted comments. Click the titles to view the comments.

Oct 2013 EC EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 16 - Certification by a Qualified Person and Batch Release ( 126 KB)
Sep 2013 WHO General Guidance for Inspectors on “Hold-Time” Studies, Rev 1 ( 123 KB)
Sep 2013 WHO Proposed Updated Text for Who Good Manufacturing Practices for Pharmaceutical Products: Main Principles ( 119 KB)
Sep 2013 FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ( 57 KB)
Aug 2013 FDA Guidance for Industry Expedited Programs for Serious Conditions––Drugs and Biologics ( 451 KB)
Jul 2013 FDA Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements ( 201 KB)
Jul 2013 EMA Guideline on Setting Health Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities ( 298 KB)
Jul 2013 EC Revision of EU Commission Guidelines on Good Manufacturing Practice Medicinal Products ( 221 KB)
Apr 2013 EC Guidelines on the Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use ( 122 KB)
Apr 2013 WHO General Guidance for Inspectors on "Hold-Time" Studies ( 202 KB)
Feb 2013 FDA Draft Guidance for Industry on Safety Considerations for Product Design to Minimize Medication Errors (Docket No. FDA–2012–D–1005) ( 110 KB)
Oct 2012 EMA Draft Guideline on Process Validation (EMA/CHMP/CVMP/QWP/70278/2012-Rev1) ( 166 KB)
Oct 2012 SFDA Regulations on Inspection and Administration of Drug Manufacturing Enterprises Oversea (Opinion Soliciting Draft) Document No. 82 2012 ( 385 KB)
Jan 2012 EMA Concept Paper on the Development of Toxicological Guidance for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities (EMA/CHMP/SWP/598303/2011) ( 60 KB)
Sep 2011 FDA Proposed revisions to USP General Chapter <1079> Good Storage and Distribution Practices for Drug Products ( 191 KB)
Sep 2011 WHO Comments on WHO Working Document, Definition of Active Pharmaceutical Ingredient (QAS/11.426 Rev 1) ( 127 KB)
Sep 2011 EMA ICH guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) ( 164 KB)
Sep 2011 FDA ICH Guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (Docket No. FDA–2011–D–0436) ( 131 KB)
Jul 2011 WHO Working Document Pharmaceutical Development of Multisource (Generic) FPP’s – Points to consider (QAS/08.251 Rev 3) ( 78 KB)
May 2011 FDA Guidance for Industry on Non-penicillin Beta-Lactam Risk Assessment: A CGMP Framework (Docket No. FDA-2011-D-0104) ( 100 KB)
Oct 2010 WHO Working Document Good Practices for Pharmaceutical
Microbiology Laboratories (QAS/09.297 Rev 2)
( 96 KB)
Aug 2010 EMA Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release Testing) (EMA/CHMP/QWP/811210/2009 Rev 1) ( 139 KB)
Aug 2010 WHO Working Document Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251 Rev 1) ( 115 KB)
Aug 2010 WHO Supplementary Guidelines on Good Manufacturing Practices for Heating Ventilation and Air Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms (QAS/10.342 Rev 1) ( 185 KB)
Dec 2009 WHO Good Practices for Pharmaceutical Microbiology Laboratories (QAS/09.297 Rev 1) ( 113 KB)
Oct 2009 WHO Working Document, Manufacturing Practices for Pharmaceutical Products Containing Hazardous Substances (QAS/08.256 Rev 1) ( 228 KB)
Oct 2009 WHO GMP for Sterile Pharmaceutical Products (QAS/09.295 Rev 1) ( 90 KB)
Apr 2009 ANVISA Boas Prática de Fabricação de Medicamentos ( 24 KB)
Jan 2009 FDA Draft Guidance for Industry on Process Validation: General Principles and Practices (Docket No. FDA–2008–D–0559) ( 150 KB)
Jan 2009 EMA New Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice ( 160 KB)
Nov 2008 EMA Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice ( 162 KB)
Oct 2008 EMA Proposed Revisions to Chapter 4 and Annex 11 of Volume 4 EU Guidelines to Good Manufacturing Practice ( 137 KB)
May 2008 WHO Guideline to the Inspection of Hormone Product Manufacturing Facilities (QAS/08.256) ( 141 KB)
Apr 2008 WHO Pharmaceutical Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251) ( 118 KB)
Oct 2007 FDA Draft Guidance on Q-10 Pharmaceutical Quality System CommentFDA2007-1011 ( 81 KB)
Aug 2007 EMA Comments on Batch Release Certificates for Investigational Medicinal Products (IMPs) ( 90 KB)
Mar 2007 EMA EMEA Concept Paper Regarding Computerised Systems ( 65 KB)
Dec 2006 EMA Guideline of Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (EMEA/CHMP/BWP/398498/2005) ( 128 KB)
Apr 2006 EMA GMP Annex 1: Proposals for Amendment to the Environmental Classification Table for Particles and Associated Text, Amendment to Section 42 Concerning Acceptance Criteria for Media Simulations, Amendment to Section 52 Concerning Bio-Burden Monitoring, and Additional Guidance in Section 88 on the Sealing of Vials ( 238 KB)
Apr 2006 FDA Guidance for Industry on INDs – Approaches to Complying with cGMP During Phase 1 (Docket Number 2005D- 0286) ( 31 KB)
Mar 2006 EMA ISPE White Paper in Response to the EMEA’s Concept Paper, Dealing with the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products ( 62 KB)
Sep 2005 EMA Sampling of Investigational Medicinal Products ( 227 KB)
Apr 2005 EMA Concept Paper Dealing with the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products (EMEA/152688/04) ( 62 KB)
Jul 2004 FDA Part 11 revisions Electronic Records; Electronic Signatures; Public Meeting (Docket No. 2004N-0133) ( 49 KB)
Last Update: 18 November 2013

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