Regulatory Comments

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.

Dec 2018 ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (submitted to USFDA)
Oct 2018 FDA Modernizing Pharmaceutical Quality Systems, Studying Quality Metrics and Quality Culture, Quality Metrics Feedback Program
Sep 2018 FDA Field Alert Report Submission: Questions and Answers; Draft Guidance for Industry
Apr 2018 WHO GMPs for Heating, Ventilation and Air- Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms: Part 2
Mar 2018 EMA Revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4
Feb 2018 EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Sep 2017 FDA Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket
Sep 2017 FDA Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy; Draft Guidance for Industry
Aug 2017 FDA Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11-Questions and Answers
Apr 2017 EMA Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities'
Mar 2017 FDA Revised Draft Guidance Submission of Quality Metrics
Mar 2017 FDA Cross Industry Collaboration Group comments on Revised FDA Draft Guidance Submission of Quality Metrics
Nov 2016 EMA Draft Q&A on Production of WIFI by Non-distillation Methods – reverse osmosis and biofilms and control strategies
Nov 2016 MHRA GxP Data Integrity Definitions and Guidance for Industry
Sep 2016 FDA Quality Metrics Technical Conformance Guide
Sep 2016 FDA Cross Industry Collaboration Group comments on Quality Metrics Technical Conformance Guide
Sep 2016 EC Consultation Document GMP for Advanced Therapy Medicinal Products
Jun 2016 FDA Draft Guidance Advancement Data Integrity and Compliance with CGMP Guidance for Industry
Feb 2016 FDA Draft Guidance Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base Guidance for Industry
Dec 2015 EMA Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
Nov 2015 FDA FDA Federal Register Notice on Quality Metrics and Draft Guidance, Request for Quality Metrics
Nov 2015 FDA Cross-Industry Quality Metrics Collaboration Group comments on Request for Quality Metrics.
Jul 2015 FDA Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products
Mar 2015 EMA Annex 1 of the GMP Guidelines on Good Manufacturing Practice - Manufacture of Sterile Medicinal Products
Nov 2014 OECD Application of GLP Principles to Computerised Systems
Oct 2014 EMA Process Validation for the Manufacture of Biotechnology-Derived Active Substances and Data to be Provided in the Regulatory Submission
May 2014 FDA Guidance for Industry: Analytical Procedures and Methods Validation for Drugs and Biologics
May 2014 EC EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use - Annex 15 - Qualification and Validation
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
Sep 2013 WHO General Guidance for Inspectors on “Hold-Time” Studies, Rev 1
Sep 2013 WHO Proposed Updated Text for Who Good Manufacturing Practices for Pharmaceutical Products: Main Principles
Sep 2013 FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Aug 2013 FDA Guidance for Industry Expedited Programs for Serious Conditions––Drugs and Biologics
Jul 2013 FDA Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements
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
Jul 2013 EC Revision of EU Commission Guidelines on Good Manufacturing Practice Medicinal Products
Apr 2013 EC Guidelines on the Principles of Good Distribution Practices for Active Substances for Medicinal Products for Human Use
Apr 2013 WHO General Guidance for Inspectors on "Hold-Time" Studies
Feb 2013 FDA Draft Guidance for Industry on Safety Considerations for Product Design to Minimize Medication Errors (Docket No. FDA–2012–D–1005)
Oct 2012 EMA Draft Guideline on Process Validation (EMA/CHMP/CVMP/QWP/70278/2012-Rev1)
Oct 2012 SFDA Regulations on Inspection and Administration of Drug Manufacturing Enterprises Oversea (Opinion Soliciting Draft) Document No. 82 2012
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)
Sep 2011 FDA Proposed revisions to USP General Chapter Good Storage and Distribution Practices for Drug Products
Sep 2011 WHO Comments on WHO Working Document, Definition of Active Pharmaceutical Ingredient (QAS/11.426 Rev 1)
Sep 2011 EMA ICH guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
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)
Jul 2011 WHO Working Document Pharmaceutical Development of Multisource (Generic) FPP’s – Points to consider (QAS/08.251 Rev 3)
May 2011 FDA Guidance for Industry on Non-penicillin Beta-Lactam Risk Assessment: A CGMP Framework (Docket No. FDA-2011-D-0104)
Oct 2010 WHO Working Document Good Practices for Pharmaceutical Microbiology Laboratories (QAS/09.297 Rev 2)
Aug 2010 EMA Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release Testing) (EMA/CHMP/QWP/811210/2009 Rev 1)
Aug 2010 WHO Working Document Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251 Rev 1)
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)
Dec 2009 WHO Good Practices for Pharmaceutical Microbiology Laboratories (QAS/09.297 Rev 1)
Oct 2009 WHO Working Document, Manufacturing Practices for Pharmaceutical Products Containing Hazardous Substances (QAS/08.256 Rev 1)
Oct 2009 WHO GMP for Sterile Pharmaceutical Products (QAS/09.295 Rev 1)
Apr 2009 ANVISA Boas Prática de Fabricação de Medicamentos
Jan 2009 FDA Draft Guidance for Industry on Process Validation: General Principles and Practices (Docket No. FDA–2008–D–0559)
Jan 2009 EMA New Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice
Nov 2008 EMA Proposed Revisions to Annex 13 of Volume 4 EU Guidelines to Good Manufacturing Practice
Oct 2008 EMA Proposed Revisions to Chapter 4 and Annex 11 of Volume 4 EU Guidelines to Good Manufacturing Practice
May 2008 WHO Guideline to the Inspection of Hormone Product Manufacturing Facilities (QAS/08.256)
Apr 2008 WHO Pharmaceutical Development for Multisource (Generic) Pharmaceutical Products (QAS/08.251)
Oct 2007 FDA Draft Guidance on Q-10 Pharmaceutical Quality System CommentFDA2007-1011
Aug 2007 EMA Comments on Batch Release Certificates for Investigational Medicinal Products (IMPs)
Mar 2007 EMA EMEA Concept Paper Regarding Computerised Systems
Dec 2006 EMA Guideline of Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (EMEA/CHMP/BWP/398498/2005)
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
Apr 2006 FDA Guidance for Industry on INDs – Approaches to Complying with cGMP During Phase 1 (Docket Number 2005D- 0286)
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
Sep 2005 EMA Sampling of Investigational Medicinal Products
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)
Jul 2004 FDA Part 11 revisions Electronic Records; Electronic Signatures; Public Meeting (Docket No. 2004N-0133)

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