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.
Sep 2020 WHO GMP Water for Pharmaceutical Use Sep 2020 WHO Good Reliance Practices for Regulatory Decision-making for Medical Products Sep 2020 OECD GLP Data Integrity Sep 2020 EMA HMA Network Strategy to 2025 Aug 2020 WHO Guideline on Data Integrity Rev 1 Jul 2020 EC Safe and Affordable Medicines Roadmap Jul 2020 EMA Revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4 Jan 2020 PIC/S PIC/S GMP Guide Annex 2A and 2B Jan 2020 WHO Guideline on Data Integrity
Sep 2019 EDQM Ph. Eur. Commission general chapter on Multivariate Statistical Process Control (MSPC) (5.28) Sep 2019 WHO Production of Water For Injection by Means Other Than Distillation Rev1 Jun 2019 WHO Good Storage and Distribution Practices Jun 2019 FDA Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C May 2019 EMA Guideline on the Quality of Water For Pharmaceutical Use Apr 2019 WHO Production of Water For Injection by Means Other Than Distillation Apr 2019 FDA Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Mar 2019 PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments Feb 2019 Health Canada Cleaning Validation Feb 2019 Health Canada Validating Drug Dosage Forms Jan 2019 FDA Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions
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)