• PDA comments on the proposed changes to USP General Chapter <1> Injections, described in the Pharmacopeial Forum 31 (5), September/October 2005.
• Continued Dialogue/Training Needed on ICH Q9 — PDA States in Comments….Click here for cover letter and here for comments grid.
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Draft Consensus Guideline Pharmaceutical Development Q8, November 2004 [Docket No. 2005D-0021]

• Draft Guidance for Industry - Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice, Submitted to FDA: March 5, 2004...Cover Letter PDF file (83 KB) (dated 03/05/04)
  
  
• PDA GMP in 21st Century: Risk and Quality Glossary, March 2004 (111 KB) (to be submitted to ICH Q9 and Q10)
  
  
• Draft Guidance for Industry on "Powder Blends and Finished Dosage Units - Stratified In-Process Dosage Unit Sampling and Assessment," Submitted to FDA: March 3, 2004...Cover Letter PDF file (79 KB) (dated March 3, 2004) and PDA Comment Grid PDF file (84 KB).
  
  
• WHO Working Document QAS/04.068: Good Distribution Practices (GDP) for Pharmaceutical Products (65 KB) , Submitted to WHO: March 31, 2004...Cover Letter PDF file (dated) and PDA Comment Grid PDF file.
  
  
• WHO Guideline for Sampling of Pharmaceuticals and Related Materials, Working Document QAS/03.066/Rev. 2, Submitted to WHO: April 15, 2004...Cover Letter PDF file (79 KB) (dated March 3, 2004).
  
  
• Compilation of Case Studies (54 KB) Provided by Members of EFPIA and PDA Regarding Inspectional Issues with the EU GMP Annex 1 and the FDA Draft Guidance on Aseptic Processing, Submitted to EMEA: April 22, 2004...Cover Letter PDF file (41 KB)
  
  
• Addition to Chapter 1 to the EU Guide to Good Manufacturing Practice, Titled: Product Quality Review (43 KB), Submitted to EU: June 30, 2004
  
  
• Addition to Chapter 6 (56 KB) to the EU Guide to Good Manufacturing Practice, Submitted to EU: June 30, 2004
  
  
• AS/04.066/Rev. 3, WHO Guidelines for Sampling of Pharmaceuticals and Related Materials: Risk Assessment with Respect to the n, r, p Plans (66 KB), Submitted to WHO: September 29, 2004
  
  
• DRAFT Guidance for Industry ChromPAC, Manufacturing Chromatography Systems Post-approval Changes: Chemistry, Manufacturing and Controls Document (345 KB), Submitted to FDA: October 19, 2004
  
  
• FDA White Paper: "Defining the Customer in a Regulatory Agency (110 KB)" Submitted to FDA: November 24, 2004
  
  
• FDA White Paper "Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites - A Pilot Risk Ranking Model (97 KB)", Submitted to FDA: November 24, 2004
  
  
• "Draft Guidance for Industry and FDA: Good Manufacturing Practices for Combination Products (101 KB)", Submitted to FDA: November 23, 2004
  
  
• Draft Guidance for Industry: Quality Systems Guidance Annex A. Quality Systems Guidance Appendix B. Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (90 KB), September 2004, Submitted to FDA: December 1, 2004.
  

2003

• PDA Comments on World Health Organization (WHO) "Supplementary Guidelines on Good Manufacturing Practice (GMP) Validation"...Cover Letter PDF file (83 KB) (dated November 14, 2003) and PDA Comment Grid PDF file (50 KB). (added 03/23/04)
  
  
• PDA Task Force Comments to the U.S. Food and Drug Administration (FDA) on FDA Draft Guidance for Industry on "Comparability Protocols for Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls Information" Cover Letter PDF file (79 KB) (dated December 4, 2003) and Comments Grid PDF file (110 KB) (added 12/03/03)
  
  
• PDA Comments to the U.S. Food and Drug Administration (FDA) on FDA Guidance on "Process Analytical Technologies (PAT) - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance" PDF file (81 KB) (dated November 5, 2003) (added 11/05/03).
  
  
• PDA Comments to the U.S. Food and Drug Administration (FDA) on FDA draft on Sterile Drug Products Produced by Aseptic Processing PDF file (83 KB) (dated November 4, 2003). For complete comment grid, click here PDF file (188 KB) (added 11/05/03).
  
  
• PDA Comments to the European Agency for Evaluation of Medicinal Products (EMEA) on Annex II, Note for Guidance on Process Validation–Non Standard Processes. PDF file (83 KB) (dated October 29, 2003) (added 10/30/03).
  
  
• PDA comments on World Health Organization (WHO) Guideline for Sampling of Pharmaceuticals and Related Materials. PDF file (84 KB) (dated October 15, 2003) (added 10/30/03)
  
  
• PDA comments to the FDA on the Draft Guidance for using Comparability Protocols for Post Approval Changes. (June 24, 2003)
  Cover Letter
  Comments Grid (added 06/24/03)
  
  
• PDA comments on USP <381>, Elastomeric Closures for Injections. PDF file (138 KB) (added 05/28/03)
  
  
• PDA Comments on proposed revision of Annex 1 (Manufacture of sterile medicinal products) to the EU GMP Guide (Volume 4) PDF file (359 KB) (added 01/09/03)
  
  
• PDA Responds to USP regarding Extractables in Packaged Pharmaceutical Waters
  PDA Letter to USP
  TOC Data Summary on Packaged Water
  Est. TOC Upper Limits-Summary
  Packaged Pharm. Waters-Summary (added 01/09/03)
  
  

  2002

  
  
  
• PDA comments presented at the December 18, 2002, FDA OPS Trade Association Meeting regarding FDA’s dispute resolution process, part of GMP for the 21st Century-A risk Based Approach. (added 12/18/02)
  
  
• PDA Comments on FDA's Preliminary Concept Paper, "Sterile Drug Products Produced by Aseptic Processing", which were presented to FDA's Pharmaceutical Science Advisory Committee on October 22, 2002. PDF file (31 KB) (added 10/22/02)
  
  
• Presentation on PDA’s draft comments on the FDA concept paper on aseptic processing presented at the PDA Metro Chapter Meeting, Hyatt Regency New Brunswick--October 8, 2002 PDF file (178 KB) (added 10/10/02)
  
  
• Letter PDF file (22 KB) and proposal PDF file (9 KB) to Ajaz S. Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, FDA, regarding a PAC for sterile products. See also PDA PAC Change Tables PDF file (37 KB) (added 02/21/02)
  
  
• PDA letter to PIC/S Secretariat regarding PIC/S Draft Recommendation on the Isolators Used for Aseptic Processing and Sterility Testing, PE 004-1 (Draft 3). Dated September 4, 2001. PDF file (40.4 KB). (added 02/20/02)