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PDA provided comments on “Good Manufacturing Practice for Advanced Therapy Medicinal Products pursuant to Article 5 of Regulation 1394/2007”, November 12, 2015.

PDA provided comments on “FFDA Guidance for Industry Request for Quality Metrics Docket: [FDA-2015-D-2537]”, November 12, 2015.

PDA provided comments on “EDQM Re: 5.1.2. Biological indicators and related Microbial Preparations use in the Manufacture of Sterile Products and Indicators for Depyrogenation Processes”, September 25, 2015.

PDA provided comments on “FDA Guidance for Industry Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Docket: [FDA-2015-D-1659]”, August 20, 2015.

PDA provided comments on “FDA Guidance for Industry Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application”, May 20, 2015.

PDA provided comments on “WHO Proposal for Revision of Good Trade and Distribution Practices for Pharmaceutical Starting Materials”, May 12, 2015.

PDA provided comments on “FDA Guidance for Industry Good Manufacturing Practices for Combination Products”, April 27, 2015.

PDA provided comments on “FDA Draft Guidance for Industry Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products”, April 21, 2015.

PDA provided comments on “WHO Good Pharmacopoeial Practices, Draft 14 January, 2015 Working document QAS/13.526/Rev.5”, March 1, 2015. WHO then asked PDA to provide more detailed specific line by line comments and they are attached in the above link as well. PDA submitted the second set of comments on March 30, 2015.

PDA provided comments on “FDA Draft Guidance for Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations”, February 23, 2015.

PDA provided comments on “FDA Draft Guidance for Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products”, February 23, 2015.

The expansion of the concepts beyond just parametric release provides opportunities for the use of new and future technology to improve ongoing process control, overall product quality and patient safety.