Selected PDA Documents as PDF Files
The following documents are presented as Adobe Acrobat (PDF) files. Your
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Acrobat Reader.
- PDA Comments to FDA's Proposed
Revisions to the GMP Regulations, 21 CFR 210 and 211 (PDF file)
- PDA Comments to Proposed
Change to USP Chapter <71>, Sterility Tests (published in the May-June 1995
Pharmacopeial Forum, pages 595 to 609) (PDF file)
- Draft PDA Technical Report:
"Process Simulation Testing for Aseptically Filled Products" (PDF file)
- PDA Comments on Draft FDA Guidance
"Content and Format for Submission of Drug Products for INDs, NDAs, ANDAs,
and AANDAs" February 1996 (PDF file)
- PDA Comments on "EU Guide to Good Manufacturing
Practice, Annex on the Manufacture of Sterile Medicinal Products (Draft 4,
III/5805/94,
19 June 1995) (PDF file)
- PDA Comments on Interim Guidance, SUPAC-IR;
ICH Tripartite Guideline Covering Stability Testing Requirements for New Dosage
Forms
and for Variations and Changes to New Drug Substances and New Drug Products,
Draft
Number 2 (Q1C); and Docket No. 93D-0403, Supplements to NDAs, ANDAs, AANDAs,
Draft
Guideline (60 FR 64093, December 12, 1994) (PDF File)
- PDA Comments on FDA "Guideline for Submitting
Documentation for Sterilization Process Validation in Applications for Human and
Veterinary Drug Products," Federal Register December 3, 1993 (PDF file)
- PDA Comments on FDA Review of General Biologics
and Licensing Regulations, Docket No. 94N-0066 (includes oral presentation from
1/26/95 meeting) (PDF File)
- PDA Prepared Remarks: Presentation
before FDA's Aseptic Fill Conference, October 12, 1993 (PDF file)

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