Below are FDA
guidance documents and policy memoranda that can help guide you
in validation, qualification and pre-approvals. We have these
documents available for you electronically. Click on the links
below to view the first few paragraphs of each document.
BIOAVAILABILITY REGULATIONS (21CFR 320.1 – 320,62)
Guide to Inspections of Oral Solid Dosage Forms Pre/Post
Approval Issues for Development and Validation.
COMPUTER INTEGRATED MANUFACTURING
FLUID BED GRANULATION
GENERAL INSPECTION GUIDE
GMP INSPECTIONS OF DRUG MANUFACTURERS
LABORATORY INSPECTION TECHNIQUES
MID-ATLANTIC REGIONAL INSPECTION GUIDE
NDA/ANDA PRE-APPROVAL INSPECTIONS
PARENTERAL PRODUCTS PRE-APPROVAL INSPECTIONS
INSPECTION OF PHARMACEUTICAL QUALITY CONTROL
STERILE PRODUCT PRE-APPROVAL INSPECTION GUIDE
PREAPPROVAL INSPECTION GUIDE FOR TOPICALS
STABILITY INSPECTION OUTLINE
SUPPLEMENTAL TOPICALS ISSUES
VALIDATION OF CLEANING PROCESSES
VALIDATION OF PROCESSES FOR NDA/ANDAS
VALIDATION OF PROCESSES PRIOR TO APPROVAL
If you would like the full document electronically, please
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If you have any questions, do not see documents pertaining to
your area or would like further information about any of the
documents, please contact us at: firstname.lastname@example.org or click
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