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
contact us at: firstname.lastname@example.org or click Contacts.
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: email@example.com or click
We are here to help and guide you.