| Date
Issued |
Title |
Pages |
Document
(.pdf) |
8/1/06 |
Guide
to Good Manufacturing Practice for Medicinal Products |
155 |
|
12/04 |
Inspection
of Source Plasma Establishments |
64 |
|
3/27/03 |
Office
of Regulatory Affairs - Inspection Reference. |
FDA/
ORA website |
(html
doc) |
10/1/99 |
Inspections of Licensed Vaccines; Chapter 45 of
Vaccines and Allergenic Product (FDA199910B) |
53 |
|
8/99 |
Guide
to Inspections of Quality Systems |
108 |
|
|
6/99
|
INVESTIGATIONS
OPERATIONS MANUAL: Primary procedure manual for
FDA personnel performing inspections and special
investigations. |
FDA/
ORA
website
|
(html doc)
|
| 10/1/98 |
Inspections
of Licensed Therapeutic Drug Products (FDA199810C) |
22 |
|
| 2/14/98 |
Guide to Inspections of Lyophilization of Parenterals INS199802A |
16 |
(html doc) |
| 2/14/98 |
Guide
to Inspections of Dosage Form Drug Manufacturer's
- CGMPR's INS199802B |
15 |
|
6/1/96 |
Guide
to Inspections of Infectious Disease Marker Testing
Facilities (FDA199606A) |
10 |
|
7/94 |
Guide
to Inspections of Oral Solutions and Suspensions (FDA199407C) |
5 |
|
7/94 |
Guide
to Inspections of Topical Drug Products (FDA199407B) |
6 |
|
7/94 |
Guide
to Inspections of Sterile Drug Substance Manufacturers (FDA199407A) |
7 |
|
10/93 |
Guide
to Inspections of Dosage Form Drug Manufacturers
- cGMP's (FDA199310A) |
19 |
|
7/93 |
Guide
to Inspections of High Purity Water Systems (FDA199307E) |
26 |
|
7/93 |
Guide
to Inspections of Pharmaceutical Quality Control
Laboratories (FDA199307D) |
15 |
|
7/93 |
Guide
to Inspections of Microbiological Pharmaceutical
Quality Control Laboratories (FDA199307C) |
8 |
|
7/93 |
Guide
to Inspections of Lyophilization of Parenterals (FDA199307B) |
22 |
|
7/93 |
Guide
to Inspections of Validation of Cleaning Processes (FDA199307A) |
9 |
|
5/7/93 |
Mid
Atlantic Region Inspection Guide: Cleaning Validation (FDA199305A) |
8 |
|
11/20/92 |
CBER
Inspection Manual, the Abridged Version - without
the administrative exhibits and forms (please see
the Complete Version immediately below). (FDA199211C) |
52 |
not available |
11/20/92 |
CBER
Inspection Manual, the Complete Version (please
see the Abridged Version immediately above).(FDA199211B) |
161 |
not available |
9/14/92 |
Foreign
Inspection Guide(FDA199211B) |
11 |
not available |
9/11/92 |
Federal
Standard 209E - Clean Room and Work Station Requirements,
Controlled Environment (FDA199209A) |
55 |
|
11/91 |
FDA
Biotechnology Inspection Guide (FDA199111A) |
50 |
|
9/91 |
Guide
to Inspection of Bulk Pharmaceutical Chemicals (FDA199109B) |
32 |
|
2/83 |
Guide
to Inspection of Computerized Systems in Drug Processing (FDA198302A) |
26 |
|
