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PDA TECHNICAL REPORTS |
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Technical Report
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Title |
Date of Publication
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| Paper Version |
Digital Version |
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| 01001 |
43381 |
1 |
Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control |
1980 (Revised 2007) |
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| 01003 |
43208 |
3 |
Validation of Dry Heat Processes Used for Sterilization and Depyrogenation |
1981 |
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| 01004 |
43209 |
4 |
Design Concepts for the Validation of Water-for-Injection Systems |
1983 |
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| 01005 |
43210 |
5 |
Sterile Pharmaceutical Packaging: Compatibility and Stability |
1984 |
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| 01007 |
43212 |
7 |
Depyrogenation |
1985 |
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| 01009 |
43214 |
9 |
Review of Commercially Available Particulate Measurement Systems |
1988 |
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| 01010 |
43215 |
10 |
Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers |
1988 |
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| 01011 |
43216 |
11 |
Sterilization of Parenterals by Gamma Radiation |
1988 |
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| 01012 |
43217 |
12 |
Siliconization of Parenteral Drug Packaging Components |
1988 |
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| out of print |
43218 |
13 |
Fundamentals of an Environmental Monitoring Program |
1990 (Revised 2001) |
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| 01014 |
43220 |
14 |
Validation of Column-Based Chromatography Processes for the Purification of Proteins |
1992 (Revised 2008) |
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| 01015 |
43221 |
15 |
Validation of Tangential Flow Filtration in Biopharmaceutical Applications |
1992 (Revised 2009) |
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| 01016 |
43222 |
16 |
Effect of Gamma Irradiation on Elastomeric Closures |
1992 |
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| 01017 |
43223 |
17 |
Current Practices in the Validation of Aseptic Processing -- 1992 |
1993 |
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| 01018 |
43224 |
18 |
Report on the Validation of Computer-Related Systems |
1995 |
| TECHNICAL REPORT |
|
TITLE |
DATE OF PUBLICATION |
| Paper Version |
Digital Version |
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|
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| 01019 |
43225 |
19 |
Rapid/Automated ID Methods Survey |
1990 |
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| 01020 |
41239 |
20 |
Report on Survey of Current Industry Gowning Practices |
1990 |
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| 01021 |
41258 |
21 |
Bioburden Recovery Validation |
1990 |
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| out of print |
43226 |
22 |
Process Simulation Testing for Aseptically Filled Products |
1996 (Revised 2011) |
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| out of print |
43227 |
23 |
Industry Survey on Current Sterile Filtration Practices |
1996 |
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| 01024 |
43228 |
24 |
Current Practices in the Validation of Aseptic Processing -- 1996 |
1996 |
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| out of print |
43229 |
25 |
Blend Uniformity Analysis: Validation and In-Process Testing |
1997 |
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| out of print |
43230 |
26 |
Sterilizing Filtration of Liquids |
1998 (Revised 2008) |
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| out of print |
43231 |
27 |
Pharmaceutical Package Integrity |
1998 |
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| 01028 |
43232 |
28 |
Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals |
1998 (Revised 2006) |
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| out of print |
43233 |
29 |
Points to Consider for Cleaning Validation |
1998 |
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| 01030 |
43234 |
30 |
Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat |
1999 |
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| 01031 |
43235 |
31 |
Validation and Qualification of Computerized Laboratory Data Acquisition Systems |
1999 |
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| 01032 |
43236 |
32 |
Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations |
1999 (Revised 2004) |
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| 01033 |
43238 |
33 |
Evaluation, Validation and Implementation of New Microbiogical Testing Methods |
2000 |
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| 01034 |
43239 |
34 |
Design and Validation of Isolate Systems for the Manufacturing and Testing of Health Care Products |
2001 |
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| 01035 |
43240 |
35 |
A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry |
2001 |
| TECHNICAL REPORT |
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TITLE |
DATE OF PUBLICATION |
| Paper Version |
Digital Version |
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| 01036 |
43241 |
36 |
Current Practices in the Validation of Aseptic Processing -- 2001 |
2002 |
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| 01038 |
43315 |
38 |
Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC): Chemistry, Manufacturing and Controls Documentation |
2006 |
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| 01039 |
43312 |
39 |
Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment |
2007 |
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| 01040 |
43314 |
40 |
Sterilization Filtration of Gases |
2005 |
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| 01041 |
43313 |
41 |
Virus Filtration |
2008 |
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| 01042 |
43311 |
42 |
Process Validation of Protein Manufacturing |
2005 |
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| 01043 |
43396 |
43 |
Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing |
2007 |
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| 01044 |
43410 |
44 |
Quality Risk Management for Aseptic Processes |
2008 |
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| 01045 |
43422 |
45 |
Filtration of Liquids Using Cellulose-Based Depth Filters |
2008 |
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| 01046 |
43485 |
46 |
Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User |
2009 |
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43486 |
47 |
Preparation of Virus Spikes Used for Virus Clearance Studies |
2010 |
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43487 |
48 |
Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance |
2010 |
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43488 |
49 |
Points to Consider for Biotechnology Cleaning Validation |
2010 |
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43489 |
50 |
Alternative Methods for Mycoplasma Testing |
2010 |
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43490 |
51 |
Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use |
2010 |
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43491 |
52 |
Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain |
2011 |
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43492 |
53 |
Guidance for Industry: Stability Testing to Support Distribution of New Drug Products |
2011 |
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