How to sell validatable equipment to pharmaceutical manufacturers

Contents......Page 4
Introduction......Page 10
Pharmaceutical Terminology......Page 14
How the Regulations Affect the Pharmaceutical Industry......Page 31
Notes......Page 33
2. A Very Simple Validation Example......Page 34
IQ/OQ/PQ......Page 35
Documentation......Page 38
Process Validation......Page 39
Additional Validation Requirements......Page 42
Summary......Page 46
Why the GMPs Are Vague......Page 47
The FDAs Role in Enforcing the GMPs......Page 48
The Pharmaceutical Industry's Role in Interpreting the GMPs......Page 49
Who Is Qualified to Perform Validation?......Page 55
Notes......Page 58
4. What to Be Aware of Before Working on a Job for the Pharmaceutical Industry......Page 59
Things the Equipment Supplier Can Do More Easily than the Pharmaceutical Company......Page 63
Things Either Group  the Equipment Suppliers or the Pharmaceutical Companies Can Do......Page 64
Things the Pharmaceutical Company Can Do More Easily Than the Equipment Supplier......Page 65
Notes......Page 67
5. Providing Validatable Equipment: The Role of the Equipment Supplier......Page 68
How the Equipment Supplier Can Help with Equipment Qualification......Page 69
Design and Construct Equipment According to GMP and Company Requirements......Page 70
Provide Documentation to Support Equipment Qualification......Page 71
How the Equipment Supplier Affects the Cost of Validatable Equipment......Page 73
The Extent of the Equipment Supplier's Involvement......Page 76
Note......Page 77
6. Pharmaceutical Industry Requirements for Process Equipment Design and Construction......Page 78
Contact Surfaces......Page 81
Materials of Construction......Page 83
Common Materials Used......Page 84
Design and Construction of Pharmaceutical Process Equipment......Page 86
Cleaning and Sanitization Considerations......Page 87
Methods of Attachment......Page 90
Contour......Page 91
Valves......Page 92
Elimination of Dead Legs in Water Distribution Systems......Page 93
Penetrations into the Equipment Ports......Page 94
Filters......Page 95
Instrumentation Measuring Devices......Page 96
Separation of Process and Utility Streams......Page 97
Drainage......Page 98
Special Considerations for Cleanroom Equipment......Page 99
Summary......Page 100
Notes......Page 101
7. Validatable Computer Systems......Page 102
Solid State Controllers......Page 107
Programmable Logic Controllers......Page 108
Scope of Validation Needed for Computer Systems......Page 109
Level of Confidence in Computer Systems......Page 111
Requirements for Completing Computer Systems Validation......Page 113
General Computer Systems Validation Practices......Page 114
Step 1: Define What the System Is Supposed to Do......Page 116
Step 2: Describe How the System Will Accomplish What It Is Supposed to Do......Page 118
Step 4: Develop Software That Will Satisfy the Requirements Defined in Steps 1 and 2......Page 120
Step 5: Install the System......Page 130
Step 7: Provide Support As Needed to Keep the System Running Properly......Page 133
Key Points......Page 135
Validatable Hardware......Page 138
Validatable Software......Page 137
Customized Software......Page 140
Configurable Software......Page 141
Specialized Software......Page 142
Validation Requirements for Suppliers of Computerized Equipment......Page 144
Notes......Page 147
8. Documentation: The Foundation of Good Manufacturing Practices......Page 148
Rule # 2 Never Obliterate Data......Page 149
Rule # 3 All Documentation Must Be Signed......Page 150
Rule # 4 Original Records Are the Most Important......Page 151
Rule # 6 Leave No Missing Information......Page 153
Rule # 7 Reference Procedures and Standards Whenever Possible......Page 154
Rule # 8 Drawings Should Be an Accurate Representation of the Equipment Being Supplied to the Pharmaceutical Company......Page 155
Rule # 9 Provide All the Manuals with the Equipment......Page 156
Rule # 10 Provide All the Documentation in One Package......Page 157
Summary......Page 158
Notes:......Page 159
9. The Turnover Package......Page 160
Elements of a Good Turnover Package: Contents......Page 161
Manuals......Page 163
Parts Lists......Page 164
Technical Specifications......Page 165
Inspection Certificates......Page 166
Calibration Certificates......Page 167
Mill Certificates......Page 169
As-Built Drawings......Page 170
Computer Systems Documentation......Page 171
Test Records......Page 173
Procedures......Page 174
Summary......Page 175
Step 1: Ask Customers Exactly What They Expect......Page 176
Step 2: Be Up-Front about What You Know and What You Can Do......Page 179
Step 3: Get All the Facts You Need to Give Customers What They Need......Page 180
Step 5: Have Written Procedures for Handling Quality-Related Jobs......Page 181
Step 6: Keep Good Records......Page 182
Step 8: Keep the Drawings Current......Page 183
Step 10: Follow Good Quality Practices for Design and Development of Computer Programs......Page 184
Step 11: Let the Pharmaceutical Companies Come in and See What a Good Job You Are Doing......Page 185
Step 13: Treat the Documentation with the Level of Importance It Deserves......Page 186
Step 15: If You Provide Services to the Pharmaceutical Industry, You Need to Follow Its Rules......Page 187
Summary......Page 188
11. Validation Hang-Ups: What to Watch Out for and How to Avoid Them......Page 190
Validation Hang-Up # 1 Not Recognizing the Need for Validation......Page 191
Validation Hang-Up # 2 Not Wanting to Confront Regulations......Page 192
Validation Hang-Up # 3 Raising Expectations beyond What Can Be Delivered......Page 193
Validation Hang-Up # 5 Not Providing Technical Follow-Up Support......Page 194
Summary......Page 195
12. Validation Services Performed by Equipment Suppliers......Page 196
Step 1: Write the Protocol......Page 198
Step 3: Perform the Work According to the Protocol and Document the Results......Page 200
Step 4: Prepare the Report......Page 201
Step 5: Get the Report Approved by the Pharmaceutical Company......Page 202
How to Validate Pharmaceutical Process Equipment: Step-by-Step Instructions for Conducting Equipment Qualification Studies......Page 203
Conducting Installation Qualifications......Page 204
Requirements for Operation Qualification......Page 208
Functional Testing......Page 209
Operational Testing......Page 210
Eventful Testing......Page 212
Pointers for Conducting IQ and OQ......Page 213
Summary......Page 214
13. Conclusion......Page 215
1. Current Good Manufacturing Practices cGMPs......Page 218
2. Documentation Examples......Page 254
3. Example Procedure SOP......Page 266
4. Project Planning Questionnaire......Page 270
5. Example Turnover Package......Page 276
6. Example IQ Protocol......Page 310
7. Example OQ Protocol......Page 330
References......Page 350
C......Page 352
D......Page 353
F......Page 354
M......Page 355
P......Page 356
Q......Page 357
S......Page 358
V......Page 359
Y......Page 360