How to Sell Validatable Equipment to Pharmaceutical Manufacturers

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ISBN: 9781574910971 | 1574910973
Cover: Hardcover
Copyright: 9/30/1999

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Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner.Key areas of discussion include:o Validation and GMP issueso Why validation is so important to pharmaceutical manufacturerso The role of equipment suppliers in supporting validationo How validation affects the quality of drugso A discussion of the importance of each phase of validationo Examples of pre-validation worko Pharmaceutical industry conventions for equipment design& constructiono Questions to ask about validation, including a checklisto Regulations in plain language, including the terms and vocabularyo Computer validationo Business & cost issues

Introduction	p. x
The Basics: The Regulations in Plain Language	p. 1
Pharmaceutical Terminology	p. 1
How the Regulations Affect the Pharmaceutical Industry	p. 18
Summary	p. 20
Notes	p. 20
A (Very) Simple Validation Example	p. 21
Equipment Qualification	p. 22
IQ/OQ/PQ	p. 22
Documentation	p. 25
Process Validation	p. 26
Additional Validation Requirements	p. 29
Summary	p. 33
Why Is Validation So Confusing?	p. 35
Why the GMPs Are Vague	p. 35
The FDA's Role in Enforcing the GMPs	p. 36
The Pharmaceutical Industry's Role in Interpreting the GMPs	p. 37
Who Is Qualified to Perform Validation?	p. 43
Summary	p. 46
Notes	p. 46
What to Be Aware of Before Working on a Job for the Pharmaceutical Industry	p. 47
Things the Equipment Supplier Can Do More Easily than the Pharmaceutical Company	p. 51
Things Either Group (the Equipment Suppliers or the Pharmaceutical Companies) Can Do	p. 52
Things the Pharmaceutical Company Can Do More Easily Than the Equipment Supplier	p. 53
Summary	p. 55
Notes	p. 55
Providing Validatable Equipment: The Role of the Equipment Supplier	p. 57
How the Equipment Supplier Can Help with Equipment Qualification	p. 58
Design and Construct Equipment According to GMP and Company Requirements	p. 59
Provide Documentation to Support Equipment Qualification	p. 60
How the Equipment Supplier Affects the Cost of Validatable Equipment	p. 62
The Extent of the Equipment Supplier's Involvement	p. 65
Summary	p. 66
Note	p. 66
Pharmaceutical Industry Requirements for Process Equipment Design and Construction	p. 67
Contact Surfaces	p. 70
Materials of Construction	p. 72
Common Materials Used	p. 73
Materials to Avoid	p. 75
Design and Construction of Pharmaceutical Process Equipment	p. 75
Cleaning and Sanitization Considerations	p. 76
Methods of Attachment	p. 79
Contour	p. 80
Valves	p. 81
Elimination of Dead Legs in Water Distribution Systems	p. 82
Penetrations into the Equipment (Ports)	p. 83
Filters	p. 84
Instrumentation (Measuring Devices)	p. 85
Computerized and Automated Systems	p. 86
Security of Control Systems	p. 86
Separation of Process and Utility Streams	p. 86
Drainage	p. 87
Special Considerations for Cleanroom Equipment	p. 88
Exterior Surfaces	p. 89
Summary	p. 89
Notes	p. 90
Validatable Computer Systems	p. 91
Types of Computer Systems	p. 96
Solid State Controllers	p. 96
Programmable Logic Controllers	p. 97
Personal Computers	p. 98
Functions of Computers in the Pharmaceutical Industry	p. 98
Scope of Validation Needed for Computer Systems	p. 98
How Much Validation Needs to Be Done?	p. 100
Level of Confidence in Computer Systems	p. 100
Importance of Computer Systems Applications	p. 102
Requirements for Completing Computer Systems Validation	p. 102
General Computer Systems Validation Practices	p. 103
Define What the System Is Supposed to Do	p. 105
Describe How the System Will Accomplish What It Is Supposed to Do	p. 107
Select or Construct Appropriate Hardware That Will Satisfy the Requirements and Specifications Defined in Steps 1 and 2	p. 109
Develop Software That Will Satisfy the Requirements Defined in Steps 1 and 2	p. 109
Install the System	p. 119
Release the System to the Pharmaceutical Company and Let It Test It	p. 122
Provide Support As Needed to Keep the System Running Properly	p. 122
Key Points	p. 124
Validatable Hardware	p. 127
Validatable Software	p. 126
Categorization of Software	p. 129
Customized Software	p. 129
Widely Distributed Software	p. 130
Configurable Software	p. 130
Specialized Software	p. 131
Validation Requirements for Suppliers of Computerized Equipment	p. 133
Summary	p. 136
Notes	p. 136
Documentation: The Foundation of Good Manufacturing Practices	p. 137
All Entries Must Be Made in Permanent Ink	p. 138
Never Obliterate Data	p. 138
All Documentation Must Be Signed	p. 139
Original Records Are the Most Important	p. 140
Use Templates and Forms	p. 142
Leave No Missing Information	p. 142
Reference Procedures and Standards Whenever Possible	p. 143
Drawings Should Be an Accurate Representation of the Equipment Being Supplied to the Pharmaceutical Company	p. 144
Provide All the Manuals with the Equipment	p. 145
Provide All the Documentation in One Package	p. 146
General Comments	p. 147
Summary	p. 147
Notes	p. 148
The Turnover Package	p. 149
Elements of a Good Turnover Package: Contents	p. 150
Elements of a Good Turnover Package--Purpose Behind the Information	p. 152
Manuals	p. 152
Parts Lists	p. 153
Bill of Materials	p. 154
Technical Specifications	p. 154
Inspection Certificates	p. 155
Passivation Records	p. 156
Calibration Certificates	p. 156
Mill Certificates	p. 158
As-Built Drawings	p. 159
Computer Systems Documentation	p. 160
Test Records	p. 162
Procedures	p. 163
Summary	p. 164
Providing Added Value Without a Lot of Extra Work	p. 165
Ask Customers Exactly What They Expect	p. 165
Be Up-Front about What You Know and What You Can Do	p. 168
Get All the Facts You Need to Give Customers What They Need	p. 169
Factor in Any Extra Work Required	p. 170
Have Written Procedures for Handling Quality-Related Jobs	p. 170
Keep Good Records	p. 171
Use Standard Forms Whenever Possible	p. 172
Keep the Drawings Current	p. 172
Maintain Copies of Current Manuals and Technical Information	p. 173
Follow Good Quality Practices for Design and Development of Computer Programs	p. 173
Let the Pharmaceutical Companies Come in and See What a Good Job You Are Doing	p. 174
Follow Up on All the Details (Even If They Don't Seem to Be Important or Make Sense)	p. 175
Treat the Documentation with the Level of Importance It Deserves	p. 175
Communicate Throughout the Project	p. 176
If You Provide Services to the Pharmaceutical Industry, You Need to Follow Its Rules	p. 176
Summary	p. 177
Validation Hang-Ups: What to Watch Out for and How to Avoid Them	p. 179
Not Recognizing the Need for Validation	p. 180
Not Wanting to Confront Regulations	p. 181
Raising Expectations beyond What Can Be Delivered	p. 182
Not Providing All the Documentation in a Timely Manner	p. 183
Not Providing Technical Follow-Up Support	p. 183
Summary	p. 184
Validation Services Performed by Equipment Suppliers	p. 185
How to Validate Pharmaceutical Process Equipment: Step-by-Step Instructions for Preparing Validation Documents	p. 187
Write the Protocol	p. 187
Get the Protocol Approved by the Pharmaceutical Company	p. 189
Perform the Work According to the Protocol and Document the Results	p. 189
Prepare the Report	p. 190
Get the Report Approved by the Pharmaceutical Company	p. 191
How to Validate Pharmaceutical Process Equipment: Step-by-Step Instructions for Conducting Equipment Qualification Studies	p. 192
Conducting Installation Qualifications	p. 193
Installation Qualification Documentation	p. 197
Requirements for Operation Qualification	p. 197
Functional Testing	p. 198
Operational Testing	p. 199
Eventful Testing	p. 201
Documentation of Operation Qualification	p. 202
Pointers for Conducting IQ and OQ	p. 202
Summary	p. 203
Conclusion	p. 205
Attachments
Current Good Manufacturing Practices (cGMPs)	p. 209
Documentation Examples	p. 245
Example Procedure (SOP)	p. 257
Project Planning Questionnaire	p. 261
Example Turnover Package	p. 267
Example IQ Protocol	p. 301
Example OQ Protocol	p. 321
References	p. 341
Index	p. 343
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How to Sell Validatable Equipment to Pharmaceutical Manufacturers

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