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Re: Process Validation Protocol!!!

Dave

I have not been able to locate a Process Validation Protocol template
myself from FDA Guideline but I sure there is one. A good Process
Validation Protocol may have the following format

1. Purpose
2. Background (Optional)
3. Product Description
4. Responsibilities (Different Department)
5. Scope (Tell Exact what you plan to d, i.e. when in the process samples
will be collected and etc)
6. Manufacturing Process Flow Diagram
7. A table for equipment to be used (list your company equipment, equipment
model#, IQ/OQ # and date the IQ/OQ was done)
8.Calibration Record for critical devices (i.e temperature
recorder/controller)
9. Standard Operating Procedures (Overall procedures to manufacture a
batch)
10. Analytical Test Methods
11. Process Parameter(s) to be monitored
12. Sampling plan
13. QC test Requirement (for in-process and finished products)
14. Acceptance Criteria (for in-process and finished products)
15. Validation Report (Tell what final report will consist of)

Note: These are my opinions.

Jean-Claude Simeon

----------
: From: David Wangby way of PDA Sci-Tech Forum<Moderator>
<david@scinopharm.com>
: To: PharmSciTech <PharmTech@www2.pharmweb.net>
: Subject: Process Validation Protocol!!!
: Date: Tuesday, May 04, 1999 2:48 PM
: 
: Dear all:
: Now I am writing a process validation protocol. Although I refer to the
: guideline of FDA, I still have not any idea to start it. Does it have any
: process validation protocol template? or anyone can give me some
: suggestions about how to write a good process validation protocol.
: 
: Thanks a lot!!!
: 
: David 5/1 
: 
: --------------------------------------------
: 
: David Wang
: david@scinopharm.com
: Scinopharm
: 
: --------------------------------------------
: 
: 
: 
: 
: 
: 
: 
: 

<html><head></head><BODY bgcolor="#D8D0C8"><p><font size=3 color="#000000" face="Times New Roman">Dave<br><br>I have not been able to locate a Process Validation Protocol template myself from FDA Guideline but I sure there is one. A good Process Validation Protocol may have the following format<br><br>1. Purpose<br>2. Background (Optional)<br>3. Product Description<br>4. Responsibilities (Different Department)<br>5. Scope (Tell Exact what you plan to d, i.e. when in the process samples will be collected and etc)<br>6. Manufacturing Process Flow Diagram<br>7. A table for equipment to be used (list your company equipment, equipment model#, IQ/OQ # and date the IQ/OQ was done)<br>8.Calibration Record for critical devices (i.e temperature recorder/controller)<br>9. Standard Operating Procedures (Overall procedures to manufacture a batch)<br>10. Analytical Test Methods<br>11. Process Parameter(s) to be monitored<br>12. Sampling plan<br>13. QC test Requirement (for in-process and finished products)<br>14. Acceptance Criteria (for in-process and finished products)<br>15. Validation Report (Tell what final report will consist of)<br><br>Note: These are my opinions.<br><br>Jean-Claude Simeon<br><br>----------<br>: From: David Wangby way of PDA Sci-Tech Forum&lt;Moderator&gt; &lt;<font color="#0000FF"><u>david@scinopharm.com</u><font color="#000000">&gt;<br>: To: PharmSciTech &lt;<font color="#0000FF"><u>PharmTech@www2.pharmweb.net</u><font color="#000000">&gt;<br>: Subject: Process Validation Protocol!!!<br>: Date: Tuesday, May 04, 1999 2:48 PM<br>: <br>: Dear all:<br>: Now I am writing a process validation protocol. Although I refer to the<br>: guideline of FDA, I still have not any idea to start it. Does it have any<br>: process validation protocol template? or anyone can give me some<br>: suggestions about how to write a good process validation protocol.<br>: <br>: Thanks a lot!!!<br>: <br>: David 5/1 <br>: <br>: --------------------------------------------<br>: <br>: David Wang<br>: <font color="#0000FF"><u>david@scinopharm.com</u><font color="#000000"><br>: Scinopharm<br>: <br>: --------------------------------------------<br>: <br>: <br>: <br>: <br>: <br>: <br>: <br>: </p>
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