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Manufacturing Process Documentation Guide

The document outlines the requirements for a manufacturing process, including detailed forms, specifications, and validation reports. It specifies the need for a comprehensive list of materials, process parameters, and quality analysis for both raw and recovery solvents. Additionally, it requests information regarding starting materials for KSM, including source details and testing reports.

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subbu_281
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8 views1 page

Manufacturing Process Documentation Guide

The document outlines the requirements for a manufacturing process, including detailed forms, specifications, and validation reports. It specifies the need for a comprehensive list of materials, process parameters, and quality analysis for both raw and recovery solvents. Additionally, it requests information regarding starting materials for KSM, including source details and testing reports.

Uploaded by

subbu_281
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

 Filled enquiry form.

 Filled VQ
 Detail stage wise ROS including the names of all solvents, reagents & catalysts used in
the process
 Detail  Stage wise manufacturing process including the input/output details, pH,
temperature conditions & yield ratios
 Detail stage wise process flow chart   
 List of raw materials, solvents & catalysts used in the process
 Specification & method of analysis of all raw materials, in process & intermediates
 COA’s of all raw materials used in the process
 COA’s of In process & Intermediates  
 Critical process parameters     
 Process Validation reports    
 SOP
 Deparment certificate.    NA

 Valid EIR of the manufacturing Site    NA  


 Blank  BPR
 Batch tree & Executed BPR for the validation batches supplied  NA
 Usage of recovery solvents in the manufacturing process. If yes, provide the Quality ,
NA stability comparison of fresh & recovery solvents. NA
 STP’s ,  COA’s & BPR’s of recovery solvents. NA

Below information is required for starting materials for KSM :

 Source details   
 Address declaration including the complete manufacturer name, address of
registered office, site address, details of contact person, contact no., email ID, Fax
no. etc   
 ROS & brief process   
 Process flow chart & List of RM’s
 9 Declarations as per KSM VQ format (Consider from page 9 to19)   
 STP & COA
 Testing reports of starting material
 Nitrosoamine declaration

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