Future Beacon Can Supply the following information within the CTD file:

 

Number

Content

Responsibility

Future Beacon

CUSTOMER
3.1. Table of Contents of Module 3. Index of file content  
3.2.  Body of Data Introduction summarizes the content of product
3.2.S Drug substance (Name, Manufacturer).
3.2.S.1 General information All information will be extracted from DMF and International references like USP, BP,EP and Chemical Abstract.
3.2.S.1.1  Nomenclature
3.2.S.1.2 Structure
3.2.S.1.3 General Properties
3.2.S.2 Manufacturer
3.2.S.2.1 Manufacturer Full name, address, contact persons and their functions & responsibilities to be provided by the drug substance manufacturer.
3.2.S.2.2 Description of manufacturing process and process controls Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.2.3 Control of materials Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.2.4 Control of critical steps and intermediates Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.2.5  Process validation and/or evaluation Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.2.6 Manufacturing process development Information will be obtained from DMF and written down in the CTD file by FB staff.

 

Number

Content

Responsibility

Future Beacon

CUSTOMER
3.2.S.3 Characterization
3.2.S.3.1 Elucidation of Structure and other Characteristics Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.3.2 Impurities -Structure & origin of each impurity. Information will be obtained from DMF and written down in the CTD file by FB staff.
3.2.S.4 Control of drug substance
3.2.S.4.1 Specification Testing Specification will be acquired from international compendia and/or drug substance manufacturer.
3.2.S.4.2 Analytical Procedures Analytical methods for testing the drug subatance will be acquired from international compendia and/or drug substance manufacturer
3.2.S.4.3 Validation of procedures Validation or verification report for each analytical method should be provided by drug manufacturer. CUSTOMER should perform verification for each analytical method in their labs by their staff and add their data and results to the CTD file.
3.2.S.4.4 Batch Analysis COA and test result from drug manufacturer should be provided CUSTOMER should analyze the drug substance batch and provide their own COA.
3.2.S.4.5 Justification of Specification Rationalization of specifications will be discussed briefly by FB staff.
3.2.S.5 Reference standard of materials COA of reference standards from manufacturer should be provided. If CUSTOMER uses working standards in analysis of drug substance, results of analysis of working standard against reference standards should be provided

 

Number

Content

Responsibility
Future Beacon

CUSTOMER
3.2.S.6  Container closure system Information will be obtained from DMF and written down in the CTD file by FB staff
3.2.S.7 Stability Information will be obtained from DMF and written down in the CTD file by FB staff
3.2.S.7.1  Stability summary and conclusions Information will be obtained from DMF and written down in the CTD file by FB staff
3.2.S.7.2 Post-approval stability protocol and stability commitment Information will be obtained from DMF and written down in the CTD file by FB staff
3.2.S.7.3 Stability Data Information will be obtained from DMF and written down in the CTD file by FB staff
3.2.P Drug product
3.2.P.1 Description and Composition of the Drug product Product Formula and composition is to provided in details.
3.2.P.2   Pharmaceutical Development    All pharmaceutical development studies including excipients selection, their percentage, drug-excipients mix, physical properties of drug product ….etc will be provided by FB. Testing and results of development studies which will be conducted in CUSTOMER R&D labs in cooperation with FB should be provided by Biopharm to be included in CTD file.
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer Full name and address of company, contact persons and their functions to be provided by CUSTOMER.
3.2.P.3.2 Batch Formula Batch formula including the actual contents of raw materials and packaging materials and the steps of manufacturing and packaging. Format of Master production records and master packaging records to be provided by CUSTOMER.

 

Number

Content

Responsibility
Future Beacon

CUSTOMER
3.2.P.3.3 Description of manufacturing process and process controls Flow diagram and narrative explanation of manufacturing process plus indication of critical steps and control of process.
3.2.P.3.4 Control of critical steps and intermediates Description of steps and tests to be carried out to assure control of critical steps and intermediates. Results of tests performed during manufacturing to assure control of process, critical steps and intermediates should be provided by CUSTOMER and included in the CTD file.
3.2.P.4.5 Process validation and/or Evaluation Procedure of Process validation  and/or evaluation will be set and described. Data and results that prove the validation of process should be provided by CUSTOMER and included in the CTD file. .
3.2.P.4 Control of Excipients
3.2.P.4.1  Specification Testing Specification will be acquired from international compendia and/or excipients manufacturers.
3.2.P.4.2 Analytical Procedures Analytical methods for testing excipients will be acquired from international compendia and/or manufacturers
3.2.P.4.3 Validation of Analytical procedures Verification of analytical procedures is to be performed by CUSTOMER staff  in their labs and results included in the CTD file.
3.2.P.4.4 Justification of Specification COA of manufacturer to be included in the file. COA for each excipient generated by CUSTOMER to be included in the file.
3.2.P.5 Control of drug product
      3.2.P.5.1 Specification Testing Specification will be acquired from international compendia or set in house.

 

Number

Content

Responsibility
Future Beacon

CUSTOMER
      3.2.P.5.2  Analytical Procedures Analytical methods for testing excipients will be acquired from international compendia.
      3.2.P.5.3  Validation of Analytical procedures Verification of analytical procedures is to be performed by CUSTOMER staff  in their labs and results included in the CTD file
      3.2.P.5.4 Batch Analysis Testing of batch is to be performed and Certificate of analysis COA to be generated and included in CTD file.
      3.2.P.5.5  Justification of Specification Rationalization of specifications will be discussed briefly by FB staff.
3.2.P.6  Reference standard of materials
3.2.P.7 Container closure system Specifications and methods of testing packaging materials to be provided by FB. Data of testing packaging materials to be provided by CUSTOMER and included in the file.
3.2.P.8 Stability
      3.2.P.8.1  Stability summary and conclusions Protocol of accelerated stability studies will be provided by FB. Testing of stability samples (accelerated studies) should be performed by CUSTOMER staff.
      3.2.P.8.2 Post-approval stability protocol and stability commitment Protocol will be provided by FB. Testing of stability samples (on going studies) should be performed by CUSTOMER staff.
      3.2.P.8.3 Stability Data Results and conclusions (stability report) to be provided by CUSTOMER and included in the CTD file.

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