Certified Product Information Document – Biologics (Schedule D drugs) (CPID-B (Schedule D drugs)) in the CTD Format

This template is an HTML representation of the form and it is not meant to be completed. To request a copy of the fillable form, please contact brdd-cppic_brdd-cppci@hc-sc.gc.ca.

Introduction

Submission File#

NDS Approval Date and Control#

CPID-B Revision Date and Control#

Proprietary Name:

Non-proprietary name or common name of the drug substance:

Company Name:

Name of Canadian Distributor:

Therapeutic or Pharmacological Classification: e.g., Antineoplastic agent, Antihyperglycemic agent

Dosage form(s): e.g., liquid, lyophilized powder

Presentation(s): e.g., pre-filled syringes, vials, autoinjector, cartridges

Strength(s) or Concentration(s): e.g., 20 units/mL, 10 mg/mL

Fill volume(s): e.g., vial containing 3mL solution

Route(s) of Administration: e.g., intravenous, subcutaneous

Maximum Daily Dose: (The dose should be specified and should be based on the dosing instructions in the Product Monograph)

New Active Substance (NAS)?

Control Number:

Date of Authorization:

S  Drug Substance (common name, manufacturer)

Manufacture (common name, manufacturer)

Manufacturer(s) (name, manufacturer)

[Insert the completed Module 3.2.S.2.1]

Description of Manufacturing Process and Process Controls (common name, manufacturer)

[Insert the flow diagram(s) from the completed Module 3.2.S.2.2], including information on the cell line (e.g., CHO, E.coli, etc.).

[Insert the information on the batch size or scale from the completed Module 3.2.S.2.2]

[Insert the information on reprocessing from the completed Module 3.2.S.2.2]

[Insert the information on hold times from the completed Module 3.2.S.2.2]

Control of Materials (common name, manufacturer)

[Insert the tabulated summary of the biological raw material(s) used in the manufacture of the drug substance, including the batch number of the Master Cell Bank(s) (MCBs) and Working Cell Bank(s) (WCBs) used in the manufacture of the drug substance, from the completed Module 3.2.S.2.3]

Controls of Critical Steps and Intermediates (common name, manufacturer)

[Insert a summary of critical manufacturing steps, process controls performed, and acceptance criteria from the completed Module 3.2.S.2.4, under Critical Steps.]

[Insert a summary of the quality, control and storage conditions of intermediates isolated during the process from the completed Module 3.2.S.2.4, under Intermediates.]

Characterisation (common name, manufacturer)

Elucidation of Structure and other Characteristics (common name, manufacturer)

[Insert a summarized description of the desired product and product-related substances and a summary of general properties, characteristic features and characterisation data (for example, primary and higher order structure and biological activity) from the completed Module 3.2.S.3.1]

Impurities (common name, manufacturer)

[Insert the tabulated summary on actual impurity levels detected from the completed Module 3.2.S.3.2]

Control of Drug Substance (common name, manufacturer)

Specifications (common name, manufacturer)

[Insert the specifications for the drug substance from the completed Module 3.2.S.4.1]

[Insert the declared drug substance standard from the completed Module 3.2.S.4.1]

Reference Standards or Materials (common name, manufacturer)

[Insert a brief summary of the information, including the name(s) and use(s) of the reference standards or reference materials used for testing of the drug substance from the completed Module 3.2.S.5.]

Container Closure System (common name, dosage form)

[Insert a brief description of the container closure system for the drug substance from the completed Module 3.2.S.6]

Stability (common name, manufacturer)

Stability Summary and Conclusions (common name, manufacturer)

[Insert the proposed storage conditions and shelf-life from the completed Module 3.2.S.7.1]

Post-approval Stability Protocol and Stability Commitment (common name, manufacturer)

[Insert the drug substance post-approval stability protocol for annual testing and annual stability commitment from the completed Module 3.2.S.7.2]

P  Drug product (proprietary name, dosage form)

Manufacture (proprietary name, dosage form)

Manufacturer(s) (proprietary name, dosage form)

[Insert the completed Module 3.2.P.3.1]

Batch Formula (proprietary name, dosage form)

[Insert the tabulated summary on the batch formula and the anticipated range of commercial (production) batch sizes from the completed Module 3.2.P.3.2]

Description of Manufacturing Process and Process Controls (proprietary name, dosage form)

[Insert the process flow diagram from the completed Module 3.2.P.3.3]

[Insert the information on reprocessing from the completed Module 3.2.P.3.3]

Controls of Critical Steps and Intermediates (proprietary name, dosage form)

[Insert a summary of critical manufacturing steps, process controls performed, and acceptance criteria from the completed Module 3.2.P.3.4, under Critical Steps.] 

[Insert information on the quality and control of intermediates isolated during the process, from the completed Module 3.2.P.3.4, under Intermediates.]

 Control of Excipients (proprietary name, dosage form)

Excipients of Human or Animal Origin (proprietary name, dosage form)

[Insert the tabulated summary of excipients of human or animal origin that are used from the completed Module 3.2.P.4.5]

[Insert a confirmation, that none of the non-medicinal ingredients (excipients) which appear in the final product are prohibited for use in drugs by the Canadian Food and Drugs Act and Regulations].

Control of Drug Product (proprietary name, dosage form)

Specifications (proprietary name, dosage form)

[Insert the specifications for the drug product from the completed Module 3.2.P.5.1]

[Insert the declared drug product release standard from the completed Module 3.2.P.5.1]

Reference Standards or Materials (proprietary name, manufacturer)

[Insert a brief summary of the information, including the name(s) and use(s) of the reference standards or reference materials used for testing of the drug product from the completed Module 3.2.P.6]

Container Closure System (proprietary name, dosage form)

[Insert a brief description of the container closure system for the drug product from the completed Module 3.2.P.7]

Stability (proprietary name, dosage form)

Stability Summary and Conclusion (proprietary name, dosage form)

[Insert the proposed labelled storage conditions and shelf-life, including after reconstitution (if applicable) and in-use storage conditions (if applicable) from the completed Module 3.2.P.8.1.]

Post-approval Stability Protocol and Stability Commitment (proprietary name, dosage form)

[Insert the drug product post-approval stability protocol for annual testing and annual stability commitment from the completed Module 3.2.P.8.2.]

A  Appendices

Facilities and Equipment (common name/proprietary name, manufacturer)

[Insert a summary of all manufacturing facilities (e.g., name, single- or multi-product facility) and relevant product-contact equipment information from the completed Module 3.2.A.1.]

[Insert Information on all developmental or approved products (or alternatively the product types/classes) manufactured or manipulated in the same areas as the applicant's product, along with the cell line/expression system used (e.g., E.coli, CHO) or source material (if applicable), including change over procedures if upstream processing is occurring in the facility from the completed Module 3.2.A.1.]

Adventitious Agents Safety Evaluation (common name, dosage form, manufacturer)

[Insert the tabulated summary of the reduction factors for viral clearance from the completed Module 3.2.A.2, under Viral Clearance Studies.]

[Insert the calculation of estimated particles/dose, where relevant from the completed Module 3.2.A.2, under Viral Clearance Studies.] The calculation should also be expressed as "one retroviral-like particle per number of doses".

R  Regional Information

Medical Devices (proprietary name, dosage form)

[Insert the information on novel medical devices used to deliver the dosage form that are external to the drug product (e.g. inhalation devices) from Module 3.2.R.2, under Medical Devices.]

Product Lifecycle Management Information (proprietary name, dosage form, manufacturer)

[Insert link to the Product Lifecycle Management Document from Module 3.2.R.8, Product Lifecycle Management Information, if applicable]