Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D Drugs)) Template in the CTD Format

Introduction

• Submission File#
• NDS Approval Date and Control#
• CPID 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:
• Dosage form(s):
• Strength(s):
• Route(s) of Administration:
• Maximum Daily Dose:
• New Active Substance (NAS)?

S Drug Substance (Name, Manufacturer)

Manufacture (name, manufacturer)

• Manufacturer(s) (name, manufacturer)
• [Insert the completed Module 3.2.S.2.1.]
• Description of Manufacturing Process and Process Controls (name, manufacturer)
• [Insert the flow diagram(s) from the completed Module 3.2.S.2.2.]
• Control of Materials (name, manufacturer)
• [Insert the tabulated summary of the biological raw material(s) used, from the completed Module 3.2.S.2.3.]
• [Insert the tabulated summary of prepared reagents from the completed Module 3.2.S.2.3.]
• Controls of Critical Steps and Intermediates (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 (name, manufacturer)

• Elucidation of Structure and other Characteristics (name, manufacturer)
• [Insert a summarized description of this information from the completed Module 3.2.S.3.1.]
• Impurities (name, manufacturer)
• [Insert the tabulated summary on actual impurity levels detected from the completed Module 3.2.S.3.2.]

Control of Drug Substance (name, manufacturer)

• Specification (name, manufacturer)
• [Insert the specification 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.]

Stability (name, manufacturer)

• Stability Summary and Conclusions (name, manufacturer)
• [Insert the proposed storage conditions, retest date or shelf-life, where relevant, from the completed Module 3.2.S.7.1.]

P   Drug Product (Name, Dosage Form)

Manufacture (name, dosage form)

• Manufacturer(s) (name, dosage form)
• [Insert the completed Module 3.2.P.3.1.]
• Batch Formula (name, dosage form)
• [Insert the tabulated summary on the batch formula from the completed Module 3.2.P.3.2.]
• Description of Manufacturing Process and Process Controls (name, dosage form)
• [Insert the process flow diagram from the completed Module 3.2.P.3.3.]
• Controls of Critical Steps and Intermediates (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 (name, dosage form)
• Excipients of Human or Animal Origin (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.]

Control of Drug Product (name, dosage form)

• Specification(s) (name, dosage form)
• [Insert the specification(s) 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.]

Container Closure System (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 (name, dosage form)

• Stability Summary and Conclusion (name, dosage form)
• [Insert the proposed labelled storage conditions and retest date or shelf-life, including after reconstitution and in-use storage conditions (if applicable) from the completed Module 3.2.P.8.1.]
• Post-approval Stability Protocol and Stability Commitment (name, dosage form)
• [Insert the post-approval stability protocol and stability commitment from the completed Module 3.2.P.8.2.]

A   Appendices

Facilities and Equipment (name, manufacturer)

• [Insert information on all developmental or approved products manufactured or manipulated in the same areas as the applicant's product from the completed Module 3.2.A.1.]

Adventitious Agents Safety Evaluation (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.]