Regulatory Services: Management and Control of Certified Product Information Document
By Innomar Strategies
Our international clients have frequently asked Innomar’s CMC regulatory affairs team “what is a CPID?” when filing a drug submission in Canada.
The Certified Product Information Document (CPID) is a high-level summary of essential commercial product quality (chemistry, manufacturing, and controls) information.
Drugs having received a marketing authorization by Health Canada are required to maintain a CPID. It does not apply to clinical trial applications or other types of medicinal products such as Natural Health Products. The information to be included in the CPID is defined by Health Canada within the relevant Quality guidance documents and templates for pharmaceutical and biologic drug submissions.
As part of the drug submission review process, the CPID is provided in section 1.3.6 of Module 1 and is reviewed by Health Canada. As a “living” document, it is maintained by the Marketing Authorization Holder (MAH) and continually updated to reflect post-approval changes to the product. The MAH maintains an annotated version of the CPID that identifies and references cumulative post-approval changes. When filing a pre-approvable submission, an annotated and clean version of the CPID is provided, including cumulative changes and the changes proposed in the submission.
During the Quality (CMC) Review of a submission, it is common for Health Canada to request changes to the CPID content. When approved, a clean version including the reference to the reviewed submission is generated.
When creating the CPID, the information requested by the relevant guidance should be provided. The CPID should not include any batch specific data, such as COAs, executed batch records, or stability data. Wherever possible you should avoid embedded images except for manufacturing flow charts. A CPID is a stand-alone document. It should not include any cross-references to the Quality Overall Summary or Module 3. Process validation commitments and stability protocols are to be maintained and updated appropriately.
Timely maintenance and revision of the CPID is critical to maintain regulatory compliance for drug submissions. There are different approaches to manage the CPID lifecycle but ultimately, it is a requirement to be able to present a current and accurate CPID when requested by Health Canada. The CPID is used by Health Canada during GMP inspections as a reference tool.
At Innomar Strategies, we can help support the preparation and maintenance of CPID documents, along with the management of post-approval changes throughout the lifecycle of your product.
Drugs having received a marketing authorization by Health Canada are required to maintain a CPID. It does not apply to clinical trial applications or other types of medicinal products such as Natural Health Products. The information to be included in the CPID is defined by Health Canada within the relevant Quality guidance documents and templates for pharmaceutical and biologic drug submissions.
As part of the drug submission review process, the CPID is provided in section 1.3.6 of Module 1 and is reviewed by Health Canada. As a “living” document, it is maintained by the Marketing Authorization Holder (MAH) and continually updated to reflect post-approval changes to the product. The MAH maintains an annotated version of the CPID that identifies and references cumulative post-approval changes. When filing a pre-approvable submission, an annotated and clean version of the CPID is provided, including cumulative changes and the changes proposed in the submission.
During the Quality (CMC) Review of a submission, it is common for Health Canada to request changes to the CPID content. When approved, a clean version including the reference to the reviewed submission is generated.
When creating the CPID, the information requested by the relevant guidance should be provided. The CPID should not include any batch specific data, such as COAs, executed batch records, or stability data. Wherever possible you should avoid embedded images except for manufacturing flow charts. A CPID is a stand-alone document. It should not include any cross-references to the Quality Overall Summary or Module 3. Process validation commitments and stability protocols are to be maintained and updated appropriately.
Timely maintenance and revision of the CPID is critical to maintain regulatory compliance for drug submissions. There are different approaches to manage the CPID lifecycle but ultimately, it is a requirement to be able to present a current and accurate CPID when requested by Health Canada. The CPID is used by Health Canada during GMP inspections as a reference tool.
At Innomar Strategies, we can help support the preparation and maintenance of CPID documents, along with the management of post-approval changes throughout the lifecycle of your product.
Topics:
Commercialization
Regulatory
