Draft Quality Information Summary - Radiopharmaceuticals (QIS-R)

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Draft Quality Information Summary - Radiopharmaceuticals (QIS-R) (PDF Version, 71 Kb)
Date: 2001-08-01

Biologics and Genetic
Therapies Directorate/
Direction des produits
biologiques et des thérapies
génétiques
Tunney's Pasture / Pré Tunney
A.L. / L.A. # 0703D
OTTAWA (Ontario)
K1A 0L2

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August 01, 2001/le 01 Août 2001

To: Associations

Subject: The Draft Quality Information Summary- Radiopharmaceuticals (QIS-R) and Certified Product Information Document- Radiopharmaceuticals (CPID-R) Electronic Templates for Radiopharmaceutical (Schedule C) Products

The Biologics and Genetic Therapies Directorate (BGTD) is pleased to introduce, for external consultation, the updated electronic quality (chemistry and manufacturing) templates for radiopharmaceutical (Schedule C) products: the draft Quality Information Summary- Radiopharmaceuticals (QISLa- R) and Certified Product Information Document- Radiopharmaceuticals(CPIDR) (August 01, 2001).

An electronic copy of the blank templates (available in an IBM-compatible, WP8.0 format only) can be obtained through the TPD/BGTD website(s) at http://www.hc-sc.gc.ca/hpbdgps/ therapeut/htmleng/ template.html under the blnkqisr.zip and blkcpidr.zip files. Also posted at the same TPD/BGTD Internet site(s), under the qisrguide.zip file, is an accompanying document (only available in English at the moment in an IBMcompatible, WP8.0 format) which has been developed to assist sponsors in the preparation of the QIS-R and CPID-R templates. Sponsors are encouraged to read this document, before completing the templates.

Alternatively, printed copies of the documents and a disk copy of the template files can be obtained by sending your name and address, by mail or facsimile to: Submissions Management Division, Centre for Policy and Regulatory Affairs, Address Locator # 0601E3, Tunney's Pasture, Ottawa, Ontario K1A 0L2 FAX# (613) 957-0364.

The entire QIS-R template consists of four parts:

• Part 1: G. General Information;
• Part 2: S. Drug Substance;
• Part 3: P. Drug Product;
• Part 4: Other Information.

The QIS-R has been designed to capture all types of radiopharmaceutical drug (Schedule C) submissions containing drug substances of purely synthetic chemical origin. However, for drug submissions containing a drug substance of biological origin the specifically-designed module (Part 2 only) of the QIS-B must be completed. The QIS-B Section S (Part 2) can be used (where applicable) for the following biological drug substances; submissions containing Blood Products (QIS-B-BLD), Recombinant DNA Products and Monoclonal Antibodies (QIS-BrDNA/ MAbs), etc. Parts 1, 3 and 4 of the QIS-R and the CPID-R templates apply to all Radiopharmaceutical products, including Kits and Generators. Sponsors are encouraged to use or pilot the draft QIS-R and CPID-R templates when summarizing their quality (chemistry and manufacturing) information for New Drug Submissions (NDS), Supplementary New Drug Submissions (S/NDS), Notifiable Changes (N/C),and Clinical Trial Applications (CTAs) [commonly known as Investigational New Drug Submissions (IND)].

A sponsor is not obviated of the responsibility to file the necessary unabridged quality information in submission volumes, with the preparation of a summary document (QIS-R).

From experience with the previous electronic versions of the chemistry and manufacturing summary documents, available since 1995, well-completed summaries have proven to expedite the submission review process, promote consistency, improve the quality of drug submissions as well as, reduce the number of submission deficiencies.

It should be noted that the draft QIS-R and CPID-R templates were designed to be in line with the current Canadian regulations. Sponsors are encouraged to review the draft QIS-R and CPID-R templates and to provide any comments by December 1, 2001,for consideration in the final version. Any comments, concerns, questions, and/or problems associated with the draft quality electronic templates for radiopharmaceuticals, should be forwarded to Dr. Rezaul Mannan at the Centre for Biologics Evaluation by fax: (613) 941-5841 or e-mail: rezaul_n@hc-sc.gc.ca.

Thank you for your interest and participation in this BGTD initiative.

Original signed by/Original signé par

Julia Hill Associate

Director General/Directrice générale associée