3. INTRODUCTION
SOP is a valuable tool for the preparation of a CTA to
Health Canada.
It provides the procedural description of materials and
methods
Provides details of appropriate quality, cost and time
constraints.
It is prepared based on the principles of project
management.
In general, SOP provides the user to think through the
procedure step by step and to standardize the materials,
methods, cost and time.
RAC 203/TIPT/Project Management
4. CONTENTS OF SOP FOR CLINICAL
TRIAL APPLICATION
RAC 203/TIPT/Project Management
5. Project Charter
SOP of Clinical Trials Application
Project Overview
Problem StatementIt is designed to provide tools and relevant links
in order to facilitate the successful filing of a Clinical Trial Application
(CTA) to Health Canada
Project Description This SOP will be a tool for filling of Clinical Trial
Application for Health Canada avoiding any discrepancies in
understanding of documents and requirements of Health Canada
Project Goals and Objectives It is designed to provide tools and
relevant links in order t o facilitate the successful filing of a Clinical
Trial Application (CTA) to Health Canada. It is based on Health
Canada’s Guidance for Clinical Trials.
Project Justification The information provided within this package
is for clinical trials that involve the use of Pharmaceutical and/or
Biological and Radiopharmaceutical drugs in human subjects.
RAC 203/TIPT/Project Management
6. Project Charter
SOP of Clinical Trials Application
Assumptions Sponsors conducting clinical trials in
Canada with products that have received a Notice of
Compliance with Conditions (NOC/c) are also required to
file a CTA the product is outside the parameters of the
authorized Notice of Compliance (NOC) or Drug
Identification Number (DIN) application .
Constraints Project constraints being imposed in areas
such as schedule, budget, resources, products to be
reused, technology to be employed, products to be
acquired, and project constraints based on the current
knowledge today interfaces to other products.
RAC 203/TIPT/Project Management
7. Project Charter
SOP of Clinical Trials Application
PROJECT SCOPE
RAC 203/TIPT/Project Management
9. SCOPE DEFINITION
The information provided within this package is for
clinical trials that involve the use of Pharmaceutical
and/or Biological and Radiopharmaceutical drugs in
human subjects.
RAC 203/TIPT/Project Management
14. Clinical Trial Application (CTA)
A must to file Clinical Trial Application (CTA) to conduct clinical trials in
Phases I through III of
Drug development and
Comparative bioavailability trials. This includes applications to conduct
clinical trials involving marketed products where the proposed use of the
product is outside the parameters of the authorized drugs.
A similar Health Canada review and approval process exists for clinical trials
involving natural health products. Under the Natural Health Products
Regulations, which came into effect on January 1, 2004.
Natural health products (NHPs) are defined as:
* Vitamins and minerals
* Herbal remedies
* Homeopathic medicines
* Traditional medicines such as traditional Chinese medicines
* Probiotics, and
* Other products like amino acids and essential fatty acids.
Submissions satisfying the NHP Directorate's requirements will be issued a
Notice of Authorization to commence the trial.
RAC 203/TIPT/Project Management
15. Clinical Trial Application (CTA)
It is a mandatory requirement of Health Canada
that Sponsor must file a Clinical Trial Application
(CTA) to conduct clinical trials in Phases I
through III of drug development and comparative
bioavailability trials.
The first step for the successfully filing of a CTA is
a well-documented procedure that ensures that
everyone involved is well aware of the
documentation methods
RAC 203/TIPT/Project Management
17. Outline of a CTA / CTA-A
RAC 203/TIPT/Project Management
18. Outline of a CTA / CTA-A
RAC 203/TIPT/Project Management
19. IMPORTANT
IMPORTANT: Each Module should be submitted in a
separate binder.
The modules are organized and numbered consistently in
an internationally adopted format - the Common
Technical Document (CTD). Adhering to the CTD format
facilitates evaluation by Health Canada and ensures
consistency of documents in subsequent stages of the drug
authorization process. Additional information about the
CTD format is available on the web site of the
International Conference on Harmonisation (ICH) at
www.ich.org.
The CTA should be sent directly to the appropriate
Directorate. The outer label should be clearly state
"Clinical Trial Application".
RAC 203/TIPT/Project Management
30. Three modules for CTA
IMPORTANT: Each Module should be submitted in a
separate binder.
The modules are organized and numbered
consistently in an internationally adopted format the Common Technical Document (CTD). Adhering
to the CTD format facilitates evaluation by Health
Canada and ensures consistency of documents in
subsequent stages of the drug
RAC 203/TIPT/Project Management
31. PROJECT QUALITY MANAGEMENT
Project quality management ensures that the project
satisfies the stated or implied
Level of quality and the key out puts of quality
management includes:
1. Quality Management Plan
2. Quality matrices
3. Quality Check list
RAC 203/TIPT/Project Management
32. QUALITY
Good manufacturing practices: main principles
for pharmaceutical products
Quality management in the drug industry:
philosophy and essential elements
Heating Ventilation and air-conditioning systems for
non-sterile pharmaceutical dosage forms
Validation
Water for pharmaceutical use
RAC 203/TIPT/Project Management
33. QUALITY
. Good manufacturing practices: starting
materials
Active pharmaceutical ingredients (bulk drug
substances)
Pharmaceutical excipients
RAC 203/TIPT/Project Management
34. QUALITY
Inspection
Pre-approval inspections
Inspection of pharmaceutical manufacturers
Inspection of drug distribution channels
Quality systems requirements for national good
manufacturing practice inspectorates
Guidance on good manufacturing practices:
Inspection report
Model certificate of good manufacturing practices
RAC 203/TIPT/Project Management
35. QUALITY
Good manufacturing practices: specific
pharmaceutical products
Sterile pharmaceutical products
Biological products
Investigational pharmaceutical products for clinical
trials in humans
The manufacture of herbal medicines
Radiopharmaceutical products
RAC 203/TIPT/Project Management
36. QUALITY
Hazard and risk
analysis in
pharmaceutical
products
Application of hazard
analysis and critical
control point (HACCP)
methodology to
pharmaceuticals.
Sampling operations
Sampling of
pharmaceutical products
and related materials
RAC 203/TIPT/Project Management
37. Defined Conditions for Impact Scales
of risk on Major Project Objectives
RAC 203/TIPT/Project Management
38. SOPs and Records
(a) Equipment assembly and validation;
(b) Analytical apparatus and calibration;
(c) Maintenance, cleaning and sanitization;
(d) Personnel matters including qualification,
training, clothing and hygiene;
(e) Environmental monitoring;
(f ) Pest control;
(g) Complaints;
(h) Recalls;
(i) Returns.
RAC 203/TIPT/Project Management
39. SOPs and Records
SOP for the internal labelling, quarantine and storage
of starting materials, packaging materials and other
material.
SOP should be available for each instrument and
piece of equipment (e.g. use, calibration, cleaning,
maintenance) .
Standard operating procedures for sampling.
SOP with details of the batch (lot) numbering system
Batch-number allocation should be immediately
recorded, e.g. in a logbook.
RAC 203/TIPT/Project Management
40. SOPs and Records
Analysis records should include at least the following
data:
(a) The name of the material or product and, where applicable, dosage form;
(b) The batch number and, where appropriate, the manufacturer and/or
supplier;
(c) References to the relevant specifications and testing procedures;
(d) Test results, including observations and calculations, and reference to any
specifications (limits);
(e) Date(s) and reference number(s) of testing;
(f ) The initials of the persons who performed the testing;
(g) The date and initials of the persons who verified the testing and the
calculations, where appropriate;
(h) A clear statement of release or rejection (or other status decision) and the
dated signature of the designated responsible person.
RAC 203/TIPT/Project Management
41. SOPs and Records
The records of the receipts should include:
(a) The name of the material on the delivery note and the containers;
(b) The “in-house” name and/or code of the material if different from
(a);
(c) The date of receipt;
(d) The supplier’s name and, if possible, manufacturer’s name;
(e) the manufacturer’s batch or reference number;
(f ) The total quantity, and number of containers received;
(g) The batch number assigned after receipt;
(h) Any relevant comment (e.g. state of the containers).
RAC 203/TIPT/Project Management
