Standard operating procedure for CTA

Project Management Assignment
RAC – 203

RAC 203/TIPT/Project Management

Areas of Concern in CTA


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.

CONTENTS OF SOP FOR CLINICAL
TRIAL APPLICATION


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.

Project Charter
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.


Project Charter
PROJECT SCOPE


Scope Planning Process


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.


WBS: Inputs, Tools & Techniques,
Outputs


RELATIONSHIP BETWEEN
STAKEHOLDERS AND THE PROJECT


Stakeholder’s Flow chart


WBS: Inputs, Tools & Techniques, Outputs


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.

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

TYPES OF CLINICAL TRIALS


Outline of a CTA / CTA-A


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".

Planning of Alternative Process


Barriers to introduction of new
medical product


COST ESTIMATION


Project Cost Management
overview


COST :
WORK BREAKDOWN
STRUCTURE


MILESTONE LIST


Cost Control Chart


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


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


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


QUALITY
. Good manufacturing practices: starting

materials
Active pharmaceutical ingredients (bulk drug
substances)
Pharmaceutical excipients


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

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


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


Defined Conditions for Impact Scales
of risk on Major Project Objectives


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.

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.

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.

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).


Standard operating procedure for CTA

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

En vedette

En vedette (20)

Similaire à Standard operating procedure for CTA

Similaire à Standard operating procedure for CTA (20)

Plus de Dr.RAJEEV KASHYAP

Plus de Dr.RAJEEV KASHYAP (20)

Dernier

Dernier (20)

Standard operating procedure for CTA