C TA - standard operating procedures

SOP for Clinical Trial Application

Standard Operating Procedures

Clinical Trial Application (CTA)

Project Management Assignment
RAC – 203
INSTRUCTOR
Prof. Ramjeet

Prepared by

Page

1

Rajeev Kashyap

RK/RAC/203/14/09/2009
Version 1


Toronto Institute of Pharmaceutical Technology


Project Charter
SOP of Clinical Trials Application
Version # RK/RAC-203-1

Revision Date 05September 2009

Approval of the Project Charter indicates an understanding of the
purpose and content described in this deliverable. By signing this
deliverable, each individual agrees.

APPROVER NAME

SIGNATURE

TITLE

DATE

Mission: Adherence to GMP/GLP following ICH guidelines in manufacturing and safety of
drugs.

Page

2

Vision: Target delivery system of quality drugs within affordable costs.

RK/RAC/203/14/09/2009
Version 1




PROJECT CHARTER
Project Title
Project Start Date
Project Finish Date

Standard Operating Procedure for CTA
September 14,2009
October 30,2009

Budget Information
Project Manager

$ 72,520.00 (Approved)
Mary Palmer

Project objective

Develop a standard operating procedure for
Clinical Trial Application
*Communicate with all departments
*Work closely with QC department *Collect
all documents necessary for CTA
*Monitor document; are complete and
accurate

Approach

Page

3

Roles and Responsibilities
Name and
Role
Position
Contact Information
Signature
Kathleen
Project
Vice
416 241 AZYX
Thompson,
champion
President
(signed)
Mary Palmer
Project
Director
416 221 WVUT
(signed)
Sponsor
Laura Butler
Project Manager
416 422 SRQP
(signed)
Laura Butler
Steering committee member
416 532 ONML
(signed)
Colleen James Team Leader
416 443 KJIH
(signed)
Karen Kellner Supplier management
416 324 GFED
(signed)
Approval of the Project Charter indicates an understanding of the purpose and
content described in this deliverable. By signing this deliverable, each individual
agrees to it.

RK/RAC/203/14/09/2009
Version 1




CONTENTS OF SOP FOR CLINICAL TRIAL APPLICATION

Section 1
1 . 1 Project Statement
1. 2 Project Description
1 . 3 Project Goals and Objective
1 . 4 Project Scope
1 . 5 Critical Success Factors
1 . 6 Assumptions
1 . 7 Constraints.

Section 2 Project Authority and Milestones
2 .1 Project Funding Authority
2 .2 Project Oversight Authority
2 .3 Major Project mile stones

Section 3 Project Organization
3.1 Project Structure
3.2 Roles and Responsibilities
3. 3 Project Facilities & Resources

Section 4
4.1 Point of Contact

Section 5
Glossary

Section 6
Revision History

Section 7

Page

4

Appendices

RK/RAC/203/14/09/2009
Version 1




Section 1. Project Overview
1.1

Problem Statement

It is designed to provide tools and relevant links in order to facilitate the successful filing of a
Clinical Trial Application (CTA) to Health Canada.
1.2

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
1.3

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.
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.
The information does not apply to clinical trials involving Medical Devices and Natural Health
Products.

INPUTS

TOOLS & TECHNIQUES

OUTPUTS

Organizational process assets

Product analysis

Project Scope Statement

Project Charter

Alternatives identification

Requested Changes

Project Scope Statement

Expert judgements

Project Scope management Plan

Stakeholders judgements

Project Scope management
plan(updates)

Approved change requests

Page

5

SCOPE DEFINITION: Input, Tools and Technique, and Outputs

RK/RAC/203/14/09/2009
Version 1




1.4

Project Scope

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.
The information does not apply to clinical trials involving Medical Devices and Natural Health
Products.

Project Includes

Project Excludes

PROJECT ORGANIZATION
The project sponsor will make all major decisions in consultation with project
champion and steering committee member. Project Manager is responsible for
the successful completion of the project. Team leaders and Supplier project
managers report to the Project Manager

Project Sponsor
Mary Palmer

Brian Bretz

Team Leaders
Colleen James

RK/RAC/203/14/09/2009
Version 1

Project Champion
Kathleen
Thompson,

Supplier
Management

6

Laura Butler

Project Manager

Page

Steering
committee

Karen Kellner




RELATIONSHIP BETWEEN STAKEHOLDERS AND THE PROJECT

PROJECT
STAKEHOLDERS

PROJECT TEAM

PROJECT
MANAGEMENT
TEAM

PROJECT
SPONSOR
&
PROJECT
MANAGER

Duties and Responsibilities
PROJECT ORGANIZATION: DUTIES AND RESPONSIBILITIES
Project Sponsor
Final decision making authority. Consults
Mary Palmer
Project champion and steering committee
Project Champion

Advise project sponsor

Kathleen Thompson,

Steering committee

Advise project sponsor

Laura Butler

Responsible for the success of the project
Project Manager
Brian Bretz
Team Leaders

Report to project Manager

Supplier Management

Report to project Manager

RK/RAC/203/14/09/2009
Version 1

Page

Karen Kellner

7

Colleen James




STAKEHOLDER ANALYSIS
Stakeholder analysis provides information about key stakeholders to help manage relationships
with them
External Stakeholders
Health Canada
 Reviews clinical trial protocols to assess the protection and safety of the participants
 Assesses the quality of the drugs
 assures review by Research Ethics Boards
 verifies the qualifications of Principal Investigators and monitors and reviews
 Adverse Drug Reactions (ADRs).
Sponsor
 In compliance with the Canadian Food and Drug Regulations, Division 5
 Adheres to good clinical practices for the proper use of the drugs,
 Record keeping
Reporting of Considers ethical issues
Protocol Adverse Drug Reactions (ADRs).
Research Ethics Board
The informed consent documents
Conflicts of interest
Financial agreements.
Internal Stakeholders
Project Sponso
Project Champion
Steering committee members
Project Manager
RA Manager
Team Leaders
Project management Lead

Page

8

Supplier Management

RK/RAC/203/14/09/2009
Version 1




Stakeholders

Internal

External

Health Canada

Project Sponsor

Kathleen
Thompson,

Mary Palmer

Steering committee

Project Champion

Laura Butler

Kathleen
Thompson,

Project Manager

RA

Brian Bretz

REB

Sonia Barragan

Project
Management
Jeanne Heschele

Mila Dacorro

Suppliers
Tiffany Binderup
Group

Team Leaders
Colleen James

Supplier
Management
Karen Kellner

Stakeholder’s Flow chart

Standard Operating Procedures
A CTA contains information and documentation to support the objectives and goals of the
proposed clinical trial. It also includes data to support the drug product quality. The clinical and
quality components of the application are reviewed in parallel and both must be satisfactory
before a No Objection Letter can be issued.
Sponsors must file a Clinical Trial Application (CTA) to conduct clinical trials in Phases I through
III of drug development and comparative bioavailability trials.

RK/RAC/203/14/09/2009
Version 1



Page

SOP is an authorized written procedure giving instructions for performing operations not
necessarily specific to a given product or material (e.g. equipment operation, maintenance and
cleaning; validation; cleaning of premises and environmental control; sampling and inspection).

9

This includes applications to conduct clinical trials involving marketed products where the
proposed use of the product is outside the parameters of the authorized


Certain SOPs may be used to supplement product-specific master and batch production
documentation

SAFETY

QUALITY

EFFICASY

SCOPE
Project Justification
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 welldocumented procedure that ensures that everyone involved is well aware of the documentation

Page

10

methods.

RK/RAC/203/14/09/2009
Version 1




SCOPE
PLANNING

SCOPE

CREATE
WBS

DEFINITION

SCOPE
CONTROL

1.5

SCOPE
VERIFICATION

Critical Success Factors

The Food and Drugs Act and Regulations provide authority to Health Canada to regulate the
sale of drugs for the purposes of use in human clinical trials. Part C, Division 5 of the
Regulations defines specific Clinical Trial Application (CTA) and Clinical Trial Application
Amendment (CTA-A) requirements for the sale and importation of drugs for use in human
clinical trials in Canada.
Division 5 of the Regulations came into force since September 2001 and was developed to
recognize the generally accepted principles of good clinical practice
The Regulations are consistent with the principles, definitions and standards found in the


Health Canada / ICH Guidance Documents E6: Good Clinical Practice: Consolidated
Guideline,



E8: General Considerations for Clinical Trials and



E2A: Clinical Safety Data Management:



Definitions and Standards for Expedited Reporting.

This guidance documents, developed through the International Conference on Harmonisation
(ICH) process have been adopted by Health Canada. Together, they define parameters for the


Conduct



Performance

RK/RAC/203/14/09/2009
Version 1

11

Design

Page








Monitoring



Auditing,



Recording, analysis



Reporting of clinical trials.

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.
1.6

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

Page

12

Identification Number (DIN) application .

RK/RAC/203/14/09/2009
Version 1




1.7

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.

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".

DOCUMENT NOT INCLUDED IN THESE MODULES SHOULD NOT BE FILED AND IT IS
OUT OF PROJECT SCOPE.
3.3 Project success:
Studies conducted by the sponsor have stated that the project will be a success if it can be
completed within 50 days.

3.4 Deliverables;
Team Contract
Project management plan

13

Scope statement

Page

Work breakdown Structure
Standard operating Procedure
RK/RAC/203/14/09/2009
Version 1




The CTA is composed of three parts (modules):

Outline of a CTA / CTA-A
Module

Pharmaceuticals

1

Administrative / Clinical Information

1.1

Table of Contents (Modules 1-3)

1.2

Biologicals and Radiopharmaceuticals

Application Information
Drug Submission Application Form (HC/SC 3011)

1.2.1
1.2.2
1.2.3*
1.2.4*

Information on Prior-related Applications
Investigator’s Brochure
Protocol Synopsis (PSEAT-CTA)
Study Protocol(s)
Informed Consent Document(s)
Clinical Trial Site Information
Canadian Research Ethics Board(s) Refusals
Foreign Refusals

1.2.10

Letters of Access
Other Application-related Information
Electronic Review Documents

1.3

2

Page

1.2.11

14

1.2.5*
1.2.6
1.2.7
1.2.8
1.2.9

Submission Rationale /
Brief Summary of the Drug Product

Common Technical Document Summaries

RK/RAC/203/14/09/2009
Version 1




2.1
2.3
2.3⁷*
3
3.1
3.2

Common Technical Document Table of Contents
..............
Quality Overall Summary
Quality
Table of Contents of Module 3
Body of Data

3.2.R.1

Production Documentation

3.2.R.2

Executed Batch Records

Literature References
3.3
* These items should be submitted in hard copy and in electronic format accepted by Health Canada
( CD - ROM)
TIME MANAGEMENT
The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total
duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project
software or any other validated program must be used for this task.

Page

15

7.1 Gantt Chart Activity List: Level 2

RK/RAC/203/14/09/2009
Version 1




RK/RAC/203/14/09/2009
Version 1



17


RK/RAC/203/14/09/2009
Version 1


Page

7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA



The WBS at level 3 is given in the above Gantt Chart

Milestones
At completion of a specific set of documentation milestones are given to review project progress. There
are 10 milestones for this project. The following Gantt chart lists the dates of each milestone

MILESTONE LIST

Milestone List
Activity

Milestone Date

2.Study Correspondence 0d

Mon 28/09/09

Mon 28/09/09

"6,10SS"RA

Mon 05/10/09

Mon 05/10/09

21SS

RA

"Correspondence: letters, faxes, memos, emails"

0d

Fri 09/10/09

Fri 09/10/09

30SS

RA


0d

Mon 12/10/09

Mon 12/10/09

44SS

RA

RK/RAC/203/14/09/2009
Version 1



18

0d

Page




0d

Tue 13/10/09

Tue 13/10/09

61SS

RA


0d

Thu 15/10/09

Thu 15/10/09

88SS

RA


0d

Tue 20/10/09

Tue 20/10/09

106SS

RA


0d

Thu 22/10/09

Thu 22/10/09

117SS

RA


0d

Mon 26/10/09

Mon 26/10/09

141SS

RA


0d

Wed 28/10/09

Wed 28/10/09

148SS

RA

8.0 COST MANAGEMENT
Project cost management includes the process required to ensure that a project team completes a
project within in an approved budget.
TIME MANAGEMENT
The start date of the project is September 14, 2009 and the Finish date is October 30, 2009. The total
duration for this project is 35 days. A work breakdown structure at level 2 is given below. MS Project
software or any other validated program must be used for this task.

Page

19

Gantt Chart Activity List: Level 2

RK/RAC/203/14/09/2009
Version 1




7.2 Gantt chart: Activity List Level 3 : Standard Operating Procedure for CTA

RK/RAC/203/14/09/2009
Version 1




The WBS at level 3 is given in the above Gantt Chart

7.3 Milestones
At completion of a specific set of documentation milestones are given to review project progress. There
are 10 milestones for this project. The following Gantt chart lists the dates of each milestone

MILESTONE LIST

Page

22


RK/RAC/203/14/09/2009
Version 1




7.4 Milestone List

Activity

Milestone Date

2. Study Correspondence 0d

Mon 28/09/09

Mon 28/09/09

"6,10SS"RA


0d

Mon 05/10/09

Mon 05/10/09

21SS

RA


0d

Fri 09/10/09

Fri 09/10/09

30SS

RA


0d

Mon 12/10/09

Mon 12/10/09

44SS

RA


0d

Tue 13/10/09

Tue 13/10/09

61SS

RA


0d

Thu 15/10/09

Thu 15/10/09

88SS

RA


0d

Tue 20/10/09

Tue 20/10/09

106SS

RA


0d

Thu 22/10/09

Thu 22/10/09

117SS

RA


0d

Mon 26/10/09

Mon 26/10/09

141SS

RA


0d

Wed 28/10/09

Wed 28/10/09

148SS

RA

WBS: Inputs, Tools & Techniques, Outputs

OUTPUTS

INPUTS
Organisational process
assets
Project scope statement
Project Scope Management
Plan

TOOLS & TECHNIQUES
Work Breakdown Structure
Template
Decomposition

Project scope statement(updates)
WBS & WBS Dictonary
Scope Baseline
Project Scope management
plan(updates) & requested Changes

Page

23

Approved Change requests

RK/RAC/203/14/09/2009
Version 1




8.0 COST MANAGEMENT
Project cost management includes the process required toensure that a project team completes a
project within in an approved budget.
8.1 Project Cost
Project team normally prepares cost estimates at various stages of the project and this estimates are
fine tuned as time progress.
8.2 Bottom up Cost estimation
To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this
project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the
following Gantt chart using MS Project program.

Project Cost Management overview

COST ESTIMATING
•1. INPUT
•Enterprise Enviornmental Factors
•Organisational Process Assets
•Project Scope Statement
•WBS & WBS Dictionary
•Project Management Plan :
Schedule management plan,
Staffing Management plan, Risk
register.

•2. TOOLS & TECHNIQUES
•Analogous estimating.
•Determine resourse cost rates
•Bottom-up estimating.
•Parameteric estimating
•Project management software.
•Vendor bid analysis
•Cost of quality.

•3. OUTPUTS

•1. INPUTS
•Project scope statement
•WBS &WBS Dictonary
•activity cost estimates
•activity cost estimate supporting
details
•Project schedule
•Resourse Calandars.
•Contracts
•Cost management plan

•2. TOOLS & TECHNIQUES
•Cost aggregation
•Reserve analysis
•Parametric estimating.
•Funding limit reconcilition

•3. OUTPUTS
•Cost Baseline
•Project funding requiements
•Cost management plan (updates)
•Request changes

COST CONTROL
•1. INPUTS
•Cost baseline
•Project funding requirements
•Performance report
•Work Performence inforfation
•Approvd change request
•Project management plan

•2. TOOLS &TECHNIQUES
•Cost change control system
•Performance measuements analysis
•Forecasting
•Project performancce reviews
•Project management software
•Variance measurements

•3. OUTPUTS
•Cost estimate (updates)
•Performance Measures
•Cost baseline (updates)
•Forecasted completion
•Requested Changes
•Recomended corrective actions
•Organisational process assets
•Project management plan(updates)

Page

24

•Activity cost estimates
•Activity cost estimate supporting
details
•Requested changes.
•Cost management plan(updates)

COST BUDGETING

RK/RAC/203/14/09/2009
Version 1




Project cost Estimation Gantt Chart
COST :

WORK BREAKDOWN STRUCTURE

SOP FOR CTA Cost Analysis Level 2.mpp

8.4 COST BUDGETING

Project cost budgeting involves allocating the project cost estimate to various tasks

The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other
validated system as given in the following Gantt. Chart.

Page

25

Cost budgeting Gantt Chart

RK/RAC/203/14/09/2009
Version 1



26


Page

8.1 Project Cost

RK/RAC/203/14/09/2009
Version 1




Project team normally prepares cost estimates at various stages of the project and this estimates are
fine tuned as time progress.
8.2 Bottom up Cost estimation
To increase the accuracy of cost estimation a bottom up cost estimation method is followed for this
project The current project cost is estimated to be $72,520. The cost WBS at level 2 is given in the
following Gantt chart using MS Project program.
8.3 Project cost Estimation Gantt Chart
COST :

WORK BREAKDOWN STRUCTURE

SOP FOR CTA Cost Analysis Level 2.mpp

8.4 COST BUDGETING
Project cost budgeting involves allocating the project cost estimate to various tasks

The Cost budgeting based on WBS level 3 is to be carried out using MS Project software or any other
validated system as given in the following Gantt. Chart.

Page

27

PROJECT QUALITY MANAGEMENT

RK/RAC/203/14/09/2009
Version 1




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 lists

9.1 Quality Management Plan
The main goal of the project is to develop a Standard Operating Procedure for a CTA within the targeted
time.
By scheduling a suite of Quality Assurance Reviews, to be undertaken by an independent
person to the project, the customer will be provided with a “trusted view” of the overall progress
of the project and the likelihood of the deliverables actually meeting the quality targets agreed.
All the procedures and procurements will be carried out as per established standards ie
GMP, GLP, ICH and ISO standards

9.2 Matrices and Reporting
A metric is a standard of measurement. Examples are customer satisfaction, failure
rates and availability of service and goods. The quality management team at the site is
responsible for actively identifying issues and trends to support continuous
improvement. This is facilitated through the collection of quality and compliance Key
Performance Indicators. The information collected could be from a variety of sources
such regulatory audits, self inspections, trending reports or non-conformance quality
systems monitoring programs.
The site quality team is responsible for providing visibility of the quality information
through appropriate forums, reports and communication channels. The quality and
management teams and Corporate Quality and Operations management on a

RK/RAC/203/14/09/2009
Version 1

Page

scheduled basis.

28

compliance Key Performance Indicators are reviewed and reported to both the Project




9.3 Quality Check list
A list if items to be noted or consulted. It helps the project team to verify that a set of required steps has
been performed.
Whether reports are complete
Whether suppliers are qualified or ISO certified
Whether the reports are signed and dated.

9.4 Quality control measures

9.5 Control charts .control charts illustrates the progress of a task overtime

Page

29

In this cost control chart mean amount is calculated from the total cost divided by number of days.
Lower and upper limits are fixed for daily cost control.

RK/RAC/203/14/09/2009
Version 1




Cost Control Chart
3000
Amount in $

2500
Lower Limit
2000

Mean

1500

Upper Limit

1000

Daily expense
Linear (Daily expense)

500
0
1

2

3

4

5

6

7

8

9

10

Days

9.6 Histograms
A histogram showing number of tasks completed on a daily basis

Page

30

Histograms show a bar graph of distribution of variables

RK/RAC/203/14/09/2009
Version 1




QC HISTOGRAM

Number of Tasks

16
14
12
10
8
6
4
2
0
1

2

3

4

5

6

7

8

9

10
HISTOGRAM

Days

10.0 Conclusion.

Project success is an intangible, realized through consensus, collaboration and communication. In this
SOP best project management standards and practices are used to increase the likelihood of overall
success. Throughout this project milestones are provided for the logical flow of project planning and
execution, providing for periodic review and ongoing reflection. It will provide potential benefits, as
defined checkpoints for management control and success of the project.

Standard operating procedures (SOPs) and records


Standard operating procedures and associated records of actions taken or, where
appropriate, conclusions reached should be available for:

31

(a) Equipment assembly and validation;

Page

(b) Analytical apparatus and calibration;
(c) Maintenance, cleaning and sanitization;
RK/RAC/203/14/09/2009
Version 1




(d) Personnel matters including qualification, training, clothing and hygiene;
(e) Environmental monitoring;
(f ) Pest control;
(g) Complaints;
(h) Recalls;
(i) Returns.


There should be standard operating procedures and records for the receipt of each
delivery of starting material and primary and printed packaging material.



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).



There should be standard operating procedures for the internal labelling, quarantine and
storage of starting materials, packaging materials and other materials, as appropriate.



Standard operating procedures should be available for each instrument and piece of
equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to
the equipment.



There should be standard operating procedures for sampling, which specify the
person(s) authorized to take samples.



The sampling instructions should include:
(a) The method of sampling and the sampling plan;
(b) The equipment to be used;
(c) Any precautions to be observed to avoid contamination of the material or
any Deterioration in its quality;
(d) The amount(s) of sample(s) to be taken;

(f ) The type of sample container(s) to be used, and whether they are for aseptic

RK/RAC/203/14/09/2009
Version 1


Page

sampling or for normal sampling, and labelling;

32

(e) Instructions for any required subdivision of the sample;



(g) Any specific precautions to be observed, especially in regard to the sampling of
sterile or noxious material.


There should be a standard operating procedure describing the details of the batch (lot)
numbering system, with the objective of ensuring that each batch of intermediate, bulk or
finished product is identified with a specific batch number.



The standard operating procedures for batch numbering that are applied to the
processing stage and to the respective packaging stage should be related to each other.



The standard operating procedure for batch numbering should ensure that the same
batch numbers will not be used repeatedly; this applies also to reprocessing.



Batch-number allocation should be immediately recorded, e.g. in a logbook. The record
should include at least the date of allocation, product identity and size of batch.



There should be written procedures for testing materials and products at different stages
of manufacture, describing the methods and equipment to be used. The tests performed
should be recorded.



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.



Written release and rejection procedures should be available for materials and products,
and in particular for the release for sale of the finished product by an authorized person.



Records should be maintained of the distribution of each batch of a product in order, e.g.
to facilitate the recall of the batch if necessary.

validations, calibrations, maintenance, cleaning, or repair operations, including dates
and the identity of the people who carried these operations out.

RK/RAC/203/14/09/2009
Version 1



33

Records should be kept for major and critical equipment, as appropriate, of any

Page






The use of major and critical equipment and the areas where products have been
processed should be appropriately recorded in chronological order.



There should be written procedures assigning responsibility for cleaning and sanitation
and describing in sufficient detail the cleaning schedules, methods, equipment and
materials to be used and facilities and equipment to be cleaned. Such written
procedures should be followed.

References.
www.ich.org.
RAC 203 Resource Materials

Page

34

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_pre_applicationeng.php

RK/RAC/203/14/09/2009
Version 1



C TA - standard operating procedures

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to C TA - standard operating procedures

Similar to C TA - standard operating procedures (20)

More from Dr.RAJEEV KASHYAP

More from Dr.RAJEEV KASHYAP (20)

Recently uploaded

Recently uploaded (20)

C TA - standard operating procedures