Quality Manual as per ICH Guidelines

Title: Table of Contents Section: QM 0.1

Sr. No. Description ISO 9001 Clause Ref. Section No.

01 Table of Contents -- QM-0.1
02 Revision History -- QM-0.2
03 List of Controlled Manual Holders -- QM-0.3
04 Introduction -- QM-1.0
05 Scope of the Quality Management System -- QM-2.0
06 Exclusions & Justifications -- QM-3.0
07 Quality Management System 4.0 QM-4.0
08 Management Responsibility 5.0 QM-5.0
09 Resource Management 6.0 QM-6.0
10 Product Realization 7.0 QM-7.0
11 Measurement Analysis and Improvement 8.0 QM-8.0
12 Organogram -- QM-9.0

Title: Revision History Section: QM 0.2

Page No.
Sr. No. Brief Description of Change Rev. No.
 Title: List of Controlled Manual Holders Section: QM 0.3
Sr. No. Manual Holders Copy No.
01 TM / MR 01 (Master Copy)
02 Production / Stores / Quality Control /Purchase / Marketing 02
03 Certification Agency 03

Title: Introduction Section: QM 1.0

Our Company is one of the leading company in its class.

We at our company are dedicated to supply quality products with above mentioned High
Quality Testing Equipment, Highly qualified technical staff, in-house tool room, checking &
packing we are confident of handling your requirements.
 Title: Scope of the Quality Section: QM 2.0
Management System

Scope of the Quality Management System for ISO 9001: 2000 Standard Implementation is as
Under :

Manufacturer and Exporter of Bulk Drugs and Pharma

Intermediates
 Title: Exclusions & Justifications Section: QM 3.0

The Following Clauses of ISO 9001:2000 Standard are not applicable in purview with the Scope
of the Organization:

Clause 7.3 : Design & Development :-

The organization is manufacturing as per the IP (31431-39-7), USP and B.P. and doesn’t have its
own design hence this clause is not applicable.

Title: Quality Management System Section: QM 4.0

4.1 GENERAL REQUIREMENTS

The company has established, documented, implemented and maintained a quality management
system to continually improve its effectiveness in accordance with ISO 9001:2000 QMS
standards
The process needed for quality management system and their applications throughout the
organization are identified.
The sequences and interaction of these processes are determined and documented in respective
sections of this manual and in respective documents. Also a Flow chart of interaction of these
processes is prepared.
The criteria and methods needed to ensure that both operation and control of these processes are
effective are determined.
Availability of resources and information necessary to support the operation and monitoring of
these processes are ensured.
These processes are monitored, measured and analyzed.
Action necessary to achieve planned results and continual improvement of these processes are
implemented.
These processes are managed by company in accordance with the requirements of ISO
9001:2000
Nitration process is outsourced and the same is controlled through outgoing and incoming
quality checks and the reports for the same are being maintained.

4.2 DOCUMENTATION

4.2.1 General
The Quality Management System Documentation includes:-

 Quality Policy and Quality Objectives

  Quality Manual
 Quality System Activities required by ISO 9001:2000 standards, which is identified by
the organization for its operations to be effective.
 Work instructions, SOPs, product specifications, inspection and testing procedures,
supplier provided standards, etc.
 Quality records

4.2.2 Quality Manual

This manual is in full conformity with requirements of ISO 9001 : 2000 Standards and is
supported by further levels of documentation as detailed in 4.2.1
The scope of quality management system covers activities relating to “scope” The documented
procedures established for the quality management activities under the scope are defined in level
‘B’ documentation.
This manual and cross-reference procedures in Process Interactions Chart describe the
interaction between various processes under the scope of Quality Management System.
4.2.3 Control of Documents
Documents as described in 4.2.1 are controlled, implemented, circulated, reviewed and approved
as activity flow charts, referred as under:

4.2.4 Control of Records

It is essential that Quality Records are maintained, since the records are the objective evidence
that the system is operating effectively at all stages. The activities for Control of Records are
referred as under:

ACTIVITY REFERENCE:
PROCEDURE MANUAL- MANAGEMENT REPRESENTATIVE
 Title: Management Responsibility Section: QM 5.0

5.1 MANAGEMENT COMMITMENT

The company commits itself to the development and implementation of quality management
system and continually improves its effectiveness. Regular meetings wherein the importance of
meeting customer requirements and feedback are communicated to employees whenever
necessity arises will achieve this. The administrative personnel are briefed regularly about the
statutory and regulatory requirements in meeting.
The quality policy is established and the text of the Quality Policy is given in 5.3
The Quality Policy is supported by tangible Quality Objectives as given in 5.3
Management Reviews are conducted regularly to ascertain effectiveness of QMS (refer 5.6)
The company ensures that adequate resources are made available to meet customer requirement,
Quality System requirements as well as statutory and regulatory requirements.

5.2 CUSTOMER FOCUS

The Company has belief in the philosophy that, CUSTOMER is the purpose of its business.
Employees are regularly trained on customer focus. The feedback from customer in terms of
quality, delivery, quality complaints etc. are accorded top priority and their cause and preventive
measures are immediately implemented.
Customer Satisfaction is enhanced through regular meeting with customer/representatives and
fulfilling their targets in terms of quality, delivery lead-time and price expectations. Periodically
customer feedback form is sent to ascertain their needs and expectations.

ACTIVITY REFERENCE:
PROCEDURE MANUAL - MANAGEMENT REPRESENTATIVE AND MARKETING

5.3 QUALITY POLICY

Considering the needs and expectations of customers and our company’s business strategy, Top
Management has formulated the quality policy:

The quality policy of the company is defined, documented and made known to all the employees
by way of display at prominent places and emphasizing its intents in regular training at all level.
The policy is regularly reviewed in management review meeting for its continuing suitability and
revised as and when necessary.

ACTIVITY REFERENCE:
QUALITY POLICY
5.4.1 QUALITY OBJECTIVES

The quality objective is segmented department wise and the measures to evaluate its
achievements are defined. These objectives are periodically reviewed, updated and MR identifies
actions for implementation.

ACTIVITY REFERENCE:
QUANTIFICATION OF QUALITY OBJECTIVES

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

The Management Representative ensures that the quality management system is planned with
defined responsibility and authorities, which is documented in Quality Activities. The system is
planned to meet the requirements of clause 4.1 and quality objectives as defined in clause 5.4.1
of the manual.
The integrity of the QMS is ensured by way of review of the system, when the scope of the
system is enhanced or when new product lines are introduced. Quality Manual and Quality
Activities are reviewed for changes as and when required.
Internal audit results are reviewed and the corrective actions are standardized in the quality
system Documents.
Product configuration changes are reviewed and product related documents are updated as
applicable.
Corrective and preventive actions are reviewed and the changes are standardized in appropriate
documents.
The result of internal and external audit is reviewed and appropriate corrective and preventive
actions are initiated.

5.5.1 Responsibility, Authority and Communication

The organogram chart included in Section 09.0 of this manual shows the relationships between
the respective functions.

All employees are responsible for the quality of their own work and for advising their
responsible Manager or supervisor of any conditions that are adverse to the quality of the work
being produced or adverse to the satisfactory operations of the quality system.
Managers and supervisors are responsible, and have the authority within their defined areas of
control for:

 the quality of work carried out

 initiating action to prevent the occurrence of nonconformance
 identifying and recording quality problems
 initiating, recommending and providing solutions to quality problems.

The responsibilities and authorities of the organization chart are described as below:
 TOP MANAGEMENT
Responsibility:
a) Overall business development of the organization
b) Financial Management of the organization
c) Recruit executives in Managerial Cadre
d) Formulate quality policy with objectives for the organization
e) Overall responsible for implemented quality management system
Authority:
a) Make key decisions and can supercede decisions taken by others
b) Approve purchase of capital goods
c) Approve the formulated quality management system
d) Final authority in all policies of the company

HOD– OPERATIONS
Responsibility:
a) Maintain Harmonic cultures in the company
b) Liaison and handling prospective customers
c) Recruitment of personnel at works
d) Handling and resolving customer complaints
e) Execution of work orders in time
f) Procurement of all material and services required for the organization
g) Manage supplier development
h) Overall responsible for processes of the organization
i) To implement on-line inspection stage wise
j) To plan production and manpower
k) Impart regular training at shop floor
l) To maintain plant and machinery and general house keeping
m) Co-ordinate with Materials, QC&I and Design department

Authority:
a) Approve all purchases of material and services
b) Approve recruitment personnel at works
c) Sanction commercial transactions at work
d) Approve the formulated quality management system

SUPERVISOR
Responsibility:
a) To Inspect, approve, reject all incoming material
b) To Inspect, approve, reject process activity
c) For final inspection of the product
d) Co-ordination with third party for inspection
e) Co-ordination with production dept. for product quality improvement
f) Co-ordination with MR for QMS implementation
Authority:
a) Approve deviation in production processes
b) To prepare dispatch documents
c) Control of material at shop floor
d) Recruit workers required for production activity

5.5.2 MANAGEMENT REPRESENTATIVE

Management Representative’s Responsibilities and authorities include:-

 Preparation, Updating and maintenance of Quality Manual

 Issue of Quality Manual. Quality Activities
 Implementation of Quality Systems.
 Review of document & data control, making current version available, precludes use of
obsolete documents, identifying nature of change.
 Control of quality records is means of identification, collection, indexing, disposition and
retention time.
 Liaison with external agency for ISO 9001 certification
 Conducting the internal quality audit as per schedule, recording non-conformities, and
verification of effectiveness of corrective action against non-conformities.
 Conducting the Management Review Meeting and reporting the finding of IQA to Top
Management.
 Promoting the awareness of customer requirements throughout the organization.
 5.5.3 INTERNAL COMMUNICATION

Internal communication channels are ensured as follows:-

 Quality Policy: Display, Induction Program & Training

 Quality Objectives: Distribution of documents
 Customer Feed Back: Meetings, Letters, Emails, Feedback form & proactive actions
 Internal Audit, C & P Actions: Management Review Meetings
 MR is overall responsible to maintain internal communication channels.

5.6 MANAGEMENT REVIEW

5.6.1 General
Top Management with all HODs will conduct Management Review Meeting once in every six
months or as when required. The purpose of the meeting is to ensure that Quality System meets
or exceeds the requirement of ISO 9001 : 2000 standard. In addition it will assess the Quality
System’s continued suitability with respect to achieving company’s Quality Policy and
Objectives and opportunity for improvement in quality management system, quality policy and
quality objectives.
The MR records review inputs in agenda for management review. Review outputs are recorded
in minutes of MRM and communicated to all concerned.

5.6.2 Review Input

The input to management review shall include:
a) Results of internal audit and external audit
b) Customer feedback and complaints
c) Routine Operational performance of the organization
d) Status of corrective and preventive actions taken
e) Pending actions from previous management reviews
f) Changes that are required/effected in documentation of QMS
g) Other general points

5.6.3 Review Output

The review output is recorded by MR and shall include decisions and actions, target date and
responsibility related to:
a) Improvement of effectiveness of quality management system
b) Improvement in processes to meet customer requirements
c) Requirement of resources necessary for effective overall functioning

ACTIVITY REFERENCE:
PROCEDURE MANUAL - MANAGEMENT REPRESENTATIVE
 Title: Resource Management Section: QM 6.0

6.1 PROVISION OF RESOURCES

The Company ensures provision of resources that are needed:-

 To implement and maintain the quality management system and continually improve its
effectiveness.
 To enhance customer satisfaction by meeting customer requirements.
 The resource needs are identified through activities such as product planning, internal
audit, management reviews and review of quality objectives.

6.2 HUMAN RESOURCES

6.2.1 General
The Company ensures that personnel performing work affecting product quality are competent
on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, Awareness & Training

Necessary competence needed for performing work affecting product quality are determined by
the MR and HODs and documented.
The personnel are assessed on the basis of determined competence requirements. Gaps, if any,
are assessed and training is provided to personnel to meet the competence need. The training
may be in-house or external classroom training.
The effectiveness of the actions taken in terms of enhancing the competence levels is evaluated.
Employees are made known the requirement of skills and knowledge required relating to the jobs
they handle and how they contribute for attaining quality objectives.
Appropriate records are maintained regarding, education, training, skills & experience

ACTIVITY REFERENCE:
PROCEDURE MANUAL - MANAGEMENT REPRESENTATIVE

6.3 INFRASTRUCTURE
Infrastructure needs are assessed on the basis of the resource requirement and business plan.
The infrastructure such as building and amenities for the operators are provided.
Tools & Tackles, Testing Instruments, Testing facilities are provided on the basis of quality plan.
Need for supporting services such as logistics, computer support, etc. are provided.

6.4 WORK ENVIRONMENT

The Company ensures that proper layout, adequate ventilation, lighting, house keeping systems
and safety devices maintain the work environment neatly where appropriate.
 Title: Product Realization Section: QM 7.0

7.1 PLANNING OF PRODUCT REALIZATION

The Company plans the requirement of quality and identifies the controls of the process,
inspection and test methods, measurement needs and standards of acceptability, acquisition of
any controls, equipment, etc.
The quality planning also includes the compatibility of product/process, establishment inspection
and test activities, development of newer measurement methods, identification of inspection and
testing requirement, identification and preparation of quality records.
For each product line, such controls are defined in quality plan and are used as a means of
controlling quality. Quality Plan is prepared for final approval of equipment

7.2 CUSTOMER RELATED PROCESS

7.2.1 Development of requirements related to products

The Company identifies the requirements specified by customer though work order inputs and
application details provided by customer, delivery schedules desired b customers and feedback
on products supplied.
Requirements not specified by customer, who is required for intended use are identified by
Departmental Head.
Statutory and regulatory requirements related to the products are identified through customer
communication
Any additional requirements related to the products are identified based on the organization’s
experience in supplying products to similar application

7.2.2 Review of requirements related to the product

The Company ensures to review the requirements related to the product as follows:-
Product specification/application is reviewed during the order processing and any mismatch or
incompatibility is reported to the customer. Order requirements are reviewed and recorded.
Delivery requirements are reviewed and recorded.
During this review, if any product or order requirements are deviating from those previously
expressed, they are resolved
After review it is ensured that confirmation to customer is established to prove ability to meet
customer requirements.
Where the customer requirements are communicated verbally, the customer requirements are
confirmed in review documents as above, prior to acceptance.
When the product requirements are changed, the amendments are reviewed and the changes are
incorporated on all relevant internal documents.
The document changes are made known and communicated to relevant functions.
7.2.2 Customer Communication

The various communication systems to customers are as follows

Product information: sales executives communicate product configuration and price information.

Order handling, queries and amendment handling are carried out by Marketing Personnel and
communicated to customers.
Customer feed back and complaints are analyzed and communicated to them.

ACTIVITY REFERENCE:
PROCEDURE MANUAL - MARKETING

7.3 DESIGN AND DEVELOPMENT

EXCLUDED

7.4 PURCHASING

7.4.1 Purchasing Process

The Quality System Activities ensure that products, Raw material & Packaging Material are
purchased form approved sources only
Any new source of product / make shall approve based of evaluation and/or trial production,
which shall access the ability of the source to meet the company’s quality and delivery
requirements.
The extent of control on the source of supply is based on the product criticality. This is defined
in product quality plan.
The results of supplier performance in terms of adherence to quality and delivery requirements
are monitored. The data is reviewed by HOD Purchase and Top Management and the supplier
are evaluated once in a year.
Records of evaluation, re-evaluation and ratings are maintained.

7.4.2 Purchasing information

Purchasing specification describes the following data.

Product configuration, code, makes, size and other unique information.
Requirements of approval of product such as test certificates, need for Quality system
Certificates and as per Raw Material Testing Plan
The Company ensures that adequacy of Purchase requirements are reviewed prior to release.
7.4.3 Verification of purchased products

The purchased products are verified by one of the following methods.

 Verification of Test Certificates

 Product evaluation through a plan of evaluation
 Receiving inspection as per receiving inspection plan
 Where specified by customer or when required by the company, the verification may be
done at supplier’s premises by company or by Customer.
 The verification method may include product evaluation, Supplier Quality System Audit.

In such case, purchasing information shall specify the method of verification and sub-sequent
product release.

ACTIVITY REFERENCE:
PROCEDURE MANUAL – PURCHASE

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 Control of Production and Service Provision

The production activity is carried out under controlled condition.

The information about the product configuration is provided to the Technicians and Engineers
Operations are carried out as per work instruction/ purchase order.
The equipment used for Production and testing is ensured have the requisite capability through
preventive maintenance of equipments.
Technicians and Engineers are provided with necessary Equipments and Instruments.
The monitoring of process and testing is as per Quality Plan.
The products are released to the next stage and delivery after due verification and recording.

7.5.2 Validation of process for production

Production process is validated by way of Inspection and control as per Quality plan.
No Special Process is presently carried out in the company and if any such process is carried out
in future, the records for the same will be maintained.

7.5.3 Identification and Traceability

The constituent parts, products in-process, finished products and packed products ready for
dispatch are identified by means of status boards, displayed besides the product.
The status of products after each verification stage is clearly identified as passed or failed by way
of recording on the Inspection Reports.
Traceability of constituent parts is accomplished by means of unique Batch numbers.

7.5.4 Customer Property

The organization receives drawings and samples from the customer and the same are controlled.
7.5.5 Preservation of Products
The products and constituent parts of the products are preserved appropriately to avoid any
damage or deterioration during storage, handling, packaging and delivery.
Suitable work instructions are issued to the personnel carrying-out these activities.

7.6 CONTROL OF MONITORING AND MEASURING DEVICES

The selection of the Instruments and test equipments is done in such a way that measurement
uncertainty is known and is consistent with accuracy required.
To control, calibrate and maintain inspection, measuring and test equipment to provide evidence
of conformity of product to specified requirements the procedure for calibration and
Maintenance of Instrument is followed.
It is also ensured that monitoring and measurements are carried out and in a manner that is
consistent with the monitoring and measurement requirements.
For this purpose, list of measuring and test equipment is prepared.
To ensure valid results, measuring equipment is Calibrated at specified intervals, or prior to use,
against measurement standards traceable to international or national measurement standards;
where no such standard exists, the basis used for calibration or verification is recorded.

ACTIVITY REFERENCE:
PROCEDURE MANUAL – PRODUCTION & QUALITY CONTROL

Title: Measurement Analysis and Section: QM 8.0

Improvement

8.1 GENERAL

The Company plans and implements the monitoring, measurement, analysis and improvement
process as follows:-

 To demonstrate that products produced conform to specification

 To ensure that quality management system requirements are conformed
 To continually improve the effectiveness of quality management system
 In order to measure, analyze and continually improve, methods including statistical
methods are used. The extent of use of statistical method are explained in 8.2.3

8.2 MEASUREMENT AND MONITORING

8.2.1 Customer Satisfaction

In addition to other method, performance of the Quality Management system is also measured by
monitoring the information related to customer perception provided by customers.
8.2.2 Internal Quality Audit
Internal audits are conducted at regular intervals based on a plan. The purpose of such audits is to
ascertain:-
Whether the planned system as outlined in this manual, Activities and other quality system
Documents as defined in 4.2.1 are complied with and whether the documented system is in
accordance with the requirements of ISO 9001:2000 standards.
Whether the implemented system is effective and maintained
An audit program is planned as follows:-

 The frequency and duration of an audit is determined based on the volume of activity,
importance of the activity.
 The area or department to be audited and
 Results of previous audits

8.2.3 Monitoring and Measurement Of Processes

Methods such as graphs, charts, are used to demonstrate that the processes achieve or deviate
from the targets.
When planned results are not achieved, appropriate plans are identified and implemented to
effect correction and corrective actions to ensure conformity of the product.

8.2.4 Monitoring and Measurement of Products

The Company ensures that the products are verified at appropriate stages viz., on receipt, various
production process stages and pre delivery stage. The requirements are verified against the
receiving inspection plan, in-process quality plans and customer purchase order.
Evidence of conformity of the products as defined above is maintained in the form of inspection
reports, test log/test report. These records indicate the persons authorizing product release for the
next stage or delivery to customer.
The deliveries of products are affected only after all quality requirements are completed
satisfactorily.

8.3 CONTROL OF NON-CONFORMING PRODUCT

The Company ensures that products, which do not conform to product requirements, are
Identified and controlled to avoid inadvertent use or delivery. Activity for non-conforming
products describes the controls involved in segregating non-conforming products, quarantine
areas for non-conforming products, the responsibilities and authorities for evaluation,
notification and disposal of non-conforming products.
The methods of dealing with non-conforming products are :-

 Required actions such as rework, to eliminate the detected non-conformity

 By authorizing use non-conforming products, or release for dispatch or accept under
authorized concessions by the authority as defined 5.5.1, or where applicable, by
customer.
  By taking action to scrap after due care that the scrapped products do not find its way to
the original intended use.

8.4 ANALYSIS OF DATA

The Company determines the data to be collected, analyzed to demonstrate suitability and
effectiveness of quality management system and to effect continual improvement.
The various data collected are:

 Measurement data
 Defect data
 Customer feedback data
 Analysis of these data shall provide information on :
 Level of customer satisfaction
 Level of conformity to specification
 Trends of product specification compliance, opportunity for improvement
 Supplier performance
 Tools and techniques such as graphs, charts, brainstorming etc. are used in the analysis of
data

8.5 IMPROVEMENT

8.5.1 Continual Improvement

Continuous improvement in the effectiveness of quality management system is achieved through

the use of :

 Well defined Quality policy

 Measurable quality Objectives
 Audits that identify opportunities for improvement
 Analysis of data of product conformance and operational performance, customer
satisfaction and supplier performance
 Corrective and preventive actions
 Management review
 Improvement opportunities are tracked for effective implementation and achievement of
desired results

8.5.2 Corrective Action

The Company takes appropriate action to eliminate the cause of non-conformities in order to
prevent recurrence. The corrective actions will be appropriate to the effects of non-conformities.
Activity for corrective action ensures the following requirements are defined :-

 The methods followed to review non-conformities and customer complaints

 The determination of cause of non-conformities
  Develop solutions that are needed to eliminate the recurrence of non-conformity

8.5.3 Preventive Action

The Company takes appropriate action to eliminate the potential cause of non-conformities in
order to prevent occurrence. The preventive actions will be appropriate to the effects of non-
conformities.
Activities for preventive action ensures the following requirements are defined :-

 The determination of potential cause of non-conformities

 Recommend actions that are needed to prevent occurrence of non-conformity
 Implement the actions identified to prevent occurrence of nonconformity
 Records of the results of action taken
 Reviewing the preventive actions taken

ACTIVITY REFERENCE:
PROCEDURE MANUAL – QUALITY CONTROL & INSPECTION
PROCEDURE MANUAL – MANAGEMENT REPRESENTATIVE
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