QUALITY MANUAL with new times-1

Uncontrolled Copy if RAJ PHARMACEUTICAL INC. Logo NOT in BLUE

Issued By: QMR Approved By: CEO

QUALITY MANUAL

Model ISO 9001:2008

Effective Date 17 April 2014

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ISSUED BY

QUALITY MANAGEMENT REPRESNETATIVE

AUTHORIZED BY

RAJ PHARMACEUTICAL INC. MANAGEMENT



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TABLE OF CONENTS

Clause Description Page

QM 1.0 OVERVIEW AND SCOPE 03 QM 1.1 Overview 03 QM 1.2 Manual Distribution Record 03 QM 1.3 Manual Revision 03 QM 1.4 Scope 03 QM 1.5 Exclusion and Justifications 04 QM 2.0 REFERENCE 04 QM 3.0 TERMS AND DEFINITIONS 05 QM 4.0 QUALITY MANAGEMENT SYSTEM 05 QM 4.1 General Requirements 05 QM 4.2 Documentation Requirements 06 QM 4.3 Quality System Process Interactions 07 QM 5.0 MANAGEMENT RESPONSIBILITY 08 QM 5.1 Management Commitment 08 QM 5.2 Customer Focus 08 QM 5.3 Quality Policy 08 QM 5.4 Planning 09 QM 5.5 Organizational Chart 10 QM 5.6 Management Review 11 QM 6.0 RESOURCE MANAGEMENT 12 QM 6.1 General Requirements 12 QM 6.2 Human Resources 13 QM 6.3 Infrastructure 14 QM 6.4 Work Environment 14 QM 7.0 PRODUCT REALIZATION 15 QM 7.1 Planning Product Realization 15 QM 7.2 Customer-Related Process 15 QM 7.4 Purchasing 17 QM 7.5 Production Operation 18 QM 7.6 Control of Monitoring and Measuring Equipment 19 QM 8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 21 QM 8.1 General 21 QM 8.2 Monitoring and Measurement 21 QM 8.3 Control of Nonconforming Product 22 QM 8.4 Analysis of Data 23 QM 8.5 Improvement 23



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QM 1.0 OVERVIEW AND SCOPE

QM 1.1- Overview:

This Quality Manual is a level 1 document that establishes the quality policies, and practices of

RAJ PHARMACEUTICAL INC. and its management to support a Quality Management System

based on the requirements of ISO 9001:2008

QM 1.2- Manual Distribution Record:

The master copy of this Quality Manual is saved on Quality Manager’s computer. Only one copy

has been printed and kept in Document center for reference.

Uncontrolled copies may be allowed for training employees and creating organization-wide

awareness of ISO 9001:2008 and also for customer reference.

QM 1.3- Manual Revision:

Revision Level: 00, Effective April 17 2014

This Quality Manual has been rewritten to conform to ISO 9001:2008; This Manual supersedes all

documents becomes effective as on date 17 April 2014

QM 1.4- Scope:

Company: RAJ PHARMACEUTICAL INC.

Business: Chemotherapeutics Drug Manufacturing

Client: Multinational Pharmaceutical Company, Hospitals, Pharmacy stores.

Address: 7 Copper Bays, Calgary, Alberta L6T 4W5, Canada

Phone No: - 647-763-2727

Fax No: - 647-713-1729



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A QMS enables a company to implement effective, efficient, transparent and simple processes and

structures to achieve continual compliance. In addition, this will benefit the company’s business

in terms of improved quality, optimized costs, inspection readiness and customer satisfaction. This

document gives detailed guidance for implementing a QMS. It provides a standard for API (Active

Pharmaceutical Ingredients) manufacturers and other parties involved, including official bodies.

QM 1.5- Exclusion and Justification(s):

The QMR has identified exclusion, from the scope of the quality system, to the requirements of

ISO 9001:2008, that do not apply to products and services provided by RPI. RPI Management

Team has evaluated and approved them.

a) Section 7.3 Design and Development – including all sub- sections-

Justifications RPI does not design or develop products. The customers or their consultants

provide and specify all principal product’s drawings, samples, etc.

b) Section 7.5.2 Validation of process for production and service provision- includ ing

all sub-sections-

Justifications RPI verifies all subsequent monitoring or measurements for each successive

process output.

QM 2.0- REFERENCE

RAJ PHARMACEUTICAL INC has developed and implemented a Quality Management System

in accordance with-

ISO 10013:2001- Guidelines for Quality Management System Documentation

ISO 9000:2005- Quality Management System- Fundamentals and Vocabulary

ISO 9001: 2008- Quality Management System-Requirements

GMP- Good Manufacturing Practices.



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QM 3.0- TERMS AND DIFINITIONS

Terms and definitions adopted in this Manual are in accordance with those of ISO 9000:2005, ISO

9001:2008 and GMP (Good Manufacturing Practice ).

RAJ PHARMACEUTICAL INC specific terms and abbreviations:

Term For

CAR Corrective Action Request

C of C Certificate of Conformance

MT Management Team/ Company Management

PAR Preventive Action Report

PO Purchase Order

PM Preventive Maintenance

QM Quality Manual

QMR Quality Management Representative

QMS Quality Management System

QSP Quality System Procedure

RFQ Request for Quotation

WI Work Instruction

R.P.I Raj Pharmaceutical Inc.

GMP Good Manufacturing Practice

HVAC Heating Ventilation Air Conditioning

SOP Standard Operating Procedure

QM 4.0-QUALITY MANAGEMENT SYSTEM

QM 4.1- General Requirements:

Requirements

RPI has established documented, implemented, and maintains and continually improves a quality

management system in accordance with the requirements of ISO 9001:2008. The organization has-

Identified the process needed for the QMS and their application throughout the

organization

Determines the sequence and interaction of these processes

Determines criteria and methods needed to ensure that both the operation and control of

these processes are effective



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Ensured the availability of resources and information necessary to support the operation

and control of these processes

Established a means of monitoring, measuring and analyzing these processes. Where

applicable

Established the implementation of action necessary to achieve planned results and

continual improvement of these processes

RPI has monitored and controlled to the best of its ability, outsourced products also.

QM 4.2- Documentation Requirements:

General

RPI’s QMS documentation includes documented statements of a quality policy and quality

objectives, a quality manual, documented procedures and records required by ISO 9001:2008,

including records determined by the organization to be necessary to ensure the effective planning,

operation and control of processes.

Quality Manual

RPI’s Quality Manual includes:

The scope of the QMS, including applicable exclusions and justifications

The documented procedures established for the QMS or reference to them

Description of the interaction between the processes of the QMS

Organizational chart

Control of Documents

RPI has a procedure for establishing, maintain, and controlling all documentation required to

support the QMS and ensure its continued effectiveness.

Control of Records

RPI controls the records established to provide evidence of conformity to requirements and the

effective operation of the QMS. RPI has a procedure QSP-02(4.2.4) for controlling quality records

to ensure that they are:

Identified and stored safely

Legible and readily retrievable and have established retention times



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QM 4.3-Quality System Process Interaction:

Customer

RFQ/PO

(QM 7.0)

Contract Review

(QM 7.2)

Planning Production

Realization

(QM 7.1)

Product Inspection

(QM 7.1)

Handling

Packaging

Shipping

(QM 7.5)

Delivery to

Customer

(QM 7.5)

Customer

Supplied Product

(QM 7.5)

Equipment

Calibration

(QM 7.6)

Quality Management System

Management Responsibility (QM 5.0)

Quality System (QM 4.0)

Document Control (QSP 01)

Nonconforming Product (QSP 04)

Corrective Action (QSP 05)

Control of Records (QSP 02)

Internal Quality Audit (QSP 03)

Training (QM 6.2)

)

Customer Satisfaction (QM 7.2)

Continual Improvement (QM 8.5)

Preventive Action (QSP 06)



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QM 5.0-MANAGEMENT RESPONSIBILITY

QM 5.1- Management Commitment:

General

RPI is committed to the development and implementation of the QMS and continual improvement

of the quality system by:

Communicating the importance of meeting customer, statutory and regulatory

requirements throughout the organization.

Established and documenting the quality policy and quality objectives as described in the

management review procedure.

Conducting management reviews as described in the Management Review, Ensuring the

availability of necessary resources. This compromise in Management review form RQF

01

QM 5.2- Customer Focus:

General

RPI is committed towards identifying customer requirements and their fulfillment to ensure

customer satisfaction.

QM 5.3- Quality Policy:

General

The Quality policy provides a framework for establishing and reviewing quality objectives. The

following Quality Policy is communicated throughout the organization. The Quality Policy is

reviewed during management reviews to ensure its continuing suitability and effectiveness.

“RPI is committed to achieve and provide high quality precision products that are machined to

close tolerances for Hi-Tech pharmaceutical industry by continually improving its quality system

and processes in order to meet and exceed ever-changing customer requirements and enhancing

the satisfaction of customers and employees by delivering best Quality of Drug products.”



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QM 5.4- Quality Planning:

Quality Objectives

RPI has established Quality Objectives, particularly those concerning product requirements.

Quality Objectives are measurable and consistent with the Quality Policy.

QMS Planning

RPI has developed its QMS with the following priorities in mind:

The requirements given in QMS 4.1 and those mentioned in Quality Objectives are

satisfied

Any plans for changes will consider their impact on the QMS, and will ensure the integr ity

of the QMS is maintained

QM 5.5- Responsibility, Authority, and Communication:

Responsibility and Authority

Job descriptions for all personnel in accordance with the RPI are prepared by Administra t ion

affairs manager cooperating with other managers and after being approved by managing director,

job descriptions are submitted to all personnel in all organizational levels. Administration affairs

manager has ensured that responsibilities and authorities are defined in all organizational levels

and are available for all personnel.



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RPI’s Organizational Chart:



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Management Representative

RPI management has appointed Quality Manager as its Quality Management Representative. Who,

irrespective of other responsibilities, has responsibilities that include:

Ensuring that process of the quality system are established, implemented and maintained

Reporting to top management on the performance of the quality system, including any

needs for improvement.

Ensuring promotion of awareness of customer requirements throughout the organization

Acting as liaison with external parties on matters relating to the quality system.

The person named below has full responsibility and authority for the implementation and

maintenance of Quality Management System as defined in this Quality Manual and promoting the

awareness of customer requirements throughout the organization.

RONAK PATEL QUALITY MANAGER (ASQ-CQE)

M/s RAJ PHARMACEUTICAL INC. Phone : 647-763-2727

Internal Communication

RPI recognizes that all employees and their work activities affect product quality and RPI’s ability

to satisfy customer requirements. Information communication and transfer methods are different

according to the type of information and it includes using computer systems, designed quality

system documents and conducting internal meetings at different organizational levels. The type of

these communicating methods is defined in quality management system.

QM 5.6- Management Review:

RPI management reviews the organization’s QMS, at least once in a year, to ensure its continuing

suitability, adequacy and effectiveness. This review includes assessing opportunities for

improvement and the need for changes to the QMS, including the quality policy and quality

objectives.

The QMR chairs the Management Review meetings and records are maintained on form RQF 01



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Review Input

Inputs to management review include but are not limited to current performance and improvement

opportunities related to the following:

Audit results

Customer feedback

Process performance and product conformity

Preventive and corrective action reports

Follow up actions from previous management reviews

Changes that may affect QMS

Recommendations for improvement

Quality policy and objectives

Supplier information

Resource requirements

Review Output

The outputs from the management review include but are not limited to decisions and actions

related to:

Improvement of the effectiveness of the QMS and its processes

Improvement of product related to customer requirements

Resource needs

Results of management reviews are recorded.

QM 6.0- RESOURCCE MANAGEMENT

QM 6.1-General Requirements:

Requirements

Top management of RPI determines and provides, in a timely manner, the resources needed:

To implement, maintain and improve the effective operations of the QMS processes and

To enhance customer satisfaction by meeting requirements.



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These resources are assessed and reviewed on a periodic basis consistent with annual and strategic

business planning activities.

QM 6.2- Human Resources:

General

RPI ensures that personnel who are assigned responsibilities directly or indirectly affecting

conformity to product (Quality) requirements are determined to be qualified and competent based

on education, training, observed skills, and experience .

Competence, Awareness and Training

RPI identifies training needs and provides for the training of all personnel performing activit ies

affecting quality. Personnel performing specific assigned tasks are qualified on the basis on the

appropriate education, training, observed skills, and experience, as required. All Tablets and

Capsules manufacturing machine operators must be evaluated as fully competent in a discipline of

manufacturing of drug product before being allowed to work independently in that discipline.

A training plan is prepared and scheduled annually with periodic updates. This comprise of training

skills in form RQF 02

Training is provided either on or off the job, internally or externally, as appropriate. The ongoing

effectiveness of training is periodically assessed by observation, proficiency, testing or other

appropriate means.

Personnel in all levels shall be aware of:

Quality policy

Quality management system requirements

The importance of conformance with customer requirements, regulatory bodies,

organization commercial partners and organizational requirements

How they contribute to the achievement of the quality objectives

The impact of their work in quality

The potential consequences of departure from the specified procedures

The signatures of employees on a quality document are sufficient as evidence of relevant training.



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QM 6.3- Infrastructure:

Requirements

RPI’s infrastructure needed to achieve conformity to product requirements has been determined

and provided and maintained according to the repairs and maintenance procedure. These

infrastructures may include, but not be limited to:

Buildings, workspace and associated utilities (such as cleanrooms, HVAC system, water

systems, etc)

Process equipment, (including production and laboratory equipment, reference standards

used for calibration, the software used to production and laboratory , etc)

Supporting services (such as computers, computer networks, lift trucks, etc)

QM 6.4-Work Environment:

Requirements

RPI’s Work environmental conditions at different working areas including temperature, humid ity,

differential pressure, other relevant parameters and also safety relevant issues that affect product

quality (such as personnel clothes, entering into and exiting from cleanrooms, etc) have been

determined in production and laboratory environments according to the regulatory requirements

related to the products as follows:

Requirements related to health, cleanliness and clothing of personnel if contact between

such personnel and the product or work environment could adversely affect the quality of

the products.

Requirements of environment conditions when these conditions can have an adverse effect

on product quality.

Providing special trainings for all personnel who are required to work temporarily under

special environmental conditions.

Special arrangements for the control of cross contamination

All above requirements have been established in production SOPs and test methods.



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QM 7.0- PRODUCT REALIZATION

QM 7.1-Planning Product Realization:

RPI has established and maintains a documented Product Realization Planning Procedure to ensure

that processes and sub-processes are conducted under controlled conditions. The processes needed

for product realization are planned and developed, and the interaction between these processes and

other processes of the quality management system is also defined. In planning product realizat ion,

the following has been taken into consideration:

Determination of required documents, sub-processes and resources needed to realize

these processes

Verification, inspection and test activities of row materials, packaging material, semi-

finished and finished products and their conformance to products acceptance criteria

Records needed to provide evidence that the realization processes and resulting product

meet requirements

QM 7.2 –Customer-Related Processes:

Determination of Requirements Related to the Product

RPI determines requirements related to the product have been determined by the organizat ion,

including:

Requirements related to the product have been determined by the organization, including:

Requirements specified by customers (distribution companies), including the

requirements for products type and quantity and delivery time

Requirements not stated by the customer but necessary for intended use of the products

such as requirements for packaging and information accompanying product

Regulatory requirements related to the product including the requirement stated in

pharmacopeias or determined by Ministry of Health

Organizational requirements and requirements stated by commercial partners



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Review of Requirements Related to the Product

Requirements related to the product are reviewed. This review is conducted prior to committing to

supply a product to customers. These reviews are conducted annually by sales manager according

to received information from production planning, marketing and statistics about sales

Quantity in a year, production lines capacity and other constraints. Review output is reported to

Ministry of Health by managing director. The intent of these reviews is to ensure that:

Product requirements (including requirements related to delivery and post-delivery

activities) are defined

Records of the results of review and actions arising from this review are maintained

When product requirements are changed, relevant documents are amended and the

relevant personnel are made aware of the changed requirements.

Customer Communication

Required arrangements for communication with customers relating to the followings are

determined and implemented:

Product information according to the customer communication procedure

Enquiries, contracts or order handling, according to the sales procedure

Customer feedback, according to the customer communication procedure and when

receiving complaints from customer according to the complaints follow-up procedure and

when product recall is necessary, this process will be handled according to the product

recall procedure

RPI encourages its customer to send their enquiry in writing. The necessary information from

the written enquiries is transferred to Contract Review form RQF 18. In case of verbal

enquiries the information is confirmed by repeated statement and recorded onto form RQF

24. For assembly orders, the necessary information is transferred onto Assembly Contract

review from RQF 18

In case of customer’s verbal or telephonic proposal for modification in specifications/

requirements, formal approval is initiated using form RQF 24

QM 7.3-Design and Development:

Out of scope and excluded



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QM 7.4- Purchasing:

Purchasing Process

RPI ensures that purchasing processes are controlled to ensure purchased product conforms to

specified purchase requirements. This control is applied to purchased items, goods, equipment and

services that affect product quality, and where applicable, on the quality audit reports and/ or

quality records of suppliers previously demonstrated capability and performance. In all cases,

incoming product is not used until it is inspected or otherwise verified against specified

requirements.

RPI has established and maintain local records of acceptable suppliers. A critical supplier list also

maintained.

Purchasing Information

RPI requires purchasing information describes the product to be purchased, including where

appropriate:

Requirements for approval of product, procedures, processes and equipment,

requirements for qualification of personnel, and

Quality management system requirements.

Purchasing information adequacy is reviewed prior to stating the specified requirements to contain

in the purchasing documents. Purchasing information including relevant documents and records

are maintained in order to provide product traceability.

Verification of Purchased Product

RPI identifies and implements inspection and testing activities are performed according to Quality

Assurance department on raw materials and packaging to ensure that purchased products meet

specified requirements. For other items and equipment which affect the quality, inspection and

testing activities are performed.

Where verification of purchased product is intended at suppliers’ premises, verification includes

comparing products with specified specifications via testing and inspection at supplier’s premises

or supervision on testing process and examining results and measuring equipment accuracy.



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QM 7.5 – Production Operations:

Controls of production provision

RPI ensures that products production process is planned. Production and material planning is

performed by using Manufacturing Report form RQF 04 and the production tracking sheet form

RQF 12

The following activities are carried out by RPI to control production process:

The availability of documented procedures (to describe production processes and

equipment usage), documented requirements, work instructions, reference materials and

reference measurement procedures

The use of suitable equipment according to the world latest technologies

The availability and use of monitoring and measuring devices (such as balances,

thermometers and humidity meters)

The implementation of monitoring and measurement by control laboratories at different

stages of production process such as raw materials, semi-finished products and final

products

The implementation of release, delivery, and post-delivery activities

The implementation of defined operations for labeling an packaging

RPI establishes and maintains a record for each batch of its products (batch record) to provide

traceability and identify amount manufactured and amount approved for distribution. Batch record

is verified and approved by quality assurance manager.

Identification and Traceability

RPI’s all products of are identified according to identification and traceability procedure form RQF

12 the primary stages of production to packaging. Recalled products are also identified according

to product recall procedure and conforming products are segregated from the non-conforming

ones. The records of all product components (including test results), materials and work

environment conditions are considered in batch record to demonstrate the tractability.

Products status is identified with respect to monitoring and measurement requirements by sticking

labels defined in quality control procedures



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Customer Property

RPI takes care of all customer-supplied materials and/or products under its control. RPI identifies,

verifies, and protects customer property provided for use or incorporation into the product.

Receipts of customer supplied samples/parts are recorded in the Customer Material Log form RQF

13 and stored safely.

Customer supplied products / materials are identified by the Receiver appropriately and handled

carefully. Customer supplied drawings are stored in separate folders of concerned jobs with

identification by unique drawing/ part numbers. Copies of these drawings are made for production

and inspections. Normally, the Office Coordinator handles the drawings but any member of the

Management Team or the Quality Manager can also handle the drawings if the office coordinator

is not present.

Any nonconformity or damage to the customer property is brought to the attention of any member

of Management Team who then advises the customer of the situation. The decision about

disposition is taken after discussion with customer.

Preservation of Product

Preservation includes identification, handling, packaging, storage and protection. Preservation is

also applied to the constituent parts of a product. Handling and preservation of products throughout

internal processing is performed according to production procedures. Packaging of products is

carried out according to packaging procedures. Storage of products is carried out according to

storage procedure.

QM 7.6 – Control of Monitoring and Measuring Equipment:

RPI ensures the accuracy and the validity of product characteristics by using controlled monitor ing

and measuring equipment calibrated periodically to master traceable to recognized standards. In

the event of non-availability of such standard, the basis used for calibration or verification and

criteria for acceptable schedule is maintained on form RQF 16



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All measuring and monitoring devices in RPI are:

Calibrated at specified intervals, or prior to use, against measurement standards traceable

to international or national measurement standards; where no such standards exist, the basis

used for calibration is recorded

Adjusted or re-adjusted as necessary

Safeguarded from adjustments that would invalidate the measurement result; and,

Protected from damage and deterioration during handling, maintenance and storage

according to equipment technical instructions

Have the validity of previous results re-assessed if measuring and monitoring devices are

subsequently found to be out of calibration, and corrective action taken.

The equipment is sent for calibration before the specified time when it is found not to conform to

requirements. If necessary, the parameters measured by the nonconforming device are measured

again according to calibration process. The computer software used for measurement and

monitoring are validated according to computer systems validation protocol and their ability to

meet the requirements is confirmed



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QM 8.0-MEASUREMENT, ANALYSIS, AND IMPROVEMENT

QM 8.1-General:

RPI plans and implements required processes for monitoring, measurement, analysis and

improvement in order to demonstrate product conformity, ensure quality management system

compliance and continual improvement of quality management system effectiveness. In this

regard, specific methods are defined for use of statistical techniques including control charts,

analysis using histograms, Pareto, cause and effect diagrams and other statistical tools.

QM 8.2-Monitoring and Measurement:

Customer Satisfaction

RPI Company monitors and measures information related to customers (doctors, distributing

companies and patients) perception at defined intervals as to whether the organization has met

customers’ needs and expectations according to customer communication process.

Internal Audit

Periodic internal audits are conducted at planned intervals according to internal audit procedure in

order to:

Conforms to the requirements of the standard.

Evaluate the effectiveness and deployment of quality management system

Audit plan is prepared with respect to the status and importance of quality management system

processes, according to internal audit procedure. This plan includes audit schedule, audit criteria,

scope and audit team. In selecting audit team members it is noted that auditors should be qualified.

Auditors should be independent from the process being audited and do not audit their own work.

The responsibilities and requirements for planning and conducting audits, audit report preparation,

records maintenance and nonconformities follow-up are described in internal audit procedure.



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Monitoring and Measurement of Processes

RPI applies suitable methods for measurement and monitoring of the realization processes

necessary to meet customer requirement. These methods confirm the continuing ability of each

process to satisfy its intended purpose. Suitable methods are determined by Quality Assurance

department and may include various quality control tests with its efficiency and effectiveness.

Monitoring and Measurement of product

RPI ensures that the characteristics of the product are monitored and measured at different stages

of production according to quality control procedures and testing instructions through physical,

chemical, microbial and biological tests to verify that product requirements are fulfilled.

Evidence of conformity with the acceptance criteria (test results) is maintained. These records

compose part of the batch record. Product release does not proceed until the batch records are

checked by quality assurance manager.

QM 8.3- Control of Nonconforming Product:

RPI ensures that nonconforming products are not used unintentionally; these products are

segregated from other products according to control of nonconforming product procedure QSP 03

(8.3).Controls, related responsibilities and authorities for dealing with nonconforming product and

disposition of these products are defined in control of nonconforming product procedure.

Nonconforming product is managed by one or more of the following methods:

Taking action to eliminate the detected nonconformity and performing required corrections

Authorizing its use, release or acceptance under concession where regulatory requirements

are met.

Taking action to preclude product use or application.

Records of the nature of nonconformities and any subsequent actions taken, including concessions

obtained, are maintained according to control of nonconforming product procedure. When

nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to

the requirements.



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QM 8.4- Analysis of Data:

RPI ensures that determination, collection, and analysis of appropriate data to demonstrate the

suitability and effectiveness of the quality management system, and to evaluate where continual

improvement of the quality management system can be made.

This includes data generated as a result of monitoring and measurement (customer feedback,

monitoring sand measurement of processes, monitoring and measurement of product, etc) and

from other relevant sources.

The analysis of data provides information relating to:

Customer feedback

Conformance to product requirements

Characteristics and trends of processes and products including opportunities for

preventive action

Suppliers.

QM 8.5- Improvement:

Continual Improvement

RPI continually improves its quality management system efficiency through the use of quality

policy, quality objectives, audit results, analysis of data, corrective and preventive actions and

management review according to continual improvement procedure and defining improvement

projects.

Corrective Action

RPI identifies corrective actions are taken to eliminate the cause of nonconformities in order to

prevent recurrence according to corrective action procedure-QSP 05(8.5). Determining and

implementing of corrective action includes the following stages:

Reviewing nonconformities

Determining the causes of nonconformities

Evaluating the need for action to ensure that nonconformities do not reoccur

Determining and implementing action needed

Records of the results of actions taken



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Reviewing corrective action taken.

Preventive Action

RPI identifies preventive actions are determined to eliminate the causes of potential

nonconformities in order to prevent occurrence according to preventive action procedure QSP

06(8.5). Determining and implementing preventive action includes the following stages:

Determining potential nonconformities and their causes

Evaluating the need for action to prevent occurrence of nonconformities

Determining and implementing action needed

Records of results of action taken; and

Reviewing preventive action taken.