1.

Company History
Page 1 of 19
2-1- Purpose
This document defines quality system policies and procedures for governing the design &
manufacture of all Sobhan Chemotherapeutical Co. products.
2-2- Scope
This quality manual provides details on the policies and procedures Sobhan
Chemotherapeutical Co. uses to meet IS 9!!1"#!!! $uality management system
requirements & applicable regulatory requirements %including requirements of &ood
manufacturing Practice'. The intent of these policies and procedures is to demonstrate
Sobhan Chemotherapeutical Co. ability to consistently provide products that meet
customer and applicable regulatory requirements and to enhance customer satisfaction
through the effective application of the quality management system processes.
The scope of the quality management system is as the follo(ings"
)Insert the organi*ation scope clearly including all products and a statement such as
+,esign and manufacturing of -../
2-3- Exclusions
IS 9!!1"#!!! 0equirements 12C34SI5 T6731
Clause or Sub-clause Exclusion Justifications
8.9.: %full' Customer Property
Sobhan Chemotherapeutical Co. does not
use customer properties %including
intellectual properties' in none of its
products reali*ation processes.
3-1- Definitions
The definitions and terms used in this quality manual are based on the follo(ing
documents"
; %Insert relevant references (hich contains technical terms of pharmaceutical
industry'
; IS 9!!!"#!!9" $uality management systems < =undamentals and >ocabulary
3-2- References
This manual is organi*ed and (ritten to comply (ith the follo(ing documents and
standards"
IS 9!!1"#!!!" $uality management systems ; 0equirements
%Insert relevant regulatory bodies requirements that meeting theses requirements
are mandatory in pharmaceutical industry and organi*ation specific products'
Sobhan Chemotherapeutical Co. quality management system complies (ith the most
recent edition of the aforementioned documents and standards. 5ecessary changes to
quality management system are applied continuously by the organi*ation to ensure
compliance (ith applicable standards.
6ll references to specific policies? procedures? or (or@ instructions in this manual are the
latest revision of these documents.
Page # of 19
- !uality mana"ement System
-1- #eneral Re$uirements
$uality management system in Sobhan Chemotherapeutical Company has been
established? documented? and is continually improved in accordance (ith the
requirements of IS 9!!1" #!!!. To implement the system? the follo(ing actions have
been ta@en in the organi*ation"
; The processes needed for the quality management system and their application
throughout the organi*ationA have been identified. These processes have been
sho(n in process map %anneB number-..'. ther additional information related to
each process including the inputs? the outputs? the sub;processes? the criteria
needed for monitoring and measuring processes and methods used to control
processes have been sho(n specifically in process identification table %SIPC
1
'
for each process individually.
; The sequence and interaction of these processes has been determined in process
map %anneB number -..'.
; The criteria and methods needed to monitor and measure the effectiveness of
processes have been identified as Cey Performance Indicators %CPIs'. These
criteria and methods have been described for each processes and sub;processes in
the determination of process criteria form.
; The resources and information necessary to support the operation and monitoring
of the processes have been identified for each process in turtle diagrams.
; The identified processes have been regularly monitored? measured? and analy*ed
through internal audits? analysis of data meetings and management revie(s.
; 6ctions necessary to achieve planned results and continual improvement of these
processes are defined in accordance (ith the monitoring? measurement and
analysis results.
These processes are managed in accordance (ith IS 9!!1" #!!!.
0equired controls over outsourced processes that affect product conformity (ith
requirements are being done through the specified mechanisms for evaluation of sub;
contractors performance mentioned in clause 8;: of this quality manual. These processes
are identified specifically (ithin the quality management system.
-2- Documentation re$uirements%
-2-1- #eneral
$uality management system documentation in Sobhan Chemotherapeutical Company
includes"
; $uality policy
; $uality obDectives
; $uality manual
; ,ocumented procedures required by IS 9!!1"#!!! and legal requirements such
as &EP
; ,ocuments needed by the organi*ation in order to ensure the effective planning?
operation and control of processes
; 0ecords
1
Supplier? Input? Process? utput? Customer
Page F of 19
!uality
Policy
!uality &anual
Stan'ar' (peratin" Proce'ures )S(Ps*
+or, -nstructions
.orms/ 0ists/ Recor's
; 1Bternal documents such as relevant standards? guidelines and boo@s in relevant
fields according to eBternal documents list
The levels of theses documents have been sho(n in figure 1;1 %hierarchy of documents'
=igure 1;1; Gierarchy of ,ocuments
-2-2- !uality &anual
$uality manual includes"
; The scope of the quality management system %including Dustification for
eBclusions of IS 9!!1"#!!! requirements' and details related to implementation
of IS 9!!1"#!!! in organi*ation.
; 0eference to the documented procedures used in quality management system
; $uality policy
; Process map %including a description of quality management system processes
and the interaction of these processes'
; rgani*ational chart
; Company history
-2-3- Control of 'ocuments%
Page : of 19
,ocuments and records required by the quality management system are controlled.
,ocument control procedure has been established to define the controls needed to"
; 6pprove documents for adequacy prior to issue
; 0evie( and update as necessary and re;approve documents
; 1nsure that changes and the current revision status of documents are identified
; 1nsure that relevant versions of applicable documents are available at points of
use
; 1nsure that documents remain legible and readily identifiable %Coding system of
documents'
; 1nsure that documents of eBternal origin are identified and their distribution
controlled
; Prevent the unintended use of obsolete documents? and to apply suitable
identification to them if they are retained for any purpose
In order to define the format and contents of SP
#
s? SPs preparation procedure has been
prepared.
-2-- Control of Recor's
0ecords are established and maintained to provide evidence of conformity to
requirements and of the effective operation of the quality management system.
0ecords are legible? readily identifiable and retrievable.
6 documented procedure %Control of records procedure' has been established to define
the controls needed for the identification? storage? protection? retrieval? retention time and
disposition of records.
References of Clause %
; IS 9!!1"#!!! Standard
; Process map
; Processes Identification Table 5o. ----
; Identification of Processes Indicators 5o. ------..
; ,ocument Control Procedure? SPH$6;&1;!!1
; SPs Preparation Procedure? SPH$6;&1;!!#
; Control of records Procedure 5o. ----..-.
#
Standard perating Procedures
Page 9 of 19
1- &ana"ement Responsibility
1-1- &ana"ement Commitment
Sobhan Chemotherapeutical Company top management has provided evidence of its
commitment to the development and implementation of the quality management system
and continually improving its effectiveness by"
; Communicating to the organi*ation the importance of meeting customer
requirements as (ell as statutory and regulatory requirements through conducting
regular meetings in all organi*ational levels and providing trainings for all
personnel.
; 1stablishing the quality policyA
; 1nsuring that quality obDectives are achieved and monitoring the trend of
achieving these obDectives during management revie( meetings
; Conducting management revie(s in I months intervals
; 1nsuring the availability of resources
1-2- Customer .ocus
The quality management system in Sobhan Chemotherapeutical Company has been
designed (ith the focus on requirements of different customer groups %including patients?
doctors? pharmacies? distribution companies and legal bodies such as Einistry of Gealth'
as the main approach. Top management identifies changes that must be made to align the
organi*ation direction (ith customer needs. To achieve this obDective? top management
revie(s and analy*es customer surveys? mar@eting reports and mar@eting department
reports of on;sight visits %during management revie( meetings' and evaluates
organi*ation ability to meet customer needs.
1-3- !uality Policy
Sobhan Chemotherapeutical Company top management has documented the quality
policy and encourages all personnel to follo( this policy. The steering committee ensures
that the policy is understood and implemented in all organi*ational levels. The quality
policy is periodically revie(ed during the management revie( meetings in order to
ensure its continuing suitability and if necessary it (ill be republished. The quality policy
is"
; 6ppropriate to organi*ation vision and mission.
; Includes management commitment to comply (ith quality management
requirements and continually improve its effectiveness
; Provides a frame(or@ for establishing and revie(ing quality obDectives
1-- Plannin"
1--1- !uality (b2ecti3es
The steering committee defines quality obDectives for different areas of the organi*ation
according to the company management policies (hich are specified in quality policy
statement annually. These obDectives should be"
; Specific and clear
; Eeasurable
; 6ttainable
Page I of 19
; 0elated to the quality policy
; Time;bound
Jhen determining quality obDectives? product requirements? customer requirements and
required resources needed to achieve the obDectives are ta@en into consideration. 6fter
defining the obDectives? responsible personnel in determined areas establish the obDective
achievement plan. This plan includes" time schedule? responsibilities? required resources?
obDective achievement monitoring methods and other relevant requirements. $uality
obDective plans should be approved by steering committee and committee is responsible
to support the plan through providing the required resources.
1--2- !uality &ana"ement System Plannin"
Eanagement representative is responsible for quality management system planning.
6ctivities related to identification of all processes and supervision of developing
documents and quality manual are also the responsibility of management representative.
1-1- Responsibility/ 4ut5ority an' Communications
1-1- 1-Responsibility an' 4ut5ority
Kob descriptions for all personnel in accordance (ith the Sobhan Chemotherapeutical
Company organi*ational chart %(hich is attached to this quality manual' are prepared by
6dministration affairs manager cooperating (ith other managers and after being
approved by managing director? Dob descriptions are submitted to all personnel in all
organi*ational levels. 6dministration affairs manager has to ensure that responsibilities
and authorities are defined in all organi*ational levels and are available for all personnel.
1-1-2- &ana"ement Representati3e
The top management has appointed the Information Technology chief as management
representative. Jho? irrespective of other responsibilities? has responsibilities that
include"
; 1nsuring that processes needed for the quality management system are
established? implemented and maintainedA
; 0eporting to top management on the performance of the quality management
system? and any need for improvement
; 1nsuring of a(areness
; Supervising of communication processes to ensure the promotion of a(areness of
customer requirements and needs throughout the organi*ation
; 6cting as liaison (ith eBternal parties on matters relating to the quality
management system
1-1-3- Communication
The steering committee is responsible for identifying the @ey communication processes in
Sobhan Chemotherapeutical Company. Information communication and transfer methods
are different according to the type of information and might include using computer
systems? designed quality system documents and conducting internal meetings at
different organi*ational levels. The type of these communicating methods is defined in
quality management system.
1-6- &ana"ement Re3ie7
Page 8 of 19
1-6-1- #eneral
The quality management system is revie(ed at I months intervals to ensure its
continuing suitability? adequacy and effectiveness and also includes opportunities for
improvement and required changes in quality policy and quality obDective.
Eanaging director? management representative? quality assurance manager? factory
manager? commercial manager? sales and mar@eting manager? research and development
manager and if necessary other relevant personnel participate in management revie(
meetings.
The management revie( procedure has been developed to describe management revie(
process.
1-6-2- &ana"ement Re3ie7 -nputs
Eanagement revie( input includes"
; 0esults of audits %Internal and eBternal'
; Customer feedbac@
; Status of preventive and corrective actions
; $uality policy and quality obDectives
; 0ecommendations for improvement
; Process performance and product conformity
; Planned changes that could affect the quality management system
; =ollo(;up actions from earlier management revie(s
1-6-3- &ana"ement Re3ie7 (utputs
utput from management revie( includes any decisions and actions related to"
; Improvement of the effectiveness of quality management system and its processes
; Improvement of product related to customer requirements
; 0equired resources
References of Clause 1
; $uality policy
; Eanagement revie( procedure 5o. -----.
; Personnel Dob descriptions
Page L of 19
6- Resource &ana"ement
6-1- Pro3ision of resources
Sobhan Chemotherapeutical Company determines and provides in planned intervals? all
resources needed to implement and improve the processes of the quality management
system and to address customer satisfaction %including human resources? process
equipment? utilities? etc'. 1vidences that required resources %in accordance (ith the
requirement of customers and products requirements and organi*ation development
plans' have been provided are documented in the organi*ation annual budget.
6-2- Human Resources
6-2-1- #eneral
Personnel performing (or@ affecting product quality are assigned to the described Dobs in
the organi*ational chart in accordance (ith the competencies %education? training? s@ills
and eBperience' defined in Dob descriptions.
6-2-2- Competence/ 47areness an' 8rainin"
In Sobhan Chemotherapeutical Company"
; The required competencies for personnel performing (or@ affecting product
quality are defined in Dob descriptions in accordance (ith clause I;#;1
; 6ll required trainings are provided in order to meet quality system requirements
and inserted needs in Dob descriptions in accordance (ith training procedure.
; The effectiveness of trainings is evaluated according to the determined
mechanism mentioned in the training procedure.
; Personnel in all levels shall be a(are of"
$uality policy
$uality management system requirements
The importance of conformance (ith customer requirements? regulatory
bodies? organi*ation commercial partners and organi*ational requirements
Go( they contribute to the achievement of the quality obDectives
The impact of their (or@ in quality
The benefits of improved performance
Their roles and responsibilities in achieving conformance
The potential consequences of departure from the specified procedures
; 6ll the relevant records of education? training? s@ills and (or@ eBperiences are
maintained by 6dministration affairs manager and training head.
6-3- -nfrastructure
The 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"
; 7uildings? (or@space and associated utilities %such as cleanrooms? G>6C
F
system? (ater systems? etc'
F
Geating? >entilation and 6ir Conditioning
Page 9 of 19
; Process equipment? %including production and laboratory equipment? reference
standards used for calibration? the soft(are used to production and laboratory ?
etc'
; Supporting services %such as computers? computer net(or@s? lift truc@s? etc'
6ll the requirements related to the repair and maintenance activities including
maintenance activities frequencies are described in the repairs and maintenance
procedure.
6-- +or, En3ironment
Jor@ environmental conditions at different (or@ing areas including temperature?
humidity? differential pressure? other relevant parameters and also safety relevant issues
that affect product quality %such as personnel clothes? entering into and eBiting from
cleanrooms? etc' have been determined in production and laboratory environments
according to the regulatory requirements related to the products as follo(s"
; 0equirements related to health? cleanliness and clothing of personnel if contact
bet(een such personnel and the product or (or@ environment could adversely
affect the quality of the products.
; 0equirements of environment conditions (hen these conditions can have an
adverse effect on product quality.
; Providing special trainings for all personnel (ho are required to (or@ temporarily
under special environmental conditions.
; Special arrangements for the control of cross contamination
6ll above requirements have been established in production SPs and test methods.
Eonitoring and controlling environmental conditions methods have been also identified
in these instructions.
References of Clause 6
; Training procedure 5o. SPHT0;&1;!!1
; 0epair and maintenance procedure 5o. --------
; Eanagement revie( procedure 5o. ------..
; Personnel Dob descriptions
; Production SPs
; Test methods
Page 1! of 19
9- Pro'uct Reali:ation
9-1- Plannin" of Pro'uct Reali:ation
The processes needed for product reali*ation are planned and developed? and the
interaction bet(een these processes and other processes of the quality management
system is also defined. In planning product reali*ation? the follo(ing has been ta@en into
consideration"
; ,etermination of required documents? sub;processes and resources needed to
reali*e these processes
; >erification? validation? inspection and test activities of ro( materials? pac@aging
material? semi;finished and finished products and their conformance to products
acceptance criteria
; 0ecords needed to provide evidence that the reali*ation processes and resulting
product meet requirements
6ll above requirements have been prepared in ,rug Easter =ile %,E=' format for all
products. SIPC tables have also been prepared for reali*ation processes at all required
levels.
9-2- Customer Relate' Processes
9-2-1- Determination of Re$uirements Relate' to t5e Pro'uct
0equirements related to the product have been determined by the organi*ation? including"
; 0equirements specified by customers %distribution companies'? including the
requirements for products type and quantity and delivery time
; 0equirements not stated by the customer but necessary for intended use of the
products such as requirements for pac@aging and information accompanying
product
; Statutory and regulatory requirements related to the product including the
requirement stated in pharmacopeias or determined by Einistry of Gealth
; rgani*ational requirements and requirements stated by commercial partners
The method for defining these requirements has been described in sales procedure.
9-2-2- Re3ie7 of Re$uirements Relate' to t5e Pro'uct
0equirements related to the product are revie(ed. This revie( is conducted prior to
committing to supply a product to customers. These revie(s are conducted annually by
sales manager according to received information from production planning? mar@eting
and statistics about sales quantity in previous years? production lines capacity and other
constraints. 0evie( output is reported to Einistry of Gealth by managing director. The
revie( of distribution companiesM requirements is also conducted through out the year by
sales manager. The intent of these revie(s is to ensure that"
; Product requirements %including requirements related to delivery and post;
delivery activities' are defined
; Contract or order requirements differing from those previously eBpressed are
resolved
; 0ecords of the results of revie( and actions arising from this revie( are
maintained
Page 11 of 19
; Jhen product requirements are changed? relevant documents are amended and
the relevant personnel are made a(are of the changed requirements.
The detailed information is described in sales procedure.
9-2-3- Customer Communication
0equired arrangements for communication (ith customers relating to the follo(ings are
determined and implemented"
; Product information according to the customer communication procedure
; 1nquiries? contracts or order handling? according to the sales procedure
; Customer feedbac@? according to the customer communication procedure and
(hen receiving complaints from customer according to the complaints follo(;up
procedure and (hen product recall is necessary? this process (ill be handled
according to the product recall procedure
9-3- Desi"n an' De3elopment
9-3-1- Desi"n an' De3elopment Plannin"
Planning of 0&,
:
proDects %products design' is being done by 0&, manager. 0&,
manager is responsible for establishing time schedule for each proDect. ,uring the
proDects planning? the follo(ings are determined"
; The proDect stages
; 0evie(? verification and validation appropriate to each stage
; 0esponsibilities and authorities
The method for managing the interfaces bet(een different groups involved in 0&,
proDects to ensure effective communication and clear assignment of responsibility has
been described in research and development procedure.
Time schedule for each proDect (ill be updated along (ith proDect completion.
9-3-2- Desi"n an' De3elopment -nputs
,esign and development Inputs are defined according to research and development
procedure and records of theses inputs are maintained. These inputs include"
; =unctional? performance and safety requirements? according to the intended use
%including physical? chemical and other specifications'
; 6pplicable statutory and regulatory requirements %according to pharmacopoeia
requirements'
; 6pplicable information derived from previous similar designs
; ther requirements essential for design and development
6ll design inputs shall be revie(ed and approved for adequacy according to design and
development procedure. 0equirements are complete? unambiguous? and not in conflict
(ith each other.
9-3-3- Desi"n an' De3elopment (utputs
The outputs of design and development are provided in a form that enables verification
against the design and development input? and are approved prior to release according to
research and development procedure. ,esign and development outputs"
; Eeet the input requirements for design and development
:
0esearch & ,evelopment
Page 1# of 19
; Provide appropriate information for purchasing and production %including
required 6PIs
9
and other ra( materials? primary formulation? etc'
; Contain products acceptance criteria
; Specify the characteristics of the product that are essential for safe and proper use
%including brochure and drug use instruction'
9-3-- Desi"n an' De3elopment Re3ie7
0evie(s of design and development are performed according to research and
development procedure in accordance (ith the nature of proDects and planned
arrangements. These revie(s are conducted to"
; 1valuate the ability of the results of design and development to meet requirements
; Identify any problems and propose necessary actions
Participants in design and development revie( include representatives of functions
concerned (ith the design and development stage being revie(ed. 0ecords of the results
of the revie(s are maintained.
9-3-1- Desi"n an' De3elopment ;erification
>erification of design and development is performed in accordance (ith planned
arrangements determined in research and development procedure and proDect time
schedule to ensure that the design and development outputs have met the design and
development input requirements. ,esign and development verification is conducted in
accordance (ith the results of tests performed on the primary formulation. 0ecords of the
results of the verification are maintained.
9-3-6- Desi"n an' De3elopment ;ali'ation
,esign and development validation is performed in accordance (ith research and
development procedure and proDect time schedule to ensure that the resulting product is
capable of meeting the requirements for the specified application or intended use.
>alidation is performed in accordance (ith the results of trial production and product
stability test results.
9-3-9- Control of Desi"n an' De3elopment C5an"es
6ll design and development changes are identified and analy*ed according to research
and development procedure. The changes are revie(ed? verified and validated as
appropriate. The revie( of design and development changes includes evaluation of the
effect of the changes on products.
9-- Purc5asin"
9--1- Purc5asin" Process
Purchasing procedure in Sobhan Chemotherapeutical Company is divided to internal
purchasing and eBternal purchasing. Purchasing process depends on the type of purchased
products %supplied internally or eBternally' and is being done according to internal and
eBternal purchasing procedures.
Purchasing processes are controlled to ensure purchased product conforms to specified
purchase requirements. This control is applied to purchased items? goods? equipment and
9
6ctive Pharmaceutical Ingredients
Page 1F of 19
services that affect product quality. Suppliers are evaluated and selected based on criteria
defined in suppliersM evaluation procedure.
9--2- Purc5asin" information
Purchasing information is defined according to internal or eBternal procedures.
Purchasing information describes the product to be purchased? including (here
appropriate"
; requirements for approval of product? procedures? processes and equipment?
; requirements for qualification of personnel? and
; $uality management system requirements.
Purchasing information adequacy is revie(ed prior to stating the specified requirements
to suppliers according to internal or eBternal procedure.
Purchasing information including relevant documents and records are maintained in order
to provide product traceability.
9--3- ;erification of Purc5ase' Pro'uct%
Inspection and testing activities are performed according to ra( materials and pac@aging
items quality control procedure to ensure that purchased products meet specified
requirements.
=or other items and equipment (hich affect the quality? inspection and testing activities
are performed according to internal or eBternal purchase procedure.
Jhere verification of purchased product is intended at suppliersM premises? verification
includes comparing products (ith specified specifications via testing and inspection at
supplierMs premises or supervision on testing process and eBamining results and
measuring equipment accuracy.
9-1- Pro'uction
9-1-1- Control of Pro'uction
6ll products production process is planned. Production and material planning is
performed according to production planning procedure.
The follo(ing activities are carried out by Sobhan Chemotherapeutical Company to
control production process"
; The availability of information that describes the characteristics of the product
%including ,E= for all products'
; The availability of documented procedures %to describe production processes and
equipment usage'? documented requirements? (or@ instructions? reference
materials and reference measurement procedures
; The use of suitable equipment according to the (orld 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 ra( materials? semi;finished
products and final products
; The implementation of release? delivery? and post;delivery activities
; The implementation of defined operations for labeling an pac@aging
Sobhan Chemotherapeutical Company establishes and maintains a record for each batch
of its products %batch record' to provide traceability and identify amount manufactured
Page 1: of 19
and amount approved for distribution. 7atch record is verified and approved by quality
assurance manager.
9-1-2- ;ali'ation of Processes for Pro'uction
6ll of production sub;processes (here their resulting output cannot be verified by
subsequent monitoring or measurement are validated. The validation of these processes is
being done according to defined procedures to prove the ability of theses processes for
reaching planned results.
The follo(ing items are considered in preparing validation procedures and chec@lists"
; ,efined criteria for revie( and approval of the processes %such as necessary
environmental conditions? time-'
; 6pproval of equipment and qualification of personnel
; 4se of specific methods and procedures
; 0equirements for records
; 0evalidation in defined intervals or (hile changes occur in process
9-1-3--'entification an' 8raceability
6ll products of Sobhan Chemotherapeutical Company are identified according to
identification and traceability procedure from the primary stages of production to
pac@aging.
0ecalled products are also identified according to product recall procedure and
conforming products are segregated from the non;conforming ones.
Traceability is established for all products according to identification and traceability
procedure. 7atch record indicates traceability for all products. rgani*ation controls and
records product unique identification throughout the production process.
The records of all product components %including test results'? materials and (or@
environment conditions are considered in batch record to demonstrate the tractability.
Products status is identified (ith respect to monitoring and measurement requirements by
stic@ing labels defined in quality control procedures.
9-1-- Customer Property
0egarding to eBplanations in clause #;F? requirements of this clause are not applicable in
Sobhan Chemotherapeutical Company.
9-1-1- Preser3ation of Pro'uct
Preservation includes identification? handling? pac@aging? storage and protection.
Preservation is also applied to the constituent parts of a product.
Identification of all products is carried out according to clause 8;9;F.
Gandling and preservation of products throughout internal processing is performed
according to production procedures.
Pac@aging of products is carried out according to pac@aging procedures.
Storage of products is carried out according to storage procedure.
9-6- Control of &easurin" an' &onitorin" De3ices
6ll requirements necessary for calibrating measuring and monitoring devices are
described in calibration procedure.
6ll measuring and monitoring devices in Sobhan Chemotherapeutical Company are"
Page 19 of 19
; Calibrated at specified intervals? or prior to use? against measurement standards
traceable to international or national measurement standardsA (here no such
standards eBist? the basis used for calibration is recorded
; 6dDusted or re;adDusted as necessary
; Identified according to repair and maintenance procedure to enable the calibration
status to be determined
; Safeguarded from adDustments that (ould invalidate the measurement resultA and?
; Protected from damage and deterioration during handling? maintenance and
storage according to equipment technical instructions
The equipment is sent for calibration before the specified time (hen it is found not to
conform to requirements. If necessary? the parameters measured by the
nonconforming device are measured again according to calibration procedure.
The computer soft(are used for measurement and monitoring are validated according
to computer systems validation protocol and their ability to meet the requirements is
confirmed.
Reference of Clause 9
; ,rug Easter =iles %,E=s'
; Sales procedure 5o. ---
; Customer communication procedure 5o. ---
; Complaints follo(;up procedure 5o. ---
; Product recall procedure 5o. ---
; 0esearch and development procedure 5o. ----.
; Internal purchasing procedure? 5o. SPHP4;&1;!!1
; 1Bternal purchasing procedure 5o. ----.
; SuppliersM evaluation procedure 5o. ----.
; 0a( materials and pac@aging items procedure 5o. ---
; Production Planning procedure 5o. ----
; >alidation procedures
; Product identification and tractability procedure 5o. ---
; $uality control procedures
; Production procedures
; Pac@aging procedures
; Storage procedure 5o. ---
; Calibration procedure? SPH15;&1;!!1
; 0epair and maintenance procedure 5o. ---
; Computer systems validation protocols
Page 1I of 19
<- &easurement/ 4nalysis an' -mpro3ement
<-1- #eneral Re$uirements
Sobhan Chemotherapeutical company 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.
<-2- &onitorin" an' &easurement
<-2-1- Customer Satisfaction
Sobhan Chemotherapeutical Company monitors and measures information related to
customersM %doctors? distributing companies and patients' perception at defined intervals
as to (hether the organi*ation has met customersM needs and eBpectations according to
customer communication procedure.
<-2-2- -nternal 4u'it
Periodic internal audits are conducted at planned intervals according to internal audit
procedure in order to"
; 1valuate quality management system compliance (ith the requirements of IS
9!!1"#!!! International Standard and
; 1valuate the effectiveness and deployment of quality management system
6udit plan is prepared (ith 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. 6uditors
should be independent from the process being audited and do not audit their o(n (or@.
The responsibilities and requirements for planning and conducting audits? audit report
preparation? records maintenance and nonconformities follo(;up are described in internal
audit procedure.
<-2-3- &onitorin" an' &easurement of Processes
6s mentioned in clause :? monitoring and measurement of processes is carried out (ith
respect to @ey performance indicators %CPIs' using methods and criteria defined in
process indicator determination form.
The ability of the processes to achieve planned results is chec@ed regarding monitoring
and measurement results %CPIs status'. Jhen planned results are not achieved? correction
and corrective action are ta@en? as defined in corrective action and preventive action
procedures.
<-2-- &onitorin" an' &easurement of Pro'uct%
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.
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1vidence of conformity (ith the acceptance criteria %test results' is maintained. Theses
records compose part of the batch record. Product release does not proceed until the batch
records are chec@ed by quality assurance manager
The identity of persons performing any @ind of inspections and tests is recorded in related
forms.
<-3- Control of =onconformin" Pro'uct
In order to ensure that nonconforming products are not used unintentionally? these
products are segregated from other products according to control of nonconforming
product procedure. Controls? related responsibilities and authorities for dealing (ith
nonconforming product and disposition of these products are defined in control of
nonconforming product procedure.
5onconforming product is managed by one or more of the follo(ing methods"
; Ta@ing action to eliminate the detected nonconformity and performing required
corrections
; 6uthori*ing its use? release or acceptance under concession (here regulatory
requirements are met.
; Ta@ing action to preclude product use or application.
0ecords of the nature of nonconformities and any subsequent actions ta@en? including
concessions obtained? are maintained according to control of nonconforming product
procedure.
Jhen nonconforming product is corrected? it is subDect to re;verification to demonstrate
conformity to the requirements.
<-- 4nalysis of Data
,etermination? collection? and analysis of appropriate data to demonstrate the suitability
and effectiveness of the quality management system? and to evaluate (here continual
improvement of the quality management system can be made is described in data analysis
procedure.
This includes data generated as a result of monitoring and measurement %customer
feedbac@? 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 feedbac@
; Conformance to product requirements
; Characteristics and trends of processes and products including opportunities for
preventive action
; Suppliers.
0ecords of data analysis are maintained according to data analysis procedure.
<-1- -mpro3ement
<-1-1- #eneral
Sobhan Chemotherapeutical Company continually improves its quality management
system efficiency through the use of quality policy? quality obDectives? audit results?
analysis of data? corrective and preventive actions and management revie( according to
continual improvement procedure and defining improvement proDects.
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<-1-2- Correcti3e 4ction
Corrective actions are ta@en to eliminate the cause of nonconformities in order to prevent
recurrence according to corrective action procedure. ,etermining and implementing of
corrective action includes the follo(ing stages"
; 0evie(ing nonconformities
; ,etermining the causes of nonconformities
; 1valuating the need for action to ensure that nonconformities do not recur
; ,etermining and implementing action needed
; 0ecords of the results of actions ta@en
; 0evie(ing corrective action ta@en.
<-1-3- Pre3enti3e 4ction
Preventive actions are determined to eliminate the causes of potential nonconformities in
order to prevent occurrence according to preventive action procedure. ,etermining and
implementing preventive action includes the follo(ing stages"
; ,etermining potential nonconformities and their causes
; 1valuating the need for action to prevent occurrence of nonconformities
; ,etermining and implementing action needed
; 0ecords of results of action ta@enA and
; 0evie(ing preventive action ta@en.
Reference of Clause <
; Customer communication procedure 5o. ---
; Internal audit procedure 5o. ---
; $uality control procedures
; Control of nonconforming product procedure 5o. ----.
; ,ata analysis procedure? 5o. --------
; Continual improvement procedure 5o. ----.
; Corrective action procedure 5o. ---
; Preventive action procedure 5o. ----
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