1. Company History
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 ISO 9001:2000 Quality management system requirements & applicable regulatory requirements (including requirements of Good 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 followings:
[Insert the organization scope clearly including all products and a statement such as “Design and manufacturing of ….”]
2-3- Exclusions
ISO 9001:2000 Requirements EXCLUSION TABLEClause or Sub-clause / Exclusion / Justifications
7.5.4 (full) / Customer Property / Sobhan Chemotherapeutical Co. does not use customer properties (including intellectual properties) in none of its products realization processes.
3-1- Definitions
The definitions and terms used in this quality manual are based on the following documents:
- (Insert relevant references which contains technical terms of pharmaceutical industry)
- ISO 9000:2005: Quality management systems – Fundamentals and Vocabulary
3-2- References
This manual is organized and written to comply with the following documents and standards:
· ISO 9001:2000: Quality management systems - Requirements
· (Insert relevant regulatory bodies requirements that meeting theses requirements are mandatory in pharmaceutical industry and organization specific products)
Sobhan Chemotherapeutical Co. quality management system complies with the most recent edition of the aforementioned documents and standards. Necessary changes to quality management system are applied continuously by the organization to ensure compliance with applicable standards.
All references to specific policies, procedures, or work instructions in this manual are the latest revision of these documents.
4- Quality management System
4-1- General Requirements
Quality management system in Sobhan Chemotherapeutical Company has been established, documented, and is continually improved in accordance with the requirements of ISO 9001: 2000. To implement the system, the following actions have been taken in the organization:
- The processes needed for the quality management system and their application throughout the organization; have been identified. These processes have been shown in process map (annex number…..). Other 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 shown specifically in process identification table (SIPOC[1]) for each process individually.
- The sequence and interaction of these processes has been determined in process map (annex number …..).
- The criteria and methods needed to monitor and measure the effectiveness of processes have been identified as Key Performance Indicators (KPIs). 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 analyzed through internal audits, analysis of data meetings and management reviews.
- Actions necessary to achieve planned results and continual improvement of these processes are defined in accordance with the monitoring, measurement and analysis results.
These processes are managed in accordance with ISO 9001: 2000.
Required controls over outsourced processes that affect product conformity with requirements are being done through the specified mechanisms for evaluation of sub-contractors performance mentioned in clause 7-4 of this quality manual. These processes are identified specifically within the quality management system.
4-2- Documentation requirements:
4-2-1- General
Quality management system documentation in Sobhan Chemotherapeutical Company includes:
- Quality policy
- Quality objectives
- Quality manual
- Documented procedures required by ISO 9001:2000 and legal requirements such as GMP
- Documents needed by the organization in order to ensure the effective planning, operation and control of processes
- Records
- External documents such as relevant standards, guidelines and books in relevant fields according to external documents list
The levels of theses documents have been shown in figure 1-1 (hierarchy of documents)
Figure 1-1- Hierarchy of Documents
4-2-2- Quality Manual
Quality manual includes:
- The scope of the quality management system (including justification for exclusions of ISO 9001:2000 requirements) and details related to implementation of ISO 9001:2000 in organization.
- Reference to the documented procedures used in quality management system
- Quality policy
- Process map (including a description of quality management system processes and the interaction of these processes)
- Organizational chart
- Company history
4-2-3- Control of documents:
Documents and records required by the quality management system are controlled. Document control procedure has been established to define the controls needed to:
- Approve documents for adequacy prior to issue
- Review and update as necessary and re-approve documents
- Ensure that changes and the current revision status of documents are identified
- Ensure that relevant versions of applicable documents are available at points of use
- Ensure that documents remain legible and readily identifiable (Coding system of documents)
- Ensure that documents of external 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 SOP[2]s, SOPs preparation procedure has been prepared.
4-2-4- Control of Records
Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.
Records are legible, readily identifiable and retrievable.
A 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 4:
- ISO 9001:2000 Standard
- Process map
- Processes Identification Table No. …………
- Identification of Processes Indicators No. ………………..
- Document Control Procedure, SP/QA-GE-001
- SOPs Preparation Procedure, SP/QA-GE-002
- Control of records Procedure No. …………..….
5- Management Responsibility
5-1- Management 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 organization the importance of meeting customer requirements as well as statutory and regulatory requirements through conducting regular meetings in all organizational levels and providing trainings for all personnel.
- Establishing the quality policy;
- Ensuring that quality objectives are achieved and monitoring the trend of achieving these objectives during management review meetings
- Conducting management reviews in 6 months intervals
- Ensuring the availability of resources
5-2- Customer Focus
The quality management system in Sobhan Chemotherapeutical Company has been designed with the focus on requirements of different customer groups (including patients, doctors, pharmacies, distribution companies and legal bodies such as Ministry of Health) as the main approach. Top management identifies changes that must be made to align the organization direction with customer needs. To achieve this objective, top management reviews and analyzes customer surveys, marketing reports and marketing department reports of on-sight visits (during management review meetings) and evaluates organization ability to meet customer needs.
5-3- Quality Policy
Sobhan Chemotherapeutical Company top management has documented the quality policy and encourages all personnel to follow this policy. The steering committee ensures that the policy is understood and implemented in all organizational levels. The quality policy is periodically reviewed during the management review meetings in order to ensure its continuing suitability and if necessary it will be republished. The quality policy is:
- Appropriate to organization vision and mission.
- Includes management commitment to comply with quality management requirements and continually improve its effectiveness
- Provides a framework for establishing and reviewing quality objectives
5-4- Planning
5-4-1- Quality Objectives
The steering committee defines quality objectives for different areas of the organization according to the company management policies which are specified in quality policy statement annually. These objectives should be:
- Specific and clear
- Measurable
- Attainable
- Related to the quality policy
- Time-bound
When determining quality objectives, product requirements, customer requirements and required resources needed to achieve the objectives are taken into consideration. After defining the objectives, responsible personnel in determined areas establish the objective achievement plan. This plan includes: time schedule, responsibilities, required resources, objective achievement monitoring methods and other relevant requirements. Quality objective plans should be approved by steering committee and committee is responsible to support the plan through providing the required resources.
5-4-2- Quality Management System Planning
Management representative is responsible for quality management system planning. Activities related to identification of all processes and supervision of developing documents and quality manual are also the responsibility of management representative.
5-5- Responsibility, Authority and Communications
5-5- 1-Responsibility and Authority
Job descriptions for all personnel in accordance with the Sobhan Chemotherapeutical Company organizational chart (which is attached to this quality manual) are prepared by Administration 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 to ensure that responsibilities and authorities are defined in all organizational levels and are available for all personnel.
5-5-2- Management Representative
The top management has appointed the Information Technology chief as management representative. Who, irrespective of other responsibilities, has responsibilities that include:
- Ensuring that processes needed for the quality management system are established, implemented and maintained;
- Reporting to top management on the performance of the quality management system, and any need for improvement
- Ensuring of awareness
- Supervising of communication processes to ensure the promotion of awareness of customer requirements and needs throughout the organization
- Acting as liaison with external parties on matters relating to the quality management system
5-5-3- Communication
The steering committee is responsible for identifying the key 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 organizational levels. The type of these communicating methods is defined in quality management system.
5-6- Management Review
5-6-1- General
The quality management system is reviewed at 6 months intervals to ensure its continuing suitability, adequacy and effectiveness and also includes opportunities for improvement and required changes in quality policy and quality objective.
Managing director, management representative, quality assurance manager, factory manager, commercial manager, sales and marketing manager, research and development manager and if necessary other relevant personnel participate in management review meetings.
The management review procedure has been developed to describe management review process.
5-6-2- Management Review Inputs
Management review input includes:
- Results of audits (Internal and external)
- Customer feedback
- Status of preventive and corrective actions
- Quality policy and quality objectives
- Recommendations for improvement
- Process performance and product conformity
- Planned changes that could affect the quality management system
- Follow-up actions from earlier management reviews
5-6-3- Management Review Outputs
Output from management review 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
- Required resources
References of Clause 5
- Quality policy
- Management review procedure No. …………….
- Personnel job descriptions
6- Resource Management
6-1- Provision 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). Evidences that required resources (in accordance with the requirement of customers and products requirements and organization development plans) have been provided are documented in the organization annual budget.
6-2- Human Resources
6-2-1- General
Personnel performing work affecting product quality are assigned to the described jobs in the organizational chart in accordance with the competencies (education, training, skills and experience) defined in job descriptions.
6-2-2- Competence, Awareness and Training
In Sobhan Chemotherapeutical Company:
- The required competencies for personnel performing work affecting product quality are defined in job descriptions in accordance with clause 6-2-1
- All required trainings are provided in order to meet quality system requirements and inserted needs in job descriptions in accordance with training procedure.
- The effectiveness of trainings is evaluated according to the determined mechanism mentioned in the training procedure.
- 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 benefits of improved performance
· Their roles and responsibilities in achieving conformance
· The potential consequences of departure from the specified procedures
- All the relevant records of education, training, skills and work experiences are maintained by Administration affairs manager and training head.
6-3- Infrastructure
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:
- Buildings, workspace and associated utilities (such as cleanrooms, HVAC[3] system, water systems, etc)