Product quality in pharmaceutical industry is not optional but it is a primary regulatory requirement for every company those manufactures pharmaceutical products. Each batch of medicinal products must be produced according to the quality standards established in their approved specifications. Achieving this level of reliability and quality requires a strong quality management system.
QMS includes everything of quality assurance, quality control, risk management, documentation and continuous improvement within the organization. Quality management system is the backbone of good manufacturing practices (GMP) and a major expectation of global regulatory agencies such as USFDA, WHO and EMA.
This article explains the structure, principles, elements and implementation of quality management system in pharmaceutical industries to align with regulatory guidelines like ICH Q10, WHO-GMP and Schedule M in India.
Quality Management System is a set of standards used by organizations to manage the process, responsibility and documentation that is required to meet quality related objectives and satisfy regulatory requirements too.
In simple words we can say that QMS provides an organized approach to ensuring that every item produced in the company meets stabilized quality standards throughout its life cycle from the raw metal stage to the delivery of product to the patient.
Key goals of a QMS include:
1. Achieving uniformity and traceability of the products.
2. Avoiding errors and inconsistent siege in products.
3. Managing changes properly.
4. Implementing continuous improvement.
5. Building trust in customers and patients.
1. Customer focus: Committed to fulfilling patient needs and regulatory requirements.
2. Leadership: A culture of quality and compliance is produced by the management’s commitment.
3. People engagement: Every employee is accountable for the quality of the product.
4. Process approach: Activities are treated as connected process of effectiveness.
5. Improvement: Continual improvement to the quality of the product.
6. Evidence based decision making: Decisions related to quality must be based on data and analysis.
7. Relationship management: Partnership with suppliers, contractors and regulators.
8. Risk management: Actively identifying and eliminating possible risks.
2. Leadership involvement in daily quality activities
3. Encouraging teamwork across departments
A fully developed quality culture makes compliance a daily practice, not just a box to check.
Download QMS Compliance Checklist
Master Control, TrackWise, Veeva Vault QMS, and Sparta Systems are amongst the most utilized eQMS applications within the pharmaceutical industry.
Examples of performance measurement tools include deviation rate, CAPA closure time and audit findings. These key performance indicators (KPIs) enable organizations to assess their quality management system (QMS) effectiveness.
The foundation of GMP compliance in pharmaceutical is an effective Quality Management System (QMS). The QMS establishes controls over all processes related to pharmaceuticals including raw material sourcing through product release process.
As the regulatory environment continues to evolve so the expectations of regulatory agencies from pharmaceutical companies are increasing for GxP compliance. The data based on risk based QMS approach will enable pharmaceutical companies to maintain compliance with GxP regulations and continue to remain globally competitive.
By incorporating QMS within the organization’s culture pharmaceutical manufacturers can achieve their business objectives by providing safe, effective and good quality medicines to patients globally.
QMS includes everything of quality assurance, quality control, risk management, documentation and continuous improvement within the organization. Quality management system is the backbone of good manufacturing practices (GMP) and a major expectation of global regulatory agencies such as USFDA, WHO and EMA.
This article explains the structure, principles, elements and implementation of quality management system in pharmaceutical industries to align with regulatory guidelines like ICH Q10, WHO-GMP and Schedule M in India.
What Is a Quality Management System (QMS)?
Quality Management System is a set of standards used by organizations to manage the process, responsibility and documentation that is required to meet quality related objectives and satisfy regulatory requirements too. In simple words we can say that QMS provides an organized approach to ensuring that every item produced in the company meets stabilized quality standards throughout its life cycle from the raw metal stage to the delivery of product to the patient.
Key goals of a QMS include:
1. Achieving uniformity and traceability of the products.
2. Avoiding errors and inconsistent siege in products.
3. Managing changes properly.
4. Implementing continuous improvement.
5. Building trust in customers and patients.
Importance of QMS in Pharmaceuticals
Quality management system is essential for compliance with regulatory requirements and ensuring safety for patients. QMS includes the following components that make it important to pharmaceutical industry.1. Regulatory Compliance
Good manufacturing practices, ICH Q10 and Schedule M have been established as minimum regulatory requirements for all pharmaceutical manufacturers. As a part of regulatory inspections, regulators evaluate the effectiveness of QMS within the manufacturing facility.2. Risk Mitigation
QMS identifies and controls the risk associated with product quality and patient safety because it makes it mandatory to follow the regulatory standards.3. Efficiency/Cost Reduction
It helps to avoid unnecessary deviation and product recall by promoting a systematic approach to documentation and corrective and preventive actions.4. Continuous Improvement
QMS enables continuous improvement through the regular review of data, audits and management reviews.5. Market Credibility
Companies that have a strong QMS are viewed as reliable and trustworthy by regulators, customers and other global business partners.Regulatory Guidelines for QMS
- ICH Q10 is a perfect model for the pharmaceutical QMS across all stages of product life cycle.
- WHO-GMP establishes requirements of facility, equipment, documentation and quality control for GMP.
- USFDA 21 CFR Part 211 covers the manufacturing practices for finished pharmaceutical products in the United States.
- EU-GMP Part 1 Chapter 1 establishes the pharmaceutical quality system requirements for EU markets.
- Schedule M establishes the GMP standards for manufacturers in India.
Principles of a Quality Management System (QMS)
The eight concepts of QMS are the basis of pharmaceutical QMS implementation.1. Customer focus: Committed to fulfilling patient needs and regulatory requirements.
2. Leadership: A culture of quality and compliance is produced by the management’s commitment.
3. People engagement: Every employee is accountable for the quality of the product.
4. Process approach: Activities are treated as connected process of effectiveness.
5. Improvement: Continual improvement to the quality of the product.
6. Evidence based decision making: Decisions related to quality must be based on data and analysis.
7. Relationship management: Partnership with suppliers, contractors and regulators.
8. Risk management: Actively identifying and eliminating possible risks.
Key Elements of QMS in Pharmaceuticals
In pharmaceutical sector an efficient quality management system has several linked elements that together support the quality of product during its entire life cycle.1. The Quality Policy and Quality Objectives
For any organization to ensure quality, it should have a defined Quality Policy and Quality Objectives that have been endorsed by senior management. An organization's Quality Policy describes how an organization is committed to compliance with regulations, commitment to safe working environments and commitment to continual improvement of quality. Quality objectives should be realistic and not based solely on the perception of what an organization hopes to accomplish. Quality objectives should be reviewed at a predetermined frequency, and they should be communicated to an organization’s employees.2. Organizational Structure and Responsibilities
The quality management system must have clearly defined roles and responsibilities for personnel within the organization. Examples of major functional departments of a QMS would have Quality Assurance, Quality control, Production and Engineering. Each department within a QMS must have documented processes and procedures for communicating with one another and also for reporting up to their managers.3. Document Control
Proper documentation is critical to ensuring proper traceability and storage in a pharmaceutical company. The documents required in QMS include but are not limited to standard operating procedures, batch manufacturing records, batch processing records, validation protocols and log books. In addition, by establishing controlled process for document distribution, document versioning and document archiving an organization can prevent the loss of data and errors through the documentation process.4. Change Control
Whenever there is a change in process, equipment or material, a documented change control procedure must be followed. All changes will require an evaluation of their impact on the product quality and must be approved by Quality Assurance department as well as validated before its implementation.5. Deviation Management
Any deviation from an approved procedure must be reported immediately. All deviations must have an investigation completed and the root identified and corrective and preventive actions documented in the CAPA system.6. Risk Management Plan
Risk management is the identification of risk of potential failures that may affect product quality. Methods such as failure mode and effects analysis (FMEA) and fishbone analysis are effective tools in identifying and mitigating risk to assure product quality.7. Training and Competency
GMP and technical training must be provided to all personnel based upon their assigned responsibilities on a periodic basis. Training records must be kept and the effectiveness of training must be evaluated and documented.8. Internal Audits and Self-Inspections
SOPs and GMP standards must be audited to determine compliance with those requirements by scheduled audits within all departments of the plant. Finding of audits must be categorized critical, major and minor and the status of the CAPA must be tracked until closure.9. Supplier Qualification
Vendors that supply raw materials, packaging materials or service must be qualified based upon risk assessment and historical vendor performance. Approved vendor list should be maintained and reviewed periodically.10. Product Quality Review (PQR)
Annual product quality reviews assess process performance, deviations, customer complaints and performance consistency. In addition, PQRs provide valuable insight into potential areas for development and highlight trends.11. Validation and Qualification
Validation confirms that a process, method or system has consistency and delivers the desired outcome. Validation includes process validation, cleaning validation, computer system validation and computer software validation this may include validation of software that is used to run a device or instrument.12. Complaint Handling and Recall
The quality management system must include a defined procedure for receiving documenting investigating and responding to the product complaints. Recall systems must also be tested at regular intervals to ensure that the product can be removed rapidly and completely from the market. This is an essential step in ensuring the health and safety of the customer.Implementation of QMS in Pharmaceuticals
Step 1: Gap Assessment
Evaluate current quality management system's status and identify gaps, weaknesses, or areas in need of improvement against GMP and ICH Q10 guidance documents.Step 2: Develop QMS Framework
Prepare a draft of the QMS that includes policies, procedures and responsibilities. Create a quality manual and create the necessary SOPs to support the quality manual.Step 3: Training and Awareness
Educate all levels of staff regarding the objectives and requirements of QMS including documentation and responsibilities and create a culture of quality first.Step 4: Establish Documentation System
Create a structured documentation system using controlled templates of SOPs formats and records. Where possible implement an electronic document management system.Step 5: Implement Change Control, Deviation, and CAPA
Establish real time reporting and approval process. Establish links between your QMS tool such as audit tracking and risk assessments. Establish a system for performing regular QMS compliance audits, internal audits of each department with corrective action follow up.Step 6: Conduct Internal Audits
Conduct regular audits of each department and the documentation of the flow of corrective actions and compliance verification.Step 7: Management Reviews
Conduct management review for the quality management system performance, deviations, trends and opportunities for improvement periodically.Quality Culture and Its Importance
A quality management system is only as good as the environment in which it operates. The best way to maintain product integrity is to develop a corporate culture of quality that encourages employee at all levels to understand their responsibilities.Key Components of Quality Culture
1. Open communication and reporting deviations2. Leadership involvement in daily quality activities
3. Encouraging teamwork across departments
A fully developed quality culture makes compliance a daily practice, not just a box to check.
Download QMS Compliance Checklist
Digitalization of QMS
The use of Electronic Quality Management Systems (eQMS) is being adopted by many of today’s pharmaceutical companies to increase productivity and improve traceability by employing Digital Systems for the management of CAPA, training records, audit scheduling and deviation management. Companies can eliminate the manual oversight that has been traditionally associated with these processes and allowing the real time compliance and decision making.Master Control, TrackWise, Veeva Vault QMS, and Sparta Systems are amongst the most utilized eQMS applications within the pharmaceutical industry.
Continuous Improvement
The improvement of quality management system is an ongoing process. Improvement tools (Kaizen, Six Sigma, PDCA) provide organizations a great support to identify and eliminate inefficiencies within their operations.Examples of performance measurement tools include deviation rate, CAPA closure time and audit findings. These key performance indicators (KPIs) enable organizations to assess their quality management system (QMS) effectiveness.
The foundation of GMP compliance in pharmaceutical is an effective Quality Management System (QMS). The QMS establishes controls over all processes related to pharmaceuticals including raw material sourcing through product release process.
As the regulatory environment continues to evolve so the expectations of regulatory agencies from pharmaceutical companies are increasing for GxP compliance. The data based on risk based QMS approach will enable pharmaceutical companies to maintain compliance with GxP regulations and continue to remain globally competitive.
By incorporating QMS within the organization’s culture pharmaceutical manufacturers can achieve their business objectives by providing safe, effective and good quality medicines to patients globally.
gOOD , USEFUL ONE
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