Pharmaceuticals Quality Management

System
A quality management system (QMS) can be defined as a set of policies, processes, and

procedures required for planning and execution (production/development/service) in the

core business area of an organization. A QMS integrates the various internal processes

within the organization and provides a process approach for project execution. The QMS

enables organizations to identify, measure, control, and improve the various core business

processes, which ultimately leads to improved business performance.

The design and implementation of a QMS will vary depending on the type, size, and

products of the organization. Implementing a QMS within an organization needs to be a

decision by top management. Continued support by top management is critical to the

ongoing success of the QMS.

The objectives of the QMS need to be clearly defined so that the system can be effective.

QMS objectives must be measurable and reflect the overall company objectives. The

QMS must be managed properly, and adequate resources must be allocated. The system

must be practical and accessible to all employees within the organization. The system

also must be reviewed regularly and measured for effectiveness, and adjustments must be

made to reflect major changes to the organization and business practices.

Each company will have its own objectives for implementing a QMS; however,

enhancing company effectiveness and profitability are often cited as primary drivers for

implementation. A QMS can assist a company by managing costs and risks, increasing

effectiveness and productivity, identifying improvement opportunities, and increasing

customer satisfaction. A well-managed QMS will have an impact on customer loyalty

and repeat business, market share, operational efficiencies, and flexibility and the ability

to respond to market opportunities. It also helps in the effective and efficient use of

resources and reducing costs, provides competitive advantages, and can increase

participation and motivation of human resources, industry reputation, and control on all

processes.

ESTABLISHING A QUALITY MANAGEMENT SYSTEM

A QMS must ensure that the products/services conform to customer needs and

expectations and, at the same time, meet the objectives of the organization. Factors to be

considered when setting up a QMS include design and build, deployment and

implementation, control, measurement, review, and improvement.

Design and build include the structure of the QMS, the process, and its implementation.

The design should be led by senior managers and ideally is accomplished using a

framework to lead the thinking. Design of the QMS should result from determining the

organization’s core processes and well-defined goals and strategies, and be linked to the

needs of the stakeholders. The process for designing and building the QMS must be clear.

The quality function plays a key role in the design and build of the QMS, but

involvement and buy-in to the system must come from all other functions as well.

Deployment and implementation are best achieved using process packages, where each

core process is broken down into subprocesses and described by a combination of

documentation, education, training, tools, systems, and metrics.

Control of the QMS will depend on the size and complexity of the organization. Local

control, where possible, is effective, and good practice is found where key stakeholders

are documented within the process and where the process owner is allowed to control all
of the process. Ideally, process owners/operators are involved in writing the procedures

that document the QMS.

Measurement determines the effectiveness and efficiency of each process toward

attaining its objectives. It should include the contribution of the QMS to the

organization’s goals, and could be achieved by measuring policy definition completeness,

business coverage, reflection of policies, deployment, usage, opinion regarding

helpfulness of the QMS by staff, speed of change of the QMS, and relevance of QMS

architecture to the job at hand. A form of scorecard deployed throughout the organization

down to the individual objective level can be used, and the setting of targets at all levels

is vital.

Review of the effectiveness, efficiency, and capability of the QMS is vital, and the

outcome of these reviews should be communicated to all employees, including senior

management. Reviewing and monitoring should be conducted whether or not

improvement activities have achieved their expected outcomes.

Improvement should follow as a result of the review process, with the aim of seeking

internal best practice. It is part of the overall improvement activities and an integral part

of managing change within the organization.

QUALITY MANAGEMENT SYSTEM PRINCIPLES

ISO 9001:2008 (Quality management systems—Requirements) is an internationally

recognized standard that specifies the requirements for a QMS that may be used by

organizations for internal application, certification, or contractual purposes.

ISO 9001:2008 and ISO 9004:2009 (Managing for the sustained success of an

organization—A quality management approach) are QMS standards that complement

each other, but also may be used independently. ISO 9001 emphasizes a need for

management commitment, customer focus, a quality policy, quality planning,

communication of responsibility and authority, and the need for a review of the

organization’s QMS.

Monitoring of customer satisfaction is necessary to evaluate and validate whether

customer requirements have been met. Reference is made in the standard to a

methodology known as plan–do–check–act (PDCA) that can be applied to all processes.

The standard suggests that an effective QMS must be a strategic tool designed to deliver

business objectives and must have, at its core, a process approach, with each process

transforming one or more inputs to create an output of value to the customer. The key

business processes may be supported by procedures and work instructions in those cases

where it is judged necessary to rigidly define what rules are to be followed when

undertaking a task. Most organizations will have core business processes that define

those activities that directly add value to the product or service for the external customer,

and supporting processes that are required to maintain the effectiveness of the core

processes.

The understanding of the many interrelationships between these processes demands that a

systems approach to management is adopted. The processes must be thoroughly

understood and managed so that the most efficient use is made of available resources to

ensure that the needs of all the stakeholders—customers, employees, shareholders, and

the community—are met.

Customer satisfaction is a constantly moving target depending on changes in technology

and the marketplace, so an effective QMS must be in a state of continual improvement.

For this goal to be achieved, attention needs to be given to both the voice of the customer

—through complaint analysis, opinion surveys, and regular contacts— and the voice of

the processes—through measurement, monitoring, and analysis of both process and

product data.

QUALITY MANAGEMENT SYSTEM PRACTICES

Audits, Reviews, and Assessments

A good QMS will not function or improve without adequate audits and reviews. Audits

are done to ensure that actual practices adhere to documented procedures. System

reviews should be done periodically and methodically to ensure that the system achieves

the required effect.

A schedule for audits, with different activities requiring different frequencies, should be

established. An audit should not be conducted solely for the purpose of revealing defects

or irregularities; it should be conducted to establish the facts rather than to find fault.

Audits may indicate necessary improvement and corrective actions, but also are intended

to determine whether processes are effective and responsibilities have been correctly

assigned. The emphasis on process improvement and enhancing customer satisfaction in

the revised ISO 9001:2008 standard will require a more thoughtful approach to auditing.

Typically, a QMS review should take place once a year, and should cover:

• Results of audits

• Customer feedback

• Process and product conformity

• Status of preventive and corrective actions

• Follow-up actions from previous management reviews

• Changes that could affect the QMS

• Recommendations for improvements

Outputs should include improvements to the QMS and processes, product improvements

related to customer requirements, and identification of resource needs. In addition, the

procedures for conducting audits and reviews, and the results from them, should be

documented and be subject to review. Internal system audits and reviews should be

positive and conducted as part of the preventive strategy, and not as a matter of

expediency resulting from problems.

The assessment of a quality system against a standard or set of requirements by internal

audit and review is known as a first-party assessment or approval scheme. If an external

customer makes the assessment of a supplier against its own requirements, or a national

or international standard, a second-party scheme is in operation. The assessment by an

independent organization, not connected with any contract between the customer and

supplier, but acceptable to them both, is an independent, third-party assessment scheme.

ICH Q10: Pharmaceutical Quality System

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality

management system that is based on International Organization for Standardization (ISO)

quality concepts, includes applicable good manufacturing practices (GMP) regulations,

and complements ICH Q8 Pharmaceutical Development and ICH Q9 Quality Risk

Management.

ICH Q10 is a model for a pharmaceutical QMS that can be implemented throughout the

different stages of a product life cycle. Much of the content of ICH Q10 applicable to

manufacturing sites is currently specified by regional GMP requirements and ICH Q7

Good Manufacturing Practice Guidance for Active Ingredients.

ICH Q10 demonstrates industry and regulatory authorities’ support of an effective

pharmaceutical QMS to enhance the quality and availability of medicines globally in the

interest of public health. Implementation of ICH Q10 throughout the product life cycle

should facilitate innovation and continual improvement and strengthen the link between

pharmaceutical development and commercial manufacturing activities. The elements of

ICH Q10 should be applied in a manner that is appropriate and proportionate to each of

the product life cycle stages, recognizing the differences between, and the different goals

of, each stage