QMS 101: Pharmaceutical Quality Management System

Jan 2, 2023 | 0 comments

Pharmaceutical quality management system

When people use the term Quality Management System, or QMS, they are usually referring to an integrated set of forms and processes used to track complaints, incidents, issues or problems from the time they arise until they are resolved. 

A QMS is used to manage and track the process from the initial incident (the “deviation”) right through the implementation of a fix, which is the “corrective action” and is documented in a “change control”. While all of the steps and forms that comprise a QMS can be paper-based, the process is much easier to manage with a computer-based system.

A computer-based QMS application automates each step, and manages the workflow between each step. A key concept is that the system ensures a “closed loop” process, which means that every deviation is ultimately resolved and connected to a change control if there is a need for a corrective action.

Automated QMS systems have been around for quite some time (since the 1990’s) but the older legacy systems are expensive, cumbersome and generic, meaning they are not designed specifically for life sciences. A modern QMS designed for the specific needs of the pharma industry is much more effective for addressing the unique requirements of life sciences companies and addressing the specific regulatory requirements of the pharma industry.

The term GMP is an important concept in the world of pharma quality managers. It refers to good manufacturing practice, which in turn refers to a set of regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. Quality managers in the pharma world are required to meet GMP standards.

Quality management systems are indispensable to pharma, biotech, and medical device companies. The level of quality provided by QMS guarantees that every aspect of the drug development process, from initial formulations to finished product specifications, is performed with a high standard for quality and regulatory compliance.

What is a pharmaceutical quality management system?

A pharmaceutical quality management system (QMS) is a set of interconnected processes and activities designed to cater to the needs of life sciences companies. A pharmaceutical QMS can be used for quality control operations during every step of a product’s life cycle.

Thanks to QMS, organizations can track complaints, incidents, issues, or problems from the time they arise until they are resolved. Traditionally, the standard for quality management operations has been to record QMS information in paper documents. However, QMS electronic records can also be handled via quality management software.

Quality management software solution

What are the benefits of using a QMS for pharmaceutical companies?

Pharma companies that adopt QMS software can manage external and internal processes more efficiently and enjoy higher quality standards. QMS supplies a reliable source of truth that is easy to access, review, and maintain.

Deviations

To create high-quality products and services, pharmaceutical manufacturers must always keep a vigilant eye on deviations. A deviation is a difference between an observed value from what that value was expected to be. It is important to notice deviations and correct them so the project can continue according to plan.

When using paper documents or legacy QMS, there isn’t a specific solution to deal with quality concerns. Defective products and other quality deviations must be physically documented and monitored. If deviations go unnoticed, they can cause disruptions to the manufacturing process, the supply chain, and the general public’s quality standards. Likewise, they can lead to heavy fines and to products being removed from the market.

On the other hand, pharma QMS software has built-in technology designed to simplify dealing with deviations. The purpose of deviation management software is to identify, assess, and correct any event that intercedes with approved instructions or established standards.

Deviations may come from a vast array of sources. For instance, when sampling and testing raw materials or during the manufacturing process of a finished product. An organization that doesn’t have a pharmaceutical quality system capable of recognizing deviations is at a serious disadvantage.

Investigations

To conduct a proper risk assessment, it is important to investigate when an issue first arises and document the process of correcting it. Pharmaceutical organizations can use QMS software to receive the information required to deal with deviations.

Usually, a deviation report will be needed for minor, isolated issues that can be kept under control without much effort. Nonetheless, one may also be faced with more serious deviations such as product safety concerns or accidental GMP violations. All pharmaceutical companies should strive to keep accurate information in order to be prepared for any unforeseen event.

Corrective and Preventive Actions (CAPA)

Corrective actions and preventive actions are performed to improve an organization’s processes and properly deal with deviations. For a CAPA strategy to be successful, it must not only solve deviations and other possible issues but must also put solutions in place that will avoid the recurrence of inconveniences in the future.

During a CAPA process, the scope of the issue at hand is analyzed, its root causes determined, and solutions are brought to the table. It is important for a CAPA strategy to be deployed as fast as possible to swiftly put a project back on track.

Change Control

The change control process consists of a set of coordinated activities used to implement necessary changes. For instance, if a production department requires to change the packaging of a finished product, a change control process will be used to make it happen.

A pharmaceutical QMS can be used to create seamless change control management processes. Electronic QMS features like automatic data collection can be used to obtain complete visibility of projects. Various types of information, including control change records, deviations, risks, customer complaints, CAPA data, and audit findings, can be made readily available through a digital QMS.

What are the key capabilities of a modern QMS software application?

A modern QMS software application is tailor-made to handle deviation management as well as corrective actions, preventive actions, and change control initiatives. Likewise, the app can keep accurate records of all processes to enhance record-keeping, compliance, and visibility

Deviations

To create high-quality products and services, pharmaceutical manufacturers must always keep a vigilant eye on deviations. A deviation is a difference between an observed value from what that value was expected to be. It is important to notice deviations and correct them so the project can continue according to plan.

When using paper documents or legacy QMS, there isn’t a specific solution to deal with quality concerns. Defective products and other quality deviations must be physically documented and monitored. If deviations go unnoticed, they can cause disruptions to the manufacturing process, the supply chain, and the general public’s quality standards. Likewise, they can lead to heavy fines and to products being removed from the market.

On the other hand, pharma QMS software has built-in technology designed to simplify dealing with deviations. The purpose of deviation management software is to identify, assess, and correct any event that intercedes with approved instructions or established standards.

Deviations may come from a vast array of sources. For instance, when sampling and testing raw materials or during the manufacturing process of a finished product. An organization that doesn’t have a pharmaceutical quality system capable of recognizing deviations is at a serious disadvantage.

Investigations

To conduct a proper risk assessment, it is important to investigate when an issue first arises and document the process of correcting it. Pharmaceutical organizations can use QMS software to receive the information required to deal with deviations.

Usually, a deviation report will be needed for minor, isolated issues that can be kept under control without much effort. Nonetheless, one may also be faced with more serious deviations such as product safety concerns or accidental GMP violations. All pharmaceutical companies should strive to keep accurate information in order to be prepared for any unforeseen event.

Corrective and Preventive Actions (CAPA)

Corrective actions and preventive actions are performed to improve an organization’s processes and properly deal with deviations. For a CAPA strategy to be successful, it must not only solve deviations and other possible issues but must also put solutions in place that will avoid the recurrence of inconveniences in the future.

During a CAPA process, the scope of the issue at hand is analyzed, its root causes determined, and solutions are brought to the table. It is important for a CAPA strategy to be deployed as fast as possible to swiftly put a project back on track.

Change Control

The change control process consists of a set of coordinated activities used to implement necessary changes. For instance, if a production department requires to change the packaging of a finished product, a change control process will be used to make it happen.

A pharmaceutical QMS can be used to create seamless change control management processes. Electronic QMS features like automatic data collection can be used to obtain complete visibility of projects. Various types of information, including control change records, deviations, risks, customer complaints, CAPA data, and audit findings, can be made readily available through a digital QMS.

Why is a quality management system important in the pharmaceutical industry

Enhanced quality assurance

A good quality management system guarantees that operations will run smoothly. Even in times when unforeseen risk management is needed, an efficient QMS solution will lend a hand by outlining and portraying information relevant to the issue at hand.

Because a QMS keeps accurate records of every procedure, it is ideal to certify good quality assurance practices during the whole product development process. Every party involved in the production and control of drugs, from the quality control department to regulatory inspectors, benefits from the existence of a reliable QMS.

Regulatory compliance

Many regulatory bodies, such as the Food and Drug Administration (FDA), consider QMS to be critical to life sciences companies. It is important to always have an up-to-date QMS, ready for auditing and any other quality control procedures.

Quality management is one of the main principles outlined by the Good Manufacturing Practices (GMP). The GMP is is a set of regulatory requirements created to ensure the integrity of the healthcare industry. The GMP sets specific industry standards to nullify the sale of products of inadequate safety, quality, efficacy, purity, or identity.

However, dealing with the required GMP paperwork by hand can be a challenging ordeal. Manually filling and reviewing every document is a repetitive and time-consuming task. A key advantage of QMS software is that it can handle those procedures automatically, thus saving health care professionals a considerable amount of time and effort.

The continual improvement of operations

We are living in a period of time where operational efficiency and cost-effectiveness are indispensable to succeed in the market. Traditional quality manual procedures take away valuable time and energy from the hands of staff and lengthen the time it takes to handle operations. The digital transformation of quality management systems helps life sciences companies take a bold step into the future without being overburdened by an ever-growing number of challenges.

QMS software eliminates duplicate or unnecessary documentation. Additionally, it reduces the number of critical processes as well as the time it takes to accomplish them. By reaping these benefits, pharma companies gain access to considerable improvement opportunities. A life sciences company can design strategies to improve its quality policies, quality objectives, document control capabilities, compliance standards, company morale and active participation, and much more.

Pharmaceutical quality management system software

The implementation of state-of-the-art pharmaceutical quality management software offers senior management improved quality control, helps staff perform their duties, simplifies regulatory action, and creates an environment with a high level of quality.

Agatha Quality is the ideal QMS for life sciences. The improvements it brings to the table help accelerate trials, improve the results of clinical studies, and positively influence product quality. As a complete, ready-to-use quality management application, Agatha Quality can capture deviations, document corrective and preventive actions, and manage change control processes seamlessly. The system combines forms, frameworks, documents, and workflows to provide a complete toolset for effective quality management.

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