Illustration of Pharmaceutical Products

Pharmaceutical Quality Management System (QMS)

by | Aug 11, 2021 | QMS

Pharmaceutical Quality Management System (QMS) is a set of procedures and practices that contribute to product quality.

It targets individual processes and personnel involved in product manufacturing and prevents them from drifting away from quality standards such as ISO and ICH Q10.

For example, process validation studies of the pharmaceutical drugs contain data that is used to verify whether the drug manufacturing is carried out according to the quality steps. This ensures that the final product contains all the attributes of a high-quality product.

Here’s everything you’ll learn:

What is Pharmaceutical Quality Management System (QMS)?

A Pharmaceutical Quality Management System (QMS) develops and ensures quality procedures in various product life cycle stages such as manufacturing and product testing.

It includes all the critical stages of drug manufacturing, including:

  • Formulation
  • Method development
  • Facilities
  • Utility system
  • Equipment

It ensures that the final product is according to customer requirements, as well as regulatory requirements to which the manufacturer is obliged to follow. It uses monitoring methods such as Quality Assurance to prevent quality deviation and emphasize documentation to record all problems and their solutions.

Applicable Pharmaceutical QMS Regulations and Standards

The Quality Management System (QMS) is not a standard of its own. Its definition, applicability, and practical implementation rely on other approved standards. It’s the organization’s responsibility to adopt the relevant standards, which depend on many factors, including geographical location, product type, and target market.

Some of the most common standards and regulations applicable to the Pharmaceutical Quality Management System (QMS) are described below.

International Organization for Standardization (ISO)

The ISO is an international body involved in developing standards in various industries, including the Pharmaceuticals. The current standard for Quality Management System (QMS) is ISO 9001:2015, and previously it was ISO 9001:2005.

The ISO is not involved in the inspection and certification process. Instead, independent contractors inspect organizations for compliance with ISO standards.

The ISO’s Committee on Conformity Assessment (CASCO) is the ISO representative for developing standards for the certification bodies involved in the ISO certification process.

Current Good Manufacturing Practice (cGMP)

cGMP is a regulation enforced by the Food and Drug Administration (FDA), the US federal agency is responsible for safe production of drugs. The cGMP focuses on the manufacturing process.

The product must be safe for human consumption, with quantity, quality, and purpose taken into consideration. The output must be free from contamination, risk, and most importantly, prevent mix-up of one product with another product.

The FDA inspects its accredited manufacturers for cGMP compliance. If FDA finds non-compliance with cGMP regulation and serious drug adulteration, the manufacturer is directed to recall the product. Failure to follow the subsequent FDA directions can result in seizure, fines, and jail time.

ICH Guideline Q10 on Pharmaceutical Quality System

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a non-profit association under Swiss law. The ICH comprises professionals from both the manufacturing sector and regulatory bodies.

The ICH consists of many Pharmaceutical guidelines such as:

  • Validation
  • Impurities
  • Risk management

These quality guidelines are designated by the combination of letter Q and specific numbers, such as Q8, Q9, etc.

The Q10 guideline is for the Pharmaceutical Quality System.

It does not intend to establish separate enforcement for the pharmaceutical quality systems. Instead, it provides a consolidated structure for the quality procedures based on established standards, including:

  • ISO
  • cGMP
  • ICH Q8 Pharmaceutical Development
  • ICH Q9 Quality Risk Management

21 CFR Part 211

21 CFR are FDA guidelines for cGMP compliance, and 21 CFR Part 211 includes the cGMP requirements for finished Pharmaceuticals.

Areas this regulation covers are the following:

  • Quality control
  • Qualification and skills of the personnel involved
  • Quality buildings and facilities
  • Ventilation and filtration system
  • Process equipment
  • Product labels
  • Warehouse requirements

21 CFR Part 11 for Electronic Records and Electronic Signatures

Industrial automation systems have allowed recording process variables automatically, without human involvement. The automated recording has the advantage of accuracy and restricts tampering of data.

The 21 CFR Part 11 is a set of rules that describes how electronic records are developed, maintained, and stored. It describes the ways of authorizing these documents by the relevant supervisors, alternate to manual signatures.

Core ISO Principles of Quality Management System (QMS)

According to the ISO, there are seven quality management principles (QMPs).

An organization doesn’t need to adopt all of these, but it depends on the individual organization’s process requirements.

Illustration of Core ISO Principles of Quality Management System (QMS)

QMP 1 – Customer Focus

The first principle focuses on the customer.

The process should be optimized enough to meet existing customers’ requirements by delivering value for their money. This keeps the customer loyal and increases the company’s revenue by attracting new customers. The company should remain updated on the customer needs, expectations and complaints.

QMP 2 – Leadership

The leadership principle helps to set the organization’s direction towards success and facilitates other people to achieve these goals. It is responsible for setting quality goals for achieving high product quality.

It is also responsible for harmonization between all departments and personnel through open and accessible communication. It provides training opportunities following the latest development and regulatory requirements.

The leadership’s role in establishing a pharmaceutical quality management system is summarized below.

  • Commitment: The leadership principle is responsible for establishing QMS and defines the roles and responsibilities of individuals in implementing a QMS.
  • Quality Policy and Quality Planning: The leadership is responsible for establishing, and reviewing Quality Policy in line with the company’s direction and objectives.
  • Resource Management: The leadership provides adequate resources to implement the quality and ensures that resources are not being misused or wasted.
  • Communication: The leadership ensures effective communication across all the departments and functions.
  • Review: The leadership should review and assess the process performance and product quality.

QMP 3 – Engagement of People

People’s engagement is necessary at all levels by recognizing and respecting them. People can be engaged in discussion with knowledge sharing across all levels of the employee hierarchy.

One of the effective ways to judge people’s engagement is by conducting surveys indicating people’s satisfaction levels and their commitment to the overall process and product quality.

QMP 4 – Process Approach

This Quality Management Principle (QMP) requires that the quality objectives of an organization should be implemented on an individual step rather than as an actual outcome.

It starts by defining interrelated steps that impact the performance of each other. The system is analyzed for possible risks affecting the system on an individual basis and as a whole.

QMP 5 – Improvement

Improvement should focus on all levels of the organization, and people should be aware of new trends in the pharmaceutical industry mainly in areas like regulatory affairs and product development.

The management should review QMS objectives. It should track the performance of pharmaceutical QMS by adopting systems such as:

  • CAPA
  • Feedback system
  • Risk assessments
  • Regulatory body reports
  • Supplier audits

QMP 6 – Evidence-Based Decision Making

This principle relies on the objective and realistic approach in making decisions across various processes. Real-world processes are full of uncertainties with vulnerabilities, creating confusion for the decision-makers.

Before taking any decision, it is important to ensure all the data points are accurate by evaluating these data points. People carrying out the data analysis must be experts in using various techniques and can identify relevant data from irrelevant information.

QMP 7 – Relationship Management

The organization’s success is directly dependent on its relationship with all its interested parties, such as the suppliers. A good relationship creates common goals, increases opportunities for each other, and facilitates a healthy relationship.

Each party has a different impact level, so it’s important to prioritize the relationship level. Start by focusing on short and long-term goals. Collaborate with the important parties by sharing information, resources, and expertise. Give them feedback and propose ways of improvement.

Elements of Pharmaceutical Quality Management System

There are four elements of a Pharmaceutical Quality System. The drug manufacturer can incorporate these elements as per product life cycle requirements, and there is no fixed scheme for applying these elements.

The four elements are:

  • Process performance and product quality monitoring system
  • Corrective action and preventive action (CAPA) system
  • Change management system
  • Management review of process performance and product quality

Process Performance and Product Quality Monitoring System

The process monitoring system is an integral part of an organization’s efforts in delivering a quality product. It shows the company’s commitment to sustained resources and control.

Risk assessment techniques can be used to detect shortcomings in-process components. Specialized tools and feedback can also be used to perform analysis on given parameters.

An example could be detecting faults with the inspection system in Blister Packaging Machines. The inspection system is designed to detect empty pockets. Sometimes external factors affect the system, such as the accumulation of dust particles on the camera lens. In this case, the inspection system can accept all or just some empty blisters.

The inspection system is checked randomly by both production personnel and the Quality Department to identify faults or malfunctions.

Luckily, a tool like Issue Management Software by SimplerQMS, automates data collection, routing, and escalation of overdue activities. This makes the performance and safety monitoring of your products and processes much easier.

Corrective Action and Preventive Action (CAPA) System

Corrective Action and Preventive Action (CAPA) is a system for identifying the causes of the fault and preventing them from recurring in the future. The CAPA can be applied in case of complaints from both inside and outside the organization.

The CAPA structure and format can be different from organization to organization, but mainly it consists of the following information:

  • The department where process deficiency is found
  • Fault detail and its implications
  • A possible effect of fault on process or product
  • Corrective Action to remove the problem
  • Preventive action to prevent recurrence of the fault
  • Due date to implement the corrective and preventive actions
  • Next review date to assess the effectiveness of corrective action

See the illustrated CAPA process below.

CAPA Process Illustration

After necessary Corrective and Preventive actions are applied, the CAPA is sent again to auditors for approvals. Upon approval, the CAPA is closed, and the format is made part of the records.

For example, during a routine audit, the Job Description (JD) of one of the employees was out of date. The auditors initiated CAPA and gave time to make the JD available in the department. The respective department contacted the Human Resource (HR) department regarding the JD. When JD was available, the respective department filled the CAPA by stating the problem and proposing corrective action to avoid a similar condition in the future. The CAPA was presented to the auditors for approval. After approval, the CAPA format was made part of the records presented to regulatory bodies upon investigation.

The process presented in the example above can easily be automated with CAPA Management Software. It automates data collection, routing, follow-ups, notifications, approvals, and escalation of overdue activities allowing you to manage Corrective and Preventive Actions more effectively.

Change Management System

Different standards such as ISO and ICH promote innovation in existing processes to increase product quality. Pharmaceutical companies must have Change Management System to study, monitor, adapt, and approve the change.

If the change is implemented after regulatory filings, the change in the respective process or procedure is submitted to the regulatory body for review and approval, as per the regulations.

For example, the supply chain department proposes to change the packaging size to reduce logistics costs. The quality department analyzes the packaging requirement in light of accredited regulatory bodies and approves the change. The engineering department analyzes the current equipment and its system to apply the change. After approvals from these departments supply chain orders the new packaging material size to implement in a small number of products. When these small quantities of products are prepared, the supply chain checks for its success and communicates it to all relevant departments.

After approval from the supply chain, the production department updates its standard operating procedure (SOP) and communicates it to the Quality and Engineering department. The change is made official in change control format, with necessary approvals from the Production, Quality, and Engineering departments. The change is then reviewed by higher management to made part of the company’s policy and process.

Fortunately, Change Management Software by SimplerQMS makes the change management process a whole lot easier. It allows you to automatically track changes to SOPs, instructions, products, and product processes. Using the software, you can easily send changes through the approval process, and ensure that changes are implemented.

Management Review of Process Performance and Product Quality

Management review is a process of reviewing process and product quality across various management hierarchy levels to escalate urgent quality and product problems. The purpose of management review is to propose improvements in product quality and process.

The management review includes the following:

  • The commitment made to regulatory bodies
  • Customer complaints
  • Nonconformances
  • CAPA review
  • Audit findings
  • Process performance
  • Any pending matter or follow-up from previous management review

After the management review issues are typically escalated to improve a specific area of business.

Illustration of Process Performance Management Review

How to Streamline Your QMS Processes with an eQMS

The digital revolution in manufacturing industries has paved the way for more production with less cost and time. Digital tools can take care of routine processes without comprising product quality, allowing the company owners to focus more on innovation and exploring new avenues.

The manufacturing industry is already used to digital tools such as Computerized Maintenance Management System (CMMS) and Warehouse Management System (WMS). These tools are effectively streamlining processes with a proven track record, and the latest addition is Electronic Quality Management System Software for the pharmaceutical industry or an eQMS.

Unlike other digital tools such as CMMS, where there are no or fewer regulatory requirements, pharmaceutical Quality Management System Software must comply with the regulatory requirements applicable for pharmaceutical companies. Failure to which would make such a platform useless or even shut down manufacturing operations.

SimplerQMS provides a fully compliant Electronic Quality Management System (eQMS) for the pharmaceutical industry. This means you don’t have to worry about different compliance requirements or spend extra effort to make your eQMS regulatory compliant.

The eQMS developed by SimplerQMS is built on the foundations of ISO core principles. It is compliant with all the relevant regulatory and standards such as cGMP, ICH Q10, 21 CFR Part 211, and 21 CFR Part 11 for electronic records and electronic signatures.

Additionally, you don’t have to validate the eQMS against the above-stated standards. SimplerQMS platform is pre-validated and validation proof can easily be presented during audits or inspections.

SimplerQMS Quality Management System Software solution for pharmaceutical companies can be easily integrated into existing software solutions such as ERP, CMMS, and WMS. This means you do not have to spend an extra resource or upgrade existing software systems that are already installed without disturbing your routine operations and working.

To see SimplerQMS Quality Management Software in action and learn how it can help your organization achieve better quality management processes book a free demo!

Final Thoughts

The pharmaceutical industry is regulated by many regulatory and standardization bodies with a wealth of information and skills. Accreditation or approval of these bodies means the organization has sufficient resources and capabilities to manufacture safe, efficient, and quality products.

Accreditation or approval of these bodies is not an easy task. It requires massive investment in capital, infrastructure, and the human workforce. Furthermore, it requires the right skill, knowledge, and expertise. All this is necessary to manufacture quality pharmaceutical products and acquire regulatory bodies’ approval by complying with their compliance requirements.

A digital tool like an Electronic Quality Management System (eQMS) from SimplerQMS provides a helping hand to pharmaceutical professionals to focus more on problem-solving rather than routine documentation processes.

eQMS Business Case Template

Illustration of Non Conformance Report Template