What is Pharmaceutical Quality Assurance?

Pharmaceutical Quality Assurance is the assurance of quality requirements for a product or service in the pharmaceutical industry. Quality assurance aims to create and maintain customer confidence in the product, and the goal is to detect defects early or to prevent them. 

Quality assurance in the pharmaceutical industry is a continuous process that focuses on the constant review of customer requirements. A variety of methods can support this process, but it is also important to note that quality assurance shall not result in any high additional costs for the company. The pharmaceutical quality assurance focus is also to reduce costs through quality, and every action taken to assure quality must follow the applicable standards and laws.

Pharmaceutical quality assurance: FDA’s quality unit expectations

After a regulatory inspection, we often find ourselves receiving Inspectional Observations and Warning Letters that state that we failed to comply with the responsibilities of the quality control unit. Why does this happen, even though we have the most advanced control systems in place?

In most cases, these non-conformities result from misunderstanding the Quality Unit’s responsibilities and scope. In other words, we may have a quality unit performing its activities differently than expected, the performed activities may or may not be according to the cGXP practices, or we may have a quality unit overstepping other units’ activities.

To better understand this, we have to look at the definition of the quality unit activities according to the FDA and GMP guidelines, which are to create, monitor, and implement a quality system.

“QA primarily involves (1) review and approval of all procedures related to production and maintenance, (2) review of associated records, and (3) auditing and

performing/evaluating trend analyses.”

According to the FDA’s “Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.”

“Quality should be built into the product, and testing alone cannot be relied on to ensure product quality.” 

Therefore when we receive these letters, the FDA inspectors have detected inefficiencies in our process that fail to demonstrate a set of behaviors needed to ensure quality is maintained through the process. These are:

• Implementing and completing controls effectively during operations
• Ensuring procedures and specifications are proper and followed, including those used by contractors.
• Approving or rejecting in-process materials, incoming materials, and drug products
• Reviewing production records and investigating unexplained discrepancies, if any. 

Functions of quality assurance

Quality assurance can take place both internally and externally by a third party; either way, an organization usually defines its quality requirements and develops corresponding specifications and measures. 

The pharmaceutical quality assurance activities should guarantee that the defined quality requirements are being met from the early stages (design) of a new product to the end stages (after-sale service). QA must take place over the entire process. Thus some of the main functions of QA are:

1. Technology transfer

This function involves the description of the productive and administrative activities to be carried out in the value chain, the review of all work steps, the definition of tests, measurements, and assurance procedures, all training measures to qualify employees, guidelines, and norms relating to production conditions, safety, and hygiene standards.

2. Documentation

This function consists of the overview and control of how records are transmitted and archived throughout the value chain. Moreover, it consists of documenting every measure and step taken to preserve the product’s quality.

3. Quality management programs

This function focuses on creating programs to ensure that the products meet the right quality standards and the investigation of any discrepancies.

4. Assurance of the quality of the product

This involves making sure that products meet the quality standards prescribed through activities such as; the initial sampling of the products purchased from suppliers and the release of the production process running there, supplier evaluation concerning delivery quality, delivery reliability, adherence to delivery dates, etc., the incoming goods inspection, statistical process controls, the test equipment management to ensure the use of suitable measuring and test equipment. 

5. Validation

This function consists mainly in enforcing a validation plan and verifying the completion of the resource planning.

The risks of poor-quality assurance in the pharmaceutical industry

Usually, we understand the risks and consequences of poor product quality, which, as expected, always leads to dissatisfied customers and, in the worst cases, the death of patients, which leads to a bad image and the resulting declining business figures. Still, the risks and consequences of poor quality assurance, or in other words, poor company and process quality, are more challenging to grasp as their effects are often only noticeable in the medium and long term.

Poor quality assurance can jeopardize a company’s economic success, as constant changes in the execution and process planning often result in additional work and costs. 

Thus, some consequences of poor quality assurance include loss of business, loss of liability, loss of productivity, and increased costs.

Remember that quality assurance does not exist to create more bottlenecks in the value chain; the main purpose of quality assurance is to reduce time and costs through the quality of the processes.

Here are some signs that may help you identify a poor quality assurance system:

• Over-reporting: it is usually more likely that there is too much data than missing data. This extra data is generally meaningless to the company’s product and processes. 

• No goals: similar to over-reporting, some companies have a quality system without having a clear plan of what they want to achieve with this system. If you don’t have a strategy in mind, you will get bogged down and collect data without getting a usable statement.

• Unrealistic KPIs: Some companies tend to dream too much too fast and define key figures that are too unambiguous or just unreachable. These KPIs take up a lot of resources later and hinder the process of continuous improvement. 

• One-sided controlling: A one-sided view is not meaningful. Different perspectives are crucial to obtaining meaningful data and deriving the right measures. It is also important to show everyone involved the benefits of controlling to create acceptance.

With a good and sturdy quality assurance plan, significantly fewer mistakes occur due to organizational inadequacies. In addition, a good quality assurance system allows things to be remembered correctly and sufficiently communicated. And redundancies are also avoided. 

Pharmaceutical quality systems in making medicines

A Pharmaceutical Quality System (PQS) is a management system for directing and controlling a pharmaceutical company in terms of quality, with the primary objective of ensuring the quality and efficacy of the medicinal product and patient safety while improving the overall quality and the performance of the business.

In the pharmaceutical industry, risk-taking is restricted by the precautionary principle of patient safety. Therefore, the PQS is created, according to ICH Q10, to assist in developing a robust and efficient way to reduce quality risks and improve the quality and safety of the pharmaceutical product. 

With ICH Q10, a harmonized pharmaceutical quality system can be applied throughout the life cycle of a product and used alongside regional GMP requirements. According to ICH Q10, there are four elements that it is useful to apply consistently and commensurate with the life cycle:

1. A performance monitoring system of the process and product quality.
2. A system of preventive and corrective actions (CAPA).
3. A change management system 
4. A management review of process performance and product quality; 

There needs to be more than just applying these elements to achieve the quality goals reliably; companies must have a comprehensively planned and correctly implemented Pharmaceutical Quality System, which includes Good Manufacturing Practice and Quality Risk Management.

Create a quality assurance plan

Creating a quality assurance plan (QAP) from scratch or modifying an existing one helps you reduce noncompliance and avoid mistakes that could occur during a process. In addition, having a plan provides a structured work environment that makes it easier for staff to know their responsibilities and help them focus on performing their job the best way possible.

A QAP is used to define the criteria and processes that will ensure and verify that a product or process meets specific quality objectives throughout its lifecycle. Creating a QAP does not have to be a complicated process; that’s why we give you some tips to help you create a robust and successful quality assurance plan:

1. Defining Quality Objectives

The first step for quality control planning is to define your quality objectives. Focus on the strategy and not on projects. Transform your organization’s strategies into actionable plans. Ask yourself questions in order to determine your own objectives. For example;

• What are your five most important quality goals? 
• How should they affect your bottom line? 
• How do you intend to achieve these goals?

Focus on creating a plan you can implement in future projects and iterations. Quality objectives also have to match what your customer is expecting. You should also make sure that you adhere to GMP regulations.

2. Defining roles and responsibilities 

Ensure that the roles and responsibilities of the personnel involved in your quality unit are aligned with your objectives and the regulatory authorities requirements.

3. Funding strategies rather than department budgets.

Distribute funds based on the strategic goals, simplify and streamline the annual plan. Focusing on projects rather than on the strategy may hinder the progress and implementation of your quality plan, causing more issues and delays during the implementation phase that may reflect poor-quality products and processes.

4. Creating a continuous planning process.

When you have a quality plan for your company, you will need to be able to measure it and monitor it regularly. First, focus on the value of each activity and then roll those up to the program level to better understand of its impact. 

5. Implementing the quality assurance plan, examining the results, and making adjustments

Break your plan into iterations; this will allow you to deliver more frequently, measuring failures and making adjustments before further funding and reaching a point of no return. 

Ensure all staff members are trained and aware of the plan’s contents. Then, listen to the team, employees, and customers to ensure you meet everyone’s realistic expectations. Did you achieve the desired results? If not, know to refrain from investing further in this initiative. This knowledge can help you effectively prioritize and allocate resources and capacity.
And last but not least, the most important tip is that you don’t need to do everything on your own. You can improve your quality assurance system by seeking support and partnering with experts with the appropriate knowledge. Read out to us today to learn more about how we can help you improve your quality assurance system.