Everything you need to know about pharmaceuticals and life sciences (and a Little More)

The pharmaceutical industry is the business area dedicated to the design, development, and manufacturing of chemical products used to diagnose and treat diseases, deficiencies, and other types of dysfunction. Pharmaceutical organizations create their products from chemical and synthetic processes, while biopharmaceuticals manufacture them using biotechnology.

The modern era of the pharmaceutical industry began in the 19th century with the creation of chemical synthesis and processes to isolate and purify compounds. Over time, computer-aided drug design methods were developed, which enhanced the discovery of new drugs.

The main challenges of the pharmaceutical industry today are identifying new drug targets, obtaining approval from regulatory agencies, and seeking more refined techniques for drug production. The evolution of organizations in this area would represent better control and the potential elimination of certain diseases worldwide.

This special article will discuss everything you need to know about the pharmaceutical and life sciences industry. Keep reading to learn more about quality management, compliance, change management, document management, and other elements of the pharmaceutical sector.

1. Quality management

No matter the industry you work in, you need to strive for excellence if you want to stand out in the market. But this is ten times more relevant in highly regulated areas, such as pharmaceuticals and life sciences.

Medicines, innovative treatments, advanced imaging exams — all of this helps us achieve levels of longevity and quality of life that were unimaginable just decades ago. To deliver all these innovations with the quality your customers deserve, you need to implement a QMS, the famous Quality Management System.

That is why the first stop on our learning journey will be the section on “The Importance of Quality in the Pharmaceutical and Life Sciences Industry.”

The importance of quality in the pharmaceutical and life sciences industry

Quality management is one of the crucial factors for your success in this segment. After all, patient health is directly affected by the safety and effectiveness of medicines and equipment.

By having a good Quality Management System, you not only ensure the integrity of your products but also ensure compliance with strict international regulations. A QMS helps your organization manage and document all aspects of your production and quality control.

The system allows process control from the selection of raw materials, helping to minimize impurities from start to finish of production. The result is that all the products you launch will be safe for your customers and perform as expected.

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Brand reputation and consumer trust

Adopting a Quality Management System brings a series of positive impacts on your brand’s reputation and consumer trust. Here are some of the main benefits:

• Compliance: A robust QMS will ensure that your company’s activities comply with stringent regulations from agencies such as Anvisa (Brazil), FDA (USA), and EMA (Europe).
• Patient Safety: The main goal of any company in the pharmaceutical and life sciences field should be to improve the health of its patients. Quality management is essential to ensure that medicines are safe, effective, and reliable.
• Branding: The reputation of a pharmaceutical brand is closely linked to the quality of its products. A recall or a safety issue with a drug can tarnish your company’s image for a long time — sometimes even forever.
• Risk Management: Without a QMS, an organization is at greater risk of non-compliance with the regulations of the countries where it operates. This can lead to fines, recalls, and even the closure of its activities.
• Product Consistency: Quality management combats inconsistencies in your product, avoiding potential safety issues that could erode trust in your brand and cause your company to lose customers.

Rich resource: Pharmacovigilance system for the pharmaceutical industry

Tools and techniques for quality assurance

Quality assurance is an essential factor for the pharmaceutical and life sciences industries. It allows for defect prevention, continuous improvement, and compliance with different standards in various markets.

To achieve this, there are two fundamental work areas within your organization: quality control (QC) and quality assurance (QA). They are responsible for ensuring that your products or services meet customer demands and help your company achieve its goals.

Some several tools and techniques can help your organization ensure the quality of its products and services. Let’s talk about them below:

Statistical Process Control (SPC)

Involves the use of statistical methods to monitor and control processes, ensuring consistent quality and allowing for the identification of variations that may indicate potential problems.

Six Sigma

A data-driven approach that seeks to improve process performance by reducing defects and variability. It should be thought of from the DMAIC framework: Define, Measure, Analyze, Improve, and Control.

Infographic: How to Implement Six Sigma in Your Organization

Lean manufacturing

Originally developed for the automotive industry, lean manufacturing has translated well to the pharmaceutical and life sciences market. Through its focus on eliminating waste, the methodology allows organizations in these areas to optimize their processes.

This can be done by reducing excess inventory, minimizing wait times, and optimizing workflows. In this way, you ensure that your resources are used more efficiently, leading to faster production cycles and financial savings.

Failure Mode and Effects Analysis (FMEA)

A proactive technique to identify potential failures in your processes or products. It allows you to assess the impact of these potential problems and prioritize actions to mitigate risks.

In this way, your organization can create strategies to reduce or eliminate high-priority threats. This may involve modifying processes, adding controls, or implementing preventive measures.

Quality audits and inspections

Systematic evaluations to ensure compliance with quality standards and regulations. These audits and inspections allow you to identify areas for improvement and ensure that your products or services have consistent quality.

Your organization can conduct internal, external, process, product, compliance, or supplier audits. Based on the final reports, you should take corrective actions and improve processes — resulting in better performance in the quality area. All of this contributes to a culture of continuous improvement and operational excellence.

Complete eBook: Statistical Process Control (SPC): a step-by-step guide to detecting and preventing problems

2. Compliance and regulatory conformity

The pharmaceutical and life sciences industries face unprecedented challenges due to increasingly stringent legislation. The market has ever-growing expectations regarding transparency, technological innovations, and the creation of strategic partnerships.

To help you deal with all these challenges, we will share key information about regulations, best practices, manufacturing, and audits within this area.

Standards and regulations in the pharmaceutical and life sciences industry

The Food and Drug Administration (FDA) is the body responsible for regulating and approving medicines, sanitary standards, and even the food industry in the United States. It publishes regulations that determine the criteria for controlling the quality of the production of medicines, vaccines, and other health treatments.

The FDA issues guidelines and regulations with the aim of defining normative procedures, methods, and criteria of excellence for items and services supervised by the entity. One of the most important is the Current Good Manufacturing Practice (CGMP) regulations, which ensure the proper design, monitoring, and control of manufacturing processes and facilities.

These regulations established the concept of the Pharmaceutical Quality System (PQS), which replaced the former Quality Assurance. From this point on, the United States began to have more robust requirements for a series of processes in the pharmaceutical industry.

Here are some of the main FDA regulations:

• 21 CFR Part 210 and 211: These regulations define the minimum CGMP for the preparation of drug products for administration to humans or animals. They ensure that products meet the requirements for safety, quality, and efficacy.
• 21 CFR Part 820: This regulation outlines the quality system requirements for medical devices, ensuring that manufacturers follow consistent practices to produce safe and effective devices.
• 21 CFR Part 11: This regulation provides criteria for the acceptance of electronic records and electronic signatures, ensuring that they are trustworthy, reliable, and equivalent to paper records.
• 21 CFR Part 600-680: These regulations cover the standards for the production and quality control of biological products, including vaccines and blood products.

In terms of standardization, the certifications from the International Organization for Standardization (ISO) are often highly regarded in this market area. After all, they bring benefits such as system simplifications, responsibility definitions, and process standardization.

Here are the main ISO standards for the pharmaceutical and life sciences industry:

• ISO 9001: The most famous certification is also the most popular worldwide. It sets guidelines for creating a Quality Management System (QMS), helping to identify process failures and present solutions to increase customer satisfaction.
• ISO 14001: Addresses environmental management for companies, aiming to meet the growing demands of the public and governments regarding sustainability. It helps organizations manage their environmental actions, reducing raw material waste, conserving resources, and achieving long-term positive returns.
• ISO 45001: Focuses on the occupational health and safety of workers, protecting their physical and mental health. Benefits include reducing costs associated with workplace accidents and promoting continuous improvements in company safety.
• ISO 27001: Covers information security standards, which are increasingly important with recent technological advances that have left companies more vulnerable than ever. This certification focuses on decision-making, information quality, and developing more secure systems.
• ISO 10015: Complements the training and awareness section of ISO 9001. Developed in 1999, this certification aims to improve the quality of company training, with the goal of enhancing the future quality of work for new employees.

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Regulatory audits and inspections

As part of one of the most regulated sectors in the world, pharmaceutical industry organizations must undergo rigorous inspections by regulatory bodies. They conduct audits in factories and other facilities, as well as verify the quality of their processes to ensure compliance with legislation and the trust of patients and stakeholders.

These regulatory inspections ensure that companies adhere to the highest standards of quality, safety, and efficacy. These regulatory bodies include Anvisa (Brazil), FDA (United States), EMA (European Union), and MHRA (United Kingdom), among others.

Inspections are crucial to verify that pharmaceutical and life sciences companies are adopting Good Manufacturing Practices (GMP). It is also checked whether these companies are concerned with protecting public health and ensuring the efficacy of their products.

Here are the main aspects checked during a regulatory inspection:

• Manufacturing Processes: Inspectors meticulously evaluate production processes, documentation, and controls to ensure consistency in production quality.
• Employee Qualifications: Regulatory bodies check if all individuals involved in the manufacturing of medicines have the necessary training and qualifications.
• Facilities and Equipment: The physical environment is assessed in terms of cleanliness, maintenance status, and suitability for pharmaceutical production.
• Quality Control: Testing procedures, data integrity, and the effectiveness of quality control systems are evaluated.

Free eBook: Find out everything you need to know about auditing and compliance

Good Manufacturing Practices

Good Manufacturing Practices (GMP) in the pharmaceutical industry were defined by the GMP Guide for the Pharmaceutical Industry, which was developed at the 28th World Health Assembly of the World Health Organization (WHO).

Several changes have been made to GMP over the years, culminating in the FDA’s Current Good Manufacturing Practice (CGMP) regulations. These regulations establish the General Guidelines for Good Manufacturing Practices for Medicines.

They set safety, efficacy, and quality requirements that must be followed for medicine to fulfill its function. To achieve this, a set of rigorous procedures was created that professionals must follow to ensure the integrity and safety of the product.

The most recent updates to the FDA’s regulations have refined the concept of the Pharmaceutical Quality System (PQS). According to the FDA, a PQS is “a set of measures and procedures that ensure that medicines are manufactured with quality, safety, and efficacy.”

It also addresses Quality Control, which is the part responsible for sampling, specifications, and testing. This area also involves the organization, documentation, and procedures necessary for the release of pharmaceuticals.

The general guidelines for Good Manufacturing Practices (GMP) were updated to facilitate the access of U.S. drug manufacturers to new markets through their participation in the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

This allowed for a modernization of the FDA’s regulatory framework, greater investment in the qualification of its inspectors, and the harmonization of Good Manufacturing Practices inspection processes. These guidelines apply to all companies with operations related to the manufacture of medicines, including experimental ones.

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Good Laboratory Practices

Good Laboratory Practices (GLP) are guidelines of a quality system for dealing with the organization process and the conditions of planning, monitoring, and conducting non-clinical laboratory studies. They also deal with the recording, reporting, and archiving of these tests.

Their main objective is to ensure the quality and integrity of safety test data that are submitted to the government to obtain research authorizations. In other words, while GMP applies to the entire drug manufacturing process, GLP is useful only during the safety testing phase.

Your organization does not need to worry about Good Laboratory Practices during the initial phases of the project — including discovery, screening, basic research, and concept evaluation. The World Health Organization (WHO) generally limits GLP to Phase 2 of the drug development process.

Infographic: See the 5 steps to build a good compliance policy

Continuous compliance monitoring

In highly regulated industries, maintaining compliance is not something you only need to do once and can forget about later. On the contrary, it is an ongoing process that requires continuous monitoring.

In addition to adhering to the legislation of the regions where your company operates, you must promote risk mitigation. Be careful to avoid suppliers or partners who are not in compliance with regulations, which could result in high-value fines, product recalls, or even damage to your reputation.

Another critical factor for this monitoring is verifying the credentials and certifications of your partners, ensuring they are not expired or canceled. Finally, it is recommended that you organize annual audits to ensure that your organization complies with the latest legislation from Anvisa, FDA, EMA, and any other relevant agencies for your work.

Infographic: Find out how to use the 5 Whys methodology

3. CAPA management (Corrective and Preventive Actions)

The CAPA process comes from the acronym in English that means Corrective and Preventive Actions. It aims to help identify, evaluate, prioritize, and manage non-conformities or problems related to products and processes.

A fundamental part of a Quality Management System (QMS), CAPA serves to prevent these threats from recurring. To do this, it is necessary to create procedures to solve the problems, as well as analyze the root cause of their occurrence.

However, it is worth noting that not every deviation from the standard should trigger a Corrective and Preventive Action. It should be reserved for non-conformities, customer complaints, audit reports, and adverse events.

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Problem identification and analysis

The CAPA process has seven steps, starting with identification and ending with follow-up. Check out all the steps of the process below:

1. Identification: The first step is to identify all quality problems in your processes and product. From there, you should classify issues such as customer complaints, records of returned products, quality audits, installation reports, legal processes, and non-conforming products.
2. Evaluation: Next, evaluate the problem to make a decision. Determine the nature of the occurrence and define whether it requires a CAPA or not.
3. Investigation: Conduct an investigation with the necessary procedures to meet your objectives and the team required to conduct the inquiry. Determine the cause of the occurrence and document everything for better understanding in the future.
4. Analysis: Confirm the root cause of the problem by evaluating the available data. The information should be described accurately and preserved in a way that reflects the real cause of the problem.
5. Action Plan: This step depends on the previous stages. Ultimately, you should create a plan to implement your corrective and preventive measures.
6. Implementation: At this stage, you should implement the action plan created in the previous step. Again, create robust documentation to record what was done.
7. Follow-up: After your team has executed the CAPA activity, it is time to follow up. This step helps measure the effectiveness of the Corrective and Preventive Actions and improve the measures that will remedy the problem.

Complete eBook: Nonconformities and CAPAs – Concepts, tools and practices for the pharmaceutical industry

4. Non-Conformity Management

No matter how controlled the pharmaceutical industry is, every process is still subject to deviations, occurrences, and production problems. These issues end up impacting product quality, threatening the efficacy, safety, and quality of medicines.

When such a deviation occurs, it must be managed as a non-conformity. This lack of compliance puts the safety of the product’s customers at risk — meaning it must be urgently investigated.

A good non-conformity management plan needs to be part of a Pharmaceutical Quality System (PQS). It should include a plan to handle non-conformities appropriately, taking into account the associated risks.

Follow these steps to manage non-conformities:

1. Identification and Recording: Start by detecting and documenting the non-conformity. You can do this through incident reports, customer complaints, or other relevant means.
2. Root Cause Analysis: Once the non-conformity is recorded, conduct a detailed analysis to identify the root cause of the problem. Investigate all sources or factors that may have contributed to the issue.
3. Risk Analysis: Assess the threats associated with the lack of compliance. From there, you can determine the severity of the impact on the quality, efficacy, and safety of the drug.
4. Corrective and Preventive Actions (CAPA): Implement immediate corrective measures to resolve the problem and prevent it from recurring. Institute preventive measures to mitigate future deviations.
5. Documentation and Monitoring: Document the entire process of evaluating and correcting non-conformities. Record the investigations, as well as the preventive and corrective actions implemented — along with periodic evaluations of their effectiveness.

Free eBook: Nonconformities and corrective actions: The ultimate guide to solve problems in a smart way

5. Change Management

In the last decade, pharmaceutical companies have increased their emphasis on innovation and the introduction of new technologies. This is a consequence of more progressive regulation, as well as advances in manufacturing and control processes.

To handle so many changes, it is essential to have a change management system. This is a systematic approach to proposing, evaluating, approving, implementing, and reviewing modifications to your processes and products.

Within this system, any proposed changes need to be evaluated according to the product’s marketing authorization, Good Manufacturing Practices (GMP), and patient safety. Collaboration with hardware and software manufacturers is crucial to manage changes, request documentation, conduct tests, and perform validations according to GMP requirements.

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Organizations must manage and prioritize changes strategically within a framework of quality improvement and innovation. This change management system is often the focus of regulatory inspections, frequently cited by agencies such as the FDA, MHRA, and EMA.

With a good change management system, you complement your Pharmaceutical Quality System with the ability to manage complex innovations and improvements. It allows you to implement strategic management to enhance your products, processes, and systems.

6. Quality Risk Management

When we talk about quality risk management, we are referring to a systematic and threat-based approach to your processes and products. The risk management procedure consists of the stages of assessment, control, communication, and review of threats to quality.

This is a comprehensive and multidisciplinary activity that seeks to implement preventive measures and controls to avoid the incidence or recurrence of failures. A good plan for this area involves a careful analysis of the potential risks involved in the production, storage, and distribution of medicines.

Your planning should include methods to mitigate and manage these possible threats, as well as foresee preventive or corrective actions — if necessary. You also need to monitor the risks and adjust your plan as needed.

Finally, it is essential to establish clear and frequent communication with everyone involved in the drug supply chain. The stakeholders involved in your operation must be aware of the potential risks involved.

eBook: Risk Management in the pharmaceutical sector

7. Document Management

The pharmaceutical industry requires strong document management and training systems to ensure compliance with safety and quality standards. Effective management in this area ensures that medicines are produced according to regulatory guidelines, while training management keeps employees up-to-date with these constantly evolving requirements.

Document management plays a crucial role in ensuring that all necessary documentation is organized, accessible, and up-to-date. This includes establishing policies and procedures for the creation, review, approval, and distribution of documents, as well as systems for version control and tracking.

Training management is equally important in the pharmaceutical industry, as it ensures that employees are equipped with the knowledge and skills necessary to perform their functions safely and efficiently. Regular training is required to maintain compliance with industry regulations and promote a culture of continuous learning.

Integrated document and training management systems are essential for pharmaceutical companies to ensure product safety, regulatory compliance, and operational efficiency. Using tools like SoftExpert Suite can help organizations optimize these processes, integrating management structures throughout the organization. This approach not only improves internal collaboration but also enhances overall efficiency and customer service.

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8. Process integration and automation

Automation is transforming pharmaceutical production by improving efficiency, accuracy, and compliance with stringent regulations. As the industry advances, implementing automation becomes essential for organizations to maintain their competitiveness.

Robotic Process Automation (RPA) enhances the accuracy of your processes by handling repetitive and complex activities with precision, such as measuring ingredients or mixing formulas. These actions are crucial to ensuring that medicines remain safe and effective.

Systems designed for automated process control are essential for ensuring regulatory compliance. These tools simplify the process of adhering to Good Manufacturing Practices (GMP) and other industry guidelines. Through real-time monitoring, manufacturers can quickly correct issues, ensuring product consistency.

The integration and automation of pharmaceutical processes also offer flexibility and growth, helping companies adapt to changes in market demand. Companies can easily adjust production quantities and batch sizes, facilitating demand management.

Increased productivity and reduced reliance on human labor also result in financial savings and more eco-friendly practices. In the end, automation simplifies operations, promoting long-term success and competitiveness in a rapidly evolving sector.

Conclusion

The pharmaceutical and life sciences industry is constantly evolving, driven by technological innovations and stringent regulations. This sector is essential for public health and faces complex challenges that require impeccable quality and compliance strategies. The adoption of robust systems, such as QMS and CAPA, represents a differential to ensure safety, efficacy, and compliance in all processes.

As new discoveries transform the global landscape, the continuous pursuit of excellence, combined with rigorous management practices, positions the pharmaceutical and life sciences industry as a fundamental pillar in combating diseases and promoting the well-being of the global population.

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Frequently Asked Questions (FAQ)

These are the most frequently asked questions about the pharmaceutical and life sciences market:

1.  What are the main tools to ensure quality in the pharmaceutical industry?

The main tools and techniques include Statistical Process Control (SPC), which monitors and controls quality during production, and Six Sigma, which aims to reduce variability and defects in processes. Lean manufacturing is used to eliminate waste and increase efficiency.

Failure Mode and Effects Analysis (FMEA) identifies and prevents potential failures, while quality audits and inspections ensure compliance with regulatory standards.

2. What is Failure Mode and Effects Analysis (FMEA) and how does it contribute to risk management?

Failure Mode and Effects Analysis (FMEA) is a preventive methodology that identifies and evaluates possible failures in processes, products, or systems before they occur.

It contributes to risk management by allowing the implementation of corrective and preventive actions, increasing the reliability and quality of products and processes. FMEA also helps prioritize risks based on the severity, occurrence, and detection of potential failures.

3. How are quality audits and inspections conducted in the sector?

Quality audits and inspections are conducted systematically and independently to assess compliance with established standards. Audits can be internal (conducted by the company itself) or external (performed by certifying entities).

Inspections involve verifying processes, products, and systems to ensure they meet quality and safety requirements. Both practices are essential for identifying non-conformities and implementing continuous improvement.

4. What are the main standards and regulations governing the pharmaceutical and life sciences industry?

The main standards include Good Manufacturing Practices (GMP), which establish criteria for production and quality control. The FDA (Food and Drug Administration) in the USA and the EMA (European Medicines Agency) in the European Union are regulatory bodies that ensure the safety and efficacy of medicines.

In Brazil, ANVISA (National Health Surveillance Agency) is responsible for regulating and overseeing the sector. Additionally, ISO standards are widely adopted in the industry — such as ISO 9001 for quality management.

5. What are Good Laboratory Practices (GLP) and why are they important?

Good Laboratory Practices (GLP) are international guidelines that ensure the quality and integrity of data generated in research and development laboratories.

They are important because they ensure the credibility and acceptance of results, both in the regulatory sphere and in the market. Additionally, GLP promotes safety in laboratory procedures and processes.

6. What is CAPA and why is it essential for continuous improvement in the pharmaceutical industry?

CAPA (Corrective and Preventive Action) is a methodology that identifies, analyzes, and corrects non-conformities — as well as prevents the recurrence of problems. It is essential for continuous improvement because it allows for the correction of failures and the implementation of preventive actions, ensuring compliance with quality and safety standards.

7. How does the pharmaceutical industry manage and resolve non-conformities?

The pharmaceutical industry manages non-conformities by identifying and recording all occurrences that do not meet established standards. Then, it conducts a root cause analysis to understand the origin of the problem and assesses the associated risk.

Corrective and preventive actions are implemented to resolve non-conformities and prevent their recurrence. The use of technology and automation facilitates the monitoring and documentation of the entire process.

8. Why is change management vital for the pharmaceutical industry?

Change management is essential to ensure compliance with regulatory standards and maintain the quality and safety of products. It allows for the assessment and mitigation of risks associated with any changes in processes, systems, or documentation.

Additionally, it promotes continuous improvement and operational efficiency, avoiding negative impacts on production. Implementing rigorous change control ensures that all modifications are properly analyzed and approved before being executed.

9. What are the best practices for identifying and mitigating risks in drug production?

Best practices include Failure Mode and Effects Analysis (FMEA), which identifies and prioritizes potential failures in processes. Implementing preventive measures and contingency plans is crucial to dealing with undesirable events.

Additionally, qualifying suppliers based on identified risks helps ensure the quality of raw materials. The use of technology and automation facilitates continuous monitoring and documentation of processes.

10. What are the challenges in managing regulatory documents and how to overcome them?

The main challenges include the complexity and volume of documents, which can make organization and quick access difficult. Compliance with constantly changing regulations also requires frequent updates.

To overcome these challenges, it is essential to implement electronic management systems like SoftExpert ECM, which automate and centralize document control. Continuous training for the team ensures the correct use of these systems and compliance with standards.

11. How can process automation improve efficiency in the pharmaceutical industry?

Process automation can increase efficiency by reducing human errors and speeding up production. It allows for continuous and precise monitoring, ensuring product quality and compliance.

Additionally, automation facilitates data management and traceability, improving decision-making. The integration of automated systems also optimizes resource use and reduces operational costs.

12. What are the benefits of integrating quality and compliance processes into a single platform?

Integrating quality and compliance processes into a single platform improves operational efficiency by reducing duplications and bureaucracies. This facilitates centralized monitoring and management, promoting a quicker response to non-conformities.

Additionally, integration helps ensure consistency and continuous compliance with regulatory standards. Finally, data centralization also improves decision-making and transparency.