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Good Manufacturing Practices Training for Life Sciences Graduates. Beginner Guide by Astra Nova Training

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Published - 24.Jun.2024

The healthcare product manufacturing industry can be quite a difficult career path to take when you don’t know where to start. There are many different ways to get into the industry of course. However, what are the most efficient ways to do so?

Naturally, a couple of medical backgrounds pave the way for such professional development. Students of Pharmacy, Biotech, and Chemical Engineering already have a good standing when it comes to working in healthcare manufacturing. But what can GMP training add to this expertise?

In this article, we will discuss the importance not only of good manufacturing practices in the healthcare industry but also have an in-depth look at what backgrounds can help you in this career choice. It is best to have a good understanding of how exactly a GMP certificate can help you combine your expertise and training to advance in the field you have chosen. Learn straight from a team of professionals accredited by Transcelerate BioPharma Inc.!


What is GMP?

When learning how being GMP-certified can help you in your career, we must first try to pursue a better understanding of what Good Manufacturing Practices are. These are regulations that are enforced by different institutions and government bodies like the Food and Drug Administration (FDA) in the US or the European Medicines Agency (EMA) in Europe. These organizations ensure that the manufacturing processes and facilities are properly designed, monitored, and controlled. 

By adhering to GMP, drug manufacturers can guarantee the quality and purity of their products. This involves implementing a couple of important aspects:

  • strong quality management systems
  • using high-quality raw materials
  • establishing effective operating procedures
  • identifying and addressing product quality issues
  • maintaining reliable testing laboratories

The proper implementation of these controls helps prevent contamination and failures. Being able to prevent critical errors in the development of pharmaceuticals is also a crucial factor in the quality and safety of a product.

The CGMP requirements are designed to be flexible, allowing manufacturers to decide how best to implement necessary controls using scientifically sound methods and procedures. This flexibility enables companies to adopt modern technologies and innovative approaches to improve quality continually. This is only a part of the job that a potential career in the industry would deal with. 

It’s important to note that GMP regulations set the minimum requirements. Many pharmaceutical manufacturers already employ advanced quality systems and risk management strategies that exceed these basic standards which a GMP certification can make you a part of.


The importance of GMP training

Everyone has been a consumer in one way or another. Especially when it comes to pharmaceutical products. 

Consumers, however, can’t typically tell if a drug is safe or effective just by looking at it, touching it, or smelling it. While GMP regulations mandate testing, testing alone isn’t enough to guarantee quality. In most cases, products are tested in batches and deemed as safe when the batch is safe. What can a deeper knowledge of GMP offer you though?

With proper GMP training a person can grasp why it’s so crucial for drugs to be produced under the stringent conditions and practices required by GMP regulations. These regulations ensure that quality is built into every step of the design and manufacturing process.

In the healthcare sector, GMP regulations are essential to ensure the safety and effectiveness of drug products. Key elements of GMP include:

  • well-maintained facilities
  • properly calibrated equipment
  • qualified and thoroughly trained employees
  • reliable and reproducible processes

Having GMP-certified employees demonstrates the healthcare manufacturers’ commitment to maintaining these high standards and provides an added layer of assurance that they are dedicated to producing safe and high-quality medicines. Professionals who possess such qualifications are also better able to ensure this level of quality.

What are the regulations that keep everything in check though? We are going to take a look in our next section.


Overview of GMP Regulations

Several key regulatory bodies are responsible for enforcing GMP regulations worldwide. These organizations ensure that pharmaceutical products, medical devices, and food are produced with high-quality standards. Familiarizing yourself with these institutions is a fundamental part of educating yourself on the topic of good manufacturing practices.

One of the main administrative organs is the FDA in the United States which enforces GMP regulations to ensure that manufacturers adhere to standards for the proper design, monitoring, and control of manufacturing processes and facilities. Similarly, the EMA, along with national regulatory authorities in the European Union, oversees GMP compliance to maintain the quality of medicines marketed within the EU.

Another institution that has to deal with proper drug manufacturing is The World Health Organization (WHO). They provide international GMP guidelines and support member states in implementing these standards to ensure the global safety and quality of medicines.

More information about specific regulations and laws are discussed in the GMP training package that Astra Nova offers as well as a more detailed look at the importance of some key GMP principles we will now mention.

Core principles of GMP

GMP regulations are built on several core principles that ensure products are consistently produced and controlled according to quality standards. These principles include:

  1. Hygiene. The principle of ensuring that manufacturing facilities are clean and sanitary to prevent contamination. Naturally, this would also include the personal hygiene of employees, cleanliness of the environment, and proper sanitation of equipment.
  2. Documentation. Another aspect of following regulations efficiently is maintaining detailed and accurate records of all manufacturing processes, from raw materials to finished products. Proper documentation helps trace the history of a product batch and identify any deviations from standard procedures.
  3. Process control. It is also important to discuss the implementation of robust controls at every stage of the manufacturing process to ensure consistency and quality. This involves monitoring critical parameters, such as temperature and pressure, and validating processes to ensure they produce the desired outcomes.

These core principles, enforced by the key regulatory bodies, ensure that GMP regulations maintain high standards. Now that we are better acquainted with the fundamentals of GMP, we must take a look at what such training can offer us in a more career-focused direction. 


Components of GMP training

GMP training programs are designed to provide comprehensive knowledge and practical skills to professionals involved in the manufacturing and quality assurance of pharmaceutical products, and the Astra Nova package provides all of that. The training includes a series of structured modules, each focusing on different aspects of GMP, from foundational concepts to advanced practices.

Key topics covered in GMP training

  • Introduction

This module provides an overview of GMP principles, the importance of GMP in the pharmaceutical industry, and the regulatory landscape. It sets the stage for understanding the critical role GMP plays in the industry.

  • Update on EU GMP regulations

Participants will learn about the latest updates and changes in EU GMP regulations. This module ensures that trainees are aware of current regulatory requirements and how they impact manufacturing processes.

  • Pharmaceutical system

This module focuses on the design and maintenance of systems that support GMP compliance.

  • Activities, quality management & information

Training in this module involves understanding the various activities involved in GMP, including quality management systems, risk management, and information handling.

  • Training and consultants in GMP

This module highlights the importance of continuous training for employees and the role of consultants in achieving and maintaining GMP compliance. It covers best practices for training programs and how to effectively utilize external expertise.

  • Quality control in GMP

Participants will learn about quality control measures, including testing and validation procedures. 

  • GMP concepts and practices

This comprehensive module delves into the core concepts and practical applications of GMP. It includes topics such as hygiene, process control, and best practices in manufacturing.

  • Documentation control

Proper documentation is a cornerstone of GMP compliance. This module trains participants on how to manage documentation effectively, including recording, storing, and retrieving information to ensure traceability and accountability.

  • Deviations management

This module addresses the management of deviations from standard operating procedures. 

  • Production

The final module focuses on the production processes, including the control of raw materials, manufacturing operations, and packaging. 

These are all the different lessons that must be taken over four hours to pass that course. We have highlighted the variety of knowledge a GMP certificate can grant, but what professions can it support in the future? Let’s take a look at our final section!


Where can GMP certification get you?

Many students graduate from medical universities and colleges. The most obvious choice is to be a healthcare practitioner, but many graduates prefer another path in the industry. Let’s see how in such cases a GMP certificate can be advantageous for their further development.

Pharmacy background

A graduate with an educational background in pharmaceuticals has a couple of positions that could be perfectly combined with good manufacturing practices training. Pharmacy students understand drug composition and safety profiles, along with drug regulations and compliance. Their training prepares them for quality control roles. GMP certification enhances their ability to ensure regulatory compliance and improve production practices. These are some such roles:

  1. Quality professionals. GMP certification is crucial for ensuring that pharmaceutical products meet regulatory standards. It equips pharmacy graduates with the knowledge to oversee quality control processes and be able to manage deviations. They are better suited to ensure compliance with stringent quality regulations as well.
  2. Production and manufacturing technicians. Pharmacists with GMP training can effectively manage the manufacturing processes. They can ensure that all operations adhere to GMP standards. This helps maintain product safety and efficacy.
  3. Sponsor organization representatives. Understanding GMP regulations is vital for pharmacists involved in contracting with GMP vendors. It ensures they can evaluate vendor compliance and ensure that outsourced manufacturing meets regulatory requirements.

Biotech background

Someone who has sufficient experience in biotech can be a great asset to a GMP-oriented company. Biotech students excel in biological and biochemical techniques crucial for bioprocessing. Their skills in genetic engineering and fermentation optimize production methods. GMP certification helps them ensure bioprocesses meet regulatory standards and monitor complex processes effectively.

  1. Validation staff. GMP certification provides biotechnologists with the expertise needed to validate systems and equipment used in the process. This ensures that all aspects of production are reliable and reproducible.
  2. Quality professionals. With GMP training, biotechnologists can oversee quality assurance programs and thoroughly ensure that biotech products meet regulatory standards.
  3. Production and manufacturing technicians. GMP certification enables biotechnologists to manage and optimize production processes to make sure they create high-quality biotech products.

Chemical engineering background

One of the most sought-after educational backgrounds in pharmaceutical manufacturing companies is precisely chemical engineering students. These graduates are skilled in optimizing manufacturing processes and understanding material properties. Their analytical skills improve production systems. GMP certification ensures their designs comply with standards, maintaining quality and implementing safety controls.

  1. Packaging staff. Chemical engineers with GMP certification can ensure that packaging processes comply with regulatory standards. This includes proper labeling, material selection, and making sure that packaging maintains product integrity.
  2. Distribution staff. Understanding GMP regulations helps chemical engineers manage the distribution of products. This way they can make certain that all handling and transportation processes maintain product quality and comply with regulatory requirements.
  3. Production and manufacturing technicians. GMP certification equips chemical engineers with the knowledge to oversee and optimize manufacturing processes. This ensures that all chemical processes involved in manufacturing produce safe, high-quality products.

To summarize how GMP training is beneficial for different educational backgrounds. For pharmacists, it strengthens their roles in quality assurance and regulatory compliance. Biotechnologists benefit by enhancing their abilities in validation and quality management. Chemical engineers gain expertise in packaging, distribution, and production processes, ensuring that all operations adhere to GMP standards. 

It is apparent that different medical backgrounds can be extremely useful when pursuing a career in pharmaceutical manufacturing. With that said, it is indeed an even great benefit not only for the companies but for the candidates as well to have a good manufacturing certificate. 

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