cGMP vs GMP: What's the Difference? | Ascendia Pharma (2024)

July 19, 2021

It’s important to understand the differences between GMP vs cGMP (Current Good Manufacturing Practices), how cGMP lays the foundation for product quality, and how it impacts new drug development and manufacturing for your pharmaceutical.

Good Manufacturing Practices (GMP) are the core regulatory standards established by the U.S. Food and Drug Administration (FDA). GMP quality standards are enforced by the FDA to ensure pharmaceutical safety and effectiveness for consumers.

cGMP vs GMP: What's the Difference? | Ascendia Pharma (1)

What is cGMP?

cGMP ensures proper design, monitoring and control of manufacturing processes and facilities for pure and high-quality drug products.

To adhere to cGMP, pharmaceuticals and CDMOs source high-quality raw materials, use rigorous quality management systems, develop and enforce comprehensive operating procedures, have protocols in place to reveal and find the source of quality deviations, and have testing practices and laboratories in place. Through these formal practices, pharmaceuticals and CDMOs alike can reduce and avoid many mishaps that cause errors, contamination, deviations and failures.

As the name suggests, cGMP means that as best practices and quality standards evolve over time, companies are using current or up-to-date technologies and systems to meet federal regulations, and following the most recent GMP regulations.

What Does cGMP Cover?

cGMP leads to more consistent and reliable manufacturing, and higher-quality drug products, which reduces risks involved in producing (and consuming) drug products. cGMP for outsourcing facilities or CDMOs encompasses:

• Quality assurance

• Facility design

• Control systems and procedures for maintaining facilities

• Environmental and personnel monitoring

• Equipment

• Containers and closures

• Components

• Production and process controls

• Release testing

• Laboratory controls

• Stability and expiration dating (for compound drug products)

• Packaging and labels

• Reserve samples

• Compliance handling

Some examples of these cGMP include equipment and technologies that are regularly inspected, adjusted and maintained on a regular basis throughout the manufacturing process. Another aspect of cGMP is making sure documents, data and product history that is collected frequently, thoroughly documented, and stored and backed up in manner that it is secured from file corruption and security breaches and can be accessed by and shared with the proper individuals.

What is GMP?

Much like cGMP, GMP (Good Manufacturing Practices) encompasses all aspects of the drug manufacturing process to reduce cross-contamination, adulteration and mislabeling of drug products. The major difference is that cGMP is focused on continuous improvement and means the most up-to-date standards and technologies are being employed to assure quality, whereas GMP are considered a set of principles that help manufacturers develop processes to ensure quality. GMP, which are outlined by the FDA, are also considered more flexible.

cGMP vs GMP: What's the Difference? | Ascendia Pharma (2)

What Does GMP Cover?

Most GMP requirements are very general and open-ended to give manufacturers the flexibility to determine how to implement and maintain the proper controls. GMP regulations address:

• Quality

• Sanitation, hygiene and cleanliness

• Facilities

• Equipment and technologies

• Materials

• Personnel

• Validation and qualification

• Documentation and recordkeeping

• Inspections and audits

Drug manufacturers and CDMOs who invest in and prioritize GMP standards are declaring to their customers and patients that they not only care about patient safety, but also providing high-quality pharmaceuticals when patients need them.

GMP helps manufacturers quickly and accurately reference batch information, which is crucial in the event of a recall, as well as to identify product lifecycle and improvements.

cGMP vs GMP: What's the Difference? | Ascendia Pharma (3)

The Differences: cGMP vs GMP

While both GMP and cGMP are in place to make sure pharmaceuticals and CDMOs are producing consistent and quality drug products (and they can evolve over time to ensure the highest quality result), there are two primary differences between the two.

  1. Quality/Rigor — With a focus on using the most current and improved standards, cGMP is more rigorous and results in higher-quality drug components and manufacturing. Beyond the manufacturing process, cGMP also extends into intended drug use to watch and make sure pharmaceuticals are not being misused. CDMOs and drug manufacturers adhering to cGMP standards also often have a digital Quality Management System, which makes sure standard processes and approvals are followed with digital steps and signatures that cannot be skipped or tampered with.
  2. Cost — With more current and innovative technologies in use, cGMP is typically more expensive than GMP. More extensive and a higher quantity of testing done in cGMP also adds to the costs.

FDA Regulation

CDMOs and drug manufacturers receive frequent check-ins, in-person and virtually, as well as announced and unannounced visits to monitor adherence to the FDA’s GMP regulations. The FDA’s cGMP sets minimum standards for the methods, facilities and controls in use for manufacturing, processing and packaging drug products. All of these regulations ensure the product works as it should and is safe for patients to use.

When cGMP is not followed, the FDA can urge the manufacturer to recall its product, or a new drug product that is in development may not receive FDA approval if cGMP regulations are not followed during its development and manufacturing.

Why GMP and cGMP Are Important When Choosing a CDMO

The importance of cGMP vs GMP boils down to patient safety and the effectiveness of the drug product.

The FDA’s rigorous regulations were developed to ensure only safe and effective treatments are tested in clinical trials. Complying with those regulations requires expertise, experience and resources that may make outsourcing to a CDMO more ideal than keeping it in house.

Ascendia offers cGMP manufacturing services for Phase 1 and Phase 2 clinical studies. The New Brunswick, NJ, facility hasClass 10,000 (ISO 7) and Class 100 (ISO 5) cleanroomsfor conducting cGMP manufacture of sterile injectable products.

Ascendia Pharmaceuticals — a leader among CDMO companies in delivering rapid, comprehensive, and cost-effective solutions for difficult formulation development projects — provides cGMP manufacture of clinical trial materials. Learn about our manufacturing facility and equipment here, and contact us today to inquire about a CDMO partnership.

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cGMP vs GMP: What's the Difference? | Ascendia Pharma (2024)

FAQs

CGMP vs GMP: What's the Difference? | Ascendia Pharma? ›

The Differences: cGMP vs GMP

What is the difference between GMP and cGMP in pharma? ›

GMP vs cGMP: Key differences to consider

GMP provides broad guidelines that are regularly updated, but offers manufacturers flexibility in how they meet those standards. cGMP demands continual evolution: compliance requires that a product be manufactured using the most current procedures possible.

Why is C small in cGMP? ›

GMP stands for Good Manufacturing Practices. The “c” that precedes it stands for “current”. This little c is VERY important. The rules are written to allow for innovation and the need to strike the balance between protecting the patient, guiding the manufacturing activities and allowing continuous improvement.

What is the cGMP for pharmacy? ›

The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

Is there a difference between the cosmetic GMP in comparison with pharmaceutical cGMP? ›

GMP can be considered as a traditional method of quality and safety assurance. CGMP is based upon the same principles but it adheres to the standards along with the latest available technology. Hence, it can be considered as a more effective and efficient method of ensuring quality assurance.

Does FDA require cGMP? ›

The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals.

What does GMP mean in pharma? ›

Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification ...

What are the 5 P's of cGMP? ›

By paying attention to the 5 P's of GMP – Products, Processes, Procedures, Premises and People, we can ensure the creation of products that meet and exceed the standards of quality and safety that our consumers expect and deserve.

Who requires cGMP? ›

The cGMPs are enforced by the Food and Drug Administration (FDA) and apply to companies operating in the United States. They apply to a wide range of products, including drugs, biologics, medical devices, food, and dietary supplements. The specific requirements of cGMPs vary depending on the type of product.

What drugs activate cGMP? ›

Inhibition of the cGMP-specific isoform PDE 5 by the popular drugs sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra) increase cGMP, activate PKG, and result in vasodilation of the penile vessels and erection.

What are the golden rules of GMP? ›

Minimise contact with product or product contact surfaces and equipment. Never eat, drink, smoke or chew in manufacturing areas. Always follow cleaning and sanitation procedures. Report any condition that may cause product contamination.

Is cGMP compliant the same as certified? ›

The FDA regularly audits pharmaceutical manufacturers to ensure that they are cGMP compliant. However, the FDA does not certify manufacturers, they only determine if the business is in compliance or not. A manufacturer must demonstrate that they are following the thorough standards set by cGMP in order to be certified.

What is the difference between GLP and cGMP? ›

An easy way to remember the difference between cGMP/GLP/GMP: GLP is meant to protect against data contamination. GMP is meant to protect against product contamination. cGMP is meant to keep that protection up-to-date as technology changes.

What is the difference between GMP and GMP+? ›

GMP stands for Good Manufacturing Practices and the plus sign indicates the integration of Hazard Analysis and Critical Control Points (HACCP). The first standard for feed sustainability was developed in 2013.

What is the difference between GxP and cGMP? ›

The preceding "c" stands for "current." For example, cGMP is an abbreviation for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines.

What is the difference between GMP and GLP in pharmaceutical industry? ›

GLP governs the research and development phase, focusing on the reliability of scientific data. GMP, meanwhile, ensures that manufacturing processes are consistently executed to produce safe and effective products.

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