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When manufacturing goods, it is important to pay special attention to the quality assurance requirements. Several Certification bodies and regulatory authorities ensure manufacturers comply with the set guidelines that protect the end consumer. The Food and Drug Authority has developed a set of good manufacturing practices (standards and requirements) recorded under the CGMP and GMP. They sound similar and people are often confused between the two, however, there’s a thin line that differentiates them. Below is a short guideline to help in understanding and differentiating both terms:

Regulation

 

What is CGMP?

CGMP in the abbreviation for “Current Good Manufacturing Practice”. The guidelines ensure that the most current and modern designs, monitoring procedures, and the required control of the manufacturing processes and the facilities are being used. Compliance with the cGMP assures the acquisition of identity, modern-ness, technologically sufficiency, purity, and high-quality standards of the drug commodities by forcing the manufacturers to apply the right control measures.

 

Adherence to these guidelines involves the establishment of updated quality managerial systems, obtaining accurate standard measures, the establishment of a robust operating system, and early detection of quality deviations. CGMP is generally taken by Pharma / Drug manufacturing companies. And most of the time, it is mandatory for such companies. Within a pharmaceutical company set-up, it reduces the chances of various risks eg. contamination, errors or even deviations, etc. In the long-run it assures the quality of the product manufactured meets all the set standards and that it does so on a regular basis.

 

The primary objective of CGMP standards is to make sure that the manufacturers use the latest available technology. Technology today plays a key role in these industries. With the right implementation of up-to-date technology, hardware and software, systems, and processes, manufacturing becomes more efficient especially inconsistency during mass production. CGMP however gives the minimal required guidelines to adhere to and leaves the rest of the decisions to the company. This includes decisions such as which hardware and software are most efficient, what technology should be implemented in the processes, and such and where deviations can cause deviations and problems.

 

Several countries have declared CGMP a legal requirement in the manufacturing industry for pharma and drug manufacturing. The FDA and Certification Bodies like Euro VERITAS Ltd runs inspections on various manufacturing facilities, finished products, and equipment used to determine their adherence to regulations. If the facility or finished products don’t meet the set regulated standards the term ‘adulterated’ will be used to refer to the products being manufactured.

 

In this case, the FDA can either advise the company to recall the goods or use legal and criminal means to seize the whole production batch from the market. This will be entirely based on the extent of the violation and geographical location- as this also depends on the country. Anyone can access all the guidelines and updates regarding CGMP by contacting us at Ascent WORLD.

quality control

 What is GMP?

The term GMP refers to the Good Manufacturing Practice Regulations. These regulations have been implemented by the Food and Drug Administration Authority of the United States.  The regulations were implemented in accordance with the Federal Drug, Food, and Cosmetic Act. The GMP regulations are applicable for manufacturers, packagers, and processors of medical devices, drugs, and certain food items. Whereas CGMP is applicable only to Pharma and Drug manufacturers. The regulations will make sure that the products are completely safe and are of the best quality (regulated quality) for the people to use. In addition, the regulations ensure the effectiveness and purity of the products as well.

 

With GMP, all chances available for the manufacturers to end up with errors, mix-ups, and contamination are reduced if not eliminated. Hence, consumers will be able to be assured of safety while they are purchasing the goods. The major sectors GMP covers include building and facilities, infrastructure, equipment, raw materials, personnel, production, QA/QC, packaging, labeling, and complaints. GMP covers broader guidelines that should be adhered to by all companies in manufacturing. Here, there are no options or alternatives as to the prior CGMP.

 

Some of the questions asked in this sector during inspection or audits include:

  • Are the buildings and facilities being used for appropriate and suitable size and design?
  • Are the personnel handling the processes competent, qualified well trained, and equipped with qualified equipment?
  • Are the raw materials stored and handled in methods that prevent mix-ups and cross-contamination?
  • Are there proper means of documenting production batches and records storage for the same?
  •  Etc.

 

Differences between GMP and cGMP

  • Availability

The applications of GMP are broader and wider when compared to the applications of CGMP. That’s mainly because some of the manufacturers do not use the latest available technology due to availability and cost implications and personnel.

 

  • Usage

GMP is widely getting used within the world in comparison to CGMP. In fact, more than 100 different countries out there in the world tend to use GMP. However, only a few countries adhere to the guidelines of CGMP.

 

  • Applicability

GMP is widely applicable to a large number of companies and situations when compared to CGMP. These applications span across a large number of industries as well. For example, GMP is used in ensuring different areas of a business, including Food & drugs, Feeds, Medical Devices, Pharma, etc and which include bookkeeping, ensuring cleanliness, meeting personnel qualifications, and manufacturing equipment. GMP can also be used to define quality in procedures followed by a business. However, the applicability of CGMP is somewhat limited. It can mainly be used for manufacturing in Pharma and Drugs.

 

  • Cost

CGMP is more expensive when compared to GMP. That’s because the manufacturers will have to go ahead and spend a considerable amount of money with the objective of purchasing the latest technology and as per regulations.

 

  • Quality Assurance

The assurance of quality with CGMP (because of the latest technology being used) is more reliable when compared to the same of GMP. The technology ensures that the quality is met in the final product, by taking many factors into consideration. In other words, a product will be analyzed from various dimensions to make sure that quality is met.

 

Summary  of CGMP vs GMP

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.

 

CGMP vs GMP: Comparison Chart- as framed by Ascent WORLD 

cGMP Vs GMP

 

 

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