Current Good Manufacturing Practice (cGMP) is a set of regulations that was initially put forth by the FDA to ensure that business organizations, manufacturers, and packagers of pharmaceutical products, medical devices, blood, and certain foods proactively guarantee that their products are effective, safe, and pure.
cGMP applies to facilities and buildings, production, equipment, process controls, laboratory controls, packaging, and labeling, and returned or salvaged drug products.
For instance, if your pharmaceutical company is selling epinephrine, a vital drug for the treatment of anaphylactic shock, patients will be assured of the safety and efficacy of this life-saving drug because you are cGMP compliant.
In this article we will learn about:
- What Is cGMP?
- What Is the Difference Between GMP and cGMP?
- What Is the Difference Between cGMP and GLP?
- Why Is cGMP Compliance Important
- What Are cGMP Requirements?
- How to Remain cGMP Compliant?
- How Does an eQMS Help With cGMP Compliance?
What Is cGMP?
cGMP stands for Current Good Manufacturing Practice. cGMP applies to the pharmaceutical, biotechnology, medical technology, and medical devices industries.
The goal of cGMP is to increase product quality.
This is done by developing systems that proactively guarantee proper product design and control of manufacturing processes and facilities.
The types of products that must comply with cGMP include:
- Pharmaceutical products
- Medical devices
- Biotechnology products
- Food and beverage
- Dietary supplements
What Is the Difference Between GMP and cGMP?
GMP stands for Good Manufacturing Practice. We know that cGMP is current good manufacturing practice. It implies that cGMP is the most current version of GMP.
As GMP standards constantly improve, the Pharmaceutical, BioTech, MedTech, and Medical Devices industries must be abreast of the latest regulations, namely, cGMP.
Your pharmaceutical company has equipment and systems in place dating from the early 2010s. These were first-rate at that point in time. However, you are unaware of the current regulations regarding this equipment and systems.
You are compliant with GMP standards, but are you compliant with cGMP standards?
Quality, cost, and current standards are the three keywords that differentiate between GMP and cGMP.
Whether you follow GMP or cGMP standards, you are following regulatory guidelines to ensure your products are safe, pure, and of the best quality.
With GMP, you are following the required standards applicable to your industry, but with cGMP, you go one (or more) steps ahead to ensure that you are in tune with the latest rules and regulations.
Both GMP and cGMP rules and regulations are expensive propositions. But, cGMP is more expensive because you will need to invest in additional testing and state-of-the-art technologies.
As mentioned at the beginning of this section, GMP rules and regulations ensure the quality and safety of your products. With cGMP, you are compliant with the most current rules and regulations applicable to your industry.
A cGMP-compliant Electronic Quality Management System (eQMS) can help you to manage training, document control, design control, and other quality processes more efficiently and ensure cGMP compliance.
An important requirement for cGMP-compliant Systems is that you have carefully considered the need for Computer System Validation, in order to operate with fully digitized processes.
What Is the Difference Between cGMP and GLP?
GLP refers to Good Laboratory Practices. Both GLP and cGMP are governed by the US FDA.
The differences between cGMP and GLP (Good Laboratory Practice) are not always clear since they share similar terminologies and oftentimes, similar applications to some extent. As a result, a common misunderstanding is a difference between cGMP and GLP.
However, the similarities and differences between the two are illustrated below.
Similarities of cGMP and GLP
Both GLP and cGMP are governed by the US FDA. Moreover, both regulations have the purpose of ensuring the safety and integrity of drugs.
Differences between cGMP and GLP
It is in laboratory testing of drugs that the differences are most obvious. GLP is focused on the preclinical development of a pharmaceutical product, including pharmacology, toxicology, and biocompatibility. When you are GLP compliant, you will provide regulatory authorities the requisite data for analyzing and assessing non-clinical laboratory studies for their scientific validity.
When you are cGMP compliant, you will demonstrate to the concerned regulatory authorities that all batches of products manufactured in your facility are according to pre-determined criteria. In other words, cGMP is mandatory for batch/lot release, manufacturing and testing, and the different marketing phases of a medicinal product.
In order to make your management of Batch Master Records efficient and compliant, you can utilize digital workflows and FDA compliant e-signatures.
Why Is cGMP Compliance Important
When your pharmaceutical company is cGMP compliant, you are assuring the end-users that the drugs manufactured in your facility are regulated by the latest industry standards.
Therefore, you will be ensuring that:
- Buildings and facilities are in good condition
- Equipment is properly maintained and calibrated
- Processes and procedures are reproducible and reliable
- Employees are fully trained and qualified
- Products are safe and of high quality
What Are cGMP Requirements?
The regulations that govern cGMP requirements for most organizations are:
- 21 CFR Part 314: FDA approval for marketing a new drug
- 21 CFR Part 210: cGMP for manufacturing, processing, packing, or holding of drugs.
- 21 CFR Part 211: cGMP for finished pharmaceutical
- 21 CFR Part 212: cGMP for PET (positron emission tomography) drugs
- 21 CFR Part 600: For general biological products
The following are the key cGMP requirements.
Facilities and Equipment
The buildings and facilities housing your pharmaceutical company must be properly maintained. This will ensure that the conditions for manufacturing are safe and effective.
The same applies to equipment that needs to be well-maintained and calibrated. Ensure that the SOPs (Standard Operating Procedures) are up-to-date.
For example, with equipment calibration management software, you can manage your equipment calibration schedules more efficiently. The software automatically triggers calibration tasks before due dates, assigns activities to relevant employees, and sends email reminders about the upcoming tasks.
Raw Materials and Products
A core cGMP requirement is a master formula for each of your pharmaceutical products that must be followed, without deviation, through the entire manufacturing process.
Managing your documentation using a manual system increases the risk of human error and takes a lot of time. A fully digital eQMS helps you work more efficiently, reduce human error, and ensure cGMP compliance by automating your document control processes.
Take any business – people are the backbone.
The same applies to your pharmaceutical company. Trained staff are required to operate every step of the manufacturing process. This is mandatory under cGMP requirements.
With SimplerQMS employee training management software you can ensure that all relevant people receive training tasks based on their job roles. Furthermore, employees will automatically get reminded every time a new trainable material gets released.
Procedures and Processes
If you are perchance using outdated technology, it is clear that you are not compliant with cGMP. Revisit all procedures regularly and make sure that you are using the latest science and technology for your products. Processes indicate the documentation of all procedures.
With our form management software module, you can ensure that all your documents and procedures follow pharmaceutical document management best practices, are up-to-date, and are cGMP compliant. For example, by setting up automated annual review reminders for your forms you will receive email notifications in due time before the next review takes place.
How to Remain cGMP Compliant?
To meet cGMP compliance and regulatory requirements, do ensure that:
- All data is complete with necessary controls
- Assign ownership to specific individuals
- Authorize only selected individuals to make changes to records
- Regular review of records for compliance, accuracy, and completeness
- Ensure that data is secure throughout its history
With a robust QMS in place, you will not only ensure that quality is maintained, but also that you are cGMP compliant.
Recommended Reading: Pharmaceutical Quality Management System (QMS)
How Does an eQMS Help With cGMP Compliance?
An eQMS helps with cGMP compliance in several ways:
- Identify and resolve problems and avert accidents by investigating data for trends
- Periodic internal audits will evaluate the usefulness of the quality systems that you have executed
- Corrective action will address the root causes of problems and how to prevent them from recurring
- Preventive actions will help you plan and train for any future problems
With an eQMS such as SimplerQMS, you can manage document control, supplier control, design control, and other quality activities more efficiently. This is possible by utilizing an automated workflow for authoring, review, and approval processes, and other features.
Our QMS Software is cGMP compliant, it provides FDA 21 CFR Part 11 compliant electronic signatures, time-stamped audit trails, and reporting capabilities that allow for full traceability.
Quality Management Software from SimplerQMS makes you better prepared for audits. All records for a specific product, with versioning, signatures, and audit trails can easily be found in one location.
Are you wondering whether we can help your organization work smarter with documentation and ensure cGMP complaince? If that is the case, we recommend you schedule a demo to see SimplerQMS in action and talk to our experts.
The main purpose of cGMP is to ensure that manufacturers, business organizations, and packagers of pharmaceutical products, medical devices, and certain foods must proactively guarantee that their products are effective, safe, and pure.
By being cGMP compliant, you have facilities that are in good condition. Equipment that is carefully maintained and calibrated. Fully trained and qualified staff, procedures and protocols that are reproducible and reliable, and products that are of high-quality, safe, and efficacious.