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What are Current Good

Manufacturing Practices
(cGMP)?
by Germans Frolovs | Sep 30, 2021 | Regulations

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 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
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 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.

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 Quality
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.

Cost
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Both GMP and cGMP rules and regulations are expensive propositions.
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But, cGMP is more expensive because you will need to invest in additional
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 testing and state-of-the-art technologies.

Current Standards
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.

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 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.

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 Laboratory Quality Management System (QMS)
Clinical Quality Management System [Role of an eQMS]

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

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The buildings and facilities housing your pharmaceutical company must
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be properly maintained. This will ensure that the conditions for
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 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.

Staff
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
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happy with it. for your products.
Processes indicate the documentation
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of all procedures.
 With our form and template management 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 pharmaceutical QMS in place, you will not only ensure that
quality is maintained, but also that you are cGMP compliant.

You can learn more about how GMP compliance is reflected in QMS in our
full guide.

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
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Preventive actions will help you plan

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 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.

Final Thoughts
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.

Non-Conformance Report Template

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