What is GMP?

Good Manufacturing Practices or GMP is a system that consists of processes, procedures and
documentation that ensures manufacturing products, such as food, cosmetics, and pharmaceutical
goods, are consistently produced and controlled according to set quality standards. Implementing
GMP can help cut down on losses and waste, avoid recall, seizure, fines and jail time. Overall, it
protects both company and consumer from negative food safety events.

GMPs examine and cover every aspect of the manufacturing process to guard against any risks
that can be catastrophic for products, such as cross-contamination, adulteration, and mislabeling.
Some areas that can influence the safety and quality of products that GMP guideline and
regulation address are the following :

 Quality management
 Sanitation and hygiene
 Building and facilities
 Equipment
 Raw materials
 Personnel
 Validation and qualification
 Complaints
 Documentation and recordkeeping
 Inspections & quality audits

What is the difference between GMP and

cGMP?
Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP) are, in
most cases, interchangeable. GMP is the basic regulation promulgated by the US Food and Drug
Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to
ensure that manufacturers are taking proactive steps to guarantee their products are safe and
effective. cGMP, on the other hand, was implemented by the FDA to ensure continuous
improvement in the approach of manufacturers to product quality. It implies a constant
commitment to the highest available quality standards through the use of up-to-date systems and
technologies.

What are the 5 Main Components of

Good Manufacturing Practice?
It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure
consistent quality and safety of products. Focusing on the following 5 P’s of GMP helps comply
with strict standards throughout the entire production process.

The 5 P’s of GMP

1. People
All employees are expected to strictly adhere to manufacturing processes and
regulations. A current GMP training must be undertaken by all employees to fully
understand their roles and responsibilities. Assessing their performance helps
boost their productivity, efficiency, and competency.
2. Products
All products must undergo constant testing, comparison, and quality assurance
before distributing to consumers. Manufacturers should ensure that primary
materials including raw products and other components have clear
 specifications at every phase of production. The standard method must be
observed for packing, testing, and allocating sample products.
3. Processes
Processes should be properly documented, clear, consistent, and distributed to
all employees. Regular evaluation should be conducted to ensure all employees
are complying with the current processes and are meeting the required standards
of the organization.
4. Procedures
A procedure is a set of guidelines for undertaking a critical process or part of a
process to achieve a consistent result. It must be laid out to all employees and
followed consistently. Any deviation from the standard procedure should be
reported immediately and investigated.
5. Premises
Premises should promote cleanliness at all times to avoid cross-contamination,
accidents, or even fatalities. All equipment should be placed or stored properly
and calibrated regularly to ensure they are fit for the purpose of producing
consistent results to prevent the risk of equipment failure.

What are the 10 Principles of GMP?

1. Create Standard Operating Procedures (SOPs) 
2. Enforce / Implement SOPs and work instructions
3. Document procedures and processes
4. Validate the effectiveness of SOPs
5. Design and use working systems
6. Maintain systems, facilities, and equipment
7. Develop job competence of workers
8. Prevent contamination through cleanliness
9. Prioritize quality and integrate into workflow
10. Conduct GMP audits regularly

Regulations
GMP regulations are mandated by manufacturers’ respective national government to regulate the
production, verification, and validation of manufactured products and ensure that they are
effective and safe for market distribution.

For example, in the United States, GMP is enforced by the US FDA through Current Good
Manufacturing Practices (CGMP) which cover a broader range of industries such as cosmetics,
food, medical devices, and prescription drugs. The FDA conducts facility inspections to assess if
a manufacturing company complies with CGMP regulations. If any serious violations are found
during the inspection, FDA recalls all products, which is problematic for manufacturers in terms
of both profit and business operations.
The quality of manufactured products is highly regulated as it can pose negative health risks to
consumers and even the environment. Poor hygiene, temperature-control, cross-contamination,
and adulteration in any step of the manufacturing process are some examples of how a
manufactured product that doesn’t follow GMP regulations can bring fatal consequences to
consumers. See GMP regulation and preamble sources by country here.

Standards
GMP standards are developed to enhance the safety of manufactured products, especially
pharmaceutical goods, and to ensure consumers get the highest quality possible. Adherence to
GMP standards not only positively impacts the reputation of manufacturing companies but also
reduces batch recalls and negative reports from consumers. Below are 4 measures you can follow
to uphold GMP standards:

1. Quality team
Have a team of skilled workers that will focus on improving current
manufacturing procedures and complying with GMP. Members will perform
quality assessments on operations to identify problems and develop appropriate
corrective measures. Part of the team’s responsibility will also be performing
scheduled monitoring of instruments, equipment, processes, and staff skills.
2. Validation
Validation is the documented act of demonstrating instruments, processes, and
activities that are regularly used or done. This is done to check if they function
according to expectations. GMP can involve a number of things to be validated,
but it’s good to focus on the following processes:
 Process validation
 Cleaning and sanitation validation
 Computer system validation
 Analytical method validation
3. Surprise Audits
A surprise audit every now and then can help gain a more accurate insight into
what goes on in the facility. Identify real root causes of non-compliance and take
action before it progresses into a larger issue. Read more about best practices in
doing GMP audits.
 4. Compliance Training
Providing compliance training to staff is the best way to ensure compliance with
GMP standards. Help staff gain a better understanding of GMP and continually
improve operations or systems in place to ensure standards are GMP-compliant.
All employees should receive training on recordkeeping, sanitation, proper
equipment handling, and labeling, and SOPs to minimize errors and maintain
compliance.

Guidelines and Basic Concepts

GMP guidelines are a set of principles that help manufacturers implement an effective
manufacturing process and ensure that quality is built into the organization and the processes
involved. GMP guidelines are customarily flexible, with countries having their own legislation to
comply with local GMP guidelines and principles. But almost all regulations are derived from
the basic concept and guidelines which are:

Quality management
The principle of quality management is to ensure that manufactured products are fit for their
intended use, comply with requirements and does not place consumers at risk due to inadequate
safety, quality, or efficacy measures. To achieve this quality objective, quality assurance, good
manufacturing practices, quality control, and quality risk management should be
comprehensively and correctly implemented.
Quality assurance
The system of quality assurance aims to ensure that manufactured products are designed and
developed in a way that meets the requirements for Good Manufacturing Practice.
Good Manufacturing Practice for Products
As a part of quality assurance, good manufacturing practice is concerned with production and
quality control. It aims to mitigate the risks that are inherent in the production process. Its basic
requirements according to WHO’s Good Manufacturing Practices for Pharmaceuticals state
the following:

 All manufacturing processes are clearly defined, systematically reviewed in the

light of experience, and shown to be capable of consistently manufacturing
medicinal products of the required quality and complying with their specifications
and/or marketing authorization;
 Critical steps of manufacturing processes and significant changes to the process
are validated;
 All necessary facilities for GMP are provided including i. appropriately qualified
and trained personnel; ii. adequate premises and space; iii. suitable equipment
and services; iv. correct materials, containers, and labels; v. approved procedures
and instructions;
 Instructions and procedures are written in an instructional form in clear and
unambiguous language, specifically applicable to the facilities provided;
 Operators are trained to carry out procedures correctly;
 Records are made, manually and/or by recording instruments, during
manufacture which demonstrate that all the steps required by the defined
procedures and instructions were in fact taken and that the quantity and quality
of the product were as expected. Any significant deviations are fully recorded
and investigated;
 Records of manufacture including distribution which enable the complete history
of a batch to be traced are retained in a comprehensible and accessible form;
 The distribution (wholesaling) of the products minimizes any risk to their quality;
 A system is available to recall any batch of product, from sale or supply;
 Complaints about marketed products are examined, the causes of quality
defects investigated and appropriate measures are taken in respect of the
defective products and to prevent re-occurrence
Quality control
Quality control is a part of Good Manufacturing Practice that focuses on sampling, specification,
and testing. It checks the organization, documentation, and release procedures to ensure that
products go through the required tests before being released for sale or supply. 
Quality risk management
Quality risk management is a systematic process of assessing risks that can affect the quality of
the product. According to its principles, quality risk management should ensure that:
 The evaluation of the risk to quality is based on scientific knowledge, experience
with the process and ultimately links to the protection of the patient and users;
 The level of effort, formality, and documentation of the quality risk management
process is commensurate with the level of risk. c) The general quality risk
management process and integration into the product quality can be referred to
in ICHQ9.
  

Sanitation and hygiene

Sanitation and hygiene are vital in every aspect of the manufacturing process. It covers anything
that can cause contamination such as personnel, the premises, equipment, containers, and
production materials. All potential sources of contamination should be identified and eliminated
with a comprehensive sanitation and hygiene program.

Building and facilities/premises

As a principle, the premises should be situated in an environment that is suitable for its
operations and one that is free from risks of contamination of materials and products. The
premises should also be designed to minimize errors in operations and should be easy to clean
and maintain.

Equipment
Same with the premises, equipment should be designed, located, and maintained to function
according to its intended use. Additionally, it should be cleaned and stored according to
procedures. In the event of a defect or malfunction, it should be removed or labeled as defective.

Raw materials
All materials used for production should be stored properly according to the appropriate
conditions which are set by the manufacturers. There should be a proper stock management
system implemented to ensure that all incoming materials are correct and of high quality.

Personnel
The success of GMP compliance heavily relies on the people implementing it. For this reason, it
is vital that all personnel are qualified and trained to do the job. They should be aware of the
principles of GMP and receive continued training, hygiene instructions, and other tools relevant
to their needs. Respective managers should be clear on job descriptions for each worker to avoid
misunderstandings and reduce the risk of issues like overlapping responsibilities.

Validation and qualification

Qualify systems, premises, and equipment if they are fit/ready for their intended use and validate
if processes and procedures can repeatedly produce high-quality products. Critical steps in the
manufacturing process should be verified to ensure that product quality is consistent and
maintained at a high level. According to the WHO (World Health Organization), qualification
and validation should establish and provide documentation stating that:

 the premises, supporting utilities, equipment, and processes have been designed
in accordance with the requirements for GMP (design qualification or DQ)
 the premises, supporting utilities, and equipment have been built and installed in
compliance with their design specifications (installation qualification or IQ);
 the premises, supporting utilities, and equipment operate in accordance with
their design specifications (operational qualification or OQ); and a specific
process will consistently produce a product meeting its predetermined
specifications and quality attributes (process validation or PV, also called
performance qualification or PQ)

Complaints
Handling complaints is also part of GMP, therefore all manufacturing companies should have a
well-designed GMP complaint system. Ideal complaint handling should have a ready solution to
provide for all contingencies.

Documentation and recordkeeping

Good documentation and record keeping are an essential part of the quality assurance system and
are required in compliance with GMP requirements. Accurate recordkeeping can help managers
and supervisors keep track of the historical record of manufacturing procedures and corrective
measures implemented. Below are general requirements for documentation:

 Documents must be designed, prepared, reviewed, and distributed with care.

 Documents should be clear and legible.
 Documents must be approved, signed, and dated by appropriate and authorized
personnel.
 Documents must have unambiguous contents such as title, nature, and purpose.
 Documents must be regularly reviewed and updated.
 Documents must not be handwritten.
 Any corrections made to a document or record must be signed or initialed and
dated. The reason for the correction should also be recorded (where
appropriate).
 Record each action taken for traceable activities such as manufacturing and
control of products.

Inspections & quality audits

Inspections should be regularly performed to monitor if GMP is implemented and complied with.
Document what areas need more work and provide corrective measures for continuous
improvement. Quality audits are done to assess the quality systems implemented by the
manufacturing company. GMP audit checklists can help companies comply with GMP
guidelines set by regulatory authorities. By performing site visual walkthroughs and conducting
manufacturing evaluations, you can identify non-compliant processes and take immediate action
to address areas for improvement.

How to Comply with Guidelines

GMP guidelines and regulations address different issues that can influence the safety and quality
of a product. Meeting GMP or cGMP standards helps the organization comply with legislative
orders, increase the quality of their products, improve customer satisfaction, increase sales, and
earn a profitable return of investment.
Conducting GMP audits play a big part in assessing the compliance of the organization to
manufacturing protocols and guidelines. Performing regular checks can minimize the risk of
adulteration and misbrand. A GMP audit helps improve the overall performance of different
systems including the following:

 Building and facilities

 Materials management
 Quality control systems
 Manufacturing
 Packaging and identification labeling
 Quality management systems
 Personnel and GMP training
 Purchasing
 Customer service

Compliance and Your Organization

GMP compliance is crucial in the manufacturing industry. Providing quality-assured products
can secure the health and safety of the public. Robust processes and easy-to-use systems that
enforce and monitor standards can strengthen GMP compliance in your organization. With
technological advances in the industry, food manufacturers have more opportunities to transform
reactive company culture, into a proactive, predictive workforce equipped for continuous
improvement. Utilize digital tools such as iAuditor by SafetyCulture, a mobile inspection app,
and sensors to move your GMP beyond compliance.  With iAuditor you can:
 create, customize, and use mobile-ready GMP audit checklists anytime,
anywhere;
 attach photos and make annotations within the app;
 set and notify scheduled GMP audits;
 integrate existing software systems; and
 save all GMP documents securely on a cloud.

Global companies conduct inspections

with us
 See how a trusted food delivery business in Australia, Marley Spoon, immediately takes action
based on real-time data using iAuditor temperature sensors:
iAuditor gives you the flexibility to power any inspection you require—onsite, underground, and
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GMP Checklists: Guide to Better

Manufacturing Processes and Quality
Products
GMP Compliance Checklist

iAuditor is the world’s #1 cloud-based inspection app used to convert paper forms to digital
checklists. Sign up now and download these 100% free and customizable GMP checklists!
1. FDA GMP Cosmetics Audit Checklist
2. GMP Food Manufacturing Audit
3. GMP Site Walkthrough Checklist
 Browse GMP Audit Templates