GMP: Good Manufacturing Practices
What is
GMP?
Good
Manufacturing Practices, or GMP, is a system made up of steps, instructions,
and paperwork that guarantees manufacturing commodities like food, cosmetics,
and pharmaceuticals are regularly produced and monitored in accordance with
predetermined quality standards. GMP implementation can reduce losses and waste
while preventing recalls, seizures, fines, and jail time. Overall, it guards
against bad food safety incidents for both the business and the customer.
Every step
of the manufacturing process is examined and covered by GMP to prevent hazards
that could have disastrous effects on the products, such as
cross-contamination, adulteration, and mislabeling. The following are some areas
that GMP guidelines and regulations might affect in terms of product quality
and safety:
- ·
Quality
management
- ·
Sanitation
and hygiene
- ·
Building
and facilities
- ·
Equipment
- · Raw
materials
- ·
Personnel
- ·
Validation
and qualification
- ·
Complaints
- · Documentation
and record keeping
- ·
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 using 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.
What are
the 10 Principles of GMP?
Create
Standard Operating Procedures (SOPs)
Enforce /
Implement SOPs and work instructions
Document
procedures and processes
Validate the
effectiveness of SOPs
Design and
use working systems
Maintain systems,
facilities, and equipment
Develop job
competence of workers
Prevent
contamination through cleanliness
Prioritize
quality and integrate into workflow
Conduct GMP audits regularly
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.
Ensure
consistency in quality and safety with GMP training
Good
Manufacturing Processes, or GMP, make sure that products are controlled in
quantity and produced in such a way that meets quality standards. GMP involves
many factors such as hygiene, environmental conditions, and more. Through this
process, any flaws or anomalies can already be identified earlier on which
wouldn’t be detected when the final product is tested or already out in the
market. By making sure that your products go through GMP, you’ll have high-quality
end products that are safe for use or consumption which, in turn, will give
better customer satisfaction and yield higher revenue.
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