GMP, or Good Manufacturing Practices, are a set of guidelines that pharmaceutical companies must follow to ensure their products’ quality. These guidelines vary depending on the country in which they are being followed, but they all have similar steps and principles in common.
Suppose you’re considering starting your own pharmaceutical company. In that case, it’s important to know what you’re getting into with the GMP regulations and how to keep up with them throughout your pharmaceutical product development life cycle.
This article guide will discuss GMP requirements and how they might affect your business.
Introduction to Good Manufacturing Practice (GMP)
Good manufacturing practice (GMP) is a set of guidelines that specify the conditions required for producing quality products. These guidelines are designed to help maintain product quality, consistency, and safety.
GMP covers the production and testing of pharmaceuticals, biotechnology products, food products, and cosmetics. The basic principles of GMP are:
- Every company must have its own written set of procedures with explicit instructions from raw materials through distribution.
- Employees must be adequately trained on how these procedures should be followed while working in each area of production.
- Production areas must be monitored at all times to ensure they are operating according to procedures and being cleaned and maintained regularly so as not to pose a risk to product safety or quality.
Who needs GMP Certification?
The FDA requires GMP certification, but it’s not just for pharmaceutical companies. Any company that produces a product that comes in contact with food or medicine needs GMP certification.
It’s crucial if you want your products to be sold in the US and other parts of the world. Here are some other considerations:
- Do you want to expand into new markets?
- Are you being asked by retailers or distributors about GMP certification?
- Have you had recalls because of quality concerns?
- Is FDA regulation too expensive for your small business?
Don’t let these things stop you from applying for GMP certification. Plenty of different packages are available that make getting started easier than ever. Your employees will also appreciate the training materials and any consulting services offered as part of a comprehensive package deal.
If quality has been an issue in the past, this may be exactly what your business needs to set things straight once again.
Why is GMP important for pharmacists?
Pharmacists are responsible for ensuring that drugs prescribed by physicians are safe and effective. Achieving this goal, however, can be difficult if a pharmacist doesn’t know what they’re looking for.
In general, pharmaceutical companies must comply with regulatory requirements to ensure their products’ safety and quality. One such requirement is Good Manufacturing Practices (GMP). GMP is designed to assure that a company’s manufacturing processes will consistently provide quality products and that no issues will arise from the manufacturing process.
The GMP is divided into several sections: Facility Establishment and Equipment; Design Control; Production Process Control; Production Particulate Evaluation; Document Control; Quality Systems Management; Quality Records Management, and Auditing Procedures. The facility includes everything from facilities where raw materials are stored to where packaged product leaves the factory floor.
The design control area guides how equipment should be designed to operate safely, efficiently, and economically. Production Process Control outlines the steps needed to create a finished drug product while meeting product specification limits.
Finally, production particulate evaluation ensures that the procedures are followed when processing bulk drug substances or finished drug products.
The Phases of the Manufacturing Process
· Raw Material Inspection
Raw materials are the backbone of any pharmaceutical company. The raw materials used in producing these medicines are inspected and monitored to ensure they meet the necessary quality standards. This is done through a process called raw material inspection.
This is accomplished by testing raw materials at various points before they reach their final destination: your pharmacy or drugstore.
· Initial Processing
An important part of pharmaceutical company GMP compliance is establishing and maintaining an initial processing area. An initial processing area is where incoming raw materials are processed before they are sent to the next step in production, such as a milling or packaging facility.
An initial processing area can be a standalone site or exist within another facility, depending on the pharmaceutical company’s needs. One of the key components of GMP compliance in an initial processing area is a computerized system that tracks and monitors all incoming raw materials that come into contact with products for human use. This helps protect against contamination from other products and potential sources of contamination, such as pests and vermin.
· Cleaning and Sanitizing
A clean and sanitized work environment is essential in pharmaceutical companies. Workers must be trained on how to properly perform this process, as they are responsible for ensuring equipment and areas are clean.
The cleaning process starts with vacuuming and sweeping, then wiping or mopping the floor. After that, all surfaces need to be disinfected with a solution of water and bleach. Finally, any spills must be cleaned up with a mixture of water and detergent.
· Capping, Sealing, Labeling
Capping and sealing are the last steps in pharmaceutical packaging. They complete the process of ensuring that products are not contaminated during transport or storage. The capping machines should be compatible with the size and shape of your containers, and you’ll need a good sealant to create a good quality seal.
Labeling is an important part of the packaging process because it provides information about what’s inside, who produced it, and when it was made.
· Storage or Distribution
When storage or distribution is not in compliance, companies risk federal sanctions and fines. The FDA can take regulatory action when it finds that pharmaceutical products are adulterated, misbranded, or have violated the Federal Food, Drug, and Cosmetic Act.
Adulterated products contain a substance that does not belong in the product. Misbranded products are those with labeling or labeling information that does not conform to current law.
Violations include failing to comply with good manufacturing practice regulations by the Food and Drug Administration.
· Quality Control and Product Disposition
Quality control is an important aspect of GMP. There are a lot of standards and requirements that need to be met to ensure your quality measures are met. Quality control measures can include microbiological testing, chemical analysis, and bioassays. These tests help you prove your product is what it says it is because they examine the product on a molecular level.