The 5 Ps of GMP: People, Products, Processes, Procedures, and Premises Explained!

What are the 5 Ps of GMP certification, and what is the role of each in any manufacturing unit or business? and the role of GMP certification in its strategy of making the “5 Ps”.

Everything has its own way of working, whether it is a business or a company. Even some authorized bodies work in their own ways. And we are talking about the GMP certification. This is a very important thing for any businessman or manufacturer to ensure that their business is genuinely great for the market. So, in that case, the GMP certification also has its own way of ensuring safety and quality in any business or company. And the way of this certification is called the principle of “5 Ps of GMP Certification”.

In this principle, the authorized body of GMP principles, which is WHO, includes People, Products, Processes, Procedures, and Premises. Which means any company or production unit that works in the food and pharma quality framework industry has to follow these 5 steps in their facility. Even the authorized bodies will mandate these steps for any company or unit. Because of these 5 steps, GMP ensures that the facility is safe and producing high-quality products. 

1. Details on the “5 Ps” of GMP Certification

Mainly, the strategy of “5 Ps of GMP Certification” refers to People, Premises, Processes, Products, and Procedures. And with the help of this strategy, GMP ensures that products are consistently manufactured, controlled, and meet quality standards. Also, highly experienced persons and employees are working for the production unit.

With this, GMP also ensures that any production unit that comes under the food and pharma industry has suitable facilities, validated workflows, quality-focused products, and documented instructions.

GMP guidelines in India mandate this principle of every manufacturing unit because manually checking these things in a facility becomes much harder, and checking them one by one is not possible due to having number of manufacturers in any country.

The detailed points of these 5 steps are mentioned below:

1. People

This means that in any manufacturing unit, the humans who are involved in the role of workers, employees, etc., must be fully trained, including roles, training, and responsibilities.

Employees must be qualified enough to perform different responsibilities in a unit productively and understand the compulsory of quality with safety. They understand their clear role and responsibilities for preventing errors and confusion.

2. Premises

This step includes the manufacturing unit and equipment of a company. This step of the premises is designed and maintained to ensure that products do not have contamination, mix-ups, and other quality issues.

GMPs ensure this with the help of cleanliness, sanitation, and a controlled environment. This helps them in reducing risks like those from pests or cross-contamination.

3. Processes

With this step, GMP certification focuses on the actual production steps of any facility. By mandating a clearly defined, consistently executed. And validated process steps to make sure that products are made of high-quality materials.

With the help of monitoring and controlling the process to ensure that the unit is staying within specified parameters.

4. Procedures

In this, GMP includes the documented instructions for how to perform a task in your manufacturing unit. With the help of Standard Operating Procedures (SOPs), which perfectly ensure consistency and traceability.

And if procedures are not mentioned by any manufacturer, then it is considered to have happened in the facility. Any step or process that happens in the unit must be documented, investigated, and reported.

5. Products

This step covers the whole process of any products that are made in the facility, from raw materials to the final finished product. This says that all material that is used in manufacturing must meet the required specifications and quality standards.

This element also mandates that the final product, which is made, must follow the quality standards for safety, identity, strength, and purity.

2. Advantages of GMP’s “5 Ps” Policy for a Facility

If any production unit has the GMP certification, then this policy of “5 Ps” automatically becomes mandatory for that unit. And it also provides many benefits to a facility because it ensures all five things of a unit. These are known to be very important. Due to this framework of GMP certificate registration also becomes beneficial for any manufacturer.

In terms of benefits, it provides a mark of quality to a manufacturer because when a facility successfully passes all five steps. It is shown as the best production unit in terms of safety, quality, and production of high-level products. Also, it helps a manufacturer by protecting it from regulatory compliance issues that arise in its company. Because any legal actions do not happen for that company that passes all these steps easily.

Some detailed benefits are also included below:

1. Prevents errors and risks – After applying these steps in your production unit, this helps you in getting product quality or safety. With the help of continuous training of employees.
2. Maintaining hygiene and sanitation – Due to these principles, maintaining hygiene becomes a mandatory thing for a unit to prevent microbial contamination. And other forms of contamination caused by human contact.
3. Reduces equipment failure – When a facility starts doing calibration and maintenance of equipment. It causes them to function correctly, providing consistent and accurate results.
4. Increase workflows – If any facility’s layout is logical and great for working. Then it improves the flow of materials, personnel, and equipment, which enhances efficiency and reduces mix-ups.
5. Increases productivity – By standardizing and making your processes more repeatable create efficiency, leading to higher productivity and lower operational costs.
6. Claims consistency – If you provide well-maintained SOPs with the help of this GMP principle. Then it shows that every task is performed consistently, regardless of who is performing it.
7. Build customer trust – Providing high-quality, safe products continuously helps in getting a better brand reputation and also increases strong relations between you and your customers.
8. Build transparency – By the principle of “5 Ps,” manufacturers more actively emphasize documentation and record-keeping. This helps them provide a transparent and traceable manufacturing process.

3. Who Needs the GMPs’ “5 Ps” Policy the Most?

Mainly, there are some companies that require this framework the most because in those businesses, ensuring safety and quality becomes a mandatory thing.

The list of those businesses is mentioned below:

1. Retail and hospitality – This list includes those businesses that are related to restaurants, coffee shops, or hotels, because for these, ensuring the GMPs 5 Ps becomes very important for increasing their service quality.
2. Service-based businesses – Those businesses that provide service facilities to their consumers. Such as consulting agencies, salons, or financial planners, then for those, the policy “5 Ps” becomes very beneficial.
3. E-commerce brands – Those who deal in e-commerce marketing also get benefits from the policy of GMP and the quality of customer support.
4. Technology companies – In the tech sector, the GMP principle also works very well for ensuring the safety and reliability of their products.
5. Startups – Mainly for startups, this framework works very well because in the case of a startup company, many things become important for checking and mandating. So, due to this, GMP easily applies the “5 Ps” policy on them.
6. Food and beverage businesses – If any company is involved in producing food products requires a strict 5 Ps policy to ensure safety and quality.
7. Pharmaceutical and medical companies – These sectors are very sensitive because they are directly related to the health and well-being of consumers. Due to this, the 5 Ps policy becomes an important thing for them.

4. For the 5 Ps of GMP Certification Policy, LegalRaasta is One Way for This

Launching a business isn’t exactly that easy, and getting that all-important GMP certificate online can be a serious headache. That’s where LegalRaasta comes in. We’re a certified company, and we actually know how to get you through the GMP Certification framework process smoothly. Whether you’re running a startup or a more established related company. There aren’t many reliable GMP certification providers out there. But LegalRaasta is one of the few that can genuinely provide services for you. Need a virtual CFO? Company or LLP registration? NBFC paperwork? We will also get it covered.