Why Skipping GMP Certification Can Hold Back Your Herbal Business?
Thinking of manufacturing without having the GMP certification for herbal products? Or risks of skipping GMP compliance even for your herbal business? Learn all things with this blog.
We know that the herbal product comes from ancient times, due to which they are known to be great in terms of curing diseases. Herbal products are also known as Ayurvedic products. Mainly, these products are made from herbs, plants, and natural ingredients. Due to this, they are very secure and reliable for the health and well-being of many consumers. Especially in India, many people have trust in the herbal products because we can say that the main origin of these products is India. That’s why Indian people love these products.
When the terms of safety and quality of several authorities make sure that these products are met. These goods have received certification from the GMP certification in India. GMP certification is issued to the company that manufactures these products in order to ensure safety, quality, and contamination control throughout the processing of these products. If you are thinking of skipping GMP certification for herbal products, then you might have to face many fines and penalties, which may also disturb your company’s entire economy.
1. Cons of Skipping GMP for Your Herbal Products
Thinking of skipping GMP certification for your herbal goods and your unit of herbal items, then be ready to face many issues and hurdles in your pathway. Due to the complexity of herbal items, these come in a sensitive category, and skipping the certification for them might cause significant risks, impacting consumer safety, business viability, and regulatory compliance because the GMP certification is used for ensuring that your produced herbal products have quality, purity, and safety.
Many risks and issues arise in your herbal items because of not having appropriate proof of your safety and quality. In those terms, the GMP certification plays a role as an appropriate proof for your herbal company and products. Check out some more brief points on why GMP is essential for herbal businesses:
- Increase in Health and safety risks
- Due to the non-presence of certification, how does GMP build trust for herbal brands? The guidelines of GMP are not present in your facility. Due to this, the higher risk of contamination from toxic substances, harmful microbes, or foreign matter increases, which causes severe illness, injury, or death.
- If your products remain untested, then they may contain undisclosed or incorrect ingredients, including cheap fillers or substitutes. Which impacts the product’s purity and safety.
- Improper manufacturing processes can cause a concentration of active compounds that makes the products less potent or even toxic, because of contain dangerous doses.
- Your irresponsibility can also cause serious health issues, such as liver or kidney failure, due to having poor-quality products.
- Consequences in your business and legal
- Skipping GMP certification for herbal products can easily destroy your brand reputation and consumer confidence. Because today’s consumers are aware of product quality and safety.
- You can also get warning letters, costly fines, mandatory product recalls, and import bans through some government agencies in order to not maintaining GMP regulations in your facility.
- Evenly skipping GMP certification can also lead to suspension of your company’s operations by authorized bodies because they have the right to suspend the business.
- Also in many global markets which including the United States and Europe, require GMP certification in terms of accepting importing and selling herbal products.
- Efficacy and quality control issues
- GMP certification in India ensures that your raw materials are consistent with your final products. However, without it, each batch may vary in quality, which compromises the product’s therapeutic effect.
- Without proper quality control, producers can use poor or damaged raw materials, which could introduce pollutants and reduce the efficiency of the final product.
- Natural ingredients are used to make the herbal goods with inherent variations, due to which the GMP certification controls the entire unit from sourcing and packing, quality assurance, and processing.
2. Don’t Have Certification Yet, Steps for Getting it for Herbal Products
So, if you do not have your GMP certification yet, and you are afraid of fines and penalties. Get it now with these easy steps for your herbal products. Getting the certification for your herbal company is crucial since accreditation demonstrates that your herbal products are totally safe and reliable to use. So, the steps are provided below for getting it for your herbal items.
Implement GMP standards
- Firstly, go with implement GMP standards in your facility that cover all aspects of production, including quality control, hygiene, and thorough documentation.
- Then create and implement Standard Operating Procedures (SOPs) that maintain a record of your equipment maintenance and calibration logs.
Get your application materials ready
- Search and collect the important documents of your facility, like your manufacturing license, proof of business registration, product lists, and site master file.
- In those documents, also include detailed manufacturing process reports, analysis methods, finished product specifications, and validation reports of your entire processes. Also, prepare and include proof of safety and efficiency for your goods.
Apply for your certification
- Then submit or provide all your collected submissions to a recognized certifying authority.
- Then ask that certification body to conduct a gap analysis to identify any non-compliance or issues throughout your manufacturing unit between your current practices and GMP standards.
Conduct audits
- Your written policies, processes, and management structure will be inspected by the certification organization. Any non-compliance issues found must be fixed.
- Then, the certification also conducts a physical inspection of your unit in terms of verifying that your operations match your documentation and comply with GMP standards.
Receive your certification
- Then, if any non-compliance or issues are found during the Stage 2 audit. You must correct those and implement corrective actions.
- When all your inspections and audits are successfully done, the certification body will issue your GMP certificate. But after getting make sure to regularly check your manufacturing unit and processes.
3. Role of LegalRaasta for the Service of GMP Certification
We are a trusted partner for many business manufacturers and founders, providing a variety of services aimed at assisting you in expanding. Need a GMP certification for herbal products? We make it simple. If you are starting a business or growing an existing one, LegalRaasta provides you access to a GMP certification service that understands your needs. We’re not only limited to financial leadership, but. We also provide hassle-free legal services that actually help you in your growth, no hurdles, just results. Also, getting virtual CFO services isn’t easy. Along with that, we handle GMP certification, registration of companies, limited liability partnerships, NBFCs, and more. It’s all in one place, right on our website.
4. Frequently Asked Questions
What happens if I do not get the GMP certification for my herbal products?
Ans. Due to not having the GMP certification, this might cause you many fines and penalties. Even your manufacturing process is suspended.
What do I do to get the GMP certification?
Ans. In terms of getting your GMP certification, follow some easy steps in your production unit for obtaining the GMP certification.
Why is the certification important for herbal products?
Ans. The certification is important for herbal products because it ensures that the ingredients that you use in your items are safe and best quality.
For what industries is the GMP certification important?
Ans. The GMP certification is important for pharma, food, and health-related industries.
Who issues the GMP certification for herbal-related businesses?
Ans. For herbal companies in Indian, the CDSCO and other authorities issue the GMP certification, and for international markets, the FDA and WHO issue this certification.