In today’s worldwide pharmaceutical and healthcare manufacturing industry, product quality, safety, and testing are non-negotiable. Every pharma manufacturer offers medicines, nutrient ranges, cosmetics, and various healthcare products under WHO-GMP certifications. Most countries only accept WHO-GMP-verified healthcare and pharmaceutical products. WHO-GMP is considered the verified certification for building brand goodwill. In this article, we will explore What Is WHO-GMP Certification and Why Every Manufacturer Needs It.
Key stats of WHO-GMP certified manufacturers in India
As per the study of central drugs standard control organisation, the total WHO-GMP certified manufacturing units of pharmaceutical products are 1329.
What is WHO-GMP Certification?
WHO-GMO certifications stand for the World Health Organisation and Good Manufacturing Practices for ensuring product manufacturing quality standards. These certifications ensure the pharmaceutical products are manufactured to strict quality standards and testing as per the regulations of international quality benchmarks.
WHO-GMP covers critical areas like:
- Raw material sourcing
- Storage & distribution
- Production processes
- Packaging & labelling
- Quality control testing
- Facility cleanliness & maintenance
- Equipment validation
- Documentation & batch records
- Staff hygiene & training
Why Are WHO-GMP Certifications Important For Every Manufacturer?
These global certifications are essential for every manufacturer because every pharmaceutical product meets global safety regulations and ingredient purity standards. These certifications easily build trust among international buyers to enhance market access and increase market goodwill of pharma products or manufacturers.
Certified manufactured products are easy to import and export to other countries without any regulatory expectations.
- Global market access: Most countries require WHO-GMP certifications to import and export medical or healthcare products. Without these certificates, most companies lose out on supplying the global procurement and international market.
- Boosts product quality: These global certificates ensure the quality of the manufacturing unit at every step by reducing manufacturing errors, contamination risks, or batch failures.
- Builds customer trust: these certifications enhance customer trust and market goodwill because WHO-GMP is known for quality assurance, and every brand follows WHO health guidelines.
- Boosts Brand Reputation: WHO-GMP certifications easily build customer trust because they are known for the best quality checks and assurance.
- Reduces Costs & Waste: Most of the manufacturers take these certificates and experience fewer recalls, deviations, and standard breakdowns.
- Beneficial for international tenders: Most of the government healthcare programs, NGOs, or countries only support WHO-GMP-approved manufacturers.
- Regulatory compliance: the best certification structure works with regulatory standards and the World Health Organization’s schemes.
What Are The Key Requirements Of WHO-GMP Certifications?
Every pharmaceutical manufacturer needs several guidelines, including:
- Most of the industries need to maintain layout and gyne standards.
- Manufacturers need to ensure the machines work more accurately.
- Follow the SOPs procedure and detailed documentation for every process.
- Ensure the QC and QA processes run smoothly in your facility, like raw material and finished goods.
- Proper records of every batch with reports, testing, and material quantity usage
- Workers’ training to maintain hygiene and safety protocols.
- Validation or qualification for reducing product recall & complaint handling system.
Finding the WHO-GMP Certification Status of a Company
Using a WHO-GMP-certified manufacturer for products that you want to sell is a good way to make sure that your goods comply with international quality and safety standards. Here are some tips to help you confirm a manufacturer’s status:
- Request WHO-GMP Certification: Make your request for a valid WHO-GMP certification.
- Check Licensing: Investigate the legitimacy of the manufacturer’s licenses and whether it has any approvals from relevant authorities.
- Confirm Factory: Make sure the factory mentioned in the certificate is indeed the factory of the manufacturer. Check the GMP and ISO certifications.
- Quality check procedure: Make sure to check the quality procedures followed by the manufacturer. They must follow the standard batch-wise testing for the medicines.
- Regulatory compliance: Check if the company has the compliance to manufacture the medicines and follows them honestly.
- Check their transparency: Make sure to check the transparency of the company. Do not entertain any hidden charges.
Common Pitfalls in Selecting a WHO-GMP Certified Manufacturer
Choosing the appropriate partner for creating your manufacturing process necessitates more than simply confirming their department is accredited. Recognizing the common blunders can allow you to form a long-lasting business relationship with a credible manufacturer that will always produce your items according to the specifications.
- Adhering Only to Price Criteria: The competitive rates for the production might lead to a lower quality of the finished product.
- Neglecting Quality Control: Always check that the company in question implements quality control extensively.
- Believing in the Presence of the Accredited Department without Verification: It is never advisable to take for granted the fact that the manufacturer you are dealing with is accredited.
- Disregarding Manufacturing Potential: Check whether the manufacturer has the capabilities to fulfill both your current and future production needs.
- Experience: Not checking the experience of the manufacturer before hiring them.
- Review and testimonials: Not reading reviews and testimonials of existing customers.
- Documentation: Proper documentation is very crucial. Customers do not undergo proper documentation that leads to major issues in the future.
Which industrial manufacturers need WHO-GMP certifications?
WHO-GMP certifications are not only for quality testing and product safety, but they’re also all about customer and patient trust and following safety regulatory standards.
- Pharmaceuticals
- Manufacturing industry
- Cosmetics
- Medical devices
- Disposable health products
- Drugs and the active pharmaceutical industry.
- Disinfectants and sanitization industries
What Are the Key Benefits of Owning WHO-GMP Certifications?
| Benefits | Explanation |
| Increase Global Credibility | Every customer trusts WHO-GMP-certified brands for ensuring safety standards. |
| Boosts Global International Business Expansion | Important for exporting and importing medicine for global markets. |
| Increase Operational Efficiency | It standardizes all the procedures by reducing errors, downtime, and wastage. |
| Ensure Product Efficiency | It ensures every batch maintains the safety, purity, and work performance level. |
| Enhance Customer Satisfaction | Easily builds customer trust and a healthy relationship with manufacturers with products. |
| Reduce Risks | Cross-mixing, equipment issues, and reducing safety risks |
Why Choose Lifevision Healthcare for WHO-GMP-verified medical Or Healthcare Products?
When it comes to the pharmaceutical industry, LifeVision Healthcare stands out as the most trusted or reputable medical or healthcare products supplier. Choosing LifeVision Healthcare means partnering with reliable, quality-driven driven and internationally recognized pharma manufacturers.
People Also Ask About What the WHO-GMP Certification is and why Every Manufacturer Needs it.
Q.1 Does WHO-GMP certification have expiry dates?
A: The WHO-GMP certificates have expiry dates or need renewal as per the missing authority. These WHO-GMP certificates are valid for 3 to years.
Q.2 How much does it cost to own these certificates for the pharma manufacturing industry?
A: The cost ranges between 1.5 lakhs and 10 lakhs. Depend on the industry size or audit requirements.
Q.3 How long does it take for approval of these certifications?
A: Manufacturing of WHO-GMP certificates usually takes 2 to 6 months, but it depends on your applications and audit results.
Q.4 How does this certificate help to improve product quality or safety?
A: It enhances product quality, safety, hygiene, documentation, and testing of the manufacturing process.
Q.5 Can a company with GMP or ISO certification become eligible for exporting medicines to international markets?
A: Having ISO and GMP certifications with WHO standards makes you a trustworthy supplier for international markets. People trust your medicines and welcome you.
Q.6 Is there a possibility that a manufacturer might lose its WHO-GMP certification?
A: If a manufacturer does not adhere to quality and compliance standards, the certification might be canceled or suspended.
Q.7 Why is documentation necessary for state-of-the-art WHO-GMP manufacturing?
A: Inadequate documentation may compromise the traceability and compliance of the manufacturing process.
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