What is GMP Certification?

GMP, or Good Manufacturing Practices, is a set of processes, procedures, and documentation ensuring consistent production of food, cosmetics, and pharmaceuticals according to established quality standards. It helps in minimizing losses, waste, and potential issues like recalls or penalties. GMP safeguards both the manufacturer and the consumer against food safety risks, contributing to overall product quality and consumer confidence.

GMP Certification

A Good Manufacturing Practices (GMP) certification serves as the foundation for an effective Hazard Analysis Critical Control Point (HACCP) food safety program. It is utilized by the United States Food and Drug Administration (US FDA) to verify that foods are produced in a safe and sanitary manner, ensuring the safety of consumers.

What is the Purpose of GMP Certification?

GMP certification confirms that a company’s manufacturing process adheres to FDA or other regulatory standards. For food manufacturers, GMP ensures the production of safe products by minimizing the risk of contamination from harmful substances and improper manufacturing practices. It is essential for maintaining product quality and consumer safety.

Benefits of GMP Certification

The benefits of a GMP certification include:

• Validation of operational and administrative procedures.
• Ensured supply of raw materials.
• Access to foreign markets for food product export or import of GMP Certified foods into the United States.
• Enhanced competitiveness in the marketplace.
• Increased sales among consumers seeking products certified safe by third-party entities.
• Validation of products for consumers with stringent food safety and quality requirements.
• Expanded sales opportunities with overseas retail stores that require GMP Certification for purchase.

As consumers become more conscious of food safety and quality, GMP Certification helps businesses meet customer demands and maintain their reputable image. It serves as a powerful tool for building consumer trust and ensuring compliance with stringent safety standards.

What is cGMP?

cGMP, or Current Good Manufacturing Practice, is a set of regulations enforced by the FDA to ensure that pharmaceutical manufacturing processes and facilities are properly designed, monitored, and controlled. These standards guarantee the identity, strength, quality, and purity of pharmaceutical products by requiring manufacturers to maintain strict control over their production processes.

cGMP criteria are designed to be flexible, allowing each producer to implement necessary controls using scientifically sound design, processes, and testing protocols. Many countries have made cGMP a legal requirement in the manufacturing industry, emphasizing the importance of obtaining a GMP or cGMP certification to demonstrate compliance and ensure product quality and safety.

GMP Vs cGMP

The “c” in cGMP stands for “current,” signifying the need for organizations to adopt up-to-date technologies and systems to adhere to the regulations. GMP regulations apply to medical devices, medications, food manufacturers, packagers, and processors, ensuring that their products are safe, effective, and pure. Also known as “c GMP,” this serves as a reminder to producers to utilize cutting-edge technologies. By mandating the use of appropriate control procedures, cGMP compliance ensures the attainment of identity, purity, and high-quality standards for pharmaceutical products.

GMP Vs WHO-GMP

Both WHO-GMP and GMP are food quality standards, but they are often misunderstood. WHO-GMP, created by the “World Health Organization’s Good Manufacturing Practices,” aims to promote international health and safety.

However, WHO-GMP goes beyond mere manufacturing guidelines. It encompasses a set of ideas, beliefs, and practices that assist manufacturers in meeting the quality management system requirements of ISO 9001 and HACCP Annexure C. In this way, WHO-GMP serves as a comprehensive framework for ensuring food safety and quality in the manufacturing process.

GMP Certification Procedure in India

The responsibility for applying for GMP Certification in India typically falls on the Production Manager, Quality Assurance Manager, Quality Control Manager, or the managing director of the company. The GMP certification procedure in India involves the following steps:

STEP 1: Audit Preparation
Schedule the audit at least 8 weeks before the intended start date. Thoroughly go through every component of the production process to ensure compliance with FDA regulations. All staff members should be available to answer auditor questions.

STEP 2: Facility Audit
On the audit day, the team arrives with inspection equipment to examine all aspects of the facility, including equipment used, physical structure, and sanitation. The audit duration varies based on the product being manufactured. A preliminary report is provided within 24 hours, followed by a detailed written report and compliance instructions.

STEP 3: GMP Certificate Filing
Submit the GMP certificate application on the website after making necessary revisions. The auditing team verifies and checks documentation for compliance. Upon successful verification, an electronic and paper copy of the certificate is issued.

GMP Certification Online

GMP Certification Online offers a convenient and efficient alternative audit system, completing all certification steps online. Here’s how the process works:

STEP 1: Application Receipt
Fill in the online application for GMP Certification. If needed, our customer care executive can assist you.

STEP 2: Audit Preparation
Through remote video conferencing, IBC conducts audits and guides your organization. Staff can respond and submit documentation and records electronically.

STEP 3: Facility Audit
The major audit is conducted online via video conference, interacting with all department heads to ensure adherence to food safety standards.

STEP 4: GMP Certificate Filing
After the successful final main audit, you can file for GMP certification online. IBC reviews the documents and issues the GMP certificate to your organization. This streamlined process saves time and resources while focusing on system requirements and improvements.

Advantages of Choosing our GMP Certificate Services

1. Affordable pricing: We offer the most competitive rates for GMP certification services in the market.
2. Comprehensive packages: We provide multiple services bundled together in one cost-effective package.
3. Online certification report: Access your certification report online, which can be easily displayed on your website.
4. Convenient email delivery: Receive the certification report as a .pdf file via email for easy sharing and record-keeping.
5. Time and cost-efficient: Our GMP certification online services help minimize the time and expenses required for the certification process.

Why IBC for Getting GMP Certification?

Companies who need to approach the certification process in a way that has been proved beneficial over time shouldchoose IBC. IBC was founded in 2006 and has more than 15 years of expertise in auditing management systems, certifying GMP certification, and issuing international certifications. IBC has worked with businesses in a variety of fields, including manufacturing and software development.

We have years of experience in issuing certifications internationally, and we thoroughly examine your system to ensure that it follows all the requirements for obtaining GMP certification.