GMP Certification

What is GMP?

GMP, which stands for Good Manufacturing Practices, is a comprehensive system of processes, procedures, and documentation that guarantees the consistent production and management of various products, including food, cosmetics, and pharmaceuticals, in adherence to established quality standards. GMP plays a critical role in minimizing losses, reducing waste, and preventing issues such as recalls, seizures, penalties, and legal complications. It serves as a protective measure for both the corporation and the consumer against adverse food safety events.

GMP Certification

GMP certification validates that a company's manufacturing processes adhere to regulatory requirements, with the United States Food and Drug Administration (US FDA) employing it to ensure the safety of foods produced under sanitary conditions. This certification forms the basis for the implementation of a successful Hazard Analysis Critical Control Point (HACCP) food safety program.

Purpose of GMP Certification

The primary purpose of GMP certification is to validate that a company's manufacturing processes align with regulatory standards, ensuring the production of safe products while minimizing the risk of contamination and improper manufacturing practices. GMP certification is particularly vital for food manufacturers, as it guarantees the safe production of foods and facilitates compliance with regulatory requirements.

Benefits of GMP Certification

» Validation of operational and administrative procedures
» Assurance of a stable supply of raw materials
» Permission to export food products to foreign markets or import GMP Certified foods into the United States
» Enhanced competitiveness in the marketplace
» Increased sales among consumers seeking third-party-certified safe products
» Validation of products for consumers with additional food safety and quality requirements
» Facilitation of sales with overseas retail stores requiring GMP Certification
» Consumer confidence in products meeting high safety and quality standards

cGMP (Current Good Manufacturing Practice)

cGMP, or Current Good Manufacturing Practice, denotes the regulations enforced by the FDA to guarantee that manufacturing processes and facilities are adequately designed, monitored, and controlled. These standards concentrate on preserving the identity, strength, quality, and purity of pharmaceuticals by imposing proper control over manufacturing processes. The flexibility of cGMP enables each producer to determine the most effective way to implement necessary controls using scientifically sound designs, processes, and testing protocols.

GMP vs. cGMP

The "c" in cGMP stands for "current," emphasizing the need for organizations to employ up-to-date technologies and systems to comply with the regulations. Both GMP and cGMP regulations apply to medical devices, medications, food manufacturers, packagers, and processors. They ensure that products are safe, effective, and pure.

GMP vs. WHO-GMP

While GMP and WHO-GMP are both food quality standards, WHO-GMP specifically refers to the "World Health Organization's Good Manufacturing Practices." WHO-GMP encompasses guidelines and practices designed to help manufacturers achieve the quality management system requirements of ISO 9001 and HACCP Annexure C, promoting international health and safety.

GMP Certification Procedure in India

» The GMP certification procedure in India involves several steps:

» Audit Preparation: Schedule the audit at least 8 weeks in advance to thoroughly review each component of the production process.

» Facility Audit: Conduct on-site audits to inspect equipment, facility structure, sanitation, and cleanliness.

» GMP Certificate Filing: Submit the GMP certificate application online after making necessary revisions.

» Verification and Documentation: Verification and documentation review will be conducted, and upon successful verification, the GMP certificate will be issued.

GMP Certification Online

GMP Certification Online provides an alternative audit system conducted entirely through online processes, covering application submission, audit preparation, facility assessment, and filing of GMP certificates. This online approach saves both time and resources while emphasizing system requirements and opportunities for improvement.

Online GMP Certification Procedure:

» Application Receipt: Fill out the online application for GMP Certification.

» Audit Preparation: Ocean Standard Certification guides and audits the organization through remote video conferencing sessions.

» Facility Audit: Conduct a full facility audit online via video conferencing to ensure minimum food safety standards.

» Certificate Filing: File for GMP certification online, and upon successful verification, receive the GMP certificate.

Advantages of Choosing Ocean Standard Certification for GMP Certification:

» Cost-Effective: Affordable GMP certification services.
» Comprehensive Services: Multiple services included in one price package.
» Accessibility: Certification report available online for website inclusion.
» Documentation: Certification report sent via email in .pdf format.
» Efficiency: Minimization of cost and time for certifications.