What is GMP Certification?
GMP stands for Good Manufacturing Practices, and it is a system of processes, procedures, and documentation assuring that manufacturing products like food, cosmetics, and pharmaceuticals are consistently produced and managed according to established quality standards. GMP helps in reducing losses and waste, as well as avoiding recalls, seizures, penalties, and jail time. Overall, it safeguards both the corporation and the consumer against negative food safety events.
A Good Manufacturing Practices (GMP) certification ensures the basis for a successful Hazard Analysis Critical Control Point (HACCP) food safety program. The United States Food and Drug Administration (US FDA) uses it to verify that foods are safe for customers and that they are produced under sanitary conditions.
What is the Purpose of GMP Certification?
GMP certification validates that a company's manufacturing process meets FDA or other regulatory requirements. The purpose of GMP for food manufacturers is to ensure that they are producing safe products while minimizing the risk of contamination from harmful substances and improper manufacturing practices.
Benefits of GMP Certification
The benefits of a GMP certification include:
- Validation of your company's operational and administrative procedures.
- Guaranteed supply of raw materials.
- Ability to export food products into a foreign market or import GMP Certified foods back into the United States.
- Ability to compete in the marketplace.
- Increase sales with consumers who look for products that are certified safe by third parties.
- GMP Certification aids in the validation of products by certain consumers with additional food safety and quality requirements.
- Increase sales with overseas retail stores that may require GMP Certification at the time of purchase.
People are curious about where their food comes from, how it was prepared, and whether the producer followed all safety standards. A wide range of businesses employs standards to meet the needs of their customers and maintain their enviable reputations.
What is cGMP?
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. The cGMP provides procedures to ensure that manufacturing processes and facilities are properly designed, monitored, and controlled. The cGMP standards ensure the identity, strength, quality, and purity of pharmaceuticals by requiring producers to maintain proper control over their manufacturing processes.
The cGMP criteria were created to be flexible, allowing each producer to determine how to best implement the necessary controls, utilizing scientifically sound design, processes, and testing protocols. Several countries have declared cGMP a legal requirement in the manufacturing industry, and hence, many have realized the importance of having a GMP or cGMP certification for their manufacturing process.
GMP vs cGMP
The "c" in cGMP refers to "current," which means that organizations must employ up-to-date technologies and systems to comply with the rules. GMP regulations apply to medical devices, medication, food makers, packagers, and processors. The rules will make certain that the products are completely safe to use. Furthermore, the regulations ensure that things are effective and pure. GMP is also known as "cGMP." This serves as a reminder to producers that they must use cutting-edge technologies. By requiring manufacturers to use the appropriate control procedures, cGMP compliance ensures the acquisition of identity, purity, and high-quality standards for pharma commodities.
GMP vs WHO-GMP
Both WHO-GMP and GMP are food quality standards that are frequently misunderstood. WHO-GMP was created by the "World Health Organization's Good Manufacturing Practices," to assist their aim of promoting international health and safety.
But WHO-GMP is more than just a set of guidelines for manufacturing. It's also a set of ideas, beliefs, and practices aimed at helping manufacturers achieve the quality management system requirements of ISO 9001 and HACCP Annexure C.
GMP Certification Procedure in India
Typically, a Production Manager, a Quality Assurance Manager, the Quality Control Manager, or the managing director of the company will be responsible for applying for GMP Certification in India. The following is the GMP certification procedure in India:
Step 1: Audit Preparation
Schedule your audit at least 8 weeks before your intended start date to allow time for you and our team to thoroughly go through every component of your production process. Our GMP auditors will inspect every part of your operation to ensure that it complies with FDA regulations. At this point, all of your staff members should be available to answer any questions our auditors may have.
Step 2: Facility Audit
On the day of the audit, our team will arrive with all of the necessary inspection equipment at your facility. All staff members must be available during the audit to address any questions our team may have. Depending on the type of product being manufactured, the areas of focus vary significantly from one site to the next. The auditor will examine all factors of your facility including:
- Equipment used in manufacturing operations
- The physical structure of the facility
- Sanitation and cleanliness of the facilities
The audit procedure can take anywhere from two to five days, depending on your location. You will receive a preliminary report within 24 hours of the accomplishment of your GMP audit. You will also receive a detailed written report summarizing our findings, as well as a list of instructions defining compliance activities for your company.
Step 3: GMP Certificate Filing
Submit your application for a GMP certificate on our website after making the necessary revisions. Proper verification and documentation will be done by the auditing team to check whether GMP certification can be given or not. After successful verification, we will send you an electronic and paper copy of your certificate.
GMP Certification Online
GMP Certification Online is a new alternative audit system that demands all steps in the certification process to be completed online, including application receipt, audit preparation, facility audit, and GMP Certificate filing. Many clients choose the GMP Certification online method because it saves time and money while ensuring a focus on system requirements and improvements.
Advantages of Choosing Our GMP Certificate Services
- We are the most inexpensive GMP certification service provider in the market.
- Offering multiple services for one price package.
- Certification report is available online and can be used to include in your website.
- The certification report will also be sent via email as a .pdf file.
- Our GMP certification online services can help you to minimize the cost and time needed for certifications.
Why IAS for Getting GMP Certification?
Companies who need to approach the certification process in a way that has been proved beneficial over time should choose Integrated Assessment Services. IAS was founded in 2006 and has more than 15 years of expertise in auditing management systems, certifying GMP certification, and issuing international certifications. IAS 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.
Contact us today, or visit our GMP certification frequently asked questions page to learn more!
