What is a GMP certificate?
A Good Manufacturing Practices certificate provides independent verification and certification that guidelines for an effective Hazard Analysis Critical Control Point (HACCP) food safety program are being followed. The “GM” in “GMP” stands for “Good Manufacturing Practices”. It is used by the FDA to ensure that foods are safe for consumers and to “improve the control of food safety at all stages from production, processing, distribution, and consumption”.
GMP Vs cGMP
“c” should be written in small letters as it represents the constant change and the technology of quality is ever-evolving. From another site: GMP is also sometimes referred to as “cGMP,” with the “c” standing for “current.” This reminds manufacturers that they must employ up-to-date technologies
GMP Vs WHO-GMP
WHO-GMP is often confused with GMP as both are quality standards in the food industry. WHO-GMP, or the “World Health Organization’s Good Manufacturing Practices” standard, was developed by the World Health Organization (WHO) to support their mission to promote international health and safety.
But WHO-GMP is more than just a list of manufacturing rules. It is also a set of concepts, principles, and practices to help manufacturers meet the requirements for quality management systems described by the ISO 9001 and HACCP Annexure C standards.
Which GMP certificate do I require?
GMP certificates can be issued if a food business wants to market its product internationally and needs to establish credibility with its buyers.
The benefits of a GMP certificate 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
How to get GMP Certificate?
To become certified, a company must first assess its own food safety management system against the WHO GMP standards. The guidelines are directed towards international food suppliers who ship foods outside of their own country.
Why IAS GMP Certification?
Integrated Assessment services provide GMP services to companies who need to approach the certification process in a way that has been proven effective over time.
Advantages of choosing our GMP Certificate Services:
- We are the most competitive service provider in this field, according to your needs;
- Offering multiple services for one price package;
- Certification report is available online and can be used to include in your own website;
- Certification report will also be sent via email as a .pdf file.
- Our GMP Certificate Services can help you to minimize the cost and time needed for certifications.
Business Benefits of GMP Certification
- Increase sales with consumers who look for products that are certified safe by third parties;
- GMP Certification helps in certification of products by specific consumers who have additional requirements for food safety and quality;
- Increase sales with overseas retail stores that may require GMP Certification at the time of purchase.
An increased level of public awareness is to be credited for this growing demand among consumers. People want to know where their food comes from, how it was produced, and if the manufacturer has met all of the necessary standards to ensure that their products will remain safe.
Standards are used by a wide variety of companies in order to satisfy consumer demands and maintain good reputations for themselves.
How to get GMP Certification
The GMP certification process includes an audit of a company’s facilities and manufacturing process in order to meet regulatory guidelines outlined by the FDA.A GMP certificate issued by IAS is valid for at least three years and can be renewed online using our website if necessary.
GMP Certification process
GMP certification is one of the main certifications that companies need in addition to ISO certification. The
purpose of GMP certification is to prove that a company’s production process follows FDA or other regulatory guidelines.
The goal of GMP for food manufacturers is to ensure that they are creating safe products while minimizing the risk of contamination from unsafe ingredients and poor manufacturing practices.
IAS conducts GMP audits for all “manufacturing establishments” in order to verify that they are following GMP rules and regulations. This helps to communicate that the manufacturing establishments have documented practices that minimize the risk of contamination and maintain the integrity of their products.
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.
STEP 1: Audit Preparation
It is important to schedule your audit at least 8 weeks before your desired start date to allow time for you and our team to thoroughly go over every part of your manufacturing process. Our GMP auditors will examine each aspect of your facility and determine whether or not it complies with standards set forth by the FDA. It is crucial that you are able to have as many of your staff members available during this time so they can answer any questions posed by our auditors.
STEP 2: Facility Audit
Our team will arrive at your facility on the day of the audit with all the necessary equipment for an inspection. This includes, but is not limited to, cameras, measuring devices, and other specialized tools. Each employee must be available to answer any questions that our team may have during the audit. Areas of focus vary greatly from site to site depending on what type of product is being manufactured there.
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
This audit process can take anywhere from two to five days depending on your location. A preliminary report will be available to you within 24 hours of the completion of your GMP audit. You will also receive a detailed written report explaining our findings in greater detail along with a list of instructions detailing compliance measures for your company.
STEP 3: GMP Certificate Filing
After the completion of your audit, you will have a period of time to complete any necessary changes that are required in order to comply with FDA standards. Once those changes have been made, you may file your application for a GMP certificate online on our website. We will review your application and documents to ensure that you meet all of the requirements for GMP certification. Once our team has reviewed everything, we will send you a copy of your certificate electronically and also via mail.
A GMP audit helps improve the overall performance of different systems including the following:
- Building and facilities.
- Materials management.
- Quality control systems.
- Packaging and identification labeling.
- Quality management systems.
- Personnel and GMP training.
How much does it cost to get GMP certified?
The GMP Certificate Cost: The program registration fee costs $250 and then there is the annual certification fee of $1000.The cost varies from organization to organization. Fill in the application form and forward to us, to get back with exact
What are GMP guidelines?
A good manufacturing process (GMP) is a set of procedures to ensure products are consistently produced and controlled according to quality standards. It’s designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Some of the important requirements of GMP Standards are:
- There should be a proper quarantine of raw materials, in-process goods, and finished goods.
- A log is to maintain all the activities relating to the manufacture and testing (if any) of a particular drug product or batch.
- Receiving Finished Goods from Contract Manufacturers: It is important that you receive finished goods from your contract manufacturers that are in compliance with your company’s GMP standards.
Also see: GMP Certification Online.