GMP Certification
GMP refers for the goods manufacturing practices.GMP Certification is mainly developed for the natural and pharmaceutical product manufactures. It is a set of guidelines that gives you the assurance that your product is safe and correct. It is mainly dedicated for the food manufactures and medication manufactures and GMP provides assurance for produce safe and quality products according to the Quality standard. GMP is responsible for the safety, efficiency and quality of pharmaceutical products and medical devices
GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act (See Chapter IV for food, and Chapter V, Subchapters A, B, C, D, and E for drugs and devices.) These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective.
GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and errors. This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended, allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each individual business.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and equipment used to prevent contamination, mixups, and errors, which may have been first-rate 20 years ago may be less than adequate by current standards.
Benefits of GMP Certification
- Improves brand value or image in the market
- Provide guideline on how to produce safe and quality products.
- Develops customer satisfaction by deliver the safe and quality product and services.
- Develops motivation and team work between the employees of the organization.
- Enhances the food safety management system
- Increases consumer confidence in your products
- Helps to decrease operating costs due to rework and penalties due to non-compliance
- Helps boost export opportunities.
- Reduced duplication of inspections
- Cost saving
- Perating costs drop as rework and penalties due to non-compliance reduce and efficiencies increase.
- Help customers, employees, stockholders, regulators and competitors develop sustainable respect for an organization
- Preparation for HACCP certification
5 Main Components Of Good Manufacturing Practice
- To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products and procedures (or paperwork). And if all five are done well, there is a sixth
The key benefits to GMP certification:
- Prove organization’s management capabilities in product quality, safety assurance
- Enable employees to develop good production / operations habits
- Reduce safety risk in product quality and safety
- Timely detect production and management problems, reduce cost
- Better understand and comply with the relevant laws and regulations
- Enhance the international credibility and public image
- Increase customer’s long-term confidence in the enterprise
GMP Stand for
GMP stands for Good Manufacturing Practices and is simply a list of guidelines for the processes, procedures, and documentation that assures that the label on a product portrays a true representation of the actual constituents of the product.
This is true for the ingredient’s quantity as well as its quality, composition, strength, purity, and identity. Products that are made in facilities with this certification are held to the highest standards and provide consumers with the guarantee that they are ingesting only the best quality
This is the certification authority that Supplement Manufacturing Partners has chosen to receive their GMP Certification from. This and all other GMP certifications for the industry are enforced by the USFDA – the United States Food and Drug Administration.
Companies that have this certification bear this label to say that they manufacture supplements that are made to the highest quality and standards the world over. The certification also means that their manufacturing plants are monitored ongoing and all processes within the facility are properly controlled.
The certificate doesn’t just cover the manufacturing of the actual product but also ensures the quality control of administrative issues such as those of personnel qualifications, record keeping, complaint handling, cleanliness and sanitation along with process validation among other things.
Process To Get The GMP Certification
Application:- This is the first step to get the GMP certification, the application covers some basic information of the company. The certification body must accept the application and needs to b record or maintain all the information on the GMP database.
Review of Application:- The application received shall be reviewed by the team to ensure that the compliance requirement have been fulfilled.
Quote and Agreement:- After the review of documents we provide the price quotation to the client and performs the Gap Analysis to cover all the clauses and section of the quality standards and Gap Analysis is done to check the Gap between company planned things and achieved things.
Documentation Review:- check the document of the organization to ensure that the documentation fulfilled the compliance requirement.
Stage-1 Audit:- Evaluate your organizations documented procedure and policies against the compliance requirement.
Review:- Review the documentation of your management system to ensure that the compliance requirement have been contented.
Corrective action:- Corrective action is deal with the non conformity. It has taken when the non conformity occurs.
Verification:- Verify the documentation of the organization as per the standard requirements.
Stage-2 Audit:- In stage-2 audit, the auditor verifies that the organization implement according to its documentation and if the auditor of certification body identifies the non conformities then the auditor give the opportunity to correct the non conformities.
Review:- Review the implementation process according to the organizations document.
Corrective Action:- If there is any non conformity occurs then the corrective action has been taken.
Verification:- Verify work instruction and implementation process are being followed by your employees.
Granting of Certification:- The Certification Body will issue a certificate of compliance, which is valid for three years.
Surveillance Audit: - Surveillance audit conduct to ensure that the organization meets the requirements of the management system. Surveillance audit must be performed in every six month or one year from the date of issued certificate.
Re-Certification:- Re-certification is the process, which is done at the end of three years period.
Review:- Review the documentation and implementation process of your management system to ensure that the compliance requirement have been contented.
Corrective Action:- Recheck the non conformity, if any other problem occurs then CB give the opportunity to the organization to resolve the non conformity.
Verification:-Compare the documentation of the organization with the compliance requirement.
Acquiring GMP Certification
In order to get this certification, there is an application process that must be completed. The application for GMP certification has to be made by an authorized person within the company seeking the certification.
This is usually one with responsibility such as a Production Manager, a Quality Assurance Manager, a Quality Control Manager or the Managing Director.
The GMP Certificate is granted after a facility has been audited and has been found to have demonstrated that they are complying with the standards required to fulfill the requirements of the GMP certification.
The certificate is usually valid for a period of three years and will be issued in the name of the registered company. The certificate will show the scope of the certification as well as the name and the address of the company’s manufacturing site.
What To Do If Your Company Is Not GMP Compliant?
So you want to manufacture and sell your own supplements but this whole process of GMP certification is not one that you can afford at this time?
That doesn’t mean you have to wait until you can save enough money and get your own manufacturing facility. You can opt to have an already established manufacturer of supplements such provide you with your own brand of supplements.
By choosing us to create your private label supplements you will have your own supplement line providing your customers with top-quality supplements that carry the GMP certification label.
Here at Supplement Manufacturing Partners, we meet all of the FDA label regulations and we are 100% compliant with our manufacturing processes. Allowing us to serve you by providing you with the supplements for your brand is the smart choice… the choice that will help get your brand. What do we have to offer you, your company and your brand?
- Top-quality GMP Certified products
- Compliance with all FDA guidelines for labeling and more
- Ongoing quality control closely inspecting our manufacturing processes
- The operation of a facility that is environmentally friendly
- The manufacture of products that are of pharmaceutical-grade quality
GMP certification is of the utmost importance in the supplement industry as it is today, but it can be a long and costly process especially if you are just entering into the industry.
If you are looking at getting into the market faster and with less overhead, then let us do all the hard work for you.
We have the expertise, the line staff, the state of the art equipment and all the necessary approvals and certifications so you don’t have to worry about that stuff. We don’t cut corners and you will never regret choosing us to take your supplement brand to market.
Choose Supplement Manufacturing Partners to provide you with your very own brand of supplements ready to hit the market. We do it all from manufacture to packaging and getting your products out and we are known to be the best at what we do.
GMP Audits & Inspections
We conduct GMP audits/inspections to verify the compliance status of the manufacturer and suggest improvements. The types of audits that are covered here include gap analysis audits and mock inspections to assess the preparedness level for GMP inspections. This also supplements the internal self-inspection and expectations of the regulatory agencies of an independent audit of QA department by external agency.
The objective is also to monitor the effectiveness of GMP implementation programmes. This is done by adopting a ‘partnering’ approach with the firm and placing emphasis on sound science and current regulatory requirements. All information shall be treated as confidential and the mechanics of operation shall be based on transparency and ethical principles.
This helps the firm in assuring consistent quality and adherence to GMP across the entire supply chain i.e. from procurement to distribution, complaint evaluation and product quality reviews.
We also carry out audits to the assist the firms in establishing feasibility of third party manufacturers, qualifying vendors of raw and primary packaging material.\
Coverage
- Manufacturers of Active Pharmaceutical Ingredients ( API ) and intermediates
- Manufacturers of Finished Dosage Forms ( FDF )
- Manufacturers of Cosmetics
- Manufacturers of Medical devices
- Food manufacturers for food GMP and HACCP compliance
- Excepient manufacturers and
- Packaging material manufacturers
Training
We offer a range of services to help companies achieve GMP compliance. We help you create a Quality Management System or bring your current system into compliance.
LIST OF DOCUMENTS REQUIRED FOR APPLICATION FOR GMP
1. Application for GMP certification
2. Name of the applicant with address, telephone, fax, e-mail etc.
3. Copy of Manufacturing Licence/ Trading.
4. List of approved products.
5. Provide List of products which the firm to Register Gmp Certification.
6. List of products applied for issuance their composition.
7. Site Master file (as specified under GMP.
8. Data on Finished Formulation:
8.01 Master manufacturing formula, manufacturing process.
8.02 Finished product specification and Method of Analysis.
8.03 Stability study evaluation (Accelerated and Real Time) for 3 batches including details batch size, Batch No., Date of manufacturing, Date of Expiry, stability study condition (Accelerated/ Real time), Name of Drug etc .
(Minimum 06 months period for Accelerated Stability data and 12 months for Real time Stability data shall be submitted at the time of initial application.)
8.04 Process validation report for 3 batches.
8.05 Validation report of analytical method.
9. List of technical staff, their qualification, and experience and approval status.
10. List of equipment and instrument.
11. List of SOPs and STPs.
12. Manufacturing Plant layout.
13. Schematic diagram of water system specifying circulation loop and MOC.
14. Schematic diagram of HVAC system specifying terminal filter configuration.
15. Export data of last 2 years, in case of re-validation
16. Product summary sheet
17. Actual labels of the products applied for GMP.
18. Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
19. List of Reference standards/ marker for all active ingredients / formulation of the products applied for GMP
20. Certificates of Analysis for three batches of each product
21. Undertaking regarding absence of any non-herbal ingredients including metals/ minerals, etc. in the products applied for GMP .
22. Undertaking regarding compliance to the provisions of domestic regulations inter-alia Drugs & Cosmetics Act, 1940 and Rules thereunder, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, etc.
Time Period of Gmp Certification
One day Check Application form
One Day Check Required Documents
3 Days Gap Analysis of Documents For First Audit
1 Day Upload the Final Documents on Portal
2 Days Create First Stage Audit Report
One Days provide Soft Copy Of Certificate
After 15 Days Get Final Hard Copy Of Certificate