GMP registration | Good manufacturing practice | Unilex

What is GMP registration?

Good manufacturing practice is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing organization. It is a set of guidelines that gives you the assurance that your product safe and correct. It is very important for the food and drug manufacturers to avail for the GSP registration to ensure their consumers that they are consuming safe products. Each product safety is a social responsibility of an organization. That’s why adopting GMP in the manufacturing sector will help organization to product 100% safer product to the end users. Manufacturers can improve their credibility with GMP certification because it is responsible for a safety, efficiency and quality of the food and pharmaceuticals products.

GMP certification confirms that product identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offers a system of procedures and documentation by which the confirmation of product has given. It is issued by certifying body, which is accredited to provide certificate under the GMP. The certificate is issued for a period of 3 years, after you have to renew it by taking the help of a consultant.

At, Unilex Business Consultant, we will assist you regarding GMP registration. Right from the preparation of the documents are required for GMP, filling a form to auditing, it’s all our responsibility to manage procedure for GMP certification.

Documents required for GMP registration:

GMP manual.
GMP procedures.
GMP process approach.
Standard Operating Procedures.
Exhibits.
Sample Format/ Templates.
GMP audit checklist.

Procedure:

Contact to GMP consultant: Feel free to contact Unilex Business Consultant and share your queries with the professionals regarding GMP registration.

Choose a plan: Choose the plan that perfectly matches with the requirements. Usually all our prices are transparent. Our consultants are readily available to assist you regarding GMP certification.

Get a list of documents: Unilex Business Consultant will be emailing you all the mandatory documents and procedure to get the GMP certification.

Process : As soon as we get your documents. We will complete the relevant process and ask you to pay the fees and we can submit the application to the GMP office.

Get your GMP certification: Once everything will be done successfully, after getting an approval we will email you GMP certification and other relevant things.

Advantages of GMP Certification:

Improve brand value or image in the market.
Developes customers’ satisfaction by delivering the safe and quality products and services.
Ensures the raw materials used in the manufacture of food and drugs are known of possibly standardized possibility quality, and are free from contamination.
Enables employees to develop good production/ operation habits.
Increases customers’ satisfaction and help boost export opportunities.
Timely detects production and management problems and reduces cost.
Reduced duplication in inspection.
Reduces risk in product quality and increase safety.

Frequently asked questions:

Q1 Why GMP is important?

The food and pharmaterials products are very sensitive as it directly enter in the human body. Quality of the food and medicines would be high. Adopting GMP in manufacturing can eliminate all toxic substances from the food and medicines and make it inevitable. When you get the approval from the GMP you need to follow its guidelines in the manufacturing process. Those guidelines will make your product quality based and consumable for the humans. In the market if you selling high-quality based products, the value of your brand automatically get increased and consumers will only buy your products.

Q2 What is the process to get the GMP certification?

First you need to fill out the application for the GMP certification. The application covers some basic information of the company. The certification body must accept the application and need to maintain the record on the GMP database.

The application is submitted is reviewed by the team to ensure that the compliance requirements have been fulfilled.

Evaluate your organization documented procedure and policies against the compliance requirement.

In stage 2 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 gives the opportunity to correct the non-compliance.

The certification body will issue a certificate of compliance, which is valid for three years.

Surveillance audit conduct to ensure that the organization meets the requirements of the management system.

After the end of the three years, you can renew the certificate.

Q3 What issues are addresses in GMP?

GMP addresses issues including documentation, record keeping, personal qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling. The quality approach of the GMP ensures that the products are consistently produced and controlled to the quality standards.

Q4 What are the principles of GMP?

Writing step by step operating procedures and work instructions that provides GMP rules to control the quality of the products.

You need to carefully follow all the instructions that are mentioned in the rule book of the GMP.

Properly and accurately documenting the work for compliance.

Clearly designing developing and demonstrating the job competence.

Protecting the product against contamination by making cleanliness as a routine practice.

Control the quality of the products