GMP Certificate | The Ultimate Guide to Get Certified

Are you wondering what a GMP Certificate is and how to get one? 

 

A GMP certificate is basically a quality assurance system that demonstrates a manufacturer's compliance with Good Manufacturing Practices (GMP) and other quality standards.

 

It is essential for businesses that manufacture, process, package, or store pharmaceuticals and dietary supplements.

 

Purpose of GMP Certificate

 

The certification guarantees that products are safe, consistent, and high-quality. In fact, it reduces the risk of product returns, replacement, exchange or other issues.

 

Moreover, it also helps you to build trust with customers by demonstrating that you are meeting the highest standards in their industry.

 

With GMP certification, companies can also benefit from cost savings due to improved efficiency and compliance with regulations.

 

Eligibility Criteria to Apply for GMP Certificate

 

Companies involved in the manufacture, packaging, labeling, storage, testing, import and export of medical products are eligible for a GMP Certificate. 

 

These include: 

 

• Pharmaceutical manufacturers
• Biotechnology companies
• Medical device manufacturers 
• Producers of active pharmaceutical ingredients

 

These companies must also comply with all other applicable laws and regulations. 

 

To be eligible for a GMP Certificate, companies must demonstrate that it has established a Quality Management System (QMS) and implemented procedures to comply with the GMP regulations. 

 

They must also verify that they have adequate staff and resources to ensure compliance with the regulations. 

 

Additionally, they must document all processes related to the production of medical products and have internal quality control systems in place.

 

Process to Get a GMP Certificate 

 

Step 1 - Get in Touch With An Expert

 

If you are looking to get a GMP Certificate, the first step is to get in touch with an expert by filling out the form on your right. The process of obtaining a GMP certificate can be complex and time-consuming. 

 

Therefore, our team of experts can help you understand the requirements and processes involved in obtaining the certificate. 

 

They can also guide you on the best practices to ensure that your organization meets the standards and regulations set by GMP.

 

With their help, you can achieve a GMP Certificate quickly and easily, allowing your business to operate at its full potential.

 

Step 2 - Preparing and Submitting the Documents

 

To get the GMP certificate, companies must submit the following documents to the certifying authority:

 

Documents Required to Apply for GMP Certificate

 

• Applicant's Name, Identity Proof and Address Proof
• Email ID (to receive all the notifications, queries and alerts from the department)
• Manufacturing License (Copy)
• Business Registration Proof (Company Registration Online Certificate, Partnership Deed, LLP Agreement etc.)
• List of Approved Products
• Master File of Site (As approved by WHO TRS 823)
• Data on Finished Formulation
  • Master Manufacturing Formula and Process
  • Specification of the Finished Product along with Analysis Method
  • Stability Study Evaluation (Accelerated and Real Time) for 3 Batches (Mention batch details, size, batch number, date of manufacturing and date of expiration)
  • Process Validation Report
  • Analysis Method Validation Report
• List of Technical Staff with Details (Qualification, Experience, Approval Status)
• List of Equipment and Instrument in Use
• List of SOPs (Standard Operating Procedures) and STPs (Sewage Treatment Plants)
• Layout of Manufacturing Plant
• Schematic Diagram of Water System in Circulation and MOC
• Product Summary Sheet (As per Format B)
• Proof of Safety and Effectiveness as per Rule 158B of Drugs and Cosmetics Rule 1945

 

These documents must be prepared carefully and accurately to ensure that all regulations are met and that the products are safe for consumption.

 

Step 3 - Application Filling

 

Filling out an application form is the next step to getting a GMP certificate. 

 

The application must be filed on the official website of the Food and Drugs Administration.

 

It requires providing detailed information about the company's manufacturing processes, facilities, personnel, and other related information. 

 

To avoid any mistakes and delays, our team of experts will verify all the documents and check the application before submitting it.

 

Moreover, companies must also provide evidence of compliance with all applicable laws and regulations.

 

Step 4 - Review of Application

 

The review process involves a thorough assessment of all aspects related to the production and distribution of the product. 

 

The authorities check for compliance with GMP standards, quality control, safety measures, and other requirements. 

 

After this assessment, they decide whether or not to issue the GMP Certificate.

 

If any queries arise from the authorities, our team of experts will take care of it for you and make sure to keep you up to date on the progress.

 

Step 5 - GAP Analysis and Amendment 

 

After reviewing the application, the officers will conduct a gap analysis to identify any discrepancies between the current operations of your business and the standards set by the relevant authority.  

 

This process also involves identifying areas for improvement and implementing changes accordingly.

 

Once the gaps are identified, they will be addressed through an amendment agreement to ensure that the business meets all of the requirements for obtaining a GMP certificate.

 

Step 6 - STAGE 1 Examination of Documents

 

Review of the organizational paperwork to ensure it meets the necessary compliance regulations.

 

1. Conducting an Audit

 

Compare your documented approaches and strategies to the consistency requirements to determine if they are in line.

 

2. Survey 

 

After that, examine the records of your administrative system to ensure that the specified conditions have been met.

 

3. Corrective Procedures

 

When there is non-compliance, corrective action must be taken immediately. It helps in ensuring the problems will resolve, allowing for following the regulations efficiently.

 

4. Final Review

 

The final review of documentation of the business is to make sure that they are up to date and compliant with standards.

 

Step 7 - STAGE 2 

 

1. Conducting an Audit

 

The inspector makes sure that the organization is following its guidelines and documents, while the governmental body's examiner notes any discrepancies. Afterwards, the reviewer gives an opportunity to fix those discrepancies. Finally, the performance is rechecked based on the organization's report.

 

2. Corrective Procedures

 

If any discrepancies arise then appropriate corrective measures must be taken.

 

3. Final Review

 

To ensure that your representatives are following the work guidance and executing processes properly, the final review is necessary.

 

Step 8 - Certification

 

After completing the above steps successfully, the certification body will issue the GMP Certificate. The certificate is valid for 3 Years. Thus, you must renew it after the period.

 

Step 9 - Surveillance Audit

 

A surveillance audit is an essential part of the GMP certification process. It ensures that the quality standards set by GMP are being followed and maintained. 

 

The audit involves a thorough review of the organization's processes and systems, which includes training, documentation, personnel, equipment and facilities. 

 

It ensures that the company meets all the requirements to obtain a GMP Certificate. 

 

The audit also helps identify areas of improvement to maintain high-quality standards.

 

These reviews must be conducted at least every six months or annually from the date of the issued certification.

 

GMP Certificate Cost

 

The cost of obtaining a GMP Certificate will vary depending on the type and size of the business and its operations.

 

However, the average cost of getting a GMP Certificate in India starts from Rs.10000 excluding professional fees.

 

Basic Principles To Follow After GMP Certification

 

• Achieving a safe and secure workplace environment through lean manufacturing principles.
• It is important to ensure the shop floor, labs and warehouses are kept clean and sanitary at all times in the manufacturing process. This not only ensures health & safety but also helps develop a more productive environment.
• To maintain safe working conditions and guard against cross-contamination, it is essential to maintain strict control over a manufacturing facility's layout, operating principles and environmental conditions.
• Manufacturing processes are clearly outlined and constantly monitored to ensure they remain compliant with all required specifications and provide consistent results.
• Standard operating procedures must be drafted in a language that is straightforward and specific to avoid any confusion.
• Qualified staff are required to handle the production and checking of products with expertise.
• Keeping track of all production and quality control stages is an essential part of the manufacturing process. Accurate records should, therefore, be kept throughout the entire life cycle.
• Any anomalies or discrepancies are carefully looked into and documented for future reference.
• An efficient traceability system should be implemented to ensure the complete history of released items is available in an accessible format. This will allow you to track the progress and movements of batches throughout their lifespan.
• A written system that allows you to easily recall any batch from sale or distribution is necessary. Such a system ensures that the batches can be quickly and efficiently tracked with minimal hassle.
• The root causes of quality defects are thoroughly investigated. After that, corresponding preventive measures are taken to stop them from recurring. Subsequently, appropriate steps for defective products are also taken.