GMP

Certification

GMP certification deals with issues like documentation, record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, sanitation, complaint handling, and process validation.

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Overview

Purpose of a Good Manufacturing Process

GMP Guidelines Directs the Certification Holders

Benefits of GMP Registration

Documents Required

Process to get GMP Registration

Consequences of GMP Non-Compliance

Basic Principles that GMP Guidelines Seeks to Obey

LegalTax Procedure for GMP Certification

Why to Choose Legal Tax

FAQ’s

Overview

GMP Certification

GMP stands for Good Manufacturing Practices, which refers to global standards for the manufacturing, testing, and overall quality control and management of pharmaceutical products. It sets guidelines that ensure a quality assurance approach. GMP certification verifies that products meet the required quality standards.

The Joint Commissioner, authorized by the Commissioner of Food and Drug Administration, is responsible for signing and issuing certificates under the WHO-GMP Certification Scheme. GMP certification addresses critical factors such as documentation, record-keeping, personnel qualifications, sanitation, cleanliness, equipment verification, complaint handling, and process verification.

What is the Purpose of a Good Manufacturing Process?

The primary objective of Good Manufacturing Practices (GMP) is to minimize risks involved in the production of pharmaceutical products. These risks include issues such as:

  • Unforeseen impurities in the product that may lead to serious health complications, including death.
  • Mislabeling on containers, resulting in patients consuming the wrong medicine.
  • Incorrect dosage, either too much or too little of the active ingredient.
  • Ineffective treatments or adverse side effects.

GMP covers various aspects of production, including starting materials, equipment, facilities, and the training and personal hygiene of employees. It provides comprehensive guidelines on the processes that affect the production of the finished product, ensuring its quality is maintained.

What does GMP Guidelines Directs the Certification Holders?

The World Health Organization (WHO) has established guidelines for Good Manufacturing Practices (GMP), which many countries have adopted and adapted to fit their specific requirements. Regions such as the Association of Southeast Asian Nations (ASEAN), the European Union, and the Pharmaceutical Inspection Convention have also aligned their standards with WHO GMP.

GMP guidelines focus on quality management in manufacturing processes, enabling organizations to reduce or eliminate contamination, errors, and misunderstandings. These practices ensure that consumers are not exposed to ineffective or hazardous products.

Most GMP requirements are comprehensive and flexible, allowing manufacturers to determine the best way to implement the necessary controls based on their individual business needs. This flexibility provides customization opportunities while still requiring manufacturers to fully understand and adhere to the standards in a way that makes sense for their operations.

What are The Benefits of GMP Registration?

Each drug and medical device manufacturer adheres to Good Manufacturing Practices (GMP) guidelines, although some companies may also establish their own practices in line with local regulations.

The benefits of GMP certification include:

  • Empowering certified manufacturers to achieve superior production standards
  • Timely identification and resolution of manufacturing and management issues
  • Ensuring compliance with essential laws and regulations
  • Enhancing overall credibility and public image
  • Reducing safety risks related to product quality and safety
  • Increasing consumer confidence in products
  • Reducing operating costs by avoiding penalties and minimizing the need for product recalls
  • Promoting opportunities for international exports
  • Reducing duplication in inspections, leading to cost savings

For manufacturers, one of the primary advantages of GMP certification is the significant improvement in quality systems and compliance. These improvements are evident during the months leading up to certification and continue to benefit the business in the years following certification.

Documents Required for GMP Certification?

The following documents are typically required for GMP certification:

  • Name of the applicant, including address, telephone, fax, email, etc.
  • Copy of the manufacturing license.
  • List of approved products.
  • Site master file (as specified under WHO TRS823).
  • Data on ready formulations.
  • List of technical staff, including their qualifications, experience, and approval status.
  • List of tools and equipment used in the manufacturing process.
  • List of Standard Operating Procedures (SOPs) and Standard Testing Procedures (STPs).
  • Manufacturing plant layout.
  • Schematic diagram of the water system, specifying the circulation loop and material of construction (MOC).
  • Product summary sheet (as per Format B).
  • Proof of safety and effectiveness as per Rule 158B of the Drugs and Cosmetics Rules, 1945.
  • Compliance with the provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and related regulations, with regard to household regulations.

What is the process to get GMP Registration?

Application:
The first step in obtaining GMP certification involves submitting an application containing essential organizational data. The certifying body must register the application and maintain all data in the GMP database.

Review of Application:
The application will be reviewed by the certification team to ensure compliance with continuity requirements.

Analysis & Agreement:
After reviewing the documents, the certifying body provides a price quote for conducting a gap analysis. This analysis helps identify discrepancies between existing practices and required GMP standards.

Documentation Review:
The organization’s documentation is reviewed to ensure compliance with GMP standards.

Stage-1 Audit:
A fully online, paperless, and contactless platform is used for the audit.

  • Survey: Review of governance framework documentation to ensure continuity requirements are met.
  • Corrective Activity: If non-compliance is found, corrective actions must be taken.
  • Check: Verify documentation to ensure it meets the required standards.

Stage-2 Audit:
The inspector evaluates whether the organization’s practices align with its documented procedures. Any non-compliance is identified and addressed by the organization.

  • Corrective Action: If non-compliance is found, corrective action must be taken.
  • Check: Ensure work guidance and execution processes are followed by employees.

Granting of Certification:
The certification body will issue a certificate of compliance, which is valid for a certain period, typically for three years.

Surveillance Audit:
A surveillance audit ensures the organization continues to meet the governance framework requirements. Surveillance audits are conducted every six months or one year following the issuance of the certificate.

What are the Consequences of GMP Non-Compliance?

When working in the construction industry, adhering to good manufacturing practices (GMP) is essential for your business. It not only ensures the production of high-quality products but also protects consumer and environmental health. However, failing to follow GMP guidelines can lead to serious consequences:

Impact on Reputation & Goodwill:
Reputation is crucial for any business. The way you acquire customers, build product loyalty, and maintain repeat business depends heavily on your reputation. If GMP guidelines are not followed, your reputation will suffer first. Customers who lose trust in a manufacturer are unlikely to purchase from you again.

Loss of Consumer Confidence:
Good manufacturing practices ensure customer safety. If you fail to follow these guidelines, consumers will quickly lose confidence in your products, which can significantly harm your business.

Criminal Prosecution:
The Food and Drug Administration (FDA), which issues certificates under the WHO-GMP certification scheme, has the authority to confiscate products and halt production through court orders. If necessary, the Department of Justice and Health and Human Services can take legal action against manufacturing companies that violate GMP guidelines.

License Cancellations:
In manufacturing, many licenses are required, from building permits to facility licenses. Failing to follow GMP guidelines puts your company at risk of losing these licenses, which could halt your operations.

Allegations of Fraud:
Non-compliance with GMP can result in fraud charges, such as mislabeling materials, incorrect ingredient quantities, or failing to advertise products in accordance with GMP standards. Fraud allegations can have severe consequences for a construction company’s reputation and operations.

What are the Basic Principles that GMP Guidelines Seeks to Obey?

The pharmaceutical manufacturing facility must ensure that its production area is kept clean and sanitary. Controlled environmental conditions must be maintained to prevent cross-contamination of nutritional or pharmaceutical products with harmful substances that could pose a risk to human health.

The manufacturing process should be clearly defined and controlled. Every process step must be validated to ensure consistency with the specified standards.

Manufacturing processes must be carefully controlled, and any changes in the process should be evaluated. Modifications that affect the quality of the product must be approved as necessary.

Standard operating procedures (SOPs) should be written clearly and concisely. Operators must be adequately trained to follow documented procedures.

During production, records must be maintained, either manually or electronically, to document each step in the defined procedures. Any deviations from standard procedures must be investigated and documented.

Manufacturing records, including those related to delivery, should be kept in an organized and accessible format, allowing for the complete traceability of each batch.

Complaints related to products must be thoroughly investigated, with an emphasis on identifying the root causes of any quality defects. Appropriate corrective actions should be taken to prevent recurrence of any deficiencies.

LegalTax Procedure for GMP Certification

To legally and securely integrate GMP certification and reap the benefits of enhanced product quality, increased sales, and customer satisfaction, you can rely on our LegalTax experts. Our team will assist you with expert guidance regarding GMP Certification and ensure compliance for the smooth operation of your manufacturing business in India.

LegalTax professionals will help you plan efficiently and cost-effectively, ensuring the successful completion of the certification process. We highly recommend appointing an attorney with experience in corporate certification to navigate potential challenges within the GMP certification process and to understand the requirements thoroughly.

Once you provide the necessary information and complete the payment, our experts will initiate the process, ensuring a seamless and successful certification journey for your business.

Why To Choose LegalTax

LegalTax is a platform dedicated to coordinating and fulfilling all your legal and financial needs, connecting you with trusted professionals. Our clients consistently express satisfaction with our services due to our focus on simplifying legal processes. They appreciate our high standards and regular updates.

Our platform allows customers to track progress at any time, ensuring transparency and ease. If you have any questions regarding the GMP certification process, our experienced representatives are just a phone call away. LegalTax guarantees that your communication with professionals will be smooth and efficient.

FAQ’s

The Joint Commissioner, authorized by the Commissioner of the Food and Drug Administration, is responsible for signing and issuing certificates under the WHO-GMP Certification Scheme. GMP certification is granted after a comprehensive assessment of a manufacturer’s operations in line with GMP guidelines. The certification is issued once satisfactory documentation is provided following the examination.

The application for GMP certification must be submitted by an authorized person within the organization seeking certification. This is typically an individual with responsibility, such as a production manager, quality assurance manager, quality control manager, or managing director.

The application for GMP certification must be submitted by an authorized individual within the organization seeking certification. Typically, this would be someone with relevant responsibility, such as a production manager, quality assurance manager, quality control manager, or managing director.

Good quality can only be assured during the manufacturing process, as it is not feasible to test it later. GMP safeguards the final product from errors that could compromise its quality. Without GMP, it becomes challenging to ensure that every unit of the drug maintains the same quality as those tested in the research facility.

There are numerous benefits of GMP certification for both manufacturers and customers, including:

  • Empowering delegates to choose high-quality products
  • Identifying manufacturing and management issues
  • Ensuring compliance with laws and regulations
  • Enhancing credibility and public image
  • Reducing safety risks in product quality and safety
  • Boosting consumer confidence in your products
  • Helping to reduce operating costs due to resale and penalties from non-compliance
  • Promoting export opportunities
  • Reducing duplication of inspections

The primary objective of GMP is to consistently produce high-quality medicines or medical devices that meet the global standards required for pharmaceutical services. The manufacturing processes are carefully controlled, and any changes in the process must be thoroughly evaluated.

The certification is typically valid for a period of three years.

The purpose of inspecting pharmaceutical manufacturing facilities is to either enforce the Good Manufacturing Practices (GMP) standards or to approve the production of specific pharmaceutical products, typically in alignment with an application for marketing approval.

Unapproved quality drugs not only pose health risks but also result in financial losses for both governments and individual buyers. GMP is designed to prevent such errors. The implementation of GMP ensures the production of high-quality medicines.

cGMP refers to the ‘Current Good Manufacturing Practice’ guidelines authorized by the US Food and Drug Administration (FDA). ‘Good Manufacturing Practices’ (GMP) is a framework designed to ensure that products are consistently produced and controlled according to quality standards.