Overview of GMP Certification

GMP stands for Good Manufacturing Practice, a globally recognized term for managing the control and management of manufacturing, testing, and overall quality of pharmaceutical products. It defines specific guidelines that focus on quality assurance. GMP certification ensures that products are produced in compliance with quality standard norms.

The Joint Commissioner, authorized by the Commissioner of the Food & Drug Administration, is responsible for signing and issuing certificates under the WHO-GMP certification scheme. GMP certification addresses key issues like paperwork, record-keeping, personnel qualifications, sanitation, cleanliness, equipment verification, complaint handling, and process validation.

GMP requirements are generally flexible and easy to implement, providing manufacturers the freedom to decide how to efficiently apply the necessary controls.

What is the Purpose of Good Manufacturing Practice?
The main purpose of Good Manufacturing Practice is to reduce the risks involved in producing pharmaceutical products. Pharmaceutical items carry risks such as:
(a) Unexpected contamination in the product, which can adversely affect health, potentially leading to death.
(b) Incorrect labeling, leading to the patient consuming the wrong medicine.
(c) Inaccurate amounts of active ingredients, either too much or too little, resulting in ineffective treatment or adverse effects.

GMP covers all aspects of production, from starting materials and equipment details to staff training and personal hygiene. It outlines procedures that ensure the final product’s quality.

What Does GMP Guidelines Direct Certification Holders?
The World Health Organization (WHO) has developed guidelines for good manufacturing practices. Many countries have tailored these guidelines to create their own GMP standards. This includes organizations like the Association of South-East Asian Nations (ASEAN), the European Union, and the Pharmaceutical Inspection Convention.

GMP guidelines focus on a quality approach to manufacturing, helping organizations minimize or eliminate contamination, mistakes, and misunderstandings. This ensures that consumers are not exposed to ineffective or unsafe products.

Most GMP requirements are broad, allowing manufacturers the flexibility to interpret and implement the necessary controls according to their specific business needs.

Benefits of GMP Certification
Every pharmaceutical and medical device manufacturer follows GMP rules and procedures, with some creating their own guidelines that align with applicable legislation.

• Empowers certification holders to implement great production practices.
• Timely identification of manufacturing and management issues.
• Ensures compliance with important laws and guidelines.
• Improves overall credibility and public image.
• Reduces safety risks related to product quality and safety.
• Increases consumer confidence in products.
• Helps decrease operating costs by minimizing rework and penalties due to non-compliance.
• Boosts export opportunities.
• Reduces duplication of inspections.
• Provides cost savings.

Benefits for the Manufacturer
One of the primary benefits is significantly improved quality systems and compliance. These improvements are often seen in the months leading up to GMP certification and continue in the years immediately following the certification.

Benefits for the Customer

Customers will typically modify their oversight of manufacturers that have been GMP certified. Customers are aware that in order to be certified, the manufacturer must have systems in place and provide evidence that non-conformance and changes that require customer notification are handled appropriately. This assurance is typically not obtained through a one-day supplier audit that pharma companies carry out; rather, it is obtained as a result of thorough, multiple day audits of manufacturer as part of a certification audit program.

Documents Required for GMP Certification

• Name of the applicant with address, telephone, fax, email, etc.
• Copy of Manufacturing License.
• List of approved products.
• Site Master file (as specified under WHO TRS 823).
• Data on Finished Formulation:
  • Master manufacturing formula, manufacturing process.
  • Finished product specification and method of analysis.
  • Stability study evaluation (Accelerated and Real Time) for 3 batches, including details like batch size, batch number, manufacturing date, expiry date, stability study conditions (accelerated/real time).
  • Process validation report for 3 batches.
  • Validation report of analytical method.
• List of technical staff, their qualifications, experience, and approval status.
• List of equipment and instruments.
• List of SOPs and STPs.
• Manufacturing plant layout.
• Schematic diagram of water system specifying circulation loop and MOC.
• Product summary sheet (as per Format B).
• Proof of safety and effectiveness as per Rule 158B of Drugs & Cosmetic Rules, 1945.
• Undertaking regarding compliance to the provisions of domestic regulations, including the Drugs & Cosmetics Act, 1940, and Rules, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954, and Rules.

Procedure to Get GMP Certification

Application
This is the initial step to obtain GMP certification. The application provides essential information about the organization. The certification body must accept the application and maintain all the data in the GMP database.

Review of Application
The application will be reviewed by the team to ensure that the compliance requirements have been met.

Analysis & Agreement
After reviewing the documents, a quotation will be provided to perform a Gap Analysis, identifying the gaps between the organization's planned and achieved quality standards. The Gap Analysis helps to address any discrepancies in the system.

Documentation Review
Review the organization’s paperwork to ensure that it meets the compliance requirements.

Stage-1: Audit

• Evaluate: Review the organization’s approach and policies against the compliance requirements.
• Review: Examine the organization’s documentation to ensure that compliance requirements are addressed.
• Corrective Action: Any non-compliance identified must be corrected promptly.
• Check: Verify the organization's documentation according to the required standards.

Stage-2: Audit

• Audit: The inspector verifies whether the organization’s processes align with the documented procedures. The inspector identifies non-compliance and provides the opportunity to address the issues. Afterward, the execution process is reviewed as per the organization’s report.
• Corrective Action: If any non-compliance occurs, corrective measures should be taken.
• Check: Verify the work instructions and the execution process to ensure compliance with standards.

Consequences of GMP Non-Compliance

When operating in any manufacturing industry, adhering to Good Manufacturing Practices (GMP) is critical for both the quality of your products and the protection of consumer and environmental health. Failing to comply with GMP guidelines can have serious repercussions for your business. Here are the potential consequences of non-compliance:

Impact on Reputation & Goodwill
For businesses, reputation is everything. It’s essential for attracting customers, building product loyalty, and maintaining ongoing relationships. Non-compliance with GMP will damage your reputation, leading to customers losing trust in your products. A business with a tarnished reputation may struggle to regain consumer confidence.

Loss of Consumer Confidence
GMP guidelines are in place to protect consumers. If these guidelines are ignored, consumers will lose confidence in your product’s safety and efficacy. This loss of trust can have long-term detrimental effects on your brand and sales.

Criminal Prosecution
The Food and Drug Administration (FDA) and other authorities have the power to seize products and halt production through legal action if GMP violations occur. In more severe cases, the Department of Justice and Health & Human Services may take legal action against the manufacturing company for non-compliance with GMP regulations.

License Cancellations
Manufacturing operations often require multiple licenses, including facility permits and certifications for medical professionals. Failing to adhere to GMP standards could result in the revocation of these licenses, putting your facility and staff at risk of losing their ability to operate legally.

Fraud Charges
Non-compliance with GMP guidelines, such as mislabeling ingredients or failing to accurately advertise products, can lead to fraud charges. Accusations of fraud can have severe legal and financial consequences for the business. The GMP guidelines specifically address issues like fraudulent labeling and advertising, and violations in these areas are taken very seriously.

Basic Principles that GMP Guidelines Seeks to Obey

1. Clean Manufacturing Environment
   Pharmaceutical manufacturing facilities must maintain a clean and sanitary environment. Controlled conditions should be maintained to prevent cross-contamination of food or drug products by any harmful substances that could make the product unsafe for human use.

2. Defined and Controlled Manufacturing Process
   Manufacturing processes must be clearly defined and controlled. Each procedure should be validated to ensure it consistently meets the established specifications.

3. Controlled Process Changes
   Any changes to manufacturing processes must be controlled and assessed. Changes that affect the product's quality should be approved according to established procedures.

4. Clear and Unambiguous Documentation
   Instructions and procedures should be written clearly and concisely. Personnel must be trained to follow these documented procedures precisely.

5. Record Keeping
   Accurate records must be created manually or electronically during the manufacturing process to demonstrate that all steps have been followed as per the defined procedures. Any deviations must be investigated and documented.

6. Traceability of Product History
   Records must be maintained that allow the complete history of each batch, including distribution, to be traced. These records should be kept in a comprehensible and accessible format.

7. Complaint Handling and Corrective Actions
   Complaints regarding products must be investigated. The reasons for quality issues should be identified, and appropriate corrective actions should be taken to address the defective products and prevent recurrence.

Fastzeal Procedure for GMP Certification

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It is advisable that an attorney with "corporate certification experience" must be appointed to overwhelm many of the potential pitfalls that creep around within GMP Certification and to understand the requirement in detail. The elementary information would be mandatory from your end to start the process. The Attorney will begin working on your request once all the information is provided, and the payment is received.