Revised Good Manufacturing Practices

Context:

Recently, the government of India has directed all pharmaceutical companies to implement the Revised Good Manufacturing Practices (GMP), bringing their processes at par with Global Standards.

Relevance:

GS II: Indian Economy

Dimensions of the Articles

1. Good Manufacturing Practices (GMP)
2. Rationale Behind Revised GMP Guidelines
3. Revised GMP Guidelines for Pharmaceuticals

Good Manufacturing Practices (GMP)

• Good Manufacturing Practices (GMP) is a systematic approach to ensure consistent production and control of pharmaceutical products according to established quality standards.
• GMP is designed to mitigate risks inherent in pharmaceutical manufacturing that cannot be fully addressed through final product testing alone.

Addressing Key Risks:

GMP focuses on minimizing various critical risks associated with pharmaceutical production, including:

• Unintended contamination of products
• Potential harm to health or even fatalities
• Incorrect labeling leading to patient receiving wrong medication
• Inadequate or excessive active ingredient, resulting in ineffective treatment or adverse effects.

Guidelines by WHO and Beyond:

• The World Health Organization (WHO) has established comprehensive guidelines for GMP to ensure global consistency and safety.
• Many countries have adopted their own GMP requirements based on WHO standards.
• Some regions, like the Association of South-East Asian Nations (ASEAN) and the European Union, have harmonized their GMP requirements.
• GMP ensures that pharmaceutical products meet stringent quality criteria throughout their production lifecycle.

Evolution in India:

• India incorporated the GMP framework in 1988 through Schedule M of the Drugs and Cosmetics Rules, 1945.
• The last amendment to Schedule M was made in June 2005, aligning with evolving global standards.
• WHO-GMP standards have been integrated into the revised Schedule M, emphasizing the importance of adhering to international quality benchmarks.

Role in Quality Assurance:

• GMP plays a pivotal role in maintaining product quality, patient safety, and regulatory compliance.
• By adhering to GMP, pharmaceutical manufacturers ensure that their processes consistently meet established quality standards.

Continuous Improvement:

• GMP emphasizes ongoing quality improvement and risk management.
• Pharmaceutical companies are encouraged to regularly review and enhance their manufacturing processes to achieve higher levels of quality and safety.

Global Impact:

• GMP is a cornerstone of pharmaceutical regulation worldwide.
• Its implementation fosters consumer trust, ensures product effectiveness, and safeguards public health.

Rationale Behind Revised GMP Guidelines

Alignment with Global Norms:

• The introduction of revised Good Manufacturing Practices (GMP) guidelines aims to bring the Indian pharmaceutical industry in line with international standards.
• This step is essential to enhance India’s reputation and competitiveness on the global stage.

Addressing Contamination Concerns:

• Recent incidents have highlighted alleged contamination issues in products manufactured in India, such as syrups, eye-drops, and eye ointments.
• Reports of adverse effects and fatalities, such as the deaths of children in the Gambia, Uzbekistan, the United States, and Cameroon, have raised serious concerns.

Identified Deficiencies:

• Risk-based inspections have identified multiple shortcomings in 162 manufacturing units across India.
• These deficiencies encompass various aspects, including inadequate raw material testing, absence of product quality reviews, infrastructure limitations, and a shortage of qualified professionals.

Limited WHO-GMP Certification:

• Presently, out of the 10,500 drug manufacturing units in India, only around 2,000 are certified to meet WHO-GMP standards.
• This indicates a substantial gap between domestic pharmaceutical practices and globally recognized quality benchmarks.

Ensuring Process Integrity:

• The enhanced GMP standards aim to compel pharmaceutical companies to adhere to standardized processes and stringent quality control measures.
• By preventing shortcuts and substandard practices, the quality of medicines available both within India and in the global market is expected to improve.

Boosting Regulatory Confidence:

• Implementation of uniform quality standards throughout the industry will instill confidence in regulatory bodies from other countries.
• This harmonization enhances India’s credibility as a reliable and responsible player in the global pharmaceutical arena.

Domestic Impact:

• The upgraded GMP guidelines will not only benefit the international market but also have a positive impact on the quality of drugs circulating in the domestic market.
• A majority of the 8,500 non-WHO-GMP certified manufacturing units supply medicines within India.

Revised GMP Guidelines for Pharmaceuticals

Pharmaceutical Quality System and Risk Management:

• Pharmaceutical Quality System: The updated guidelines introduce a comprehensive pharmaceutical quality system, emphasizing the establishment of a robust quality management system throughout the manufacturing process.
• Quality Risk Management: Companies are now obligated to implement effective risk management practices. This involves identifying potential risks to product quality and taking proactive measures to mitigate these risks. Regular quality reviews of all products are mandatory to ensure consistent quality and processes.

Stability Studies:

• Climate-Responsive Stability Studies: A notable change is the requirement for stability studies based on specific climate conditions. Manufacturers must conduct stability tests by subjecting drugs to controlled temperatures and humidity levels in stability chambers. This assessment determines the product’s stability over time.
• Accelerated Stability Tests: Accelerated stability tests may also be performed to assess a product’s stability under expedited conditions, providing insights into its shelf life and performance.

GMP-Related Computerized Systems:

• Enhanced Computerized Systems: The revised guidelines emphasize the utilization of computerized systems to manage various GMP-related processes.
• Data Security and Integrity: These systems are designed to prevent data tampering, unauthorized access, and data omission. By automatically recording all steps and checks, they ensure strict adherence to processes without any tampering.

Investigational Products for Clinical Trials:

• Expanded Scope: The new guidelines include requirements for additional product types, such as biological products, radioactive agents, and plant-derived products.
• Clinical Trials Compliance: For investigational products intended for clinical trials, the updated guidelines outline specific requirements to ensure that these products meet the requisite quality and safety standards.

-Source: The Hindu