Nikkhil K Masurkar spoke about how Current Good Manufacturing Practice and Good Manufacturing Practice is important for the Indian Pharmaceutical Industry. He also talked about how GMP serves as the foundation for maintaining product quality, safety, and efficacy.
The Indian pharmaceutical industry, often recognized as the “pharmacy of the world,” faced a significant spotlight last year due to the alleged deaths of children in Gambia caused by an Indian syrup. Despite this unfortunate incident, India remains at the forefront of vaccine production and is the largest supplier of generic drugs worldwide, offering affordable pharmaceutical products without compromising on quality, performance, and safety. With India already contributing over 20 percent of the global supply of generic drugs, the country’s pharmaceutical sector is poised for further growth as exports continue to soar. However, this expanding industry also brings inherent risks, including the potential for tainted and counterfeit medicines, thereby putting India’s regulatory bodies to the test. To ensure the integrity of the Indian pharmaceutical market, adherence to stringent Good Manufacturing Practices (GMP) becomes crucial. GMP serves as the foundation for maintaining product quality, safety, and efficacy, safeguarding not only the reputation of Indian pharmaceutical companies but also the well-being of patients worldwide.
GMP, or Good Manufacturing Practice, is a comprehensive manufacturing system that ensures the production and control of various products, including medical devices and pharmaceuticals, in accordance with specific quality standards. These practices encompass every stage of the manufacturing process, aiming to minimize and ideally prevent risks such as cross-contamination, mislabeling, failures, and other potentially catastrophic issues. Several key areas are integral to the GMP guidelines, including sanitation and hygiene, building, facilities, and equipment, raw materials, quality management, personnel, complaints, documentation and recordkeeping, validation and qualification, as well as inspections and GMP audits.
By emphasizing on these areas, manufacturers strive to achieve GMP compliance. Adherence to Good Manufacturing Practices requires that products are consistently of high quality, designed for their intended use, and capable of meeting the requirements outlined in marketing authorization and/or clinical trial authorization. It is through the meticulous implementation of GMP that manufacturers can assure the integrity, safety, and efficacy of their products, promoting consumer trust and upholding regulatory standards.
The enforcement of Good Manufacturing Practice (GMP) regulations is carried out by individual states and regulatory bodies across the globe. In the United States, the responsibility lies with the US Food and Drug Administration (USFDA). Similarly, in the European Union, National Regulatory Agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK oversee GMP compliance. In India, the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare is responsible for ensuring GMP compliance within the pharmaceutical industry.
One of the primary regulatory standards for maintaining pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulation specifically designed for human pharmaceuticals. This standard is essential in meeting consumer expectations, as individuals rely on the assurance that each batch of medicine they consume adheres to quality standards to ensure their safety and effectiveness. By upholding CGMP regulations, regulatory authorities and manufacturers work together to safeguard public health and maintain the trust of consumers in the pharmaceutical products they rely on.
GMP (Good Manufacturing Practice) and CGMP (Current Good Manufacturing Practice) play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products within the Indian pharma industry. Here are some reasons why GMP and CGMP are important:
Product Quality: GMP and CGMP standards set stringent guidelines for manufacturing processes, ensuring that pharmaceutical products are consistently produced to high-quality standards. Compliance with these standards helps prevent manufacturing errors, contamination, and deviations that could compromise the quality of medicines.
Patient Safety: GMP and CGMP regulations prioritize patient safety by minimizing the risks associated with substandard or counterfeit drugs. By implementing robust quality control measures, including proper documentation, testing, and traceability, the industry can mitigate the chances of distributing unsafe or ineffective medications to patients.
Regulatory Compliance: Adhering to GMP and CGMP regulations is essential for compliance with the regulatory authorities in India, such as the Central Drugs Standard Control Organization (CDSCO). Compliance not only ensures smooth operations within the industry but also helps maintain India’s reputation as a trusted global pharmaceutical supplier.
International Acceptance: Indian pharma companies heavily rely on exports to global markets. Compliance with GMP and CGMP standards is a prerequisite for international market access, as many countries require proof of adherence to these regulations. Meeting these standards enhances the reputation and competitiveness of the Indian pharma industry in the global market.
Quality Management Systems: GMP and CGMP guidelines promote the establishment of comprehensive quality management systems within pharmaceutical companies. These systems encompass various aspects of manufacturing, including documentation, training, risk management, and quality assurance. Implementing such systems ensures continuous improvement, consistency, and reliability in the production of medicines.
Patient Confidence and Trust: GMP and CGMP compliance instills confidence and trust in patients and healthcare professionals regarding the safety and efficacy of pharmaceutical products. When patients have faith in the quality of medicines they receive, it strengthens their trust in the Indian pharma industry as a whole.
There is often a debate surrounding how a manufacturing facility approved by a local regulatory agency may still have gaps in compliance with current Good Manufacturing Practices (cGMP) identified by foreign regulatory agencies. The World Health Organization (WHO) has revised its guidelines multiple times since the 1992 version, with supplementary guidance documents issued in 2002, 2006, 2008, 2014, and more. Additionally, the Pharmaceutical Inspection Co-operation Scheme (PIC/s) updates its GMP guidelines annually. In India, Schedule M of GMP was incorporated in 1988 and revised in 2001 to align with WHO Technical Report Series (TRS) recommendations.
To address these compliance issues and bridge the gaps, it is essential for every pharmaceutical industry to prioritize employee training. Training is typically scheduled in two ways: in response to identified deficiencies in performance or qualification, and according to a predetermined calendar.
Deficiency-based training includes activities such as new employee orientation, business process redesign, standard operating procedure (SOP) revision, and technical training. In these cases, training aims to equip trainees with the necessary skills, knowledge, and motivation to address identified gaps.
Continuing education programs play a vital role in ensuring ongoing learning and professional development. It is important to consider continued education as an opportunity and an asset to one’s profession. Conducting a competency assessment can help identify areas that require improvement or specific attention.
Regulations from the US Food and Drug Administration (FDA) emphasize the need for continuing cGMP training. For finished pharmaceutical products, the FDA explicitly states that training in current good manufacturing practice should be conducted by qualified individuals continuously to ensure employees remain familiar with applicable cGMP requirements. The European Union (EU) similarly emphasizes the importance of continuing training in GMPs, stating that newly recruited personnel should receive appropriate training based on their assigned duties, and continuing training should be provided.
In conclusion, adherence to Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (CGMP) is of utmost importance for the Indian pharmaceutical industry. By implementing these rigorous standards, manufacturers can ensure the consistent production of high-quality medicines while prioritizing patient safety. Compliance with GMP and CGMP regulations not only ensures regulatory compliance but also enhances the industry’s reputation globally. Furthermore, addressing compliance gaps and investing in employee training are crucial steps in bridging deficiencies and upholding the integrity of the pharmaceutical sector. By embracing GMP and CGMP principles, the Indian pharmaceutical industry can continue to thrive as the “pharmacy of the world” while safeguarding the well-being of patients worldwide.