Last Updated on December 31, 2023 by The Health Master
GMP for Pharma Companies
Pharmaceutical companies with turnovers exceeding Rs 250 crore will be granted a 6-month transition period, while companies with turnovers less than Rs 250 crore will receive 12 months to adopt Good Manufacturing Practices (GMP), as confirmed by official sources.
GMP is a mandatory standard that ensures the quality of products through the control of materials, methods, machinery, processes, personnel, facilities, and the environment.
The Evolution of GMP:
GMP was initially incorporated into Schedule M of the Drugs and Cosmetics Rules in 1988, with the last amendment in June 2005.
The existing Schedule M prescribes detailed requirements for facilities, personnel, manufacturing, control and safety testing, material storage and transport, written procedures, records, traceability, and more.
Transition Period for Implementation:
To facilitate a smooth transition from the present Schedule M to the revised one, the government has decided to provide a 6-month transition period for large manufacturers (turnover exceeding 250 crores) and a 12-month transition period for MSME (turnover less than 250 crores) companies.
Importance of GMP Compliance:
With approximately 10,500 manufacturing units in India, 8,500 of which fall under the MSME category, it is crucial to adhere to GMP regulations.
India is a significant exporter of medicines to LMIC countries that require WHO GMP certification.
Currently, around 2,000 units in the MSME category possess WHO GMP certification.
Factors Driving GMP Revision:
The pharmaceutical manufacturing and quality domains have undergone significant development in the past 15–20 years.
Insights gained from Pharmaceutical and Manufacturing Sciences have established a strong link between manufacturing and product quality.
Observations from ongoing Risk-Based Inspections (RBI) have further highlighted the need to reevaluate existing GMP regulations and Quality Management Systems followed by pharmaceutical manufacturers.
Issues Identified in RBI Inspections:
During RBI inspections of 162 units and 14 public testing labs, several major issues were identified, including:
- Poor documentation,
- Lack of process and analytical validations,
- Absence of self-assessment and quality failure investigation,
- Lack of internal product quality review,
- Failure to test incoming raw materials,
- Infrastructural deficiencies to avoid cross-contamination,
- Lack of professionally qualified employees,
- Flawed design of manufacturing and testing areas.
Revising GMP Principles and Concepts:
To align with global standards, especially those set by the WHO, it became necessary to revisit and revise the principles and concepts of GMP mentioned in the current Schedule M.
Accordingly, a draft notification was issued in 2018 to upgrade and synchronize Schedule M with international standards based on the recommendations of the DTAB (Drugs Technical Advisory Board).
Incorporating Key Changes in Revised Schedule M:
After receiving comments and suggestions from various stakeholders and conducting multiple consultations, a draft revised Schedule M was published.
The revised GMP will introduce several significant changes to support the upgradation of units, including the implementation of:
- Pharmaceutical Quality System (PQS),
- Quality Risk Management (QRM),
- Product Quality Review (PQR),
- Qualification and Validation of equipment,
- Change control management,
- Self-inspection and Quality audit team,
- Suppliers audit and approval,
- Stability studies according to recommended climate conditions,
- Validation of GMP-related computerized systems,
- Specific Requirements for Manufacturing of Hazardous products, Biological Products, Radiopharmaceuticals, and Phytopharmaceuticals.
Government’s Final Decision:
Recognizing the importance of upgraded and revised GMP in ensuring the quality of drugs, the government has decided to finalize the draft rules.
This move aims to address deficiencies related to documentation, failure investigation, and t
he need for technically qualified personnel, ensuring that the right person does the right job.
Implementing a robust quality management system will enable companies to produce medicines of globally acceptable quality, presenting significant growth opportunities for the Indian pharmaceutical business both nationally and internationally.
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