Schedule T – Good Manufacturing Practice of Indian Systems of Medicine: Hand Written Notes
Schedule T – Good Manufacturing Practice of Indian systems of medicine
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and equipment, standard operating procedures, health and hygiene, documentation and records
Detailed Explanation
Good Manufacturing Practice (GMP) as per Schedule T of the Drugs and Cosmetics Act is essential for the standardization and quality assurance of traditional Indian systems of medicine, including Ayurveda, Siddha, and Unani (ASU) drugs. The objective of GMP is to ensure that products are consistently produced and controlled to quality standards appropriate to their intended use.
Key components of GMP (Schedule T) include:
- Infrastructural Requirements: Adequate space and proper layout for manufacturing processes to prevent contamination and ensure smooth workflow.
- Working Space: Sufficient and well-organized working space for various stages of production, including raw material storage, processing, packaging, and quality control.
- Storage Area: Proper storage facilities to maintain the quality and integrity of raw materials, intermediate products, and finished goods. This includes temperature and humidity control as necessary.
- Machinery and Equipment: Use of appropriate and well-maintained machinery and equipment to ensure efficient and contamination-free production processes.
- Standard Operating Procedures (SOPs): Documented procedures for all critical processes and operations to ensure consistency and compliance with quality standards.
- Health and Hygiene: Ensuring that personnel involved in the manufacturing process follow strict health and hygiene practices to prevent contamination and ensure product safety.
- Documentation and Records: Comprehensive documentation of all processes, quality control measures, and batch records to ensure traceability and accountability.
By adhering to these GMP guidelines, manufacturers of ASU drugs can ensure that their products are safe, effective, and of high quality, thereby gaining consumer trust and meeting regulatory requirements.
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