Schedule T includes detailed guidelines and mandatory requirements covering the following core components:
Components of GMP (Schedule T)
1) Infrastructural Requirements
GMP mandates that the manufacturing facility should be properly designed to facilitate smooth workflow and prevent contamination.
Building Design: Must have a well-planned layout to separate different manufacturing sections.
Ventilation & Lighting: Adequate ventilation, air filtration systems, and lighting to maintain a hygienic environment.
2) Working Area
The manufacturing area should be spacious enough to avoid overcrowding.
Different sections should be clearly demarcated, such as:
Raw material processing
Formulation preparation
Quality control
Packaging and labeling
3) Storage Area
Raw Materials Storage: Kept in labeled and segregated areas.
Finished Products Storage: Proper environmental conditions should be maintained (temperature, humidity).
Quarantine Area: Materials under testing should be stored separately.
4) Machinery and Equipment
All machinery and equipment should be:
Suitable for the intended manufacturing process.
Regularly cleaned, maintained, and validated.
Made of non-corrosive, easy-to-clean materials.
5) Standard Operating Procedures (SOPs)
SOPs should be documented for every process, including:
Raw material handling
Manufacturing procedures
Equipment cleaning and maintenance
Quality control testing
Packaging and labeling
6) Health and Hygiene
A) Personnel Hygiene
Workers should wear protective gear (gloves, masks, aprons).
Regular medical check-ups should be conducted to ensure employee health.
B) Sanitation Practices
Regular cleaning and disinfection of work areas.
Waste disposal as per standard protocols.
7) Documentation and Records
Master Formula Records (MFR) – Details of raw materials, procedures, and final product specifications.
Batch Manufacturing Records (BMR) – Step-by-step records of each batch.
Quality Control Records – Testing data for raw materials, intermediates, and final products.
Equipment Maintenance Records – Ensuring machines are serviced periodically.
Importance of Compliance
Enhances product credibility and consumer trust.
Increases global acceptance of Indian traditional medicines.
Minimizes contamination risks, ensuring safe and effective products.
Ensures compliance with regulatory and legal standards.
