Comparative Table: Schedule M v/s WHO GMP

Aspect	Schedule M	WHO GMP
Application	Specific to Indian pharmaceutical industry	International guidelines for pharmaceutical manufacturing
Scope	Regulatory framework for pharmaceutical manufacturing in India	Global standards for pharmaceutical manufacturing
Quality Control	Emphasizes quality control measures and testing procedures	Focuses on quality assurance, including quality control and risk management
Facility Requirements	Includes guidelines for facility layout, design, and infrastructure	Provides recommendations for facility layout and design, with emphasis on hygiene and safety
Documentation	Prescribes record-keeping and documentation requirements	Stresses on thorough and accurate documentation of all aspects of manufacturing
Personnel	Specifies requirements for personnel training and qualifications	Focuses on training, qualifications, and competency assessment of personnel
Validation	Includes requirements for process validation	Emphasizes process validation, method validation, and equipment validation
Stability Studies	Provides guidance on stability testing of pharmaceutical products	Emphasizes stability studies for assessing product shelf-life and storage conditions
Environmental Control	Includes guidelines for environmental monitoring and control	Stresses on maintaining appropriate environmental conditions in manufacturing areas
Cleanliness and Hygiene	Specifies requirements for cleanliness and hygiene in manufacturing	Focuses on maintaining cleanliness, hygiene, and preventing cross-contamination