| 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 |