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 |