Scribd
Upload
304 views1 page

Schedule M Summary

Schedule M outlines the Good Manufacturing Practices (GMP) for drug manufacturing in India, ensuring safety, effectiveness, and quality. It includes requirements for facilities, equipment, personnel, sanitation, documentation, quality control, and storage. Recent amendments align with international standards, emphasizing data integrity and stricter environmental controls.

Uploaded by

harshithaputhi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
304 views1 page

Schedule M Summary

Schedule M outlines the Good Manufacturing Practices (GMP) for drug manufacturing in India, ensuring safety, effectiveness, and quality. It includes requirements for facilities, equipment, personnel, sanitation, documentation, quality control, and storage. Recent amendments align with international standards, emphasizing data integrity and stricter environmental controls.

Uploaded by

harshithaputhi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Schedule M - Summary (Drugs and Cosmetics Rules, India)

Purpose

Schedule M ensures that drugs manufactured in India are safe, effective, and of standard quality. It lays out Good

Manufacturing Practices (GMP) and requirements for manufacturing premises, equipment, and procedures.

Major Components

- General Requirements: Clean location, proper building design, ventilation, and lighting.

- Plant and Equipment: Proper design, materials, and segregation of activities.

- Personnel: Qualified staff, trained in GMP.

- Sanitation and Hygiene: Regular cleaning and hygiene protocols.

- Documentation: Records of manufacturing, testing, distribution, and recalls.

- Quality Control: Independent QC department, sampling and testing.

- Storage: Proper conditions and segregation.

- Validation: Processes, equipment, and cleaning methods.

- Self-Inspection: Internal audits and CAPA.

- Dosage Form Guidelines: Specific norms for tablets, injections, ointments, etc.

Annexures

- Annexure I: Equipment requirements for dosage forms

- Annexure II: List of SOPs and documents

- Annexure III: Glossary of GMP terms

Recent Amendments

The latest amendments (2023-2024) align with international GMP like WHO-GMP and EU-GMP, focusing on data

integrity, quality risk management, computerized systems, and stricter environmental controls.

Comparison with Pharmacy Act

Pharmacy Act, 1948 governs pharmacists' education and registration.

Schedule M under the Drugs and Cosmetics Rules governs pharmaceutical manufacturing practices.

You might also like