Schedule M is a part of Drug and Cosmetic Rules, 1945. It provides good manufacturing practices (GMP) requirements for pharmaceutical industry that must be followed by pharmaceutical manufacturing units in India. Schedule M has guidance on company premises, quality control system, quality control laboratories, GMP in production, cleaning of equipment, housekeeping, cross-contamination and other related topics.
In an amendment to this Schedule published on Dec 28 2023, Schedule M is revised significantly to provide a more detailed version which aligns more closely with other countries GMP regulations like WHO-GMP, PIC/S, EU-GMP etc.
Revised Schedule M is a shift from Document based GMP to System based GMP. Traditionally, compliance under Schedule M mostly meant having required SOP, basic infrastructure and some batch testing. But the revived version moved from checklist approach (“Do you have SOP”) to a system based GMP framework (“Can you demonstrate control”).
2. Responsibility is elevated and senior management is now accountable for quality management systems, data integrity, risk management, deviations, CAPA and self inspection.
3. Compliance requirements are broadened now, nearly all aspects of manufacturing from facility design to record keeping, need to meet modern GMP standards.
In short revised schedule M is a GMP reset for Indian pharmaceutical industry that is more demanding but also bringing Indian manufacturers closer to global standards.
Download Revised Schedule M
2. Walls, floor and ceiling should be smooth, washable and constructed with non-particle shedding materials.
3. Environmental controls such as temperature, humidity and pressure differential must be monitored and recorded.
4. Separate area must be provided for storage, manufacturing and quality control to prevent cross contamination.
2. Equipment should be qualified by completing IQ, OQ and PQ.
3. Equipment should have scheduled preventive maintenance and calibration plan.
4. HVAC, water and compressed air systems must be validated and documented to ensure consistent environmental control and air quality.
2. It is mandatory to provide continuous training on GMP, hygiene and safety.
3. Regular health checkups should be conducted for health and fitness of personnel working in cleanroom areas.
4. In manufacturing area strict gowning procedures and hygiene rules must be implemented.
2. Manufacturing records like Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) should be reviewed and approved by quality assurance.
3. Electronic systems must be validated and audit trails should be periodically reviewed by quality assurance.
4. Manufacturing and testing records should be retained for at least one year after the product expiry date.
2. Self inspections and internal audits should be conducted at a defined interval.
3. Risk based approaches must be adopted and proper risk assessment must be conducted for critical processes and systems.
4. Management review should be conducted periodically to implement and evaluate QMS effectiveness.
- list of priorities and timelines for compliance actions
- resources required to achieve compliance
- identify any critical systems such as HVAC, clean room and water system which must be upgraded first before completing all other compliance upgrades.
- proper segregation of materials, air handling and controlled environments.
- implement pest control, waste management and effluent treatment systems.
1. High cost and capital investment: This is a significant issue for small companies those lack funds and larger companies those have no access to financing.
Suggestion: You should develop an upgrade plan in phases, look for government support schemes and work on critical areas upgradation in first phase.
2. Lack of technical experts: In many cases internal QA teams have limited knowledge about global GMP requirements.
Suggestion: You should consult GMP consultants to provide training for employees and seek third party audit support.
3. Moving from a paper based data to a computerized system: Data integrity and audit trail implementation are required for compliance.
Suggestion: You should invest in purchasing validated QMS/LIMS software, train staff members and develop data backup and security.
4. Production downtime caused by upgrade process: Shutdowns result in loss of supply and revenue.
Suggestion: You should plan upgrades in phases, schedule your production shutdowns carefully, keep critical batches running during each phase of upgrade.
5. Change resistance in creating quality-first mindset: existing personnel may have outdated practices and resist documents and following SOPs.
Suggestion: You should support leaders to create a compliance culture and conduct internal audits, training as well as providing incentives for meeting compliance expectations.
Schedule M makes a turning point in India's pharmaceutical regulation. It can create problems for some manufacturers in short term but in long term, it is a good move for Indian pharmaceutical sector. It will improve quality of pharmaceutical products manufactured in India and bring them equal to world classic standards.
By understanding the updated requirements, performing gap analysis, upgrading facility, strengthening QMS and training of staff, pharmaceutical manufacturers can confidently align with Schedule M requirements and position themselves as a reliable supplier of safe, effective and high quality medicines. If you are facing issues in compliance with Schedule M requirements, feel free to contact us for support.
In an amendment to this Schedule published on Dec 28 2023, Schedule M is revised significantly to provide a more detailed version which aligns more closely with other countries GMP regulations like WHO-GMP, PIC/S, EU-GMP etc.
Why the Revision Matters?
Revised Schedule M is a shift from Document based GMP to System based GMP. Traditionally, compliance under Schedule M mostly meant having required SOP, basic infrastructure and some batch testing. But the revived version moved from checklist approach (“Do you have SOP”) to a system based GMP framework (“Can you demonstrate control”). Key Updates in Revised Schedule M
1. Auditors will look for evidence of control, not just documentation. For example, validated process, environmental monitoring, quality risk assessment.2. Responsibility is elevated and senior management is now accountable for quality management systems, data integrity, risk management, deviations, CAPA and self inspection.
3. Compliance requirements are broadened now, nearly all aspects of manufacturing from facility design to record keeping, need to meet modern GMP standards.
In short revised schedule M is a GMP reset for Indian pharmaceutical industry that is more demanding but also bringing Indian manufacturers closer to global standards.
Download Revised Schedule M
Key Requirements of Schedule M Compliance
To comply with schedule M manufacturers must address the following core areas.A. Facility and Premises
1. Manufacturing facility must be located away from source of contamination and designed to ensure logical flow of materials and personnel.2. Walls, floor and ceiling should be smooth, washable and constructed with non-particle shedding materials.
3. Environmental controls such as temperature, humidity and pressure differential must be monitored and recorded.
4. Separate area must be provided for storage, manufacturing and quality control to prevent cross contamination.
B. Equipment and Utilities
1. Equipment should be built using a non-reactive and corrosion resistant materials.2. Equipment should be qualified by completing IQ, OQ and PQ.
3. Equipment should have scheduled preventive maintenance and calibration plan.
4. HVAC, water and compressed air systems must be validated and documented to ensure consistent environmental control and air quality.
C. Personnel and Training
1. Qualified personnel must be appointed for production, quality control, quality assurance and engineering departments.2. It is mandatory to provide continuous training on GMP, hygiene and safety.
3. Regular health checkups should be conducted for health and fitness of personnel working in cleanroom areas.
4. In manufacturing area strict gowning procedures and hygiene rules must be implemented.
D. Documentation and Record Control
1. All the records must follow ALCOA+ principles whether it is digital or offline paper documents. Records must be Attributable, Legible Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available.2. Manufacturing records like Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) should be reviewed and approved by quality assurance.
3. Electronic systems must be validated and audit trails should be periodically reviewed by quality assurance.
4. Manufacturing and testing records should be retained for at least one year after the product expiry date.
E. Quality Management System (QMS)
1. A documented Quality Management System (QMS)must be implemented that should cover deviation control CAPA and change management.2. Self inspections and internal audits should be conducted at a defined interval.
3. Risk based approaches must be adopted and proper risk assessment must be conducted for critical processes and systems.
4. Management review should be conducted periodically to implement and evaluate QMS effectiveness.
Steps to Achieve Schedule M Compliance
Step 1: Conduct a Gap Analysis
Evaluate the existing GMP compliance measures in the manufacturing facility and determine what complies and does not comply with revised Schedule M standards. List the non-conformities in the facility's layout, quality systems, documentation, validation, training, and any other areas identified during the gap analysis as not being done according to revised Schedule M standards.2. Develop GMP Upgrade Work Plan
Prepare GMP upgrade work plan for submitting to the licensing authority including the following- list of priorities and timelines for compliance actions
- resources required to achieve compliance
- identify any critical systems such as HVAC, clean room and water system which must be upgraded first before completing all other compliance upgrades.
Step 3: Upgrade Facility Infrastructure
Modify facility infrastructure based on the gap analysis findings and ensure:- proper segregation of materials, air handling and controlled environments.
- implement pest control, waste management and effluent treatment systems.
Step 4: Implement Additional Quality System Procedures
Implement change control, deviation, corrective and preventive action and risk management procedures. Schedule internal audits and management reviews. Implement data integrity control, adopt ALCOA+ principles, maintain audit trail and secure storage of data.Step 5: Validate and Qualify Equipment
Complete validation of all manufacturing, quality control, engineering and utilities equipment. Also validate manufacturing processes, cleaning procedures and analytical methods according to approved validation protocols.Step 6: Train Staff
All employees must receive training in the revised Schedule M guidelines as well as the corresponding hygiene procedures, documentation procedures, health and safety procedures. Maintain all training records including assessment and evaluation documentation as per the regulatory requirements.Step 7: Review and Audit
A mock audit of your facility should be conducted using Schedule M requirements as your initial step in audit readiness. Any gap found during mock audit should be closed with implementation of corrective and preventive actions (CAPA).Essential Documents
- Quality Manual & Quality Policy
- Validation Master Plan
- All SOPs developed for each process
- All Batch Manufacturing and Packaging Records (Final Product)
- All Equipment Calibration and Qualification Logs
- Environmental Monitoring Records
- Training and Medical Fitness Documentation
- All Deviation, CAPA, and Change Control Log
- All Market Complaints, Product Recalls, and Product Disposal Records
Key Areas to Review for Schedule M Compliance
- Facility layouts, segregated areas and cleanrooms, heating ventilation and air conditioning (HVAC), environmental controls.
- Purified water system, air systems, steam systems, waste systems, waste treatment system.
- Equipment qualification, maintenance, calibration, validation, cleaning validation.
- Quality Management System (QMS) and Standard Operating Procedures (SOPs), Change Control, deviation, CAPA, self-inspection, management review.
- Batch records, logs, Quality Control (QC) data, environmental monitoring, training, market complaints/recall records.
- Personnel hygiene, training, competency, gowning, cleaning protocols.
- Quality Control (QC) laboratories, testing of products, stability studies, product specific controls for high risk products.
- Market complaint handling, recall procedures, adverse reaction reporting.
- Internal auditing process, risk assessments, validation and re-validation programs.
Common Compliance Challenges & How to Address Them
Many pharmaceutical manufacturers especially small and medium ones face practical problems during compliance with Schedule M regulations. Some common challenges are listed below.1. High cost and capital investment: This is a significant issue for small companies those lack funds and larger companies those have no access to financing.
Suggestion: You should develop an upgrade plan in phases, look for government support schemes and work on critical areas upgradation in first phase.
2. Lack of technical experts: In many cases internal QA teams have limited knowledge about global GMP requirements.
Suggestion: You should consult GMP consultants to provide training for employees and seek third party audit support.
3. Moving from a paper based data to a computerized system: Data integrity and audit trail implementation are required for compliance.
Suggestion: You should invest in purchasing validated QMS/LIMS software, train staff members and develop data backup and security.
4. Production downtime caused by upgrade process: Shutdowns result in loss of supply and revenue.
Suggestion: You should plan upgrades in phases, schedule your production shutdowns carefully, keep critical batches running during each phase of upgrade.
5. Change resistance in creating quality-first mindset: existing personnel may have outdated practices and resist documents and following SOPs.
Suggestion: You should support leaders to create a compliance culture and conduct internal audits, training as well as providing incentives for meeting compliance expectations.
Best Practices for Continuous Compliance
- Create a culture that supports good manufacturing practices instead of viewing it as simply checklist. Create a culture of compliance.
- Conduct internal audits on an ongoing basis as well as perform third party audits on the regular basis.
- Review your SOPs and make updates as necessary.
- Monitor and validate your real time data monitoring for integrity checks and utilize the latest technology available.
- Encourage employees to report deviations and incidents openly and also provide an anonymous reporting platform.
- Once per quarter conduct a management review meeting.
Schedule M makes a turning point in India's pharmaceutical regulation. It can create problems for some manufacturers in short term but in long term, it is a good move for Indian pharmaceutical sector. It will improve quality of pharmaceutical products manufactured in India and bring them equal to world classic standards.
By understanding the updated requirements, performing gap analysis, upgrading facility, strengthening QMS and training of staff, pharmaceutical manufacturers can confidently align with Schedule M requirements and position themselves as a reliable supplier of safe, effective and high quality medicines. If you are facing issues in compliance with Schedule M requirements, feel free to contact us for support.
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