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Revised Schedule M Cleaning Checklist for Pharma (2026)
Quick answer: Revised Schedule M requires pharma plants to clean and, where needed, disinfect premises “according to detailed written procedures” and keep records of it (clause 12.2.6). Equipment must be cleaned on a fixed schedule, shared equipment by validated procedures, and sterile clean areas need more than one disinfectant, including a sporicidal agent. Large manufacturers had to comply by June 2024 and MSMEs by 31 December 2025.
What is Revised Schedule M and who must comply?
Revised Schedule M is India’s updated Good Manufacturing Practice (GMP) standard for drug makers, notified as G.S.R. 922(E) on 28 December 2023. It replaced the old Schedule M and brings Indian plants closer to WHO-GMP standards.
Who | Deadline | Status |
|---|---|---|
Large manufacturers (turnover above ₹250 crore) | June 2024 | In force |
MSMEs that applied for extension | 31 December 2025 | In force; CDSCO says no further extensions |
Plants that fail inspection now risk suspension of their manufacturing licence. Cleaning and sanitation sit at the heart of the rules: clause 4 says “a high level of sanitation and hygiene shall be practiced in every aspect of the manufacture of drugs.”
What does Schedule M require on cleaning and sanitation?
Schedule M turns cleaning into a documented, controlled process, not a daily chore. These are the key clauses from Part I (general requirements) and Part II (sterile products) of the official text:
Area | Clause | What it requires |
|---|---|---|
Sanitation programme | 4 | Eliminate contamination sources through “an integrated comprehensive programme” of sanitation and hygiene |
Premises | 12.2.6 | Clean and, where applicable, disinfect premises to detailed written procedures, and keep records |
Premises design | 12.2.1, 12.6.4–5 | Surfaces and layout must allow easy, effective cleaning, with no hard-to-clean recesses |
Production equipment | 13.6 | Clean thoroughly “according to a fixed schedule” |
Shared equipment | 13.12, 12.6.1 | Clean non-dedicated equipment by validated cleaning procedures |
Pre-use check | 17.3.8.2 | Before processing, confirm and record that equipment is clean and suitable for use |
Responsibility | 17.3.10.18 | Written procedures assigning cleaning responsibility, with schedules, methods, equipment and materials |
Water tanks | 14.6 | Clean storage tanks periodically and keep records |
Personal hygiene | 11.5.2–11.5.8 | Hand sanitising before production areas, clean protective clothing, no food or personal items |
Pest control | 12.2.9, 17.3.10.1(f) | A documented rodent and pest control procedure with records |
Waste | 16.1–16.4 | No accumulation; safe, sanitary disposal at frequent intervals; bio-medical waste per rules |
Clean areas (sterile) | Part II, 3.1 | Clean frequently to an approved written programme, using more than one type of disinfectant |
Disinfectants (sterile) | Part II, 3.2–3.3 | Monitor disinfectants for contamination; sterile disinfectants in Grade A/B; include a sporicidal agent |
Cleaning staff (sterile) | Part II, 7.2 | Train cleaning and maintenance staff in hygiene and basic microbiology |
Cleaning procedures are also named in self-inspection (clause 10.2) and validation (clause 5.11), so auditors check both the cleaning itself and the paperwork behind it.
Schedule M cleaning checklist by area
Schedule M sets the rules, but each plant sets its own frequencies in its SOPs. The checklist below reflects typical industry practice. Adjust it to your validated procedures and environmental monitoring data.
Area | Every shift / daily | Weekly | Monthly or periodic |
|---|---|---|---|
Grade A/B (aseptic) | Clean and disinfect work surfaces and floors with sterile agents; record each session | Rotate to the second disinfectant per programme; clean walls and pass boxes | Sporicidal treatment; ceilings and fixtures; review EM trends |
Grade C/D | Floors, work surfaces, door handles and switches | Walls, equipment exteriors, return-air grilles | Ceilings, lights, sporicidal round |
Non-sterile production | Line clearance and equipment cleaning between batches; record status labels | Walls, drains, overhead pipes and cable trays | Deep clean during shutdowns; verify validated cleaning |
Warehouse and receiving | Floors, dock area, spill check; clean incoming containers | Racks, pallets and corners | High-level dusting, pest-control review |
Change rooms and washrooms | Floors, benches, sinks, toilets; restock hand sanitiser | Lockers, walls, step-over benches | Deep clean and drain treatment |
Utilities and surroundings | Waste removal; drain checks | Utility rooms, AHU rooms, building surroundings | Water storage tank cleaning (clause 14.6); roof and drainage |
Canteen | Tables, floors, kitchen surfaces | Exhaust hoods and storage | Deep clean, pest-control service |
Golden rules for every area: clean top to bottom and clean to dirty, use dedicated colour-coded tools per grade, never move tools from a lower grade to a higher one, and sign the log as you finish, not at the end of the day.
What cleaning records do Schedule M inspectors ask for?
If it isn’t written down, inspectors treat it as not done. Keep these ready for any inspection:
- Cleaning and sanitation SOPs naming who cleans, how often, the method, equipment and materials (clause 17.3.10.18)
- Area cleaning logs signed and dated for every session (clause 12.2.6)
- Equipment cleaning logs and status labels (“cleaned” / “to be cleaned”), plus pre-use clean checks (clause 17.3.8.2)
- Cleaning validation reports for shared, non-dedicated equipment (clauses 5.11, 13.12)
- Disinfectant programme: approved agents, dilutions, contact times, rotation schedule, sporicide use and microbial monitoring of disinfectants (Part II, 3.1–3.3)
- Training records for cleaning staff, including hygiene and gowning (Part II, 7.2)
- Pest control records and service reports (clause 17.3.10.1(f))
- Water tank cleaning records (clause 14.6)
- Waste disposal records, including bio-medical waste (clauses 16.1–16.4)
- Self-inspection reports covering sanitation and hygiene (clause 10.2)
Common cleaning gaps found in inspections, and how to fix them
Most cleaning findings are about missing proof, not dirty floors. These are the gaps plants most often need to close:
Gap | Why it fails Schedule M | Fix |
|---|---|---|
Logs filled in at end of day, or blank | Records must show cleaning was done as written (12.2.6) | Sign at the point of cleaning; supervisor review each shift |
One disinfectant used everywhere | Sterile clean areas need more than one type plus a sporicide (Part II, 3.1–3.3) | Written rotation schedule with a sporicidal round |
Cleaning staff not trained or not on record | Cleaning staff need hygiene and microbiology training (Part II, 7.2) | Documented induction and refresher training, with gowning qualification |
Equipment status unclear | Equipment must be confirmed clean before use (17.3.8.2) | “Cleaned / to be cleaned” labels with date and sign-off |
Shared tools across grades | Moving tools between grades spreads contamination (clause 4) | Colour-coded, grade-dedicated mops, wipes and buckets |
Hard-to-reach areas skipped | Dust build-up in recesses, ducts and overheads (12.2.1) | Periodic high-level cleaning on the schedule, with records |
Waste piling up | Waste must not accumulate (16.2) | Fixed removal times per area, logged |
How PinkClean helps pharma plants stay Schedule M ready
PinkClean is a member of the Contamination Control Society of India (CCSI) and an ISO-certified cleaning company serving pharma, biotech and industrial plants in Bangalore, Hyderabad, Goa and Kochi.
Our clean room cleaning and industrial teams work to your SOPs, not ours:
- Trained, gowned crews for Grade A–D areas, with training records you can show inspectors
- Grade-dedicated, colour-coded tools and top-to-bottom, clean-to-dirty methods
- Disinfectant rotation and sporicidal rounds run to your approved programme
- Signed logs at the point of cleaning, ready for audits and self-inspections
- Deep cleans during shutdowns for overheads, ducts, drains and utility areas
Our industrial projects include ISRO SHAR, RenewSys, Prova Flavours and MANN+HUMMEL. Read more about India’s top pharma companies and manufacturing hubs.
Frequently asked questions
What is Revised Schedule M?
Revised Schedule M is India’s updated Good Manufacturing Practice (GMP) standard for pharmaceutical manufacturers, notified as G.S.R. 922(E) on 28 December 2023 under the Drugs Rules, 1945.
What is the Revised Schedule M deadline for MSMEs?
MSMEs that applied for an extension had to comply by 31 December 2025. Large manufacturers had to comply by June 2024, and CDSCO has said no further extensions will be granted.
What does Schedule M say about cleaning?
Premises must be cleaned and, where applicable, disinfected according to detailed written procedures, with records kept (clause 12.2.6). Equipment must be cleaned on a fixed schedule, and shared equipment by validated procedures.
Does Schedule M require disinfectant rotation?
For sterile clean areas, Schedule M requires more than one type of disinfectant and a sporicidal agent in the disinfectant programme (Part II, paras 3.1 and 3.3). Most plants meet this with a written rotation schedule.
What are the cleanroom grades under Schedule M?
Schedule M classifies sterile manufacturing clean areas into four grades. Grade A is for high-risk operations like filling, Grade B is its background, and Grades C and D are for less critical stages.
Do cleaning staff need training under Schedule M?
Yes. In sterile areas, all personnel, including cleaning and maintenance staff, need initial and regular training, including hygiene and basic microbiology (Part II, para 7.2).
Can a pharma plant outsource cleaning under Schedule M?
Yes, provided the contractor follows the plant’s written procedures, keeps records and has trained staff. The plant remains responsible for compliance.
Get your plant inspection-ready
PinkClean, a CCSI member and ISO-certified company, provides Schedule M-aligned cleanroom and industrial cleaning for pharma plants in Bangalore, Hyderabad, Goa and Kochi. Book a free site assessment and we’ll map your cleaning needs by area grade, frequency and audit schedule.
📞 Bangalore: 96065 10235 · Mangalore: 91084 44692 · 🌐 pinkcleanindia.com
This article summarises Revised Schedule M for general guidance. Always follow the official notification and your own validated SOPs.
Sources
- Revised Schedule M, G.S.R. 922(E), 28 December 2023 (official notification text)
- Revised Schedule M enforcement and deadlines – IMARC Engineering
- MSME deadline extended to December 2025 – India Briefing
- Sanitation and hygiene under Schedule M – PharmaNow
