Revised Schedule M//Self-Audit Instrument//Instant Delivery
Revised Schedule M Gap Assessment Toolkit
A working self-inspection instrument for Indian drug manufacturing units. 272 assessable requirements, each written the way an inspector will verify it, each paired with the exact document you must produce. Scores itself, weights findings by risk, and outputs a CAPA roadmap with a remediation budget.
Regulatory context//Where the deadline now stands
The preparation window has closed. The inspection window is open.
Revised Schedule M was notified in December 2023. Large manufacturers came under it in 2024. Small and medium units that applied for the conditional extension came under it from 1 January 2026. CDSCO has since directed state licensing authorities to plan and carry out verification inspections at the units that took that extension.
The question has changed
It is no longer "how much time do we have". It is "can we demonstrate compliance when the inspector arrives, and can we produce the evidence for each requirement". A unit that cannot show a documented self-assessment, a gap register and a dated remediation plan is in a materially weaker position than one that can — regardless of how good the plant actually is.
The product//Eight linked worksheets
What is inside the file
One Excel workbook. Everything cross-references: the gap sheets feed the dashboard, the dashboard feeds your management review, the CAPA tracker feeds your budget.
Sheet 01
Read Me
Scope, scoring convention, risk-rating definitions, weighting methodology and licence terms. Written so a new QA executive can pick the file up without being briefed.
Sheet 02
Facility Profile
Licence numbers, turnover category, extension status, assessment team and dates. This becomes the cover page of your gap assessment report.
Sheet 03
Compliance Dashboard
Section-wise compliance percentage, risk-weighted score, open Critical and Major counts, and a chart. Recalculates as you fill the assessment.
Sheet 04 — the core
Part I Gap Assessment
All 22 sections of Part I: PQS, QRM, sanitation, qualification and validation, complaints, recalls, change control, contract manufacture, self-inspection, personnel, premises, equipment, materials, documentation, production, quality control and computerised systems.
181 line itemsSheet 05
Dosage Form Specific
Sterile and ophthalmic, hazardous substances, oral solids, oral liquids, external preparations, metered dose inhalers and active pharmaceutical ingredients. Filter to your licence and mark the rest not applicable.
59 line itemsSheet 06
Site Master File Checklist
All nine SMF sections, item by item. An absent or outdated Site Master File is among the most routinely cited findings at Indian units.
32 line itemsSheet 07
CAPA Tracker
Root cause, immediate correction, corrective action, preventive action, owner, target date, effectiveness check, estimated cost. Totals into a single remediation budget figure.
Sheet 08
Inspection Readiness Register
The 26 documents most often called for in the first two hours of an inspection, with a location and status field for each. Use it as a dry run the week before.
Built in
Protected formulas
Scoring columns are locked so nobody breaks the calculation by accident. Filters, sorting and every input cell stay fully open.
Specimen//Actual rows from the file
What a line item looks like
The second column is what separates this from a free checklist. A generic list tells you to "have cleaning validation". This tells your QA head precisely which document to place on the table.
| Ref ID | Requirement as the inspector will verify it | Objective evidence expected | Status | Risk |
|---|---|---|---|---|
| P1-05-007 | Cleaning validation uses worst-case product selection, MACO calculation, and a validated analytical method with recovery study. | Cleaning validation protocol and report; swab recovery data | Non-Compliant | Critical |
| P1-14-003 | Segregated facilities with independent AHUs and separate entry and exit exist for beta-lactams, cephalosporins, hormones and cytotoxics as applicable. | Layout; AHU schematics; differential pressure records | Compliant | |
| P1-19-009 | A data integrity policy implements ALCOA+ principles: no back-dating, no shared logins, no uncontrolled loose sheets. | DI policy; DI training records; audit trail review records | Partial | Major |
| P1-21-005 | Control samples of finished product are retained in the marketed pack for the prescribed period beyond expiry. | Control sample room; retention register | Compliant |
Status and risk are dropdowns · colour coding is automatic · scoring columns not shown
Methodology//Two numbers, not one
Why the toolkit reports a risk-weighted score
A plain percentage flatters a plant. If ninety small documentation items are in order and four critical validation failures are open, a simple count reports something close to ninety-six per cent. The weighted score refuses to do that.
Figure one
Compliance %
Counts every requirement equally. Answers the question: how much of Schedule M do we currently meet? Useful for tracking progress month to month.
Figure two
Risk-weighted compliance %
A Critical finding is weighted three times a Minor one, a Major twice. Answers the question the inspector is actually asking: how exposed are we? A site can show eighty-five per cent plain and sixty per cent weighted — and that gap is exactly where an inspection lands first.
Honest scope//Before you pay
Who this is for, and who it is not for
Buy it if
- You are a QA head or plant head at an MSME formulation or API unit preparing for a state FDA or CDSCO verification inspection
- You took the conditional extension and now need a documented self-assessment on file
- You are preparing for WHO-GMP renewal or a contract-giver audit
- You need a costed remediation plan to put in front of a director or a lender
- You are a consultant who wants a defensible framework instead of rebuilding a checklist per client
Do not buy it if
- You want a certificate, an approval, or anything a licensing authority issues — this is a self-assessment instrument, not a credential
- You want the Schedule M text itself; the gazette notification is free and you should read it
- You want somebody to visit your plant and write the report for you — that is a consulting engagement, not a file
- You expect it to close gaps on its own. It finds and prioritises them. Closing them is capital expenditure and calendar time
Process//From payment to management review
How you will actually use it
Pay and receive
Pay by UPI and submit the short form. The workbook is issued to your company name and emailed personally, usually within a few hours and always within 24 hours.
Set up, day one
Complete the Facility Profile. Fifteen minutes. This is the cover page of the report you will hand to your director.
Walk Part I, section by section
Filter to one section, sit with the department head responsible, and set a status on every row. Most units complete Part I across three to five working sessions.
Rate the gaps
Assign Critical, Major or Minor to every Partial and Non-Compliant row. The weighted score rebuilds itself as you go.
Build the CAPA roadmap
Raise a CAPA line for each gap with an owner, a target date and an estimated cost. The tracker totals your remediation budget in one figure.
Take it to management review
Present two numbers and one count: plain compliance, weighted compliance, open Critical findings. Repeat the assessment quarterly and the trend becomes your evidence of continuous improvement.
Provenance//Who compiled this
The experience behind the file
Before you buy//Common questions
Frequently asked questions
A single Excel workbook (.xlsx). It opens in Microsoft Excel, LibreOffice Calc and WPS Office. Dropdowns, conditional colouring and the dashboard chart behave best in Excel. It is not a PDF and not a web application — it is a file you own and edit.
Usually within a few hours of the payment being confirmed, and always within 24 hours. Each copy is issued to your company name before it is sent, so delivery is manual rather than instant.
Pay by UPI to the account of Laafon Galaxy Pharmaceuticals using the QR code or UPI ID in the payment section, then submit the short form with your UPI reference number. The payment is matched against the bank credit before the file is issued. There is no card entry and no third-party checkout.
The standard licence covers internal use at one site by the purchasing organisation. If you operate several units or you are a consultant using it across clients, write to contact@laafon.com and a multi-site licence will be quoted.
No, and it is not sold as one. It replaces the six to ten hours a consultant would otherwise bill for building an assessment framework, and it gives you a structured, evidence-linked picture of your own gaps. Judgement calls on borderline findings, remediation design and inspection defence still benefit from an experienced pair of eyes.
It follows the Revised Schedule M notified vide G.S.R. 922(E) dated 28 December 2023. The Read Me sheet asks you to verify clause references against the gazette notification and any subsequent amendment applicable on your assessment date before formal submission to a licensing authority.
Yes. Every input cell is unlocked and you can add rows, columns and your own sections. Only the three scoring columns are protected, so that the dashboard cannot be broken by accident. Sheet protection carries no password and can be removed if you want to restructure the calculation.
This is a digital product delivered as a file, so no refunds are offered once the workbook has been sent. Everything material about what is inside is set out on this page, including what it deliberately does not do. If anything is unclear, ask before you pay — WhatsApp is the fastest route.
Purchasers are emailed a revised workbook at no additional charge if a substantive amendment to Schedule M materially changes the requirement set, for twelve months from the date of purchase.
Find out where the facility actually stands before somebody else tells you
Two hundred and seventy-two requirements, the evidence expected against each, a risk-weighted score and a costed remediation plan. One file, one payment, no subscription.
Step 1 of 2 — Payment
Get the Gap Assessment Toolkit
Pay by UPI, then fill the form so the licensed copy reaches the right inbox. Files are issued personally, usually within a few hours and always within 24 hours.
₹4,999
One-time · no subscription
Pay ₹4,999 by UPI
Laafon Galaxy Pharmaceuticals · ICICI Bank
- Scan the code with any UPI app, or tap the green button on mobile.
- Enter the amount as ₹4,999 — this QR does not pre-fill it.
- Complete the payment and note the UPI reference number.
- Fill the form and submit. Your copy is emailed after the credit is confirmed.
Step 2 of 2 — Delivery details
This toolkit is an aid to self-inspection. It does not constitute regulatory or legal advice, does not replace inspection by the licensing authority, and confers no approval or certification of any kind. Single-site licence: internal use at one manufacturing site by the purchasing organisation; resale and redistribution are not permitted.