SOP and QMS documentation services
Pharma SOP writing services for your site, aligned with Revised Schedule M
Pharma SOP writing services, done for one site at a time. We write or rewrite SOPs around your equipment, rooms, people and records, review your existing SOP set against Revised Schedule M, and prepare the quality-system documents an inspector asks for first: quality manual, Site Master File and Validation Master Plan.
Every document is prepared and reviewed by a QA/QC/regulatory practitioner with 23+ years in Indian pharmaceutical plants. Fees are quoted per scope after we see what you have.
- Written for your siteYour equipment models, room numbers, roles and record formats, not a generic template
- Clause-mappedEach SOP traced to the Revised Schedule M clause it answers
- Quote-only, fixed scopeYou see the deliverables and exclusions before you commit
- ConfidentialYour documents stay with us; an NDA is signed on request
Why a downloaded template is not enough
What Revised Schedule M actually asks of your SOPs
Schedule M does not ask for a binder of SOPs. It asks that your documents describe what your site really does, and that they are controlled. A template copied from the internet usually fails on exactly those points.
| What Part I requires | Clause | Where a generic template falls short |
|---|---|---|
| Documents approved, signed and dated by the responsible persons | 17.2.2[1] | The approval block names roles your firm does not have, or no one at all |
| Documents regularly reviewed and kept up to date; a system that stops superseded versions being used; superseded versions retained for a set period | 17.2.4[1] | No review date, no version history and no link to your document-control procedure |
| An SOP for each instrument and piece of equipment | 17.3.10.5[1] | Written for a different make and model, so the steps do not match the machine on your floor |
| SOPs and records for equipment, calibration, cleaning, personnel, environmental monitoring, pest control, complaints, recalls and returns | 17.3.10.1[1] | The procedure exists but the record format it calls for does not |
| Records kept for at least one year after the expiry date of the finished product | 17.2.7[1] | Retention periods copied from a foreign guideline or left blank |
| Electronic records: only authorised persons may enter or change data, and changes and deletions are recorded | 17.2.8[1] | No mention of access control or audit trail for your software |
Scroll sideways to see the full table.
Where enforcement stands (checked 4 Nov 2026). Revised Schedule M was notified on 28 December 2023[1]. Smaller manufacturers that applied for an extension had until 31 December 2025[2]. In November 2025 CDSCO asked state regulators to begin inspections[3], and by February 2026 audits were reported to be benchmarked against the revised standard with no further extensions[4]. In Himachal Pradesh, 270 of the 360 units scheduled for review had been inspected by April 2026[5]. The question for most units is now readiness for the next inspection, not planning an upgrade.
Three services
What we write, review and prepare
Each scope lists what you send, what you receive, and what is not included, so the quote has no surprises.
SOP customisation: one SOP or a short list, written for your site
For a unit that needs specific procedures written or rebuilt, such as a new instrument, a new line, an SOP an auditor rejected, or a procedure that never matched practice.
You send
- The SOP titles you need
- Equipment make and model, room or area names
- Your current SOP, if one exists, and your SOP format
- Who prepares, checks and approves at your site
You receive
- The SOP in your format, with purpose, scope, responsibilities, procedure and references
- The record formats or annexures the SOP calls for
- The Schedule M clause each SOP answers
- One review round on the draft
Not included
- Signing or approving the SOP: that stays with your authorised persons
- Equipment qualification or calibration work itself
- Site visits, unless added to the scope
SOP review and gap audit against Revised Schedule M
For a unit preparing for a state or CDSCO inspection, or answering observations from one. We read your existing SOP set the way an inspector would and tell you what is missing, outdated or not followed in practice.
You send
- Your SOP index and the SOPs in scope
- Inspection observations, if you are responding to them
- Dosage forms and sections at the site
You receive
- A gap register: SOP, gap, clause, risk, recommended action
- A list of SOPs Part I names that your index does not have
- Rewritten SOPs for the gaps you choose to close, quoted separately
- Help drafting the CAPA wording for documentation observations
Not included
- A promise about any inspection outcome
- A physical audit of the plant, unless added to the scope
- Correspondence with the regulator on your behalf
Quality-system documents
The documents that frame every SOP you hold. Inspectors often start here, because they show whether the quality system exists on paper before they look at practice.
Documents
Core quality procedures
- Document control (17.2)
- Change control (8.1)
- Deviations and CAPA (1.5)
- Self-inspection with a stated frequency (10.1, 10.4)
- Written training programme and records (11.4)
Not included
- Executing the validation the VMP describes
- Facility drawings: for layout and design work see our plant setup consultant service
Free tool
Which SOPs does Schedule M name for your areas?
Pick the areas you want to check. The list shows the procedures and documents Part I of Revised Schedule M names in writing, with the clause[1]. Compare it with your SOP index.
Select one or more areas to see the list.
This is the minimum Part I names in writing, not a complete SOP index. The product-specific Parts of Schedule M, your dosage forms and your own processes add more, and “each instrument and piece of equipment” means one SOP per equipment type you run.
How it works
From enquiry to approved SOP
- Tell us the scopeSend the enquiry below on WhatsApp: the SOPs or documents, your dosage forms and why you need them now.
- Share what you haveYour current SOPs, equipment list and format. An NDA is signed first if you ask.
- Fixed-scope quoteDeliverables, exclusions, review rounds and the delivery date, in writing.
- Draft and reviewYou receive the drafts and mark them up. We revise once within the scope.
- Final for your approvalFinal files go into your own document control, signed by your authorised persons.
Who writes and reviews
Written by someone who has signed SOPs as QC Head, QA Head and Plant Head
Darshan Singh, co-founder and regulatory consultant, Laafon Galaxy Pharmaceuticals, Karnal.
23+ years in pharmaceutical quality control, quality assurance and drug regulatory affairs, including roles as Quality Control Head, Quality Assurance Head and Plant Head. On the inspected side of one MHRA inspection, four WHO-GMP audits and about ten State FDA inspections.
The free SOP library on this site is written the same way: every limit and clause is checked against the primary text and corrected where common versions get it wrong.
Qualifications
M.Sc. Organic ChemistryD.Pharm.QC HeadQA HeadPlant HeadWe do not publish client names or counts of SOPs written. Case studies will appear here only with written client consent.
Free sample
See the format before you ask for a quote
Download a sample of our work: SOP for Preparation, Review, Approval and Control of SOPs, the procedure every other SOP depends on. It shows the layout, the clause mapping, the responsibilities matrix and the record formats you would receive. Site details are redacted.
Download the sample SOP (PDF)Scoped enquiry
Get this SOP customised for your site
Fill in what you know. The form opens WhatsApp with your enquiry written out, so nothing is sent until you press send there. We reply within one working day.
Questions
Pharma SOP services: common questions
No. We write or adapt each SOP for the site that will use it. If you want to read how an SOP should be structured first, the free SOP library on laafon.com covers instruments, calibration, sampling and QA systems, and you can download our sample SOP from this page.
Part I, clause 17.3.10, names SOPs and records for equipment assembly and validation, analytical apparatus and calibration, maintenance, cleaning and sanitisation, personnel matters, environmental monitoring, pest control, complaints, recalls and returns, and separately for receipt of materials, sampling, batch numbering, testing and an SOP for each instrument and piece of equipment. Quality-system chapters add change control, self-inspection and training. The product-specific Parts add more for each dosage form.
By scope. The fee depends on the number and complexity of documents, whether we start from your existing SOPs, and whether a site visit is needed. You receive a written quote with deliverables, exclusions and a delivery date before any work starts.
Yes. Send the observations with the SOPs they refer to. We map each observation to the clause, rewrite or add the SOPs needed, and help you word the corrective and preventive action. The response itself is submitted by your firm.
Your firm does. Schedule M requires documents to be approved, signed and dated by the responsible persons, so the final SOP carries your preparer, checker and approver. We prepare and review; we do not sign as your approver.
Yes. Your documents are used only for your work and are not reused for other clients or published. We sign a non-disclosure agreement before you share documents if you ask for one.
Yes. The Site Master File follows the Appendix-I format referred to in clause 17.2.9, and the Validation Master Plan records the key elements of your qualification and validation programme as clause 5.2 requires. Executing the validation itself is outside this service.
Related on laafon.com
References
- Ministry of Health and Family Welfare. G.S.R. 922(E): Drugs Rules (Amendment) 2023, revised Schedule M, Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products. Gazette of India, Extraordinary; 28 Dec 2023. Reprint available from: thehealthmaster.com. Accessed Nov 2026.
- CliniExperts. Extension of timeline for implementation of revised Schedule M for small and medium manufacturers (G.S.R. 127(E), 11 Feb 2025). 2025. Available from: cliniexperts.com. Accessed Nov 2026.
- Business Standard. CDSCO asks state units to start inspections under Schedule M norms. Nov 2025. Available from: business-standard.com. Accessed Nov 2026.
- Business Standard. CDSCO tightens quality net with audits, scientific cadre overhaul. 23 Feb 2026. Available from: business-standard.com. Accessed Nov 2026.
- The Tribune. Small pharma units in Himachal shut shop as revised Schedule M norms tighten compliance net. 11 Apr 2026. Available from: tribuneindia.com. Accessed Nov 2026.
This page describes a professional documentation service and is general technical information, not legal advice. Revised Schedule M and its enforcement are subject to amendment and state-level practice; clause references are to Part I of G.S.R. 922(E) as notified, and the enforcement status above was checked on 4 November 2026. Laafon Galaxy Pharmaceuticals also manufactures and markets its own brands.