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Free assessment25 questions · about 8 minutes

Are you inspection-ready for Revised Schedule M?

State drug controllers are now inspecting against Revised Schedule M. Answer 25 questions on the essentials inspectors check and see your score, by area, as you go.

  • Instant score on screen
  • Top 3 gaps highlighted
  • Full report by email
Start the assessment The Schedule M guide

Self-assessment

Revised Schedule M readiness check.

Answer honestly for one site. There are no trick questions — “Partly” is a useful answer.

Quality system & management
Do you have a documented pharmaceutical quality system, with senior-management responsibility and a periodic management review?

Schedule M — Pharmaceutical quality system

Do you apply quality risk management (for example FMEA) and keep the assessments on record?

Schedule M — Quality risk management

Do you prepare a product quality review for every product at least once a year?

Schedule M — Product quality review

Are self-inspections planned, carried out and followed up with corrective actions?

Schedule M — Self-inspection

Deviations, CAPA & change control
Is every deviation recorded, classified and investigated, with a documented root cause?

Schedule M — Deviations and investigations

Does every CAPA have an owner, a due date and an effectiveness check?

Schedule M — Corrective and preventive action

Are changes to processes, equipment, materials and documents assessed and approved before they are made?

Schedule M — Change control

Are out-of-specification results investigated in phases, with retesting rules defined in advance?

Schedule M — Good practices in quality control

Are complaints and recalls handled by written procedures, with a recall process you have tested?

Schedule M — Complaints and product recalls

Documentation & data integrity
Are SOPs version-controlled, approved, periodically reviewed and issued as controlled copies?

Schedule M — Documentation

Are batch records issued under control and fully reviewed before batch release?

Schedule M — Documentation; Good practices in production

Are your records attributable, legible, contemporaneous, original and accurate (ALCOA+) — on paper and electronically?

Schedule M — Documentation; data integrity

If you keep GMP records in computerised systems, are those systems validated, with audit trails and controlled access?

Schedule M — Computerised systems

Are electronic audit trails reviewed at planned intervals?

Schedule M — Computerised systems; data integrity

Materials & suppliers
Are suppliers of starting and packaging materials qualified and approved, with quality agreements where needed?

Schedule M — Materials; supplier qualification

Are incoming materials kept in quarantine until QC has tested them and QA has released them?

Schedule M — Materials

Is every dispensed quantity checked by a second person, on a calibrated balance?

Schedule M — Good practices in production

Is printed packaging material reconciled after every packaging run?

Schedule M — Good practices in production

QC laboratory
Are specifications and test methods approved and version-controlled?

Schedule M — Good practices in quality control

Are QC results reviewed and approved by a second person before a material or batch is released?

Schedule M — Good practices in quality control

Do you run an ongoing stability programme with a defined pull schedule?

Schedule M — Good practices in quality control (stability)

Are instruments calibrated and qualified, and are overdue instruments blocked from use?

Schedule M — Equipment; Good practices in quality control

People, validation & release
Is GMP training planned, recorded and linked to the SOP versions people actually work to?

Schedule M — Personnel

Is process, cleaning and equipment validation planned, documented and kept current?

Schedule M — Qualification and validation

Is batch release done only by authorised QA staff, after reviewing all batch documentation?

Schedule M — Batch release

Get the full report by email

Every gap, the regulation it relates to, what good looks like and where Swat iQua Suite is designed to help — ready to share with your team.

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FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is Revised Schedule M?

Revised Schedule M is India’s updated Good Manufacturing Practice standard for pharmaceutical products, notified in December 2023 and aligned with WHO GMP. It adds a pharmaceutical quality system, quality risk management, product quality review and stronger expectations for validation, data integrity and computerised systems.

Who should answer the questions?

Ideally the QA head with input from QC and production. Answer for one site at a time.

Is the score an official compliance rating?

No. It is a self-assessment to help you prioritise. Inspections are carried out by the CDSCO and state licensing authorities.

What does the full report include?

Your score by area and every gap — with the topic of Schedule M it relates to, what good looks like and where Swat iQua Suite is designed to help.

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