Pharma
GMP (Schedule M / WHO)
Good Manufacturing Practice for pharmaceuticals
The manufacturing practice requirements Indian Schedule M and WHO-GMP inspectors apply to premises, equipment, documentation and quality control.
Typical timeline
Typically 4 to 8 months depending on facility work.
What you end up with
An inspection you walk into with the documentation and qualification evidence already in place.
Who it applies to
Is this your situation?
Formulation and API units facing a revised Schedule M inspection, a WHO-GMP application or an export market requirement.
01Formulation units under revised Schedule M timelines
02API and intermediate manufacturers
03Units applying for WHO-GMP or export registration
How we help
What we actually deliver
Gap assessment of premises and utilities, documentation set including SMF and validation master plan, qualification and validation support, and inspection readiness.
▪Premises, utility and HVAC gap assessment
▪Site Master File and validation master plan
▪Qualification, validation and calibration protocols
▪Inspection readiness and response support