VMP - Validation Master Plan
Validation protocols, records and reports:
Qualification and validation of pharmaceutical production of active pharmaceutical ingredients (API), solid dosage forms (SDF), sterile/non-sterile liquid and lyophilised injections, ointments and vaccines.
Clean rooms and HVAC: HVAC, spaces of grades A-D, isolators, biohazards, laminar boxes, temperature maps
Pure media: production and distribution of WFI – water for injection, PW – purified water, PS – pure steam, other liquids and gases
Technological equipment: steriliser, formulation vessel, reactor, washer and dryer, depyrogenisation tunnel, filling line, sealing and printing machine, lyophiliser, packing and cartoning machine, blowing machine, tabletting and capsulating machine, coating machine, blistering machine, etc.
Product and process validations according to current requirements
Check of validation documentation according to current EU/US regulations.
REGULATIONS MUST NOT BLOCK COMMON SENSE!!!