Qualification and validation

Preparation and development of qualification and validation documentation at all levels.

VMP - Validation Master Plan

Risk analysis

Validation protocols, records and reports:

• DQ – Design Qualification
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance Qualification
• PV – Process Validation
• CV – Cleaning Validation

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.

QUALIFICATION:

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.

PROCESS VALIDATION:

Product and process validations according to current requirements

• Cleaning validation
• Validation of aseptic filling (media fill)
• Special validation of sterile production (tightness of containers, microbial retention during sterile filtration, visual inspection, etc.)
• Validation of "holding time"

Check of validation documentation according to current EU/US regulations.