validation

Process Validation

Mikhak  offers expert associates to contribute to your Process Validation needs from the early stages of product development through its maturity. We setup and monitor your company’s Process Validation programs. This could potentially save your company years in time to approve your product.

Below lists a highlight of our strength in the area of Process Validation:

  • Process Validation Master Plans
  • Critical Parameter selection and studies
  • Methods validation and QC support functions
  • Protocols and Reports
  • Complete description of the process , and identify subjective criteria used to evaluate the product
  • Statistical methods and tools for process validation
    • Control charts
    • Capability studies
    • Tolerance/ Effects analysis
    • Robust design methods
    • Failure modes
    • Sampling plans
    • Mistake proofing
  • Protocol development (IQ / OQ / PQ)
    • Determine what and how to verify/measure
    • Determine how many to verify/measure, i.e. statistical significance
    • Determine when to verify/measure
    • Define acceptance/rejection criteria &required documentation
  • Monitor and control
    • Changes in process and/or product & State of control
    • Use historical data in process validation

 

 

Equipment Validation

Mikhak Equipment Validation Services Team utilizes their vast technical & regulatory knowledge & appropriate resources to quickly and reliably complete protocols that are thorough and aligned with your standards and are defendable. We pride ourselves in providing Equipment Validation Services for the following:

  • Purification skids
  • API or final product mixing tanks
  • API or final product refrigerators or freezers
  • Stability sample refrigerators, freezers, and incubators
  • Cell banking freezers
  • Filtration systems
  • Fermentors
  • Equipment steaming cycles
  • Autoclave load cycles
  • Environmental control systems including chambers/stability rooms & HVAC systems
  • Building Management Systems (BMS) such as Metasys
  • Clean rooms and temperature/humidity/differential pressure control systems
  • Plant utility systems including water-for-injection (WFI), deionized water (DI), steam systems, compressed air systems, alcohol systems, and nitrogen systems
  • Blenders, mixers, granulators, milling machines, dryers, drying rooms, metal detectors, emulsifier, steam kettles, pumps, fluid bed processors, weighing systems, tablet coating systems, tablet presses, and encapsulators
  • Temperature mapping of ovens/dryers, drying rooms, cool/cold storage rooms
  • Sterile/Biotech equipment/systems including lyophilizers, sterile/bioreactors, filter systems, filter integrity test systems, pressure/temperature controls
  • Bulk pharmaceutical manufacturing equipment trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls & automated sequences
  • Packaging lines including bar code verification systems, bottle unscramblers, inspection machines, heat sealers, labelers, pouch dispenser, and shrink bundlers

 

Equipment Installation Qualification (IQ)

  • Equipment System Details, Components and Design Features
  • Instrumentation
  • Utilities (Inputs & Discharges)
  • Operating / Cleaning / Maintenance / Calibration programs
  • System drawings / Spare Parts List (Critical & Normal)

Equipment Operational Qualification (OQ) & Performance Qualification (PQ)

  • Range of design/operating parameters
  • Operating /Testing procedures & Sampling Plan
  • Equipment Utilization List
  • Product & Commodity Utilization List
  • Test Protocol