Professional Documents
Culture Documents
EQUIPMENT
SCOPE – TO PERFORM IMPACT ASSESSMENT
AGENDA
Qualificatio
VMP Validation
n
VMP – FORMAT AND CONTENT
• THE CORE OF THE VMP BEING THE LIST/INVENTORY OF THE ITEMS TO BE VALIDATED AND
THE PLANNING SCHEDULE
VALIDATION Equipment
Analytical ❌ ❌ ✔ ❌
TEAM Methods
MEMBERSHIP Process
Cleaning
✔
✔
✔
✔
✔
✔
✔
✔
Methods
Computerized ✔ ✔ ✔ ✔
Systems
QUALIFICATION FRAMEWORK: V-MODEL
change monitor
• FACTORY ACCEPTANCE TESTING (FAT)
EQUIPMENT, ESPECIALLY IF INCORPORATION NOVEL OR
COMPLEX TECHNOLOGY, MAY BE EVALUATED, IF APPLICABLE, AT
FAT AND SAT THE VENDOR PRIOR TO DELIVERY.
Purpose
Change Control
• Changes resulting from IQ must be documented in the
Validation Report
• Commissioning changes are not (supplier
responsibility)
IQ/OQ/PQ can be applied for
DO WE USE both new and legacy
THE SAME equipment.
• For legacy equipment, DQ can be
APPROACH – replaced by a design
DQ, IQ, OQ, PQ review/installation review (depending
– FOR NEW on availability of relevant
documentation, e.g. equipment
AND LEGACY instruction and operational manuals,
EQUIPMENT? purchase orders and supplier
quotations).
Direct Impact
• Equipment which is product contact, or which
controls or maintains a critical process parameter, or
both.
Indirect Impact
IMPACT • Equipment which is not product contact, but which
ASSESSMENT has an impact on the performance or operation of
direct impact equipment.
No Impact
• Equipment which is not product contact, does not
impact on the performance or operation of direct or
indirect impact equipment.
SAMPLE QUALIFICATION MATRIX
IMPACT HIGH MEDIUM LOW
BASED ON DIRECT IMPACT IQ OQ PQ IQ OQ PQ IQ OQ
PROBABILITY AND INDIRECT IMPACT IQ OQ PQ IQ OQ IQ
CONSEQUENCE
NO IMPACT NOT POSSIBE NOT POSSIBLE COMMISSION ONLY
ICH Q8 – Critical
• A physical, chemical, biological, or
microbiological property or
PHARMACEUTICAL Quality characteristic that should be within
Attribute an appropriate limit, range, or
DEVELOPMENT (CQA) distribution to ensure the desired
product quality.
• A physical, chemical or
Critical microbiological property or
characteristic of an input material
Material that should be within an appropriate
Attribute limit, range, or distribution to ensure
(CMA)* the desired quality of output material.
• *CMA is not defined in ICH Guidance
WHEN IS A PROCESS PARAMETER A
CPP?
CPP
A PROCESS PARAMETER IS CRITICAL WHEN IT HAS A HIGH IMPACT ON A
Impact on CQA
CQA.
PP
• CPP’S ARE RESPONSIBLE FOR ENSURING THE RIGHT CQA
• CPP’S ARE IDENTIFIED FROM A LIST OF POTENTIALS CPP’S USING RISK
ASSESSMENT AND EXPERIMENTAL WORK
Operation Process Parameters Product Attributes
SAMPLE
Impeller and chopper speed
Wet massing time
PARAMET
Temperature and RH of drying air Solvent residue
Volume/flow rate of drying air
Drying time
SAMPLE
Temperature
Dissolution of non- Mixing time and speed Appearance of solution
PROCESS
active compounds Temperature Viscosity
Specific gravity
pH
RS (LIQUID Viscosity
Specific gravity
pH