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Overview
Complete
Process Validation Report Template
21 May 2019 / PharmaSafe Manufacturing, Inc. / Camilla Moralez
Created actions
2
Manufacturer
PharmaSafe Manufacturing, Inc.
Manufacturing Facility
3784 Benedum Dr., VA 23219
Equipment/System
Direct Compression
Protocol Author
Camilla Moralez
Conducted on

21st May, 2019

12:18 PM +08

Actions
2
Process Validation Report Template
2
Equipment Criticality & Risk Assessment
Mixing Tanks
Direct Impact
Photos
Risk Priority
High
Raw Material and Consumable Refrigerators and Freezers
Indirect Impact
Risk Priority
Medium
Toxic Gas Detectors
Safety Impact
Photos
Risk Priority
Medium
Pipettes
No Impact
Risk Priority
Low
Product Transfer Pumps
Direct Impact
Risk Priority
High
Unfiltered HVAC System
Indirect Impact
Risk Priority
Low
Dust Extraction
Safety Impact
Risk Priority
Medium
Trolleys
No Impact
Photos
Risk Priority
Low
Laminar Flow and Safety Cabinets
Direct Impact
Risk Priority
Medium
Safety Barriers
Safety Impact
Risk Priority
Low
Scissors/Clamps
No Impact
Risk Priority
Low
Emergency Stops
Safety Impact
Risk Priority
Low
Retort Stands
No Impact
Risk Priority
Low
Product Storage Refrigerators and Freezers
Direct Impact
Risk Priority
High
Personal Protection Equipment
Safety Impact
Photos
Risk Priority
Low
Filling Equipment
Direct Impact
Photos
Risk Priority
High
Production Balances
Indirect Impact
Risk Priority
High
Autoclaves
Direct Impact
Risk Priority
High
Centirfuges
Indirect Impact
Risk Priority
High
Fire Suppression Systems
Safety Impact
Risk Priority
Medium
Process Water Generators
Direct Impact
Photos
Risk Priority
High
Automated Cleaning Equipment
Indirect Impact
Risk Priority
Medium
Filtered HVAC Systems
Direct Impact
Risk Priority
Medium
Manual Cleaning Equipment
No Impact
Risk Priority
Low
Qualification Protocol
2
Process(es) subject to process validation
Mixing
Filling
Tableting
Release
Photos
Environmental requirements
Temperature
Humidity
Actions
To do
Add waste management requirement
Utilities supply
Electricity
Clean steam boiler
Compressed air
Nitrogen
SOPs available
Operation
Disaster Recovery
Cleaning
Actions
To do
Formulate Preventive Maintenance SOP
Qualification Protocol / Calibration Equipment
Qualification Protocol / Calibration Equipment / Calibration Equipment 1
Apparatus/Instrument
Materials testing machine
Calibration Method
Force in the tensile direction (0.02 N - 3,000 kN)
Calibration Date

10th Apr, 2019

12:27 PM +08

Qualification Protocol / Calibration Equipment / Calibration Equipment 2
Apparatus/Instrument
Pendulum impact tester
Calibration Method
Force in the compression direction (0.002 N - 5,000 kN)
Calibration Date

22nd Apr, 2019

12:31 PM +08

Qualification Protocol / Calibration Equipment / Calibration Equipment 3
Apparatus/Instrument
Brinell hardness tester
Calibration Method
Ball indentation
Calibration Date

9th May, 2019

12:32 PM +08

Qualification Protocol / Results
Qualification Protocol / Results / Results 1
Control Point/Alarm
Lubrication blend time: 34 - 46 min
Output
Uniform dosage units
Calibration
Tensile direction 1,436 kN
Qualification Protocol / Results / Results 2
Control Point/Alarm
Compression dwell time: 0.53 - 0.78 ms
Output
Conforming tablet core disintegration and dissolution
Calibration
Compression direction 3,754 kN
Qualification Protocol / Results / Results 3
Control Point/Alarm
Mill screen size 17 - 26 mm
Output
Conforming granule compactibility and particle size distribution
Calibration
N/A
Qualification Protocol / Acceptance Criteria Vs. Performance Test Results
Qualification Protocol / Acceptance Criteria Vs. Performance Test Results / Acceptance Criteria Vs. Performance Test Results 1
Criteria
A specific, stability-indicating procedure should be included to determine the content of the new drug substance. In many cases it is possible to employ the same procedure (e.g., HPLC) for both assay of the new drug substance and quantitation of impurities.
Result
Acceptable assay and impurity levels
Decision
Pass
Photos
Area(s) of Deviation
Specification
Qualification Protocol / Deviations
Qualification Protocol / Deviations / Deviations 1
Requirement/Order
Perform Factory Acceptance Test
Actual
Factory Acceptance Test not performed
Deviation
User Requirements Specification and Purchase Order
Justification for Acceptance
PharmaSafe Quality Assurance Manager performed Site Acceptance Test with Supplier Representative
Impact on Operation, Function, or Process
Negligible
Completion
Qualification Protocol Results
All acceptance criteria have been meet according to qualification protocol and all deviations resolved.
Conclusions on the validity of the equipment/system
Qualification of direct compression as per qualification protocol has been completed for the routine commercial production for a new formula.
Production Officer Name & Signature
Julian Rodrigo
21st May, 2019 2:29 PM +08
Validation Manager Name & Signature
Camilla Moralez
21st May, 2019 2:29 PM +08
Head of Quality Assurance Name & Signature
Shine Obligacion
21st May, 2019 2:30 PM +08
Media summary
22 Media files