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Production & Process Control - Coggle Diagram
Production & Process Control
General Production Requirement
Written procedures placed to ensure product identity, strength, quality & purity
procedures must be followed & documented in real time
Deviations recorded; critical deviations investigated & documented
In-process controls & testing must ensure batch uniformity & integrity
Equipment must be properly cleaned, maintained & sanitized to prevent contamination/failure
Formal change control system must evaluate changes affecting production/control
Before Starting Production (Area & Line Clearances)
SOPs & documents are current & correct, obsolete batch documents are removed
raw materials, intermediates & packaging components are properly identified & within expiry
correct equipment & lines selected; equipment is cleaned, calibrated, operational & changeover completed if required
all prior deviation have been addressed & resolved
After Production (Production Record Review)
all production & control records are reviewed & approved by QA prior to batch release/distribution
review confirms product was manufactured as intended
process aligned with GMP & GDP requirements
all deviations/non-conformances are thoroughly investigated, includes rated batches in accordance with company procedures
Equipment Cleaning & Maintenance
Cleaned, maintained & sanitized at appropriate intervals to prevent malfunctions/contamination
Cleaning
: Removal of product residues to prevent cross-contamination, eliminate microbial nutrient sources, use of soaps & collection of rinse & swab samples for testing
Sanitization (NOT sterilization):
Reduction of microbial levels on equipment surfaces using thermal/chemical sanitizing agents; applied to water utility systems
Clean In Place (CIP)
system for cleaning quipment in assembled state (eg. vessels & tanks)
cleaning solutions & rinse water circulated/passed through system once-through
ensure consistent & reproducible removal of product/media residues & cleaning agents, finalized by WFI rinse
Typical CIP Cycle
Pre-rinse with PW/WFI
Caustic wash with KOH
Rinse with PW/WFI
Acid wash with phosphoric acid
Rinse with PW/WFI
Final rinse with hot PW/WFI
Air blow
Clean Out of Place (COP)
used for cleaning parts & systems that require disassembly/removal (eg. flexible hose, end caps)
can be manual/auto
precautions taken to minimize envi exposure, cross-contamination & personnel interference
COP washer: automated COP system
used for cleaning disassembled smaller parts & fittings
follows same stages as CIP cycle
equipped with jet sprays at multiple locations in wash chamber to create turbulent flow & thorough mixing
CIP or COP
Advantages of CIP over COP
eliminate envi & personnel exposure to contaminants
improves cleaning consistency & reproducibility
doesn't require equipment shutdown/disassembly, maintaining manufacturing efficiency
Maintenance
Equipment Maintenance
SOP includes: Responsibilities of personnel, maintenance schedules, methods, equipment & materials used for maintenance
Preventive Maintenance
time-interval maintenance
based on calendar time/equipment running hours
intervals based on average deterioration rate
All production & related equipment certified by accredited bodies to ensure ongoing accuracy
ensure equipment remains in optimal condition
documents all maintenance activities
Predictive Maintenance
condition-based maintenance
based on equipment conditions
project trends from condition monitoring techniques to determine trouble-free service life of equipment
Calibration Standards
all production equipment used for data recording calibrated
newly changed/repaired instruments calibrate before use
inclusion & exclusion list maintained & quality approval
standards for inspection must eb traceable to nation/international standards
Guidelines
critical: affect product quality - calibrated every 6 months
non-critical: no direct impact on product quality - calibrated every 12 months
Records
equipment identification
-calibration dates
individual performing each calibration
next calibration date