Pharmaceutical CCPs
Raw Material Receiving and Quality Inspection
- Control Point: Ensure all incoming raw materials meet safety, quality, and regulatory standards (e.g., purity, potency).
- InterlinkIQ Feature: Supplier management module tracks incoming shipments, inspections, and testing results for contaminants and compliance with pharmacopoeial standards.
- Monitoring: Automated tracking of inspection data and test results through InterlinkIQ’s material verification system.
- Critical Limit: Raw materials must comply with established quality and regulatory criteria, managed through InterlinkIQ’s quality control module.
Storage of Raw Materials
- Control Point: Maintain optimal storage conditions to prevent degradation, contamination, or loss of potency.
- InterlinkIQ Feature: Storage monitoring module tracks real-time temperature, humidity, and environmental conditions in storage areas.
- Monitoring: Continuous monitoring with automated alerts for temperature, humidity, or contamination deviations through InterlinkIQ’s environmental control system.
- Critical Limit: Storage conditions must adhere to specified temperature and humidity ranges, managed through InterlinkIQ
Weighing and Dispensing
- Control Point: Ensure accurate weighing and dispensing of raw materials to maintain formulation integrity.
- InterlinkIQ Feature: Weighing and dispensing control module tracks equipment calibration, operator procedures, and weighing accuracy.
- Monitoring: Real-time monitoring of weighing processes and logging through InterlinkIQ’s dispensing control system.
- Critical Limit: All weights must be within specified tolerances, verified through InterlinkIQ’s monitoring system.
Manufacturing Process Control
- Control Point: Monitor critical process parameters during manufacturing to ensure product quality and compliance.
- InterlinkIQ Feature: Process control module tracks temperature, pressure, and mixing times in real time during production.
- Monitoring: Continuous logging of manufacturing conditions, with alerts for deviations through InterlinkIQ’s manufacturing control system.
- Critical Limit: Process parameters must meet established specifications for product safety and efficacy, managed through InterlinkIQ.
Granulation and Drying
- Control Point: Control granulation and drying processes to ensure product uniformity and stability.
- InterlinkIQ Feature: Granulation control module monitors temperature, humidity, and granulation time, ensuring compliance with product specifications.
- Monitoring: Continuous monitoring of drying conditions with automated alerts for any deviations through InterlinkIQ’s drying control system.
- Critical Limit: Granulation and drying parameters must meet defined limits, verified through InterlinkIQ’s process tracking.
Compression and Coating
- Control Point: Ensure proper compression and coating processes to maintain tablet integrity and release profiles.
- InterlinkIQ Feature: Compression and coating module tracks machine performance, process parameters, and coating application rates.
- Monitoring: Real-time monitoring of compression and coating processes, logged through InterlinkIQ’s production control system.
- Critical Limit: Compression and coating parameters must meet product specifications, verified through InterlinkIQ’s system.
Quality Control and In-Process Testing
- Control Point: Conduct quality control testing during production to ensure compliance with specifications.
- InterlinkIQ Feature: Quality control module tracks in-process testing for key attributes such as potency, dissolution, and uniformity.
- Monitoring: Automated tracking of test results with real-time alerts for deviations via InterlinkIQ’s quality assurance system.
- Critical Limit: All quality control tests must meet specified criteria, managed through InterlinkIQ’s quality module.
Packaging and Labeling
- Control Point: Ensure proper packaging and labeling to prevent contamination and ensure accurate information.
- InterlinkIQ Feature: Packaging control module monitors packaging integrity, labeling accuracy, and compliance with regulatory requirements.
- Monitoring: Automated monitoring of packaging processes with real-time alerts for defects or compliance issues, logged through InterlinkIQ’s packaging control system.
- Critical Limit: Packaging and labeling must meet established regulatory standards, managed through InterlinkIQ’s system.
Final Product Testing
- Control Point: Ensure finished pharmaceutical products meet safety, efficacy, and quality standards.
- InterlinkIQ Feature: Finished product testing module tracks microbial, potency, stability, and quality tests for finished products.
- Monitoring: Automated tracking of test results and real-time alerts for deviations through InterlinkIQ’s product testing system.
- Critical Limit: Finished products must pass all safety and quality tests, managed through InterlinkIQ’s testing module.
Traceability and Recall Procedures
- Control Point: Ensure full traceability of all raw materials and finished pharmaceutical products.
- InterlinkIQ Feature: Traceability module tracks batch numbers, supplier details, production data, and testing results in real time.
- Monitoring: Continuous traceability logged via InterlinkIQ’s system, ensuring quick and compliant recall management when necessary.
- Critical Limit: 100% traceability is required, with all data captured in InterlinkIQ’s recall and traceability system.