OTC CCPs

Raw Material Receiving and Quality Inspection

Control Point: Ensure all incoming raw materials (e.g., active ingredients, excipients) meet safety, quality, and regulatory standards.
InterlinkIQ Feature: Supplier management module tracks incoming shipments, certifications, and testing results for compliance with regulatory standards (e.g., GMP, USP).
Monitoring: Automated tracking of inspection data, certificates of analysis, and test results through InterlinkIQ’s material verification system.
Critical Limit: Raw materials must meet all specified safety and quality requirements, with data managed through InterlinkIQ’s quality control module.

Control Point: Maintain optimal storage conditions to preserve raw material potency and prevent contamination.
InterlinkIQ Feature: Storage monitoring module tracks real-time temperature, humidity, and environmental controls in storage areas.
Monitoring: Continuous monitoring with automated alerts for deviations in storage conditions (e.g., temperature, humidity) via InterlinkIQ’s environmental control system.
Critical Limit: Storage conditions must meet specified ranges for temperature, humidity, and other environmental parameters, managed through InterlinkIQ.

Control Point: Ensure that active ingredients and excipients are mixed uniformly to meet formulation standards.
InterlinkIQ Feature: Process monitoring module tracks mixing times, speeds, and equipment performance to ensure uniformity.
Monitoring: Real-time monitoring of mixing and blending efficiency, logged through InterlinkIQ’s batch control system.
Critical Limit: Mixing parameters must meet defined limits to ensure product consistency, verified through InterlinkIQ’s system.

Control Point: Ensure granulation process achieves proper particle size and moisture content for tablet production or other solid dosage forms.
InterlinkIQ Feature: Granulation control module tracks particle size, moisture content, and processing parameters in real time.
Monitoring: Continuous monitoring of granulation conditions through InterlinkIQ’s system, ensuring that granulation parameters are within defined specifications.
Critical Limit: Granulation parameters must meet product formulation and quality standards, managed through InterlinkIQ.

Control Point: Ensure that tablets are compressed to meet hardness, weight, and uniformity standards.
InterlinkIQ Feature: Compression and tableting module tracks tablet weight, hardness, thickness, and machine settings.
Monitoring: Real-time tracking of compression parameters and tablet quality, with alerts for deviations, managed through InterlinkIQ’s tablet control system.
Critical Limit: Tablets must meet all critical quality attributes (CQAs), verified through InterlinkIQ’s system.

Control Point: Ensure tablet coatings meet thickness, color, and uniformity requirements without affecting drug release.
InterlinkIQ Feature: Coating process control module tracks coating application, spray rates, and uniformity in real time.
Monitoring: Continuous logging of coating conditions and quality checks via InterlinkIQ’s coating control system.
Critical Limit: Coating parameters must meet predefined quality and safety limits, managed through InterlinkIQ’s process control.

Control Point: Ensure correct filling, labeling, and packaging to prevent contamination and ensure accurate dosing.
InterlinkIQ Feature: Packaging control module monitors fill volume, label accuracy, and seal integrity in real time.
Monitoring: Automated monitoring of packaging processes, with real-time alerts for defects or incorrect fills, logged through InterlinkIQ’s packaging control system.
Critical Limit: Packaging must meet quality, safety, and regulatory standards (e.g., tamper-evident seals), managed through InterlinkIQ’s packaging integrity system.

Control Point: Ensure finished products are free from metal contaminants.
InterlinkIQ Feature: Metal detection control module tracks detector calibration, operation, and performance to prevent contamination.
Monitoring: Continuous tracking of metal detection systems with real-time alerts for any anomalies through InterlinkIQ’s metal detection monitoring system.
Critical Limit: No metal contamination should be detected, verified through InterlinkIQ’s system

Control Point: Ensure finished OTC products meet microbial safety, potency, and quality standards.
InterlinkIQ Feature: Finished product testing module tracks microbial, potency, and quality tests, ensuring compliance with regulatory requirements.
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 specified tests for safety, potency, and quality, managed through InterlinkIQ’s testing module.

Control Point: Prevent cross-contact with allergens or other substances during production.
InterlinkIQ Feature: Allergen management module tracks cleaning validation, equipment segregation, and allergen testing procedures.
Monitoring: Continuous monitoring of allergen control measures, with real-time alerts for deviations via InterlinkIQ’s allergen tracking system.
Critical Limit: No cross-contact with allergens, verified through InterlinkIQ’s system, ensuring compliance with allergen management protocols.

Control Point: Ensure full traceability of all raw materials and finished OTC products for regulatory compliance.
InterlinkIQ Feature: Traceability module tracks batch numbers, supplier details, production data, and distribution in real time.
Monitoring: Continuous traceability and real-time data logging via InterlinkIQ’s system, ensuring rapid recall procedures if necessary.
Critical Limit: 100% traceability is required, with all data captured in InterlinkIQ’s recall and traceability system for compliance.