Raw Material & Excipient Quality Control

Raw Material & Excipient Quality Control performs physical, chemical and toxicological analyses to determine whether the components used in production comply with quality standards. It guarantees quality and safety by preventing inappropriate materials from entering production.

Features

•   Tests Compliant with GMP Standards
•   Raw Material Purity & Chemical Structure Analysis
•   Testing Physical & Chemical Properties (pH, melting point, viscosity etc.)
•   Heavy Metal & Toxic Substance Analysis
•   Batch & Lot Based Material Acceptance and Rejection Management
•   Transaction History & Automatic Notifications

Tests in Accordance with GMP Standards
Verifies the suitability of raw materials by performing tests in accordance with international quality standards. Provides reliable data in audit processes by complying with regulations.

Raw Material Purity & Chemical Structure Analysis
Determines the purity level of raw material components and checks whether their chemical structure is suitable. When low purity levels are detected, the system automatically warns.

Testing of Physical & Chemical Properties (pH, melting point, viscosity etc.)
Protects quality by evaluating the physical and chemical properties of raw materials and additives. When the specified threshold values ​​are exceeded, the system warns and prevents faulty products.

Heavy Metal & Toxic Substance Analysis
Analyzes the heavy metal and toxic substance content of raw materials to be used in the production process. It ensures the creation of safe products by preventing components harmful to human health from entering the production.

Batch & Lot Based Material Acceptance and Rejection Management
Provides traceability by performing quality control tests on each batch and lot basis. It initiates and records automatic rejection process for raw materials found to be inappropriate.

Process History & Automatic Notifications
Records the process history of all quality control tests in detail. In case of critical nonconformities, the system automatically notifies the relevant units and ensures rapid action is taken.

Semi-finished & Finished Product Quality Tests

Semi-finished & Finished Product Quality Tests include critical analyses that verify whether the drugs produced during the production process comply with quality standards. It ensures that safe, effective and regulatory products are introduced to the market by performing physical, chemical, microbiological and packaging controls of the products.

Features

•   Validation of Active Ingredient (API) Ratios
•   Tablet & Capsule Disintegration, Hardness, Weight Variation Tests
•   Analysis of Chemical, Physical & Rheological Properties
•   Packaging & Labeling Quality Control
•   Sterility Tests & Stability Compatibility Analyses
•   Sampling from Mass-Based Production to Quality Control
•   Transaction History & Automatic Notifications

Microbiological Quality Control & Environmental Monitoring

Microbiological Quality Control & Environmental Monitoring includes critical tests to ensure the microbiological safety of products in pharmaceutical and biotechnology production processes. It secures processes by automating analyses to prevent contamination risks, monitor sterile production environments and ensure full compliance with regulations.

Features

•   Microbial Limit Tests
•   Bacterial Endotoxin Test (LAL Test)
•   Sterility Tests (Filtration, Direct Incubation Method)
•   Yeast, Mold & Bacteria Contamination Analysis
•   Environmental Monitoring (Air, Water, Surface & Personnel Hygiene Tests)
•   Microbiology Reporting with LIMS Integration

Microbial Limit Tests
Verify that the microbial load limits specified in the products are not exceeded. It evaluates the compliance of the products with the pharmacopoeias by analyzing the levels of bacteria, yeast and mold.

Bacterial Endotoxin Test (LAL Test)
Detects pyrogenic (fever-causing) endotoxin contamination in parenteral drugs and biotechnological products. Provides early detection of toxins that pose a risk to human health.

Sterility Tests (Filtration, Direct Incubation Method)
Tests whether products are microbiologically free from contamination in sterile production processes. Filtration and direct incubation methods are used to verify sterility compliance.

Yeast, Mold & Bacteria Contamination Analysis
Analyzes microbial contamination risks in food, pharmaceutical and cosmetic products. It is a critical process to ensure that the microbiological safety of products is maintained throughout their shelf life.

Environmental Monitoring (Air, Water, Surface & Personnel Hygiene Tests)
Includes microbiological controls for air, water, surface and personnel hygiene in the production environment. Provides continuous monitoring to evaluate the effectiveness of cleaning procedures and to detect contamination sources in advance.

Microbiology Reporting with LIMS Integration
Digitalizes all stages of microbiological analysis and provides automatic reporting. Integration with Laboratory Information Management System (LIMS) ensures that data is stored on a central platform and audit processes are accelerated.

Document Management & Regulation Compliance

Document Management & Regulation Compliance ensures that all documentation required in quality control processes is managed digitally. It meets audit standards such as FDA, PIC/S by offering full compliance with international regulations. It provides data integrity and traceability while accelerating audit processes.

Features

•   Compliance with Regulations
•   Electronic Record & Digital Signature (21 CFR Part 11 Compliant)
•   Certificate Management (COA - Certificate of Analysis)
•   Internal & External Audit Process Management
•   CAPA (Corrective & Preventive Actions) Monitoring
•   Training & Quality Certification Management

Compliance with Regulations
Meets the quality standards of international authorities by fully complying with regulations. Ensures that products meet all requirements before being released to the market.

Electronic Record & Digital Signature (21 CFR Part 11 Compliant)
Provides paperless processes with digital signature and electronic record management. Protects data integrity by accelerating authorization and approval processes and increases reliability in audits.

Certificate Management (COA)
Provides the creation and management of certificates verifying analysis results. COA documents are automatically generated through the system, providing quick access to customers and authorized authorities.

Internal & External Audit Process Management
Digitalizes audit processes and stores all data needed by auditors in a central system. Saves time in internal and external audits and facilitates compliance tracking.

CAPA (Corrective & Preventive Actions) Tracking
Starts automatic CAPA processes when nonconformities, deviations or quality errors are detected. Creates action plans to prevent recurrence of errors by retrospective tracking.

Training & Quality Certification Management
Manages personnel training processes for compliance with quality standards. Ensures that employees comply with current regulations and procedures by following certification processes.

Reporting & Integration

Reporting & Integration analyzes data obtained from quality control processes and creates reports suitable for audits. Optimizes processes with real-time data tracking and advanced integration options, and provides full compatibility with ERP and other systems.

Features

•   Real Time Quality Control Reports
•   Digital Tracking & Archiving of Test Results
•   Automatic Trend Analysis & Risk Assessments
•   Analytics for Recall Scenarios
•   LOGO ERP, SAP, MES, LIMS, SCADA, WMS Integration
•   Transaction History & Automatic Notifications