Raw Material & Additive Management

Detailed management of components such as active substances (API), auxiliaries, excipients and additives used in product formulation is provided. Purity levels, concentration levels and supplier approval processes of raw materials are monitored to ensure compliance with quality standards. With potency management, the effectiveness of the components is calculated and precise dosage adjustments are made in formulation processes.

Features

•   Raw Material & Excipient Identification
•   Purity and Concentration Management of Ingredients
•   Potency Management
•   Supplier Approval and Certification Processes
•   Alternative Product Identification for Critical Materials
•   Toxicology and Side Effect Evaluations
•   Raw Material Stock Integration
•   Transaction History & Notifications

Raw Material & Excipient Identification
All raw materials and excipients are defined in detail in the system. Components are classified and tracked according to their suitability for pharmaceutical use.

Purity and Concentration Management of Ingredients
Purity levels and concentration levels of active ingredients are kept under control. Each ingredient to be used in production is tested for suitability and included in the formulation.

Potency Management
The effectiveness of each ingredient is calculated and integrated into the formulation processes. Dosage adjustments are optimized by making potency calculations for API and excipients. Variations resulting from purity differences are automatically taken into account by the system and recipe processes are updated.

Supplier Approval and Certification Processes
Raw materials are supplied only from approved suppliers. Certification processes are managed to ensure the quality compliance of each component.

Alternative Product Definition for Critical Materials
Alternative components can be defined for critical raw materials used in production, thus enabling rapid adaptation to supply problems or formulation changes.

Toxicology and Side Effect Assessments
Toxicological profiles of raw materials are examined and safety assessments are made. Potential side effects are determined and taken into account in formulation processes.

Raw Material Stock Integration
Raw material inventory is integrated with the system and stock tracking is automated. When critical stock levels are determined, instant alerts are sent to ensure uninterrupted material supply.

Transaction History & Notifications
All raw material management processes are recorded and past transactions are made traceable. With automatic notifications, relevant units are informed about supply status and quality controls.

Manufacturing Process & Process Definition

Critical stages such as granulation, tableting, encapsulation and sterile production in production processes are systematically defined. Process conditions, equipment management and quality control processes are integrated to ensure that production processes are carried out with precision and reliability. Production efficiency is increased and the margin of error is minimized thanks to full integration with machinery and equipment.

Features

•   Production Methods & Process Steps
•   Granulation, Tableting, Coating, Sterile Production Management
•   Determination of Process Conditions and Critical Parameters
•   Machinery & Equipment Integration (SCADA, IoT)
•   Automatic Production Instructions (Master Batch Record - MBR)
•   Sampling Plans Integrated with Quality Control
•   Transaction History & Notifications

Production Methods & Process Steps
The methods applied in the production process are determined and each stage is defined in detail. Process steps are managed in a specific order to ensure consistency.

Granulation, Tableting, Coating, Sterile Production Management
Different production techniques are defined in the system and the most appropriate method is determined for each formulation. Processes such as granulation, coating, sterile production and tableting are recorded and controlled.

Determination of Process Conditions and Critical Parameters
During production, critical process parameters such as temperature, humidity, pressure and time are defined in the system and made traceable. By keeping these parameters under control, standardization of processes is ensured.

Machinery & Equipment Integration (SCADA, IoT)
SCADA and IoT systems are integrated with production machines to provide instant data flow. Production processes can be continuously monitored with machine performance data and error analysis.

Automatic Production Instructions (Master Batch Record - MBR)
Automatic work instructions for production processes are created to guide employees. Recipe and process steps are executed automatically thanks to Master Batch Record (MBR) management.

Sampling Plans Integrated with Quality Control
Quality control processes are integrated by applying sampling plans at critical points determined during production. Error rates in production processes are minimized with quality analyses.

Transaction History & Notifications
All production processes are recorded and a transaction history is created. With automatic notifications, relevant units are instantly informed and processes are followed up.

Stability & Durability Tests

The shelf life of the products, their resistance to environmental conditions and long-term stability processes are managed at this stage. Stability tests are planned in accordance with ICH (International Council for Harmonization) guidelines and it is evaluated whether the products maintain their effectiveness under the specified storage conditions. This process is carried out in an integrated manner with quality assurance systems, ensuring full compliance with regulations.

Features

•   Stability Test Management
•   Accelerated & Long Term Stability Studies
•   Test Planning According to Climatic Conditions
•   Stability Sample Management & Test Reports
•   Batch Based Shelf Life Tracking
•   Formulation Updates Based on Stability Results
•   Transaction History & Notifications

Stability Test Management
Stability protocols are prepared in line with the guidelines within the scope of GMP regulations and long-term and accelerated stability studies of the products are carried out.

Accelerated & Long-Term Stability Studies
Product shelf life is verified by performing accelerated and long-term stability tests under different temperature and humidity conditions.

Test Plans According to Climatic Conditions
Stability plans appropriate to the climatic zones determined according to ICH are created and the stability of the products in different geographies is evaluated.

Stability Sample Management & Test Reports
Sampling processes, storage conditions and analysis results are systematically monitored. Test results are reported to provide feedback to formulation processes.

Batch-Based Shelf Life Tracking
Separate stability data is kept for each production batch and updates are made regarding shelf life. Product recall processes are accelerated when necessary by providing batch-based traceability.

Formulation Updates Based on Stability Results
Stability test results are evaluated and necessary changes are made to the formulation components. Recipe revisions are managed through the system to increase product stability.

Transaction History & Notifications
All stability test processes are recorded and a transaction history is created. Quality and R&D teams are informed about test results with automatic notifications.

Regulation and Compliance Management

This module ensures that formulation processes comply with international standards such as GMP, FDA, EMA, ICH, PIC/S and ISO, and guarantees quality and reliability in pharmaceutical production. Electronic record systems, digital approval mechanisms and critical process controls are managed in an integrated manner to ensure full compliance with regulations.

Features

•   GMP, FDA, EMA & ICH Regulations Compliance Management
•   Electronic Recording & Digital Approval Mechanisms (21 CFR Part 11)
•   Critical Process Parameters (CPP) & Quality Control Management
•   Internal Audit and Review Processes
•   Change Controls on Formulation
•   Authorization & Digital Signature Management
•   Transaction History & Notifications

GMP, FDA Regulations Compliance Management
Production and formulation processes are planned in line with international regulations and full compliance with standards is ensured. Quality requirements are systematically monitored during product development and production stages.

Electronic Record & Digital Approval Mechanisms (21 CFR Part 11)
All processes are tracked digitally with electronic record management in accordance with the requirements of 21 CFR Part 11. A secure and auditable record system is created by applying digital signature mechanisms for authorized users.

Critical Process Parameters (CPP) & Quality Control Management
Critical process parameters (CPP) in production processes are determined and integrated with quality control processes. Quality assurance processes are optimized with continuous monitoring and data analysis.

Internal Audit and Review Processes
Internal audit processes are managed digitally and production and formulation records are reviewed at regular intervals. When necessary, non-conformance detections are reported and necessary actions are taken.

Formulation Change Controls
Changes made in formulation processes are recorded and all version histories are made traceable. The compliance of changes with regulations is checked and reflected in production processes.

Authorization & Digital Signature Management
User authorizations are determined for all transaction steps within the system. Approval mechanisms in critical processes are secured with digital signature management.

Transaction History & Notifications
All regulation and compliance processes are recorded in the system and a transaction history is created. Quality, production and R&D teams are informed about updates with automatic notifications.

Reporting & Integration

Comprehensive reporting and integration management are provided to increase traceability of formulation processes, evaluate production efficiency and optimize quality control processes. Thanks to full integration with systems such as ERP, MES, LIMS and SCADA, formulation data is analyzed instantly and rapid feedback is provided to operational processes. With electronic scale integration, weighing data is automatically recorded, ensuring full compatibility with recipes and production processes.

Features

•   Product Formulation Reports
•   Production & Process Performance Analysis
•   ICH Stability Test Results Reports
•   GMP & Regulation Compliance Analysis
•   Supply Chain & Raw Material Usage Reports
•   ERP, MES, LIMS, SCADA & Electronic Scale Integration
•   Transaction History & Notifications

Product Formulation Reports
All components, recipe details and change histories of the formulation processes are analyzed and reported.

Production & Process Performance Analyses
Process data is monitored at every stage of the production process and performance analyses are created. Detailed evaluations are made for critical production stages.

ICH Stability Test Results Reports
Data from ICH Q1A-F stability tests are recorded and long-term and accelerated test results are analyzed.

GMP & Regulation Compliance Analyses:
Conformity reports to international standards such as GMP, FDA, EMA and ICH are created to facilitate audit processes.

Supply Chain & Raw Material Usage Reports
Raw material consumption, supplier performance and stock levels are analyzed to optimize supply chain processes.

ERP, MES, LIMS, SCADA & Electronic Scale Integration
Data flow is provided by working integrated with enterprise resource planning (ERP), production management (MES), laboratory information management (LIMS), production automation (SCADA) systems and electronic scales. Weighing data is transferred directly to the system, synchronized with recipes and production processes, and measurement errors are minimized.

Transaction History & Notifications
All reporting processes are recorded and historical data is accessed. With automatic notifications, managers are instantly informed about critical changes and process analysis.