Quality Control

To ensure compliance with the highest quality standards, InterChem SLC operates a well-coordinated and comprehensive quality system—including GMP compliance, multi-level quality control, and risk management. Each level is supported by qualified personnel, specialized facilities, modern equipment, and advanced technical resources. The company has also completed validation of technological processes, qualification of premises and equipment, and validation of analytical and microbiological methods.

These rigorous multi-tier measures are in place for one reason—to guarantee quality.

The InterChem SLC quality system ensures that:

• All medicines are developed and studied in accordance with GMP requirements.

• Manufacturing operations and control methods are properly documented and fully compliant with GMP.

• All incoming raw materials, excipients, packaging materials, intermediates, and production processes undergo strict incoming inspection.

• Finished products are manufactured according to GMP and tested per approved quality specifications.

• Ongoing procedures guarantee product quality throughout the entire shelf life.

• Regular self-inspections and audits evaluate the efficiency of the quality system at all levels.

By purchasing InterChem SLC products, every consumer can be confident—these medicines are designed to restore health, not harm it.

Quality control is an integral part of Good Manufacturing Practice. It involves sampling, specifications, testing, documentation, and release authorization for each batch of medicinal product—ensuring that no materials are used and no products are distributed until their quality is confirmed as satisfactory.

The Quality Control Department (QCD) is an independent structural unit of the company, which includes analytical and microbiological laboratories.

Main tasks of the Analytical Laboratory

• Incoming control of each batch of active pharmaceutical ingredients (APIs).

• Incoming control of excipients.

• Incoming control of primary packaging materials (PVC film, aluminum foil).

• Incoming control of printed and secondary packaging materials.

• Control of organic solvents and raw materials for API synthesis.

• Control of intermediate products of finished dosage forms (FDFs).

• Control of intermediate products of chemical organic production.

• Control of recovered solvents.

• Control of finished products from FDF and chemical production sites.

• Testing for residual API levels on equipment surfaces.

• Control of production waste.

• Sanitary and hygienic testing of workplace air.

Main tasks of the Microbiological Laboratory

• Incoming control of each batch of APIs and excipients.

• Incoming control of primary packaging materials (PVC film, aluminum foil).

• Control of drinking and purified water.

• Control of disinfectants and antiseptics.

• Control of finished products from both FDF and chemical production sites.

• Control of air cleanliness in production areas (cleanroom class D).

• Control of microbiological cleanliness of production surfaces, equipment, staff clothing, hands, and compressed air in the FDF area.

• Development of microbiological control methods for new products.

• Validation of microbiological test methods.

The laboratories of the Quality Control Department are equipped with modern analytical instruments and measuring devices accredited for pharmaceutical testing. However, equipment alone is not enough—it is the expertise of highly qualified specialists that ensures precision and reliability.

Moreover, every batch of finished products undergoes certification for compliance with its registration dossier, verified by the company’s Qualified Person (QP). This system guarantees the exceptional, stable, and unquestionable quality of all InterChem SLC medicines.