Quality control

Quality Policy

The mission of “InterChem SLC” is the complete satisfaction of our consumers, providing the population with effective and safe medicines of the consistently high level of quality, development and production of the goods competitive both in the domestic and foreign markets.

Our slogan is “Medicines from those who care!”

Our company fully realizes the quality policy in all the key areas:

•   in the field of product quality;
•   in the quality of services;
•   in the organization's quality processes;
•   in the quality of work with suppliers.

Certificates of GMP:

№15, 2007 20.03.07

№9 of 2009 16/07/09

№10 / 2011 / GMP of 23.08.11 2011

GMP certificate confirms the compliance of pharmaceutical production and quality system to the regulations of EU GMP and recommendations of PIC/S, taking into account the GMP requirements of the World Health Organization for the products that operate in the field of trade and distribution in the country of direct production and exports.

GMP (Good Manufacturing Practice) is part of the concept of quality control, guaranteeing the production and control of pharmaceutical products for the quality standards appropriate to their application and the requirements of the registration dossier.

GMP is a set of rules and regulations that must be followed at all stages of drug production to guarantee quality, safety and efficacy.

The purpose of GMP is providing higher degree of security, identity and effectiveness of medicines.

The company received the highest award of the All-Ukrainian contest rating "Highest Quality". The company is recognized as the best manufacturer of domestic products. Also, "InterChem" was awarded with the diplomas: "For high quality and competitiveness of API’s and drugs" and "For a high level of wholesale and retail sale of drugs."

At the annual competition of pharmaceutical industry professionals in Ukraine "Panacea" Amixin IC was recognized as the preparation of the year in the category "Best OTC drug among immune stimulating medicines”.

In the category "Company of the year" in competition "Panacea" "InterChem" won the honorary title of the best domestic drugs maker of the year.

At the annual competition of Ukrainian pharmaceutical industry professionals "Panacea" our company was awarded in the category "Domestic fast-growing company," and the drug "Amixin" again was  recognized as the medicine of the year.

In the same year, the company received a diploma of the winner of the Odessa Regional round of the All-Ukrainian rating of "Conscientious taxpayers - 2011" in the medical industry.

2012

The innovative drug “Levana® IC” was recognized a laureate of the Ukrainian national contest of the goods quality “100 Best Goods of Ukraine”.

2013

By results of the Ukrainian national contest of the pharmaceutical sector “Panacea – 2013” “Amixin® IC” and "Gidazepam ІC ®" were recognized as the “The Medicine of Year”.

To ensure the quality of the existing standards the system - GMP, quality control at all levels of production, and risk management are working in the company clearly and debugged. All levels of the system are provided by qualified personnel, specialized facilities, modern equipment and facilities. In addition, the company carries out the validation process, the qualification of premises and equipment, validation of analytical and microbiological techniques.

Why do we need such strict multi-level action? To guarantee!

Quality System of "InterChem" guarantees:

• drugs are developed and tested in compliance with the requirements of GMP;
• manufacturing operations and methods of control are being documented and meet the requirements of GMP;
• all incoming raw materials, auxiliary and packaging materials, intermediate products and production processes are subject to the strict input control;
• finished goods are produced in compliance with the requirements of GMP and verified in accordance with the approved ICC;
• the company carries out activities that ensure the quality of the finished products during the shelf-life;
• regular self-inspections and audits evaluate the effectiveness of quality assurance at all levels.

Buying the products with the brand "InterChem" all the consumers can be sure - these drugs have been produced to help to restore health, and not to undermine it!

Quality control is the part of Good Manufacturing Practices which is associated with sampling, specifications and testing. This work is connected with the organization of procedures, documentation, and authorizing the release of the drugs batches. This work is connected with the procedures to ensure that all necessary tests are indeed held. Thanks to this control the materials will not be allowed to be used, and the products will not be sold until the quality is confirmed to be satisfactory.

Department of Quality Control is an independent structural unit of the company which includes analytical and microbiological laboratories.

The main tasks performed by the analytical laboratory:

•   incoming inspection of each batch of the ctive pharmaceutical ingredients (API’s);
•   incoming inspection of each series of auxiliaries;
•   incoming inspection of materials for primary packaging (PVC film, aluminum foil);
•   incoming inspection of printed packaging and packaging materials;
•   input control of organic solvents and raw materials for the synthesis of API’s;
•   control intermediates of finished drugs (SFS);
•   control of chemical intermediates in the production of organic products (HPOP);
•   control of the regenerated solvents;
•   control of the finished product manufacturing site SFS;
•   control of the finished product area HPOP;
•   control of residues of API’s in washings from the equipment;
•   control of waste production;
•   hygiene research of the workplace air. 

The main tasks performed by the microbiology lab:

• incoming inspection of each series of API’s (active pharmaceutical ingredients);
• incoming inspection of each series of auxiliaries;
• incoming inspection of materials for primary packaging (PVC film, aluminum foil);
• control of drinking water and purified water;
• control of disinfectants and antiseptics;
• control of the finished product manufacturing site SFS;
• control of the finished product area HPOP;
• monitoring of the air of industrial premises (rooms of class D cleanness);
• control of microbiological purity of the surfaces of industrial premises;
• control of microbiological purity of process equipment;
• control of microbiological purity of clothing of personnel;
• control of microbiological purity of the hands of personnel;
• control of microbiological purity of compressed air at the site PGLS;
• development of the methods for new drugs control;
• validation of microbiological techniques.

Laboratory of the quality control department is equipped with the modern equipment and measuring instruments required for quality control of medicinal products according to the scope of accreditation. But any equipment without the high-class specialists is nothing. “InterChem” has highly skilled professionals and highly skilled laboratory staff.

In addition, each batch of the finished product is certified for compliance with the requirements of the registration dossier by the authorized person of the company.