Quality

EVENTS

Quality Management System

The company implemented and maintains in working order a quality management system (QMS) which is a part of the company’s general management system.

Multi-faceted approach to implementation of the QMS in the company

Multi-faceted approach to the company’s quality management system is based on implementation of:

  • Requirements of Russian laws;

  • ISO 9001, ISO 31000 concepts;

  • GxP rules (GMP EU, GDP EU, GSP WHO).

In 2015, the group successfully passed audit of the quality management system by an international system certification agency SGS, which is evidenced by the certificate CH15/0960.

Currently, Santens Group is implementing a supply chain safety management system on the basis of requirements of MS ISO 28000.

Титова-small

Director of Quality,
Santens Logistic Group LLC

Zhanna Titova

phone: +7 (495) 937-96-69 (add. 336)
titova@santens.ru

Strategy

Strategic goal of the company is to implement a Pharmaceutical Quality System based on requirements ICН Q10 and ICH Q9 Quality Risk Management system.

The company’s concept of quality management, based on the international requirements listed above, determines the approach to quality management for customers’ products stored and processed at warehouses of the company’s service providers, from the perspective of the products’ life cycle.

Our Goal

Our Goal – to keep original quality of medicinal products unchanged.

To preserve the quality which is:

  • created during the stage of pharmaceutical development,
  • confirmed during state registration,
  • assured during production of medicinal products

Our Solution

The quality management system in the company is implemented and provides the possibility to:

  • set and keep all stages of storage and warehouse processing of medicinal products stored at the company’s warehouse facilities, in controlled conditions;
  • ensure that various needs of customers are met in respect of processing of medicinal products and accompanying pharmaceutical products stored at warehouse facilities;
  • constantly improve warehouse processing processes for customers’ pharmaceutical products on the basis of new requirements of the customers and taking into account analysis and quality risk assessment.

Quality Unit

The holding has an independent subdivision – the Quality Unit.

That subdivision carries out implementation, support and improvement of the quality management system on the basis of requirements of international standards GMP EU (in respect to storage of finished medicinal products) / GDP EU/ GSP WHO.

Basic function of the Quality Unit:

  • Quality planning – developments of quality-related goals;
  • Quality assurance – development and implementation of procedures that set standards for all processes connected to storage and warehouse processing of products at the company’s warehouses, including but not limited to via control of processes of warehouse processing of products;
  • Quality management – control of due functioning of all components and elements of the Company’s quality management system;
  • Quality improvement – actions in the knowledge management system and quality risk management.

Functioning of quality management system

Proper functioning of the quality management system is ensured through:

  • process efficiency and service quality monitoring systems;
  • deviation management;
  • knowledge management;
  • corrective action and preventive action (CAPA);
  • change management;
  • risk management;
  • self inspection;
  • assessment/evaluation of suppliers of critical components/services – supplier management;
  • management review

Control of continuity of operation

Based on risk assessment, the company developed a control strategy, i.e. identified parameters and characteristics of processes, premises, equipment and computerized systems, which require constant monitoring of checkpoints and analysis to confirm continuous operation in controlled condition

Elements of the Quality Management System

Deviation management system

The deviation management system allows us to guarantee that quality of customers’ products stored at our warehouses remains unchanged.

Identification of deviations is done at every stage of circulation of customers’ products at warehouse facilities of the group managed by Santens Logistic Group LLCs:

  • Control of transportation conditions at the time of acceptance at a warehouse;
  • Acceptance control;
  • Storage at the main storage area;
  • During the process of checking parameters of required climatic regime;
  • During handling inside a warehouse;
  • During picking and assembling orders for customers’ contractors ;
  • Dispatching products to customers with control of transportation conditions on the way from the company’s warehouse to the Customer’s consignee .

Prevention of deviations
The deviation management system implemented by the company provides the possibility to prevent deviations with help of systematic monitoring and analysis of emerging deviations, investigation of reasons of the deviations, development and implementation of corrective and preventive actions.

Validation

Validation is one of the elements of implementation and improvement of the Quality Management System. According to the company’s validation policy, the following objects are subject to validation:

  • premises;
  • equipment;
  • computerized systems.

Validation of premises is carried out with the assistance of third party organizations having required certificates and takes place on every stage of construction and commencement of operation of a new warehouse building, starting from its design stage (DQ, IQ, OQ, PQ).
During the first year of operation temperature mapping of production premises is carried out (PQ1 – in the coldest season and PQ2 in the hottest season) followed by designing allocation chart for the climate monitoring system, based on results of such mapping.
The process of validation of cooling equipment includes all stages of qualification and is performed by specialists of the Quality Unit of the company.

Knowledge management

The company develops a knowledge management system.

We systemize the process of collection, analysis, accumulation and dissemination of knowledge by the company’s employees.

Key job positions in warehouse facilities are occupied by employees with professional pharmaceutical education.

Warehouse facilities are manned with sufficient number of employees capable to adequately solve professional tasks

Corrective actions and preventive actions - САРА

The company implemented an efficient system of corrective actions and preventive actions (САРА). The CAPA system is intended to eliminate reasons of identified and expected deviations.

CAPA plans are developed following results of:

  • Deviation investigations;
  • Internal inspections;
  • External inspections;
  • Inspections by a regulatory authority;
  • Analysis and evaluation of KPI ;
  • Investigation of reasons of customers’ complaints;
  • User satisfaction survey – customer satisfaction evaluation.

The level of effort, formalization and documentation of investigations is equal to the level of quality risks. Search for solutions is aimed at identification of the main reason of occurrence of deviations.
Data of process monitoring, deviation analysis, CAPA system and innovations always result in changes.
The company implemented a change management system which enables us to:

  • Make required assessment, approval, implementation and verification of changes;
  • Make required assessment, approval, implementation and verification of changes;
  • Provides us with high level of confidence that there will be no unplanned consequences of any changes we made.

Stages of change management

Main stages of the change management process are the following:

  • Initiation of a change;
  • Initial evaluation of the change;
  • Making a decision on approval or disapproval of the change;
  • Evaluation by a board of experts – analysis of the change (risks and possible effect on other processes);
  • Mutual approval of the change with the Customer/notification of the Customer of the implemented change (if required);
  • Implementation of the change;
  • Verification of the change using evaluation criteria;
  • Documented closing of the change.

Risk management system

The company implemented an operational risk management system, i.e. the system to manage risks relating to carrying out principle production activity of the company.

All decisions made in the company, irrespective of their level of significance and importance, include a detailed report and are based on identification, analysis and evaluation of risks, using the FMEA method of risk treatment.

Application of the quality risk management system ensures:

  • Understanding of potential threats and effects of their consequences on achievement of the Company’s goals;
  • Identification of vulnerable processes and key factors that shape the risk;
  • Prevention of new incidents, on the basis of investigation of consequences of previous incidents;
  • Choice of methods of risk treatment;
  • Compliance with legal and mandatory requirements, obtaining information necessary for making a justified decision on acceptance of the risk according to established criteria.

Results of the risk management process, applicable to a particular element of the system, are reviewed within a framework of the quality management system and determine decisions aimed at continuous improvement of production processes and refinement of elements of the quality management system such as deviation management, change management, internal/external inspections.

Internal inspections

The company regularly undergoes internal inspections in order to verify:

  • the level of compliance of the QMS with requirements of ISO 9001:2008 international standards and requirements of documents governing and regulating the quality management system;
  • the level of compliance of the QMS with requirements of GDP EU, GSP WHO, GMP EU standards applicable to storage of finished medicinal products;
  • compliance with requirements of applicable Russian laws relating to circulation of medicinal products;
  • efficiency of the quality management system;
  • areas of possible improvement of the quality management system.

Supplier qualification

All suppliers of components and services used in the group’s main business and being critical for quality assurance are evaluated and ranked in terms of risks and are subject to a mandatory qualification procedure prior to execution of contracts and making purshases.Further, all qualified suppliers undergo periodic evaluations.

We work to guarantee that the level of quality of products manufactured according to GMP and imported to Russia from the manufacturing plant shall be maintained at warehouses of a specialized pharmaceutical logistics operator to ensure that medicinal products are dispatched for retail without any changes of their properties and that they preserve their quality when they reach end-customer.

Учебный центр

Training center

The holding company operates a Training centre that conducts regular internal staff training within the approved training programmes by internal regulations ( SOP) according to the principle: position-functionality – SOP.
The application of the system approach in knowledge management:

  • helps our professionals to use the knowledge and skills to solve professional tasks at the appropriate level and in accordance with assigned responsibilities;
  • assists in the development, acquisition and accumulation of new practical and theoretical knowledge, including concerning the processing of pharmaceutical products;
  • causes a further professional development of staff within the company.

The quality management system in the company is implemented and provides the possibility to:

Холодильник

Set and keep all stages of storage and warehouse processing of medicinal products stored at the company’s warehouse facilities, in controlled conditions

doc1

Ensure that various needs of customers are met in respect of processing of medicinal products and accompanying pharmaceutical products stored at warehouse facilities

korobki

Constantly improve warehouse processing processes for customers’ pharmaceutical products on the basis of new requirements of the customers and taking into account analysis and quality risk assessment.

Licenses and certificates