Santens
Quality

Quality Management System (QMS)

The Quality Management System that is a part of the corporate integrated management system has been implemented and maintained as a working tool in Santens Group.

The QMS is in place at every Santens logistics site
on a full scale.

The QMS is compliant with ISO 9001:2015, which is proved by Certificate CH15/0960.00 dated July 23, 2021 and issued by SGS, international QMS
certification body.

Janna Titova
Quality Director
Santens Logistic Group LLC
+7 (495) 937-96-69 (ext. 336)
zhanna.titova@santens.ru

QMS Comprehensive Strategy

QMS of the Company is of the integrated type and is based on the requirements of:
international standard ISO 9001: 2015;
GDP EEU as approved by EEC Council
Resolution No. 80 On Approval of Eurasian
Economic Union Good Distribution Practice
and Good Practice of Storage &
Transportation of Pharmaceuticals for
Human Use in Russiainternational standards GDP EU, GSP WHO, GMP EU applicable to storage of finished pharmaceutical products;
GDP EU, GSP WHO, GMP EU as applicable
to the storage of finished pharmaceutical
products (FPP)
ICH Q9 Quality Risk Management within the pharmaceutical industry and regulatory environment and ISO 31000:2018 Risk management –
Guidelines.
Our purpose
Our purpose is to service our partners to a high standard and build the process in such a way as to maintain the original quality of pharmaceuticals moving across the supply chain (storage and transportation of
pharmaceuticals).

Preserve the quality of pharmaceuticals that is:
  • Defined at the pharmaceutical development stage
  • Proved through the state registration process
  • Delivered in the course of manufacturing the pharmaceuticals
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 policy
Our Management Team undertakes and bears responsibility for compliance with applicable requirements in place and for implementing this Quality Policy at all levels of the corporate operations along with enhancement and continual improvement of the corporate Quality Management System.

To get acquainted with the Quality Policy of the Santens Group of Companies.

Strategy

The risk-based QMS is based on the process management
model and integrates identified main and auxiliary
processes along with management processes that are
common for the system.
Santens QA philosophy is based on the above listed
international guidelines and tackles quality of customer
servicing in the course of storing and handling their
products within Santens logistics hubs along with
transporting such products from the point of view of the
product life cycle.
The QMS fully comprises statutory requirements (by the
government) that are mandatory for Santens activities
along with consumers and partners' requirements that do
not contradict to the mandatory statutory requirements.
Santens has identified QMS stakeholders along with their
requirements, needs and expectations and now regularly
review the stakeholders, monitor their satisfaction and
trends in their needs and expectations.

We focus on four major elements of the management system:
  • Monitoring of processes and service quality
  • CAPA management
  • Change management
  • Reviewing QMS performance and efficiency by the management team.
  • The processes are monitored according to a set of performance indicators that meet SMART rules.
  • Santens change management system makes it possible to assess, approve and put in place major changes in line with risk assessment with regard to the quality of pharmaceuticals and services. Thus, we ensure timely and efficient continual improvement alongside with a high degree of assurance that any changes do not entail unintended consequences.
  • The CAPA management system purpose is to rectify causes of identified and proposed non-conformities.

We develop CAPA plans as a result of:
  1. Investigating deviations
  2. In-house audits
  3. Third party audits
  4. Audits by controllers
  5. KPI reviews and assessments
  6. Investigating causes of customers' claims
  7. Customer satisfaction assessment
Our efforts, formalizing and documenting investigations
are comparable to the risks for the quality of
pharmaceuticals and services.
  • Our continual improvement of the processes and service quality is based on monitoring internal and external influences as a part of regular management team's reviews.



Quality Directorate

The Quality Directorate is a dedicated stand-alone business unit in the holding structure.
The unit is responsible for putting in place, maintaining as a working tool and continual improving the QMS.
The basic functions of the Quality
Directorate are as follows
  • Setting and developing Quality Targets
  • Quality Assurance: developing and putting in place certain procedures harmonizing all the processes relevant to storing and handling products at Santens Group warehouses and to transporting such products
  • Quality Management: supervising of proper functioning of all the components of Santens QA system
  • Quality Improvement: taking actions within the knowledge management and risk management systems
QA System Functioning
The QA system functions properly due to:
  • Monitoring system for performance of processes and service quality
  • Managing deviations
  • Staff training
  • Corrective and preventive actions
  • Change management
  • Quality risk management
  • In-house audits
  • Qualifications/assessments of suppliers of critical components/services
  • Reviewing the system by the management teamagement.

New Range of Services

The range of services provided by Santens Group has expanded and significantly changed over the recent 4 years due to the Track&Trace project that was implemented for pharmaceuticals in the RF. The QMS development
improvement trend for the recent 4 years is:
  • A new QMS requirement covering Data Integrity
  • Along with compliance with ISPE GAMP Good Practice Guide – IT Infrastructure Control and Compliance, and provision of internet security as prescribed by Santens customers.
Santens keeps on deploying new tools to automate in-house managerial and supporting processes, and offer novel IT tools and solutions to the partners to enforce compliance with mandatory government requirements with regard to
tracking details of pharmaceuticals across the supply chain in the RF.

We have in place WTS and PharmConnector IT solutions to keep records about serialized pharmaceuticals delivered to and shipped from Santens logistics hubs and also keeps records about all pharmaceutical relevant transactions while warehousing, and then transmit the data about serialized pharmaceuticals to the customer's system for further transmitting to the medical product tracking system (Pharmaceutical Movement Monitoring System) via a special integrated solution for data exchange between Santens in-house systems and the customer's ERP system.
To track IT faults, we use GLPI application.
The WebTutor tool was implemented for in-house training processes in the distant learning mode in accordance with training programmes and modules, for personnel testing, and Santens knowledge data base structuring and
maintaining.
Jira pilot project has been implemented in Santens for the recent 3 years in line with Data Integrity and Pharm requirements.
JIRA manages QMS processes and makes it possible to build management processes such as management of nonconformities (deviations, in-house and third party audits), follow up tasks (CAPA addressing non-conformities), and also generate reports and assess performance.
All the computer-aided systems used by Santens are validation objects and have been assessed by the Quality Directorate in terms of their criticality (GMP). We are implementing a number of validation projects initiated by the Quality Directorate. The computer-aided system validation scope is defined for each CAS in view of its criticality, GAMP5 category, life cycle concept, data integrity
and fault or failure probability.

Sustainable and Successful
Development Representations

Santens sustainability and success is based on its ability to be adaptable to changes and open to innovations based on knowledge and risk management.
We believe that quality knowledge management and risk management are primary tools for improving our integrated quality system.

Knowledge management system

We are identified the knowledge required for business process functioning and product and service compliance. Our knowledge collecting, reviewing, accumulating and disseminating processes have been systematized at the
corporate level.

Santens knowledge base is as follows:
  • QMS documents
  • Third party audit reports
  • In-house study materials
  • Third party instructors' study materials
  • Various corporate marketing studies
  • Lessons learned after previous tasks
  • Key employees' experience shared through mentoring



The Quality Directorate has a Training Centre that builds
and manages regular in-house trainings for QMS relevant
personnel. There are approved training programmes on
corporate regulations. There is a GDP mandatory training
that is arranged every year.
The WebTutor tool facilitates study paperwork
dissemination and post-training tests.
Our systemic approach to the knowledge management:
  • Allows our professionals to apply gained knowledgeand skills to everyday tasks and routine duties,
  • Contributes to the staff development along with acquisition and accumulation of new practical and theoretical knowledge covering storing, handling and transporting pharmaceuticals,
  • Serves as an underlying reason for further personnel professional growth within the company
We review risks and opportunities we are exposed to and that may arise due to in-house and external influences or as a result of applicable requirements that may be identified by our subject matter expert team in charge of identifying,
assessing and reviewing risks and of following up risk mitigation action plan.
Thus, our decision-making is based on the accumulated quality knowledge and risk assessment for both products being handled and services being provided.
Santens senior management is a core task force for the activities and a coordinator of the risk management process between various lines of business activities and various business units; they enable defining, putting in place and
auditing the risk management process along with allocating resources to manage risks.
Santens senior management team attitude contributes to the ongoing sustainable development of our QMS that

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