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Pharmaceutical Logistic Complex

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Presentation on theme: "Pharmaceutical Logistic Complex"— Presentation transcript:

1 Pharmaceutical Logistic Complex
Specialized Pharmaceutical Logistic Complex «BIOCON»

2 ABOUT BIOCON CPC Biocon LLC is a part of Biocon Group which was established in 1998. CPC Biocon LLC is independent service provider with only pharmaceutical logistics specialization that enables it to focus on very specific issues and to satisfy unique requirements of its customers.  The company’s strategy is the consistent development as 3PL operator and flexible adaptation to the clients needs and changes in the legislation. All operations are performed in compliance with local license conditions and international GDP requirements.  The range of services includes custom bonded and commercial warehouse services based on the own logistics complex class A, cargo customs complex services, custom clearance, transportation, etc. APPS Server Oracle Application 12.1 is used as the warehouse management system, which is validated and can be easily integrated with SAP, 1C, etc.

3 BIOCON AS A PART OF GLOBAL LOGISTICS
3PL BIOCON GLOBAL MANUFACTURERS CIS Wholesale clients from CIS and Mongolia (Kazakhstan, Azerbaijan, Uzbekistan, Belarus, Georgia, Moldova, Armenia, Turkmenistan, Kyrgyzstan, Tajikistan, Mongolia) Pharmacies, pharmacy chains, hospitals and other retail clients in Ukraine Distributers and wholesale customers in Ukraine

4 THE BIOCON’s MAIN ADVANTAGES
Pharma specialization Specialized complex «А» for storage and handling of pharmaceutical products exclusively Client orientation Best fit in size and capacity separate warehouses with individual clients’ requirements Personalized forms of reports 24/7 access to the Service-Desk, video surveillance, goods statuses and temperature control Consulting in business activity and logistics processes organization Assistance in GDP certification, wholesale and import licenses obtaining Quality management system Services are provided in compliance with GDP and Ukrainian legislation Quality management system is managed by the unique software “QMS Biocon” All procedures are performed based on Standard Operational Procedures (SOPs) Green technologies Packaging boxes made of recycled materials Geothermal fields for the maintaining of the temperature conditions (only water - no gas) Biological sewage purification plant LED lamps (long service life, high energy efficiency, destruction is not harmful for the environment) Effective logistic solutions Bonded and commercial warehouses Customs clearance sector and Zone of permanent customs control Beneficial location (close to airport, main truck routes) WMS ORACLE E-Business Suite 12.1 Very narrow aisle fork lift

5 OUR PARTNERS

6 BIOCON’s ADDITIONAL ADVANTAGES
Zone of permanent customs control and Customs clearance sector of Kiev Customs of State Fiscal Service of Ukraine that makes document and goods processing for incoming and dispatching medicines from the warehouse easier and faster. A Laboratory of regional state inspection of Ukraine on medical products is opened. It helps to obtain the confirmation of quality certificates and to make the products release after custom clearance within the shortest timeframes.

7 PSCI CERTIFICATE

8 CHARITY WORK CPC "Biocon" is actively involved in charity work.
Financial, organizational and logistical support to our partner Charitable Foundation "FARMVARTA”( allowed it to pass about packages of drugs (over 50 million UAH) to socially vulnerable and disabled Ukrainians, the elderly, children, the soldiers at the front and just patients, who are unable to buy medicines at their own expense. Biocon continues to forge international charities with developed countries in order to help Ukrainians to get easier access to drugs, medical equipment and products.

9 WAREHOUSE EQUIPMENT* Racking and loading equipment are made by the world-known manufacturers, such as Jungheinrich AG (Germany) and Still (Germany) The separated specialized room is used for charging of the forklifts’ batteries

10 24/7 CCTV CONTROL* CCTV system covers all complex.
The information from cameras is available online for our clients. * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

11 FIRE PROTECTION AND ALARM SYSTEM*
Throughout the complex following devices are installed: Smoke alarms Heat alarms Manual alarms Data processing is done by the Special Control device, made by Honeywell Company (USA): Automatic shutting down of ventilation system Switching on the smoke removal system Closing of the fire-protective valves Switching on sound and light alarms * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

12 FIRE-EXTINGUISHING SYSTEM*
Automatic sprinkler fire extinguishing system in combination with internal water pipeline for firefighting are in place Water is used as the substance for fire extinguishing Extra water is stored in separate tank with a capacity of 800 cubic meters Independent fire protection pump system is used for ongoing supply of water for firefighting Rainmakers in all areas are sprinklers The system works independently 60 minutes * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

13 AIR CONDITIONING AND VENTILATION*
Ventilation system maintains permanent temperature 15-25С with a humidity under 65% Is activated by double blower made by «Trane» Company (France): Air production capacity – cubic meters/hour Air filtration system Water heater Water cooler * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

14 ELECTRIC SUPPLY* Electric supply is provided by the two independent lines from the two different state electric power substations with an automatic switching. In addition, the diesel generator is turned on automatically in case of two permanent lines failure. * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

15 TEMPERATURE CONTROL* Online access to the real data and unlimited possibility to review an arсhive data. Alarm system for responsible persons notification about violation of storage conditions (including whole ambient storage zone and cold rooms) Notification system is realized through *.pdf reports and text messages (sms) * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

16 QMS: QUALITY MANAGEMENT SYSTEM
The main goal of the Quality Management System is to secure the quality of medical products during the whole logistics chain: RECEPTION STORAGE DISPATCHING TRANSPORTATION QMS (Quality Management System) – is an introduced internal system, which contains all necessary tools and resources to manage, control and enhance the quality of all procedures to be performed strictly in compliance with GDP principles. QMS is implemented on each level of business activity and constantly undergo the changes for improving and development. QMS is based on: Guidelines 2003/94EC in terms of human use Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use Low of Ukraine “About medicinal products” License conditions of wholesale, retail and medicinal products manufacturing activity”

17 QMS: SHORT STRUCTURE Adaptation, trainings, attestations
(programs, plans, tests, reports) Regulation documents (SOP, Instructions, politics, guidelines) External audits, inspections (protocols, plans, reports) Complaints and Requests (reception via Service-Desk, by phone, , sms) Deviations (internal investigation) Changes (corrective actions, changes implementation) Self-inspection (controlling actions, CAPA inspection) Accepted Rejected Risks (undefined and defined risks, risks assessment) Technical maintenance (protocols) Validation, calibration, verification (Master-plan, programs, protocols) Outsourcing activity (acts, protocols, reports) Suppliers management (tenders, audits, agreements)

18 QMS: LIST OF SOPs Documentation Quality review Risk management
SOP.QS. A /2015/10-UA Порядок построения, оформления и требования к содержанию SOP. Formation and drawing up procedures, contents of the SOP. SOP.QS. A /2014/5-UA Написание, распространение, использование документов. Контроль документации. Writing, sending, using of documents. Control of documentation. SOP.QS. A /2016/11-UA Кодирование стандартных операционных процедур. Standard operational procedures encoding. Quality review SOP.QS.A /2014/1 – UA Анализ со стороны руководства. Management review. Risk management SOP.QS.T /2015/2 – UA Управление рисками качества. Quality risk management. Outsourcing activity SOP.QS.T /2015/1-UA – Порядок проведения аудита аутсерсинговых компаний. The procedure for conducting audit outsourcing companies Complaints, Deviations, Changes, self-inspections SOP.QS. A /2014/6 - UA Обращения с жалобами. Handling of complaints. SOP.QS. T /2014/1-UA Отклонения. Аварийные ситуации. Deviation. Emergency. SOP.QS.A /2014/12-UA Контроль изменений Change control SOP.QS. A /2014/9 -UA Контроль отклонений, корректирующие и предупреждающие действия. Control of deviations, corrective and preventive actions. SOP.QS. A.SI /2015/10-UA Самоинспекция. Внутренний аудит. Self-inspection. Internal audit. Personnel SOP.QS. A /2014/8-UA Порядок приема на работу. Employment procedures. SOP.QS. A /2014/10-UA Тренинги и аттестация персонала. Trainings and attestation staff.

19 QMS: LIST OF SOPs Hygiene and sanitary condition Validation
SOP.QS. T /2014/13-UA Санитарно-гигиеническое состояние склада. Sanitary-hygienic state of a warehouse. SOP.QS.T /2014/10-UA Санитарно-гигиеническое состояние участка переупаковки/перемаркировки Sanitary condition of the site repackaging / relabeling of drugs. SOP.QS. T /20155/10-UA Проведение дератизационных мероприятий. Pest control performance. SOP.QS.T /2015/3 – UA Использование и обслуживание электрического улавливателя летающих насекомых. Use and service of the Electric catcher of flying insects. SOP.QS. T /2014/9-UA Санитарная очистка холодильной камеры. Sanitary purification of refrigerator. SOP.QS.T /2014/3-UA Санитарно-гигиенические нормы и правила для складского персонала ООО «ХФК «Биокон». Hygiene regulations and rules for the warehouse staff of "CPC "Biocon" LLC. Validation SOP.QS.T /2015/2 – UA Система вентиляции. System of ventilation. SOP.QS. A /2014/6-UA Калибровка термогигрометров. Calibration of thermo hygrometer’s SOP.QS. А /2015/4-UA Программа планирования квалификационных работ. Program planning qualification works Emergency cases SOP.QS.T /2014/1 – UA Порядок действий при возникновении чрезвычайных ситуаций на предприятии Procedure in case of emergencies in the enterprise. SOP.QS.T /2015/1- UA План неотложных действий Immediate Plan of Action SOP.QS. T /2014/7-UA Система тревоги холодильной камеры. Действия персонала в случае форс-мажорных обстоятельств. Cool camera alarm system. The action of personnel in the event of force majeure. Security and access control SOP.QS.A /2015/2 – UA Организация и обеспечение безопасности ООО «ХФК «Биокон» (охрана и пропускной режим) Organization and safety profile "CPC" Biocon "(security and access control. SOP.QS. T /2014/13-UA Контроль доступа на ТС «Биокон». Access control to Biocon’s bonded warehouse.

20 QMS: LIST OF SOPs Logistics SOP.QS. T.01.0.05/2015/17-UA
Прием препаратов. Receipt of medicines. SOP.QS. T /2014/13-UA Хранение препаратов и ведение документации. Storage of medicines and keeping of documentation. SOP.QS. T /2015/17-UA Отпуск препаратов. Dispatch of medicines. SOP.QS. T /2014/10-UA Складирование и распределение продукции. Warehousing and allocation of production. SOP.QS. T /2015/2-UA Мониторинг, регистрация температуры и относительной влажности. Monitoring, recording temperature and relative humidity. SOP.QS. T /2015/11-UA Упаковка термолабильных препаратов. Packing heat-labile drugs. SOP.QS. T /2014/11-UA Отзыв продукции. Production recall. SOP.QS. T /2014/6-UA Транспортировка лекарственных препаратов. Transportation of medicines. SOP. QS. T /2015/5 -UA Инвентаризация. Inventory. SOP.QS. T /2014/3-UA Сюрвейерский контроль лекарственных препаратов Control performed by surveyor SOP.QS. T /2014/8-UA Переупаковка лекарственных препаратов. Repackaging of medicines SOP.QS.T /2014/3 – UA Хранение, обращение и отпуск цитостатиков. Storage, handling and dispensing tsitotatikov. SOP.QS.A /2015/2 - UA Размещение и хранение препаратов в Зоне брака. Placement and storage of drugs in the Zone of damaged goods SOP.QS.T /2015/1- UA Уничтожение лекарственных средств находящихся под таможенным контролем. Destruction of drugs under customs control SOP.QS.T /2014/7- UA Уничтожение вторичного упаковочного материала. Destruction of secondary packaging material.

21 WAREHOUSE MANAGEMENT SYSTEM
WMS system is based on ORACLE E-Business Suite 12.1 WMS follows FEFO and FIFO principles WMS minimizes human factor and maximizes warehouse efficiency WMS system is validated for usage in pharmaceutical business WMS can be easily integrated with corporate ERP – system (SAP, 1С:Enterprise, Navision) Back-up storage (for more than 10 years) is performed on daily routine

22 WMS: INTERFACES INTEGRATION
QA MANUAL (optional) ERP AUTOMATED By means of Service-Desk WMS Purchase order Reception Receiving confirmation Request for sales release Request for sales release (optional) Sales release Movement Request for statuses/location change Request for statuses/location change (optional) Statuses change Movement Picking request Picking Picking confirmation Stock reconciliation Stock reconciliation

23 WMS: KPI and REPORTS WMS allows to create regular automated and/or individually designed reports regarding: Daily operational statistics KI (key indicators) KPI (key performance indicators) The range of standard logistics reports includes but not limited by: Stock reconciliation report Stock size report Goods movements report Received goods report Shipped goods report Batch protocol Batch distribution report, etc.

24 WMS: KPI and REPORTS Some examples of standard logistics reports

25 WMS: KPI and REPORTS One of the examples of the monthly KPI report

26 WMS: KPI and REPORTS One of the examples of the monthly KPI report

27 WMS: KPI and REPORTS One of the examples of the monthly KPI report

28 THE BIOCON’s DEVELOPMENT
The 2nd warehouse on the territory of our logistics complex is under the final stage of the construction You can track a process of construction on-line through our web-site ( . The detailed plan of the standard section is provided in the next slide. Within this project our clients have a unique possibility to realize any of their desires regarding size and configuration of the premises. During the current stage we can install any specific shelf storage system and to consider any requirements of the zones division. The installed equipment and engineering systems are based on green technologies and meet all requirements of GDP and local license conditions. The launch of the warehouse is arranged for the March 2016.

29 LOCATION 9, Boryspilska Str., village Velyka Oleksandrivka, Boryspil District, Kyiv Region, Ukraine Kiev circumurban road Biocon Borispil highway <- Kiev (16,1 km) Airport Borispil (10,6 km)

30 PLAN OF THE TERRITORY

31 THE OVERALL VIEW OF THE TERRITORY

32 Technical details for the 2nd WAREHOUSE
The current warehouse is in operation and has sq.m. of the total area and pallets capacity. Technical details for the 2nd WAREHOUSE (launch is in the June 2016) Total area sq. m Shelf storage area 8 levels Overall storage capacity pallets Ambient area (+15C…+25C) Cold rooms areas (+2C…+8C) and (+10C…+15C) Office premises Individual for the each section Q-ty of gates for loading and uploading 38 gates Division into sections: quantity 16 sections Division into sections: area 750 sq.m. each Division into sections: capacity 1350 pallets each

33 DETAILED PLAN OF THE STANDART SECTION
IN THE NEW WAREHOUSE

34 GEOTHERMAL FIELDS* The temperature of the heat carrying agent for heating and cooling is maintained by the geothermal fields. This technology is not only environmentally friendly, highly efficient and reliable but also helps to decrease significantly utility bills for our clients. Moreover, the usage of the geothermal fields enable us to guarantee to our customers the high stability of the utility service cost even in case of the sharp increase of the gas price. * Detailed description of main objects and technical systems of the Logistics complex can be found in the audit report from the company “Crawford” (is attached to this presentation).

35 CONCLUSION BIOCON stands out among others by availability of different resources and opportunities to support International Pharmaceutical Companies in their successful development on the territory of Ukraine and CIS. Thank you for attention and do not hesitate to contact me if any additional questions emerge! Our contact information: Pavlova Vera Director CPC “Biocon” LLC mob: +38 (067) Tel: +38 (044) (81) Romanova Anastasiia Consultant of business efficiency CPC “Biocon” LLC mob: +38 (098) Tel: +38 (044) (81)


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