PARSAN ENGINEERS AND CONSULTANTS

Transcription

1 PARSAN ENGINEERS AND CONSULTANTS ONE STOP SOLUTION FOR ALL VALIDATION ACTIVITIES VALIDATION QUALIFICATION Kolkata office: Bengal Eco Intelligent Park. Flat no.: 27, 13 th Floor, EM Block, Sector 5, Salt Lake City. Kolkata AUDIT DOCUMENTATION QUALITY MANAGEMENT SYSTEM Delhi Office: 707, Eros Apartments 56, Nehru Place, New Delhi partha@parsan.co Phone:

2 ABOUT PARSAN ENGINEERS AND CONSULTANTS: PARSAN ENGINEERS AND CONSULTANTS, an ISO 9001:2015 certified Organization (Estd. in 2000), are primarily engaged in executing greenfield pharmaceutical/biotech turnkey projects as well as revamping of existing facilities. We also offer cost effective solutions for validation services in Pharmaceutical as well as in other healthcare sectors. Parsan, a renowned name in the pharmaceutical consultancy sector, has been offering Validation Services to clients for the last 13 years. We have executed number of projects in various countries around the globe including Iran, Bangladesh and India. PARSAN ENGINEERS AND CONSULTANTS are specialized in preparation and execution of Validation Protocols (IQ/OQ/PQ) compliance documents for equipments, utilities, Processes, laboratory instruments and computer system. Our range of validation services includes: Equipment validation Utility validation Process validation Laboratory instrument validation Cleaning validation OEL validation Risk Assessments Computer system validation Parsan also provides support during Factory Acceptance Test and Site Acceptance Test.

3 SERVICES FOR VALIDATION NEEDS EQUIPMENT VALIDATION: Parsan provides commissioning and qualification services for a wide variety of process equipments including, but are not limited to the list below, Blender Tray dryer Fluid bed dryer Fluid bed processer Rapid Mixer Granulator Tablet Compression machine Capsule Filling Machine Liquid Manufacturing and Filling Line Ointment Manufacturing line Tube Filling Machine Sterile Manufacturing line Reactor Media Preparation vessel Autoclave Ampoule and vial filling line. Packing and labeling equipments. RLAF & passboxes.

4 UTILITY SYSTEM QUALIFICATION Parsan provides commissioning and qualification services for a wide verity of Utility System including, but are not limited to the list below, Purified Water Generation and Distribution Systems WFI Generation and Distribution Systems Plant Steam Systems Pure Steam Systems Compressed Air Systems HVAC Systems CIP and SIP system LABORATORY INSTRUMENTS Parsan provides Qualification services for a wide variety of Laboratory instrument including, but are not limited to the list below, Analytical Balance Disintegration test apparatus Dissolution Test Apparatus Leak Test Apparatus Friability Test Apparatus Karl Fisher Titrator Potentiometer FTIR UV Spectrophotometer Laboratory Centrifuges HPLC GC

5 PROCESS: Parsan provides Validation services for process including, but not limited to the list below, Process Validation OEL Validation Cleaning Validation Parsan provides Product Validation for the following sectors: Tablet Capsule Injectable Syrup/ Suspensions Ointments AUDITING, RISK ASSESSMENTS, REGULATORY CONSULTING Parsan offers regulatory and compliance services to clients and compliance including, but are not limited to the following, Auditing and Risk Assessments Third Party Independent Audit before the inspection by Regulatory authorities (Optional). Parsan also provides internal auditing services and can provide a report based on quantitative evaluations of procedures, policies, and practices at your site. GMP Consulting Parsan helps clients develop and implement cgmp compliance strategies. QA/ QC documentation review Design Reviews Evaluation of Quality Systems and Development of Quality Systems and SOPs based on existing Quality Management System.

6 COMPUTER SYSTEM VALIDATION Parsan has experience in all areas of computer and automation validation. Following are sectors which are covered under this validation services, Computerized Systems Validation & support documentation development Laboratory Management Systems (LIMS) Building Management Systems (BMS) Supervisory Control and Data Acquisition Systems (SCADA) Programmable Logic Controllers (PLC) Software for Quality Assurance and Quality Control GMP / GAMP Compliance Assessment and Remediation 21CFR Part 11 Assessment and Remediation DOCUMENTATION SERVICES Preparation of Validation documents includes: Site Master File Master Validation Plan User Requirements Specifications (URS) Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Change Control / Deviation Risk Assessment SOPs and Checklist Execution of Validation Protocols and resolution of deviations Validation Summary report. Preparation of Validation Protocols and relevant SOPs for: Process Validation Cleaning Validation

7 Validation of Computer system and PLC Validation of Utilities Preparation of Calibration Schedule and checklist, Training protocols, Logbooks etc.: Preparation of Calibration Schedule, equipment log book, status tags and room clearance checklists. Personnel training protocols in the issues of Good Manufacturing Practice. OUR EXPERTS: Our experts have decades of experience in project management consultancy, design, construction, equipment and system implementation for companies in the Pharmaceutical and Biotechnology sectors. By means of external and in-service trainings as well as by membership of different associations our experts always maintain the appropriate level of efficiency. A brief overview of key personnel with PARSAN is as below: Mr. P. S Mukherjee: Mr. Mukherjee holds an MBA degree along with PGDIT in International Trade and is the founder Director of Parsan Overseas. He has over 30 years of experience in the field of international trade, as well as in trading and manufacturing, with companies like Mohan Exports, Ace Laboratories, DCM, IFB, GRASIM etc. Experience includes a wide spectrum of products and markets including CIS, Africa, Europe and Asia. Mr. Mukherjee has accomplished various business projects in countries like Georgia, Azerbaijan, Uzbekistan, and North Africa including Algeria, Mauritius, and others. He has an extremely rich experience in International Marketing. During his tenure with Mohan Exports he was directly handling the operations in Algeria. The company was the largest utilizer of 50 million credit line to Algeria, utilizing as much as 20 million. Clients included a wide spectrum of buyers ranging from ministry of Defense to National Electricity Company to the agriculture sector and entertainment electronics. The association with ACE laboratories was directly in the field of setting up a pharma project in CIS and Mauritius. That provided Mr. Mukherjee a rare exposure of these market and finer details of operations in the pharmaceutical sector. By virtue of his association with pharmaceutical sector for so long, Mr. Mukherjee has developed an in- depth insight into all the aspects of industry be it technical or commercial.

8 Mr. Gairik Samaddar: Mr. Samaddar has Master of Pharmacy qualifications from Jadavpur University, Kolkata with an experience of 36 years in the field of Pharmaceutical Sciences (Production, Purchase, Engineering etc.). He has been responsible for execution of various projects in the capacity of team leader, including Ointment, Tablet & capsule in Bengal Chemicals & Pharmaceuticals Ltd. Kolkata, India; Tablet & Capsule, Liquid Preparation, Injectable (both SVP & Dry powder) in Martina Bio Genics Pvt. Ltd., Kolkata, India, (a WHOGMP certified unit); Tablet section in Algeria; and Tablet & Capsule section in Iran. He is presently working on a Biotech Project in Iran. Mr. Samaddar has gone through various specialized trainings in his career that includes training on Janatorial Products in Evans Vanodyne, Manchester. Mr. Partha Dutta: Mr. Dutta has completed his Master degree in Pharmacy and has 8 years of work experience as quality assurance officer in reputed Pharma Company. He has good experience related to pharma production, IPQC activities and all documentation related to pharma equipment, utilities and validation. He is responsible for conducting project Survey, study in details all designs and drawings and project planning from conceptual design to completion stage. Mr. Dutta is well versed in current regulatory norms and guidelines. Mr. Sk. Morsadul Anam: Mr. Anam has completed his Bachelor degree in Pharmacy and has g o t 5 years of work experience in reputed pharma companies as Quality Assurance chemist. He has got a good experience related to the product handling, new product introduction & technology transfer, IPQC activities, Validation activities, Documentation. H e is well versed with the cgmp norms and guidelines. Mr. Pradyut Ghosh: Mr. Ghosh has over 28 years of experience in designing and installation of HVAC system and is an MBA (Healthcare), with a Diploma in Air- conditioning & Refrigeration as well as a Diploma in Industrial Biotechnology. He has rich experience in the field of HVAC and has been responsible for execution of various HVAC projects including Bengal Chemicals and Pharmaceuticals Ltd., Albert David, Dey s Medical and Martina Biogenics Pvt. Ltd. in Kolkata, India; Cipla Ltd. in Sikkim, India; Septy Pharmaceuticals in Guwahati, India. His international experiences include Soprodim in Algeria, Tablet capsule project of Actoverco in Iran and Biotech project of Actoverco, Iran.

9 Mr. Sudarson Das: Mr. Das has completed his B.Tech in mechanical engineering from Kalyani Govt. Engineering College & has around 12 years of industrial experience in Designing & engineering, Business development, Project Planning & Co Ordination etc in various reputed organizations. Have sound knowledge & experience in HVAC system, Chillers / Refrigeration package (VOC & VAM type), Water Treatment system, Effluent Treatment system, Pumps, Compressed Air system, Cooling Tower, Pneumatic Conveying & Powder material handling system, Vendor development, Preparation & review of Piping & Plant layout, Equipment sizing & selection etc PARSAN also employs a broad range of experienced and motivated professionals with specific background and qualification appropriate to projects in the Pharmaceutical & Biotechnology field. OUR STRATEGY: We provide industrious and experienced consultants who complete projects on time and on budget. Emphasis is given to strong project management and innovative thinking that enhances the quality and value of our services. We can look at a company's unique situation objectively, uncover their needs and priorities, clearly define project requirements and tailor our services accordingly to our clients needs. Parsan provides the desired level of detail and customization to your documentation, emphasizing regulatory trends that impact the level of detail required. Parsan is accustomed to presenting top quality services in a highly cost conscious manner to our client's. Y:

10 PROJECTS EXECUTED: ACTOVERCO, IRAN (OSD FACILITY): The scope included validation of HVAC system, Cleanroom equipments, preparation of complete validation documents. We are also involved in the GMP certification of the facility by working with the local team for implementation of GMP as well as conducting the GMP audit. In addition, we were also involved in third party auditing of the facility. ACTOVERCO (BIOTECH - PHASE I), IRAN: This validation project h as b e e n successfully completed. Scope of work included Process validation, complete utility validation including HVAC validation, preparation of all Quality Assurance Documentation & SOPs. NUVISTA PHARMA LTD., STERILE FACILITY, BANGLADESH: This project has been successfully completed. Scope of work included Process validation, HVAC & other utility validation, as well as execution of validation tasks for the sterile facility as per cgmp norms as well as provision of accompanying documentation. NUVISTA PHARMA LTD., OSD FACILITY, BANGLADESH: Parsan has successfully completed the validation tasks for the Oral solid dosage facility (Oral contraceptives & steroids) as per cgmp norms. Scope of work included process validation including the OEL validation jobs as well as providing all documentation related to validation and SOP.

11 BAIDYANATH AYURVEDIC (GOOD CARE), INDIA In this project is under implementation now. Project involves two production lines (Tablet and Capsule). Scope of work would include complete process & utility validation, Validation protocols, preparation of all Quality Assurance Documentation & SOPs. ALBORZ ZAGROS PHARMACEUTICAL CORPORATION, IRAN: This project is under implementation now. Scope include Complete process validation including OEL validation, Computer system validation, complete utility validation including HVAC validation, Validation protocols, preparation of all Quality Assurance Documentation & SOPs. OUR GUARANTEE: We will carry out the assigned task with complete professionalism, transparency, dedication and in compliance with international standard. We will bring to the client advantage derived out of latest technologies and tools available in our field of operations. Health, Safety and Environment norms in addition to standards as prescribed for the industry in the region of our operations will be adhered to. CONTACT INFORMATION Partha Sarathi Mukherjee, Managing Partner Parsan Engineers and Consultants. Kolkata Office: Bengal Eco Intelligent Park. Flat no.: 27, 13 th Floor, EM Block, Sector 5, Salt Lake City, Kolkata Delhi Office: 707, Eros Apartment, 56 - Nehru Place, New Delhi partha@parsan.co Web:

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