Management of Popular Pharmaceuticals PLC Introduce of Group Members S/L Name of Group Member Group Member ID 01 ROTHIN SARKAR 20232065 02 SUSMITA SAHA 20233021 03 ABDULLAH AL ISAM 20232102 04 MST SONIA KHATUN 20232130 05 MD. FUAD HASAN KHAN 20233035 1. Introduction Popular Pharmaceuticals Ltd. (PPL) was established in 8 December 2002, with a vision to lead the branded generics market in Bangladesh with a high quality, diversified range of life saving and vital molecules. It is now a vertically integrated generic pharmaceuticals formulation products manufacturer, marketer, promoter and distributor. The company has achieved ISO 9001:2015 certification for its quality management system and is continuously updating the same. The company has state-of-the-art factory in Bangladesh having eight separate and dedicated modern manufacturing facilities. High production capacity of PPL is now being utilized for its own products portfolio as well as for toll manufacturing of specialty products for 18 leading pharmaceutical companies of Bangladesh. PPL has a strong presence in the domestic pharmaceutical market with regards to prescription share & sales. Popular is now among one of the top 15 pharmaceutical companies of Bangladesh by revenue and ranked as one of the most rapid growing companies in the country. PPL’s remarkable growth within a very short span of time has resulted mainly from its product diversification coupled with many “high-tech-highscience” product launches. It sales has also been powered by its knowledge-based medico-marketing promotional activities by its skilled marketing and sales people. 1. Facility of Popular Pharmaceuticals PLC S/L 01 02 Department Human Resource Financial Resource 03 Production 04 Quality Assurance 05 Quality Control S/L Department 06 Engineering 07 Microbiology 08 Warehouse 2. Sub department, Oral Solid Liquid & Cream Ointment Area Production Sterile Hormone Solid Hormone Injection Cephalosporin Sachet Vaccine Dialysis LVP Human resources The HR SOP in Pharma (HR department) of an organisation manages human resources and handles a variety of employment-related tasks, including hiring, interviewing, administering employee benefits, maintaining files with the necessary paperwork for future use, acquiring talent, and onboarding new hires. Quality Assurance. As its name suggests, this department takes care of ensuring quality standards are applied to raw materials, intermediate products, finished goods, operations, processes, staff and so on. o It is up to them to approve or reject raw materials, packaging materials, semi-finished goods and end products. o Managing the area’s documentation, drafting SOPs and drawing up Master Batch Records. o Handling Deviations, Investigations, CAPAs and Change Controls. o Coordinating a multi-discipline team to write Product Quality Review (PQR) reports. o Handling claims and technical enquiries. o Taking care of delivering training on Introduction to GMPs and Standards for document completion. o Conducting Risk Assessments. o Introducing process improvement points (KPIs) and adverse impact indicators (rework and claims), compliance with plans. o Managing and conducting internal and/or external audits. o Drawing up and managing the Site Master File. o Defining and monitoring Plant Quality indicators. Quality Control. In charge of microbiological, physical-chemical and biological control of raw materials, intermediate goods and finished goods, as well as assessing end product stability. The activities they undertake include: o Controlling and managing formal stability and in-process stability studies. o Emitting stability protocols and/or any related documentation. o Design activities, monitoring tests and conducting an initial assessment of analytical results. o In terms of stability, collaborating with and supporting developments, technology transfers, etc. o o o Conducting physical-chemical analyses to monitor stability in specialities both on the market and under development, using mainly the following analytical techniques: HPLC, GC, DSC, CCF, IR and UV spectroscopy, etc. Controlling the physical-chemical properties of Raw Materials, In-Process Products and End Products. Checking the microbiological analyses carried out on products (TYMC, TAMC, counts), production and cleaning waters, and room air monitoring. o Inspecting related documentation (growth promotion test, identifications, autoclaves). o Taking part in lab equipment validation and qualification. o Assessing pharmacopoeia review changes. Procurement o o o Preparing the annual Procurement budget and analysing expenses. Identifying which suppliers offer the highest value in each case, constantly coming up with alternatives, anticipating requirements, monitoring prices and tracking trends to finalize orders at the right time. Supply o o Defining policies and procedures. Planning purchases with other departments to keep up the best ratios between sales, stock levels and number of options per work centre or department. Ensuring optimal stock levels at each warehouse to secure the plant’s production processes and customer orders. Coordinating, supervising and programming department projects to meet deadlines Transport y logistic o Ensuring that all deliveries arrive on time. o Selecting and dealing with service providers and suppliers, and negotiating product and service agreements. o Taking care of balancing prime material shipment costs and contacting logistical operators to solve any Global Presence Of Popular Pharmaceuticals PLC Popular Pharma is already supplying products to the following markets & try to enter other highly influencing Economy Top 5 Quality Management Goals for 2025 Now, let's delve into the 5 transformative goals that will shape your pharmaceutical company's quality management journey in 2025: South Asia Southeast Asia Africa Europe Latin America Thanks
