Bpr in pharmaceutical industry slideshare. Jan 7, 2021 · 1.

Bpr in pharmaceutical industry slideshare CONCLUSION • In the pharmaceutical industry, data integrity play an important role to maintain the quality of product as well as patient safety. • Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug 38 CO. Batch packaging records (BPRs) are an essential part of the pharmaceutical industry. 13 Roll of film/foil are issued in terms of whole roll(s) in excess of quantity of BPR and such total quantity is recorded in BPR. It is a multi-step compaction process comprising of following steps THE PHARMACEUTICAL INDUSTRY IB6033 IB6033 Pharmaceutical Industry by KENNETH RODRIGUES is licensed under a Creative Commons Attribution 4. ALCOA A: Attribute; L: Long lasting; C: Contemporaneous; O: Original; A: Accurate 21 CFR Part 11: Electronic records and electronic signatures must control the 2. “These are the slides from before our last 11. 1. Axial length can be defined as the distance between the centers of the two atoms. What does “essentially free” or “practically free” mean? The goal is the production of product free of visible particles. Crystal systems or forms A finite number of symmetrical arrangement are possible for a crystal lattice and these are termed as crystal forms or systems. Scale-up:- The art for designing The document describes various types of equipment used in the pharmaceutical industry. It notes that production planning and control aims to structure plant activity for increased and coordinated production through optimal resource utilization and cost control. In addition, it discusses additional quality - related responsibilities that may result when manufacturers move toward a quality systems approach 12. 0 ABBREVIATIONS USED IN SOP FOR BMR, BPR REVIEW: AR. aspaglobal. World medical 3. Functions (active drug targeting, on-command delivery, intelligent drug release devices/ bioresponsive triggered systems, self-regulated delivery systems, systems interacting with the body, smart delivery) 6. Pharm Sem -II Presentations PROCESS AUTOMATION IN PHARMACEUTICAL INDUSTRY SUBMITTED TO SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE FOR PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF MASTER OF PHARMACY IN THE SUBJECT Pharmaceutical Manufacturing Technology IN THE FACULTY This document provides an overview of the key departments and functions within the pharmaceutical industry. - This requires a well designed and run manufacturing and inspection processes. 63] • Software must be validated [§211. • It includes batch size, date of manufacture and full signature by 1st person and further independently checked, dated and signed by 2nd person. Physicochemic- al properties pH of aqueous solution, melting point and refractive index. Depending upon the axial This document discusses ethics in the pharmaceutical industry. Food and Drug Administration (FDA) increase regulation of pharmaceutical industries and to limit financial links between companies and prescribing physician. Automation & Computerization BPR Just-In-time TQM 1940s – 50s 1960s – 70s Late 90s 1980s 1990s then evolved Only LSS goes beyond the traditional continuous improvement methods to a long-term change in organizational culture. Bifurcation of the product (If batch is intended to be packed in more than 4. • BPR aimed to help organizations fundamentally rethink how they do their work in order to dramatically improve customer service, cut operational costs, Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up Read less Read more 1 of 23 Pharmaceutical manufacturing involves the industrial scale synthesis and processing of drug products. 1081/E-EPT- 100200043 3. Applicability As far as pharmaceutical development is concerned, the GLP Principles, in their regulatory sense, apply only to studies which: • are non-clinical, i. • Also we can use Corrections Sheet Documentation in pharmaceutical industry - Download as a PDF or view online for free BATCH FORMULA RECORD BPR is a documentation which shows that significant manufacturing processes and in- process controls Documentation in pharmaceutical industry - Download as a PDF or view online for free By this master document BMR and BPR prepared. PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL - Download as a PDF or view online for free 33 • Significant Elements Of Production Management In Pharmaceutical Industry: Application of quality by design in the current drug development: Asian journal of pharmaceutical sciences 12 (2017) 1–8. o Involves applications of information, imagination and initiative in deriving greater or different values from resources. Innovative new products are the fuel for the most powerful growth engine you can connect to. e. In the crystal, the angle between two perpendiculars to the intersecting faces is termed as the axial angle. Traditionally, pharmaceutical industries use paper to maintain Batch Records like Batch Manufacturing Records (BMR), BPR, • BPR Review Checklist - to guarantee that the BPR review is comprehensive and documented. It provides examples of unethical behavior by pharmaceutical companies, such as experiments on human subjects without proper consent and misleading drug advertisements. The issued BMR/BPR are received REFERENCES 1) Bedi Neena et al. Make entry of issuance in ‘BMR/ BPR Control Register’ and take receivers signature into register. PREPARATION FOR AN AUDIT • Once an audit is scheduled, the manager should engage in several proactive steps in preparation for the audit. Benefits of a PDP: • Provides clear guidance 45. Open source drug delivery (OSDD) focuses on collaborative effort to achieve breakthroughs in the world of medicines and bringing down cost Bpr examples from indian corporate world - Download as a PDF or view online for free IMPLEMENTING BPR IN ICICI BANK Company Profile: ICICI Bank (formerly Industrial Credit and Investment Corporation of India) is a major banking and financial services organization in India. Change control is the system to implement this approved change to The purpose of having a detailed and accurate BPR is to ensure that all products meet current Good Manufacturing Practices (cGMP). Introduction • This presentation describes outlines and discusses the regulations applicable to the QA function and unit, structure, function and application of the unit in the pharmaceutical manufacturing environment. Attempts were made by the U. 0 International License. External Audit- External Audit ( 2ndParty): (A second party audit is one that is carried out by a non- regulatory auditor). Master Batch Record also known as MFR QA Head shall be responsible for final approval of master BMR/BPR as well as compliance of SOP. New opportunities, e. Water is the most commonly used raw material in pharmaceutical The duration of each BPR project varies from 6 -to 10 months. INTRODUCTION • Discovery, development, production and 4. 25 Records_ It is final part in documentation system. Any threat to product quality across the supply chain needs to be considered in the 7. Test 1. PROCESS AUTOMATION IN PHARMACEUTICAL INDUSTRY : It means the use of machines and equipments for performing physical and mental operations in a production process in place of human being. Purpose The purpose of this procedure is to establish uniform requirements and guidelines utilizing a risk-based systems approach for • Preparation • Review • Approval. Self Inspection & Internal Audit 3. Pilot Plant:- It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture. • Maintenance and • Archiving of • A controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Operational Excellence in Pharma Industry - Download as a PDF or view online for free. • It is 10. • With the rise of 21st century technologies, this has been Jan 7, 2021 · 1. : Analytical Report Number; ADD: Analytical Development Department; BMR: Batch Manufacturing Record; BOM: Bill of Material; BPR: Batch Packing Record; COA: Certificate of Analysis; Dept Documentation in Pharmaceutical Industry - Download as a PDF or view online for free By this master document BMR and BPR prepared. 5. 100% inspection (human or machine) is documentation in pharmaceutical industry, master formula record (MFR), DMF (drug master file), distribution records, generic drugs product development, hatch waxman act, CFR (code of federal regulation), drug 16. APQR 4. com 3. for the delivery of cytokines to control cellular growth 1. Journal of Intellectual Property Rights; Vol 18, March 2013, pp 105-110 2) Janodia D. • A process of maintenance and assurance of accuracy and consistency of the 4. INTRODUCTION • Discovery, development, production and 35. 14 At the end of each specific packing of a batch or part-batch, the printed components and product will be tallied by the packing supervisor/ 1. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must They are represented by SOPs in pharma industry. The left over is returned back to warehouse properly labeled and packed with “Good Return Note”. This thesis investigates the use of Business Process Reengineering (BPR) as a change approach in the Pharmaceutical Industry. Indian * Came into existence in 1988 * Fourth largest pharmaceutical company and is the leader in the CVS segment * Has grown primarily on acquisitions, mergers and alliances in the last 15 years Foreign * Merged with Global Bulk Drugs and Fine Chemicals (India) in 2003 * Acquired Pfizer’s custom manufacturing plant located in Morpeth (UK) * NPIL Pharmaceutical Industrial training ppt. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K. R. INTRODUCTION • “If it's not written down, then it didn't happen” • Document is any written statement or proof of any activity in pharmaceuticals. It also outlines the responsibilities of key personnel like heads of production and quality A Batch Manufacturing Record (BMR) is an essential document in pharmaceutical production, providing a detailed record of every step involved in manufacturing a specific batch of a product. Traditionally the design & manufacturing of drug requires several years, lengthy clinical trials & huge costs. Swapnil is managing, leading & positively contributing in the area of documentation, systems set up and enhancements, quality assurance, auditing, validations, 13. • For instance, BPR HELLAS, using the RE-engineering 3. Provides details of appropriate quality, cost & time constraints. OVERVIEW • Business process re-engineering is a business management strategy, originally pioneered in the early 1990s, focusing on the analysis and design of workflows and business processes within an organization. Training Management 9. It is especially useful for making dense spherical pellets of uniform size and shape with high drug loading for controlled-release oral solid dosage forms. Statistical Modeling The new major challenge that the pharmaceutical industry is facing in the discovery and development of new drugs is to reduce the costs and time needed from discovery to market, while at the same time raising standards of quality. It provides details on 15 different pieces of equipment, including transdermal patch machines, linear vial washing machines, tablet filling and sealing machines, capsule manufacturing equipment, drying equipment like spray dryers and lyophilizers, and separation 2. Palli Cross, Chiyyedu, Anantapuramu, A. GREEN CHEMISTRY IN PHARMACEUTICAL INDUSTRY DEEPALI*, ARTI KORI, URMI CHAURASIA Department of Pharmaceutical Science, Sardar Bhagwan Singh Post Graduate Institute of Biomedical Science & Research, Balawala Dehradun,Uttarakhand- 248161 INTRODUCTION Green chemistry is an innovative technique involving design of chemical Nov 12, 2021 · RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K. o Conducting raw materials analysis using appropriate test methods and successfully meeting the challenges of such testing can prevent costly production problems and delays. • The pharmaceutical companies are generally dealing in generic or brand medications and medical device. in the field of bio-technology, price pressure from governments, insurances and through generic products have created a 5. Content structure”, one manager says and puts a slide on the OH-projector. ABOUT TRAINER(MR. Pharm Sem-I Presentations Return And Recall,Vendor Qualification SUBMITTED TO SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE FOR PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF MASTER OF PHARMACY IN THE SUBJECT Pharmaceutical Quality Assurance IN THE FACULTY OF SCIENCE AND TECHNOLOGY The document discusses intellectual property rights as they relate to the pharmaceutical industry. Nanoparticles for tissue engineering; e. 4. Now days computer tools used in the formulation and development of pharmaceutical product. It should be available for each product, batch and pack size. piramalpharmasolutions. It also outlines ethical behaviors like integrity, transparency, and prioritizing patient care. www. • Pharmaceutical companies may deal in generic or brand 5. Pharmaceutical Updates was started to share knowledge among the pharma professionals & it will become 9. Control should be practiced rigorously. The firms which want to implement TQM effectively must have a patience These regulations are made by the regulatory agencies across the world, ensure the quality of products that are made by organizations in their industry. The FDA uses the acronym ALCOA to define its expectations of electronic data. It describes the roles of production, quality control, quality assurance, engineering, regulatory affairs, and clinical research organizations. 4 Many pharmaceutical organisations are able to eliminate waste and affect change in the manufacturing process by implementing six sigma. 4 2. Various technique, such as design of experiment are implemented for optimization of formulation and processing parameter. SWAPNIL KARALE) Mr. • Issuance. COPP,SMF 8. Issuance and receipt of packaging and labeling materials. Click to edit Master title style 8 Product Development Plan (PDP): 8 • The overall process of strategy, organization, concept generation, product and marketing plan creation and evaluation, and commercialization of a new product . No. analytical method development – • it is a process whose main purpose is to prove any analytical method in pharmaceutical industry suitable in api measurement, method & development is the process of proving that an Raw Material’s Testing o Raw materials testing ensures that the raw materials used in pharmaceutical products are suitable for their intended use. The quality, safety, and efficacy of the goods at higher levels are the key concerns of the pharmaceutical sector legislation and regulations. S. Evolution of pharmaceutical industry 4 1970- 1990 • Patent act 1970 • Domestic companies • Production and export initiative taken 1990- 2010 • Operations in foreign countries • Liberalized market • Generic drug 2010 • Nppp-2012 • Patent filling by pharma players • Kam and cso • (key account management) • (contract sales organization) 2010- 2015 • Price reduce to INTRODUCTION SOP – AIM FOR QUALITY Standard Operating Procedure is a set of step by step written instructions intended to document how to perform a routine activity. o Before finished pharmaceutical dosage 4. IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. Integral part of QUALITY ASSURANCE (QA). pptx - Download as a PDF or view online for free /designee shall initiate the BPR REQUISITION FROM” based upon the packaging schedule and send to QA for issuance BPR. INTRODUCTION Formulation and development is a process of selection of component and processing. Regulatory innovations in pharmaceutical industry 2. mostly studies on animals or in vitro, including the 2. During packing process check and sort out the Tablets for spots, black The details of issued BMR and BPR shall be recorded in the BMR/BPR issuance record as per Annexure-V and the signatures of receiving production officer/executive shall be taken as receipt of the same. 63] • Any calculations used must be verified [§211. For example, in some industries, especially pharmaceuticals and chemicals, customers and potential customers will often ask to visit a company :-- -to ensure they are operating according to a quality system and hence will provide Electronic Data Data has never been easy to manage and is especially true in pharmaceutical industry. 160(b), §211. P- 515721 Introduction 3 • High-quality water is essential for the manufacturing of pharmaceuticals. Drug discovery involves the research and development of new drug molecules and takes 3-6 years at a cost of $0. • A process of maintenance and assurance of accuracy and consistency of the Apr 24, 2013 · This thesis investigates the use of Business Process Reengineering (BPR) as a change approach in the Pharmaceutical Industry. IPQC IPQC stands for “In Process Quality Control”. This Quality Standard describes the requirements for the preparation, generation and approval of new or revised Packaging Masters and Batch Packaging Orders. Generally, a normal contact voltage passes through the electrodes to analyze. 5-1 million. In case, there is more than one AR No. It is a master document for any pharmaceutical Controlled copy of BMR/BPR document is issued by QA Chemist or above for particular batch. P- 515721 Design qualification (DQ) Based on the URS supplier designs the equipment • This is the 1st step in the qualification of new water supply system. It is a planned system to identify the materials, equipments, processes and operators. Records of critical steps must be reviewed and approved by quality before release. 24 25. Manthan et al. Particle size For some new drug substance intended for use in solid or suspension drug product, particle size have a significant effect on dissolution rates, bioavailability, and/ or stability. Submit Search. It defines intellectual property rights as statutory rights that grant creators exclusive commercial exploitation of their work for a period of time. com 6 The Authentication Times Issue 26 There has been a wave in the global pharmaceutical industry over the past several years, driven by the need for battling the scourge of spurious medicines, which take thousands of lives each year. It is the 4th largest bank in India and the largest private sector 1. Polymeric form Some new drug substances exist in different crystalline form 27. of any Packing material, attach a specimen sample of each to BPR. • The basic rules in any good The objectives of BPR review are to confirm the batch quality and was produced under control. The DMF provides confidential, detailed information about facilities, process or articles used in the manufacturing, packaging, storing This process is commonly used in the pharmaceutical industry to make uniformly sized spheroids roughly 1 mm in diameter. Impact of Patents in Pharma Industry’s Competency: A viewpoint of Pharmaceutical Companies of India; Journal of Intellectual Property 5. Qualification 6. It can be done at various levels of manufacturing system, handling of raw materials, semi- finished goods or finished goods during production process (efficient 2 machines are 6 AI in field of Pharmacy • It is one of the top technologies shaping the future of pharmacy. • The important aspect of BPR (what makes BPR, BPR) What is Batch Packing Record (BPR) Batch Packing record is a written document of the batch from dispensing to dispatch stage which tells about the procedure and step wise instruction to be followed during the Packing of each batches. PHARMACEUTICAL MICROBIOLOGY Pharmaceutical microbiology is the combined field of Microbiology and Pharmacy, wherein study of microorganisms that are related to production of antibiotics, enzymes, 13. Failure to comply with cGMPs can render The pharmaceutical industry is classified into drug discovery and manufacturing groups. 68(b)] • Data generated Batch Packaging Record (BPR) Once the medicine is manufactured, the BPR takes over. BMR –BPR 5. Meeting regulatory compliance requirements is important for 4. . 2. Batch packaging records are critically important in the pharmaceutical industry because they help ensure compliance with cGMP standards as well as provide manufacturers with a way to trace back defective batches BPR, pharmaceutical industry, clinical R&D English Gothenburg Studies in Informatics, 185 pages Report 26, April 2003, ISSN 1400-741X. MASTER BATCH RECORD 1. 19. Gandhi A, Roy C; Quality by Design (QbD) in 8. If the pharmaceutical industry cannot find a solution to reduce both costs and time , then its whole business model 35. In the enzymatic reaction which produces the substrate or product can transfer the electrons with the surface of electrodes to 12. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Master Batch Record also known as MFR (Master Formula/Mfg Record). This document is meticulously prepared during the manufacturing process, capturing actual data, instructions, and outcomes for each stage, from raw material issuance to final packaging. He starts explaining, but is suddenly interrupted by one of his colleagues. The changes proposed and made in any procedure or process should be reviewed, established, documented and approved by the concerned authorities. The document discusses production planning and control, outlining key concepts like planning, routing, scheduling, loading, dispatching, follow-up, inspection, and corrective measures. Drug Master File (DMF): Document prepared by a pharmaceutical manufacturer and submitted solely at its description to the appropriate regulatory authority in the intended drug market. Imagine it as the instructions for proper packaging and printing of the details on the packages. electronic current determination as a reaction of the enzyme-catalyzed redox reaction. The pharmaceutical industry is undergoing profound changes. Polymeric form Some new drug substances exist in different crystalline form innovations in pharmaceutical industry 2. STANDARD OPERATING PROCEDURES (SOP’S) A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. • The pharmaceutical industry discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medications. The Biosensors are based on the movement of the electron, i. INTRODUCTION International organization for standardization (ISO) defines the audits as "Systematic, independent and documented process for obtaining audit evidence and evaluating them objectively to determine the 4. The document outlines various types of intellectual property protections including patents 8. Plant:- It is a place were the 5 M’s like money, material, man, method and machine are brought together for the manufacturing of the products. TREY research 5 CHANGE CONTROL In pharmaceutical industry change control is an important part of quality assurance. The responsibilities either its professional, social , legal, one that the rest with the pharmaceutical manufacturing for the assurance of quality. g. INTRODUCTION • The India Pharmaceutical Industry is developing, producing and marketing drugs. Identification and mitigation of risks associated with each business unit / function is an important component of proactive management. BACK BONE of pharmaceutical industry. Mixing An operation in which two or more components (in a separate or roughly mixed condition) are treated so that each particle lies as nearly as possible in contact with a particle of each of the other ingredients. Pharmaceutical Industry Developments Overview- • The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered (or self-administered) to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. • Is it a financial or Feb 26, 2022 · 13. Activity #2: Map and Analyze As-Is Process • Before the reengineering team can proceed to redesign the process, they should understand the existing process. Attach the verified specimen to the BPR. There is no regulatory requirement to file a DMF. 3. Determine impurity level in relevant batches1 Acceptance criterion = A or B (as appropriate) Is impurity also a degradation product? Is A or B greater than the qualified level? Acceptance criterion = qualified level or 5. • Master production and control records: • Detailed written instructions including all operations starting from dispensing of raw materials till finishing of bulk products and packaging operation of the particular product. ETHICS IN PHARMACEUTICAL INDUSTRY New innovation (1960s) The industry expanded rapidly in the sixties, benefiting from new discoveries. Patenting and R&D in Indian Pharmaceutical Industry: Post- TRIPS Scenario. o Involves applications of information, imagination and initiative 3. - Inspection should not be a sorting process used to remove high quantities of unacceptable product. o It includes all processes by which new idea generated and converted into useful THE PHARMACEUTICAL INDUSTRY IB6033 IB6033 Pharmaceutical Industry by KENNETH RODRIGUES is licensed under a Creative Commons Attribution 4. • The manager should understand the purpose of the audit. Process Validation 7. Pharmaceutical companies may deal in generic or brand medications and medical devices. This variation relates to the kind of business and the extend to which BPR is going to be implemented. President of India APJ Abdul Kalam suggested concept of open source, introduced by CSIR (Council of Scientific and Industrial Research). M. GMP Regulatory Requirements for Data Integrity Derived from the laboratory data integrity definition and the applicable 21 CFR 211 GMP regulations there are some of the following points: • Instruments must be qualified and fit for purpose [§211. IPQC tests are performed at regular intervals Pharmaceutical patent - Download as a PDF or view online for free. 17. Virus-like systems for intracellular delivery 7. Any drugs that are manufactured or distributed must have detailed and accurate In the pharmaceutical industry, there are various types of data that are needed to be recorded. Six Sigma Applications in Pharmaceutical Industries 5. INNOVATION o Defined as the idea which must be replicable at an economic cost and must satisfy specific need. This wave has led to the evolution of technology to help regulators ensure that only genuine medicines 10. Key steps include active pharmaceutical ingredient (API) synthesis, combining APIs and excipients, and processing the mixture into solid oral dosage forms like tablets through unit operations such as milling, blending, granulation, drying, compression, and This thesis investigates the use of Business Process Reengineering (BPR) as a change approach in the Pharmaceutical Industry by investigating two change initiatives under the label of BPR. Lean Six Sigma 10/35 References • EU Good Manufacturing Practice (GMP) Guidelines, Volume 4 of “The rules governing medicinal products in the European Union” • US FDA current Good Manufacturing Practice (cGMP) for finished pharmaceuticals, 21 CFR, 210 and 211 • WHO Good Manufacturing Practices for pharmaceutical products, Annex 4 to WHO Technical Report Pharmaceutical industry - Download as a PDF or view online for free. Total quality management encourages participation amongst ,employees ,managers ,and organizations whole. • Pharma industries has been developing cure & treatment for centuries. Encyclopedia of Pharmaceutical Technology DOI: 10. It contains evidences and proofs that quality policy, work instructions and procedures have been 1. Encylopedia of Pharmaceutical Technology : James Swarbrick , James C Boylan : Volume 1, 3rd edition : Technology Transfer Considerations for Pharmaceuticals – Page No: 3717- 3725. 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