Defect clasification
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This document provides a classification of defects that can occur in pharmaceutical products. It defines a defect as an imperfection that causes a product to fail to meet specifications. Defects are classified based on their measurability (variable or attributive), seriousness (critical, major, or minor), and nature (ocular, internal, or performance). The document also discusses defect classifications used by the Pharmaceutical Quality System and the UK Medicines and Healthcare products Regulatory Agency, and lists some common root causes of deficiencies in a pharmaceutical quality system.
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This document provides an overview of intellectual property rights (IPR) and various types of IPR protections. It defines IPR as exclusive rights granted by states to protect inventions, designs, trademarks, and original works. The document then discusses key types of IPR protections including patents, trademarks, industrial designs, copyright, trade secrets, and geographical indications. It provides examples and details on requirements for each type. The document aims to educate about IPR and facilitate discussion on related topics.Analytical method validation 2020
Analytical method validation 2020PRANJAY PATIL
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This document provides a summary of analytical method validation. It discusses the types of analytical procedures that should be validated, including identification tests, quantitative impurity tests, limit tests, and active moiety assays. It also summarizes key validation characteristics that should be considered, such as accuracy, precision, specificity, range, detection limit, quantitation limit, linearity, and robustness. The document provides definitions and methodology recommendations for validating analytical procedures. It emphasizes that the validation process verifies that an analytical method is suitable for its intended purpose.Process anaytical technology
Process anaytical technologyPRANJAY PATIL
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This document summarizes a presentation on Process Analytical Technology (PAT). It defines PAT as a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality attributes during processing. The goals of PAT are to build quality into products, enhance process understanding and control, and reduce process variation. It discusses types of PAT implementation, applications of PAT in different process steps, advantages like reduced cycle time and human error, and disadvantages like high costs. It also covers the PAT regulatory approach and guidance.Plant layout
Plant layoutPRANJAY PATIL
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This document discusses plant layout for pharmaceutical manufacturing facilities. It begins by defining plant layout and its importance for efficient production. There are two main types of layouts: process/functional layout which groups similar machines together and product/straight line layout which arranges machines in the order of operations. Key factors that influence layout include the production process, available space, operational convenience, and regulatory requirements. Special provisions for pharmaceutical facilities include preventing confusion or contamination. Storage areas for raw materials and finished goods are also discussed, including specific storage requirements. The document concludes by outlining the layout of sterile or aseptic manufacturing areas which separate different operations and control air flow and personnel movement to maintain sterility. production planning
production planningPRANJAY PATIL
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This document discusses various aspects of production planning and control in the pharmaceutical industry. It defines key terms like production planning, routing, loading, scheduling, dispatching. It describes the importance of production planning for procuring raw materials and tools in a timely manner. It explains different types of production systems like continuous, intermittent, batch production. Overall, the document provides an overview of the production planning and control process in the pharmaceutical industry.Quality assurance tools & techniques
Quality assurance tools & techniquesPRANJAY PATIL
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This document discusses concepts of quality assurance in the pharmaceutical industry. It begins with definitions of quality assurance from WHO and ISO. It then discusses the concept of quality assurance, covering all aspects that influence drug quality. Advantages include ensuring high quality drugs while disadvantages include perfection being difficult. Quality assurance tools discussed include total quality management, quality control systems, documentation, validation, and Six Sigma methodology. Total quality management aims to continuously improve quality through participation at all levels. Quality control systems involve qualified staff and standardized procedures. Documentation and validation are important for defining systems and ensuring quality. Six Sigma uses a data-driven approach to reduce defects and improve processes.Standard operating procedure 
Standard operating procedure PRANJAY PATIL
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This document provides guidance on standard operating procedures (SOPs). It defines SOPs and discusses their purpose and benefits. Key points include:
- SOPs are written instructions that document routine activities and ensure consistency. Their development is integral to a successful quality system.
- SOPs should describe technical and operational elements, and be specific to each organization. They facilitate adherence to requirements and support data quality.
- The document outlines best practices for SOP content, writing style, preparation, review, revision, formatting, and types. It emphasizes clear, step-by-step instructions to ensure consistent implementation.Packging material 
Packging material PRANJAY PATIL
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This document discusses pharmaceutical packaging materials and quality control testing. It defines primary, secondary, and tertiary packaging. Common materials used include glass, plastic, rubber, and paper. Quality control tests are described for glass including powdered glass and water attack tests. Plastic container tests include leakage, collapsibility, water vapor permeability, and transparency. Rubber closure tests include fragmentation, self-sealability, extractive, and compatibility testing. Proper packaging protects pharmaceutical products and quality testing ensures the materials are suitable for drug products.Recently uploaded (20)
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- Autonomy, Teams and Tension
- Oliver Randall & David Bovis
- Own Your Autonomy
Oliver Randall
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Oliver is a career project professional since 2011 and started volunteering with APM in 2016 and has since chaired the People Interest Network and the North East Regional Network. Oliver has been consulting in culture, leadership and behaviours since 2019 and co-developed HPTM速an off the shelf high performance framework for teams and organisations and is currently working with SAS (Stellenbosch Academy for Sport) developing the culture, leadership and behaviours framework for future elite sportspeople whilst also holding down work as a project manager in the NHS at North Tees and Hartlepool Foundation Trust.
David Bovis
Consultant, Duxinaroe
A Leadership and Culture Change expert, David is the originator of BTFA and The Dux Model.
With a Masters in Applied Neuroscience from the Institute of Organisational Neuroscience, he is widely regarded as the Go-To expert in the field, recognised as an inspiring keynote speaker and change strategist.
He has an industrial engineering background, majoring in TPS / Lean. David worked his way up from his apprenticeship to earn his seat at the C-suite table. His career spans several industries, including Automotive, Aerospace, Defence, Space, Heavy Industries and Elec-Mech / polymer contract manufacture.
Published in Londons Evening Standard quarterly business supplement, James Caans Your business Magazine, Quality World, the Lean Management Journal and Cambridge Universities PMA, he works as comfortably with leaders from FTSE and Fortune 100 companies as he does owner-managers in SMEs. He is passionate about helping leaders understand the neurological root cause of a high-performance culture and sustainable change, in business.
Session | Own Your Autonomy The Importance of Autonomy in Project Management
#OwnYourAutonomy is aiming to be a global APM initiative to position everyone to take a more conscious role in their decision making process leading to increased outcomes for everyone and contribute to a world in which all projects succeed.
We want everyone to join the journey.
#OwnYourAutonomy is the culmination of 3 years of collaborative exploration within the Leadership Focus Group which is part of the APM People Interest Network. The work has been pulled together using the 5 HPTM速 Systems and the BTFA neuroscience leadership programme.
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Defect clasification
- 1. Defect Classification PRESENTD BY :- PATIL PRANJAY SADASHIV. FIRST YEAR M.PHARM. DEPARTMENT OF QUALITY ASSURANCE. H. R. Patel Institute of Pharmaceutical Education and Research, Shirpur
- 2. Defect Classification WHAT IS A DEFECT Imperfection Shortcoming In the- Quality Quantity Potency Purity Or Standards Which is required to be maintained -Undesirable characteristics of a product due to its failure in conforming to the standard set of specification.
- 3. WHAT IS A DEFICIENCY ? Fault Imperfection Shortcoming Or Inadequacy In the- Quality Standard and Manner of performance Which is required to be maintained by or under any law for the time being in force
- 4. 1. According to its MEASURABILITY a. Variable defect can be measured by instruments - length, weight, height, thickness, concentration volume, viscosity, pH b. Attributive defect can be measured directly by inspection - detects odor, and visual examinations like color, clarity, cleanliness, smoothness, taste and presence or absence of a characteristics.
- 5. 2. According to SERIOUSNESS OR GRAVITY a. Critical defect endanger life or property & may render the product non-functional. - absence of warning in label, disintegration time of an analgesic b. Major defect affect the function of the product and render the preparation useless. - crack in the bottle, caking of an emulsion c. Minor defect does not endanger life nor affect the function of the product. - discoloration of the label or box
- 6. 3. According to NATURE a. Ocular defect a visible defect - foreign particles contamination b. Internal defect a defect that is not seen - a sub-potent drug product c. Performance defect a defect in function - suppository that does not melt at body temperature
- 7. PQS- Pharmaceutical Quality System Vs GMP Compliance MHRA groupings of Deficiency- 1. Quality Management 2. Production 3. Material Management 4. Premises and Equipment 5. Quality Control 6. Validation 7. Regulatory Compliance 8. Personnel
- 9. Root Cause of PQS deficiency