This document outlines the process for handling pharmaceutical product complaints. It defines a complaint and discusses the need for proper complaint handling procedures. It classifies complaints as critical, major, or minor and describes the 4 main steps to handling complaints: receiving complaints, technical investigation, corrective and preventive actions/feedback, and trend analysis/reporting. Key aspects of each step like documentation, sampling, testing, reporting, and record keeping are described. Regulatory guidelines for complaint management are also provided.
The document discusses complaint handling and product recalls in pharmaceutical companies. It defines a complaint as an expression of customer dissatisfaction and explains the need for an effective complaint handling system to improve quality, maintain regulatory compliance and build customer relationships. It outlines the objectives, responsibilities and types of complaints, as well as the steps to handle complaints which include receiving, investigating, implementing corrective actions, providing feedback and reporting. The document also defines and discusses the objectives, classification, strategy and procedures for conducting an effective product recall.
This document presents a case study about colored spots appearing on tablets during production. An investigation found that the spots were caused by an interaction between trace impurities in a new talc batch and the tablet press's oil-based lubricant, exacerbated by worn dust cups. Corrective actions included replacing the dust cups, switching to a grease-based lubricant compatible with talc, training personnel, and documenting the investigation and corrective actions. The root cause was issues with the tablet press operation interacting with the talc ingredient.
A Detailed Study on Pharmaceutical Drug RecallTeny Thomas
1. A drug recall is a process of removing a pharmaceutical product from distribution due to defects, adverse reactions, or counterfeiting concerns.
2. The objectives of a drug recall are to stop distribution and sale of the affected product, notify relevant parties, efficiently remove the product, and implement corrective actions to prevent future recalls.
3. Recalls are classified by the CDSCO as Class I, II, or III depending on the health risks posed by the defective product. A recall strategy and team must be in place to effectively execute any necessary recalls.
Quality control test for packaging material ,qc test for glass,metal,rubberKunalPatel257
This document describes quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It provides details on tests for glass, plastic, and metal containers to evaluate properties like chemical resistance, leakage, hydrolytic resistance, and thermal shock resistance. Tests for closures examine sterility, fragmentation, self-sealability, pH, and absorption. Secondary packaging materials are tested for moisture content, folding endurance, air permeability, tensile strength, and burst resistance. The document provides testing methodologies and acceptance limits for ensuring packaging integrity and suitability for drug products.
This document discusses complaints and recalls procedures for pharmaceutical products. It outlines the objectives of complaint handling, defines complaint procedures and classifications of defects. Critical defects pose life-threatening risks and require immediate action. Major defects present some risk to patients and require batch recall within days. Other defects have minimal risks. Recall procedures include designating an authorized person to manage the recall according to a standard operating procedure and maintaining distribution records to effectively recall affected products.
1. The Production Head is responsible for manufacturing operations while the QC Head approves materials and finished products. They share responsibilities like monitoring suppliers and environment.
2. Personnel must be trained on technical and cGMP aspects of their work. Training is required for those working in clean areas or with hazardous materials. Training must be done regularly and effectiveness assessed.
3. Personnel must be free of contagious conditions and undergo health exams. Precautions include proper protective clothing, hygiene practices like hand washing, and keeping ill personnel away from products.
Premises - Part of Good Manufacturing PracticesTeny Thomas
This document discusses good manufacturing practices for pharmaceutical premises. It covers factors to consider for location, design, construction, sanitation, maintenance, utilities, and environmental control of premises to prevent contamination. The premises must have defined areas for receiving, sampling, storage, production, packaging, and quality control. Cleaning procedures and environmental monitoring programs are important to control contamination. Grade A or B areas for sterile products require additional controls like air quality standards and maintenance of sterile conditions.
This document provides an overview of equipments and raw materials used in pharmaceutical manufacturing. It discusses the selection, purchase specifications, maintenance, and storage of both equipments and raw materials. Key points covered include cleaning and calibration of equipments, purchasing raw materials from approved vendors against specifications, and storing materials under proper conditions to prevent degradation.
The document provides an introduction to ICH guidelines and stability testing guidelines. It discusses that ICH aims to harmonize technical requirements for pharmaceuticals across regions to eliminate unnecessary delays and ensure safety. ICH has six participants representing regulatory bodies and industry. Guidelines are developed on quality, safety, efficacy and other topics. Quality guidelines (Q series) focus on chemical and pharmaceutical quality assurance. Stability testing guidelines provide guidance on conducting stability studies to ensure quality, safety and efficacy of drug products over time under various environmental conditions.
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
QUALIFICATION & VALIDATION.Validation is an essential part of GMP, and an element of QA.Critical steps in the process need to be validated.Need for confidence that the product will consistently meet predetermined specifications and attributes.
This document discusses product complaints and recalls. It defines a complaint as any expression of dissatisfaction with a product. Complaints can come internally from production or quality control or externally from customers. Complaints are classified as critical, major, or minor depending on their severity and health risks. The document outlines guidelines for designating a person to handle complaints, investigating complaints, providing corrective actions and feedback, and analyzing complaint trends. It also defines and discusses the types and procedures for product recalls when serious quality issues are found.
Quality audits involve the systematic and independent examination of quality activities and processes to determine compliance with established standards. They can be internal or external. The presented document discusses the definition, purpose, types, procedures, and important aspects of quality audits for pharmaceutical companies. It provides an overview of audit planning, conducting audits, common difficulties found, and essential features of audit reports. The goal is to evaluate procedures, records, and operations to ensure they meet quality goals and identify any non-compliances or deficiencies.
General Principles of Analytical Method of Validation.pdfTamannaKumari8
Validation is the process of establishing documentary evidence demonstrating that a procedure, process, activity carried out in
testing and then production maintain the desirable level of compliance all stages.
The process of providing the analytical procedure is acceptable or its intended us.(ICH Q
GLP provides a quality system for non-clinical laboratory studies to ensure reliability of results. It aims to develop quality test data and avoid duplication through adherence to standards for organization, personnel, facilities, equipment, operation of studies and reporting. GLP was created by the FDA in 1978 and adopted internationally by organizations like OECD to facilitate acceptance of study data across regions.
Quality control test: Containers, Closures and Secondary packing materialsPranali Polshettiwar
This document summarizes quality control tests for containers, closures, and secondary packaging materials. It describes common materials used for each, such as glass, plastic, metal for containers and rubber, plastic, metal for closures. Key quality tests for containers include powdered glass test, water attack test, hydrolytic resistance test, and thermal shock test. Tests for closures include residue on evaporation, pH of extract, and sterility. Secondary packaging materials like paper and cardboard are also tested for quality.
This document discusses market complaints in the pharmaceutical industry. It defines a complaint and outlines different types of customers that complain, including meek, aggressive, high roller, chronic, and rip-off customers. Complaints are classified into A, B, and C types based on their severity, such as adverse drug reactions or major health hazards. The document also covers rules for handling complaints, including thanking customers, training staff, and setting up a logging and analysis process. It emphasizes that complaint handling is important for maintaining customer relationships and identifying manufacturing problems.
The document provides an overview of ISO 9000 and ISO 14000 standards for quality management and environmental management systems. It defines the International Organization for Standardization (ISO) and outlines the objectives and benefits of the ISO 9000 and ISO 14000 families of standards. The key elements and steps for registration and certification are also summarized for both ISO 9000 and ISO 14000.
This document outlines organization and personnel requirements for good manufacturing practices. It discusses that organizations must have sufficient qualified personnel to carry out tasks, with individual responsibilities clearly defined. Key personnel positions include the authorized person, head of production, and head of quality control. All personnel must receive training in GMPs initially and continuously. Personnel responsibilities include ensuring hygiene standards are followed.
This document discusses product complaint handling procedures. It defines a complaint and provides reasons for having a complaint handling process. It describes the types of complaints that may occur and the steps involved in handling complaints which include receiving the complaint, investigating it technically and through documentation, determining if it is confirmed or not, taking corrective actions and feedback to customers, and performing monthly reporting and trend analysis. It also discusses regulatory guidelines around complaint handling and provides an example standard operating procedure on complaint handling.
1. The document outlines the standard operating procedure (SOP) for handling product complaints at a pharmaceutical company. It describes the process for receiving, investigating, taking corrective actions for complaints, and generating monthly reports.
2. Key aspects of the SOP include categorizing complaints, timelines for investigation, using a product complaint data sheet to document details, conducting documentation-based and laboratory investigations, and providing feedback and corrective actions to customers.
3. Monthly reports analyze complaint trends to assess quantities and types of complaints received. This allows the company to improve product quality and maintain good customer relationships.
B PHARAM 6TH SEM
PHARAMACEUTICAL QUALITY ASSURANCE
COMPLAINT
Reasons
Types of Complaint
Steps involved in Handling of complaints
Product Complaint Data Sheet
Complaint Record
Regulatory Guidelines
SOP on Complaint Handling
RECALL
Reasons
Types of Recall
Recall Classification
Levels of Recall
How to Recall the Product?
How To Notify The Consumers?
Regulatory Guidelines
SOP on Product Recall
DRUG RECALL IN 2013 AND 2014
1. The document discusses procedures for handling complaints and product recalls in the pharmaceutical industry. It defines complaints, outlines standard operating procedures for complaint handling, investigation and corrective actions.
2. Recall procedures include classification of recalls based on health hazards, forming a recall team, developing a recall strategy, notifying customers, and terminating a recall once all affected products are removed from the market.
3. Key aspects of complaint handling covered are documentation of complaints, investigating complaints by analyzing customer and retained samples, determining if complaints are confirmed or non-confirmed, and providing feedback to customers.
The document discusses complaints procedures for pharmaceutical products. It defines complaints, lists types of complaints (critical, major, minor), and sources of complaints (internal, external, verbal, written). It outlines the steps to evaluate complaints - receiving, investigating, root cause analysis, handling, and recording. Key aspects covered are types of investigations, corrective actions, feedback to customers, monthly reporting and trend analysis, handling returned goods, and recall procedures.
This document discusses customer satisfaction, customer delight, and handling customer complaints. It defines customer satisfaction as meeting a customer's expectations, while customer delight is exceeding their expectations. Several key steps in the customer satisfaction process are outlined, such as understanding expectations, making promises to customers, fulfilling commitments, and conducting surveys. The document also discusses the benefits of effective complaint management for businesses and outlines the typical steps involved, from receiving complaints to conducting investigations and providing feedback. Overall, the document emphasizes the importance of prioritizing customers and using their feedback to continuously improve products, services, and the customer experience.
Presentation on customer focus / customer satisfactioon , customer delight and customer complaints handling. In a sense, customer service attains importance within the context of customer focus. In customer focus, the company puts great emphasis on customer success and customer happiness while customer service is one of the various activities to ensure customer happiness.Make the Effort to Follow-up. Some customer service situations require a follow-up contact. ...
Use Clear Language. It's easy to fall into the trap of using unclear language. ...
Do the Time Zone Math. ...
Anticipate Hidden Needs. ...
Use the Pre-Emptive Acknowledgement. ...
Take the Thank You Letter Challenge. ...
Take Action!
10 Steps to Create a Customer-Focused Culture
Define the culture. If you want to have a customer-centric culture, think about exactly what it should look like. ...
Communicate the culture. ...
Hire the right people. ...
Train your people right. ...
5. Make the training inclusive. ...
Be an example. ...
Empower employees to succeed. ...
Give recognition.
The orientation of an organization toward serving its clients' needs. Having a customer focus is usually a strong contributor to the overall success of a business and involves ensuring that all aspects of the company put its customers' satisfaction first.
Complaints in Quality Management SystemMayuriMore15
Complaints evaluation and handling, Investigation and Determination, CAPA and Return and Recall of products in Quality Management system in pharmaceutical or any industry.
Handling of Customer Complaint_Dr.A.AmsavelDr. Amsavel A
Reference Guideline
Definitions
GMP Requirement: 21 CFR § 211.198 and ICH Q7
Procedure for Handling of Complaints
Complaint Investigation
Remedial action and CAPA
Report preparation
Response to customer
Verification of CAPA effectiveness
Review of Complaints
This document discusses pharmaceutical quality assurance processes related to complaints and recalls. It defines a complaint and outlines the need for an effective complaint handling system. It describes how to evaluate complaints, including designating a person to handle complaints and maintaining proper records. Returned goods are also discussed, including how to classify, handle, and make decisions regarding returned products. The document then covers recall procedures, including classification of recalls and the recall process. It provides templates for recall documentation. Finally, it addresses proper waste disposal procedures for rejects and leftovers from production.
The document discusses the process of vendor qualification in the pharmaceutical industry. It defines what a vendor is and different types of vendors. It then describes the classification of vendors into categories based on risk and provides examples. The key steps in the vendor selection process are analyzed, including defining requirements, identifying candidates, evaluation criteria, vendor briefings and selection. Finally, the document outlines the procedure for qualifying new raw material and packaging material vendors, which includes sample testing, audits, approval and transferring to the permanent vendor list.
1. A drug recall is a process of withdrawing a pharmaceutical product from distribution due to defects, adverse reactions, or counterfeiting concerns. The recall can be initiated by the manufacturer or regulatory authorities.
2. The objectives of a drug recall are to stop distribution of the affected product, notify relevant parties, remove the product from the marketplace, analyze the root cause, and implement corrective actions to prevent future recalls.
3. Recalls are classified by the CDSCO as Class I, II, or III based on the health risk posed by the defective product, with Class I posing the greatest risk requiring the fastest response.
This document discusses procedures for handling market complaints and product recalls in the pharmaceutical industry. It begins by explaining that market complaints are serious issues that can damage a firm's reputation and inventory if not addressed properly. It then outlines the typical procedure for handling market complaints, which includes designating a department to investigate complaints, performing a root cause analysis, determining corrective actions, and documenting the process. The document also provides sample forms that can be used for investigating complaints and documenting recalls. It emphasizes that an efficient recall system is important to quickly remove unsatisfactory products from the market. Finally, it stresses the importance of properly addressing complaints and recalls to protect a firm's brand image.
This document discusses types of complaints regarding pharmaceutical products and the procedures for handling complaints and conducting product recalls. There are three main types of complaints: quality complaints, adverse reaction complaints, and other medically related complaints. All complaints should be documented in writing. Quality complaints are handled by quality control, while adverse reactions are reviewed by medical experts. Recalls are conducted when a product's quality is in question, with three degrees of recall depending on health risk. Procedures and documentation are required for complaint handling and recalls. Returned products must be properly stored, examined, and either reprocessed, destroyed, or have their disposition documented.
Complaints Management: Integrating and Automating the ProcessCognizant
Manufacturers of medical devices are highly regulated and serve various types of customers. Today, these companies can take advantage of a cloud-based, integrated platform, Cognizant's MedVantage(TM), to manage and resolve customer complaints and connect with them throughout the complaints-management life cycle.
1) Vendor qualification is the process used by finished dosage form manufacturers to approve vendors for active pharmaceutical ingredients (APIs) that will be used in products. It involves selecting vendors based on criteria like quality, delivery, price, and auditing them.
2) Vendors are categorized as A, B, or C depending on which tests they perform on APIs. Category A vendors perform all tests, B vendors are well-known and certified, and C vendors undergo full testing by the manufacturer.
3) The vendor qualification process determines if a vendor is suitable and can consistently supply quality APIs. It aims to develop long-term supplier relationships and ensure regulatory expectations are met.
The special measures that need to be considered in the
storage and distribution of product, such that the
products will be of the nature and quality intended
when it reaches the consumer
1. Dosage forms can be classified in several ways including by route of administration, physical form, sterility, and dose accuracy.
2. Common solid dosage forms include tablets, capsules, powders, and granules while common liquid forms include solutions, suspensions, emulsions, and elixirs.
3. Semi-solid dosage forms for external use include ointments, creams, gels, and suppositories which are administered via different routes such as oral, topical, rectal, etc.
The document discusses parenteral formulations, which are sterile dosage forms administered directly into the body rather than orally. It defines parenterals and describes various types including small and large volume injections, powders, and implants. Key factors in parenteral design are discussed such as drug solubility, vehicle selection, dosage form, ingredients, pH, and color. Common vehicles like water and buffers are outlined. The document also covers routes of administration, isotonicity, production facilities and procedures, and quality control testing for parenteral products.
HISTORICAL BACKGROUND & DEVELOPMENT OF PROFESSION OF PHARMACYTeny Thomas
The following presentation deals with what the course of pharmacy is and what a pharmacist is. Also a short brief on the historical growth of the profession of pharmacy when related to education and industry is also discussed here. A detailed view on career in pharmacy is described lastly.
A comprehensive interpretation of pellets based on their definitions, advantages, disadvantages, mechanism of pellet formation and growth, pelletization techniques, formulation requirements, and the equipment system for manufacture of pellets.
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
The document describes preparing and evaluating paracetamol granules using the wet granulation method. Key steps in the wet granulation process are outlined, including weighing and sifting powders, blending, wet granulation, drying, dry screening, and lubrication. Granules containing 500mg of paracetamol per tablet are prepared and submitted. The granules are then evaluated for bulk density, tapped density, Hausner's ratio, Carr's compressibility index, and angle of repose to determine flow properties before compression into tablets.
Hard gelatin capsules - a detailed studyTeny Thomas
The presentation involves a descriptive study on hard gelatin capsules which includes the production of the hard gelatin capsule shell, size of the capsules, capsule filling machines and the finishing techniques. The presentation also involves the special techniques of capsule formulation and the quality control tests of hard gelatin capsules
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
A detailed study on Tablets which describes about tablets, coating of tablets and then a study on the quality control of tablets. The chapter deals with the minute aspects of tablets and gives us an enlightenment of the solid dosage form which is commonly used all around the world
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
The document discusses preformulation studies, which involve characterizing the physical and chemical properties of a drug substance before developing a dosage form. The goals are to generate stability-indicating parameters and select an appropriate dosage form. Key topics covered include the physical properties tested (such as solubility, polymorphism, particle size), chemical degradation pathways (such as hydrolysis, oxidation), and how these properties influence dosage form design and drug performance. Understanding a drug's preformulation behavior is critical for developing a safe, effective, and stable drug product.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
A study on waste disposal in the pharmaceutical areas. the chapter deals with types of waste, how the waste is disposed, the procedure of waste disposale and the regulatory guidelines.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
Is Email Marketing Really Effective In 2024?Rakesh Jalan
Slide 1
Is Email Marketing Really Effective in 2024?
Yes, Email Marketing is still a great method for direct marketing.
Slide 2
In this article we will cover:
- What is Email Marketing?
- Pros and cons of Email Marketing.
- Tools available for Email Marketing.
- Ways to make Email Marketing effective.
Slide 3
What Is Email Marketing?
Using email to contact customers is called Email Marketing. It's a quiet and effective communication method. Mastering it can significantly boost business. In digital marketing, two long-term assets are your website and your email list. Social media apps may change, but your website and email list remain constant.
Slide 4
Types of Email Marketing:
1. Welcome Emails
2. Information Emails
3. Transactional Emails
4. Newsletter Emails
5. Lead Nurturing Emails
6. Sponsorship Emails
7. Sales Letter Emails
8. Re-Engagement Emails
9. Brand Story Emails
10. Review Request Emails
Slide 5
Advantages Of Email Marketing
1. Cost-Effective: Cheaper than other methods.
2. Easy: Simple to learn and use.
3. Targeted Audience: Reach your exact audience.
4. Detailed Messages: Convey clear, detailed messages.
5. Non-Disturbing: Less intrusive than social media.
6. Non-Irritating: Customers are less likely to get annoyed.
7. Long Format: Use detailed text, photos, and videos.
8. Easy to Unsubscribe: Customers can easily opt out.
9. Easy Tracking: Track delivery, open rates, and clicks.
10. Professional: Seen as more professional; customers read carefully.
Slide 6
Disadvantages Of Email Marketing:
1. Irrelevant Emails: Costs can rise with irrelevant emails.
2. Poor Content: Boring emails can lead to disengagement.
3. Easy Unsubscribe: Customers can easily leave your list.
Slide 7
Email Marketing Tools
Choosing a good tool involves considering:
1. Deliverability: Email delivery rate.
2. Inbox Placement: Reaching inbox, not spam or promotions.
3. Ease of Use: Simplicity of use.
4. Cost: Affordability.
5. List Maintenance: Keeping the list clean.
6. Features: Regular features like Broadcast and Sequence.
7. Automation: Better with automation.
Slide 8
Top 5 Email Marketing Tools:
1. ConvertKit
2. Get Response
3. Mailchimp
4. Active Campaign
5. Aweber
Slide 9
Email Marketing Strategy
To get good results, consider:
1. Build your own list.
2. Never buy leads.
3. Respect your customers.
4. Always provide value.
5. Don’t email just to sell.
6. Write heartfelt emails.
7. Stick to a schedule.
8. Use photos and videos.
9. Segment your list.
10. Personalize emails.
11. Ensure mobile-friendliness.
12. Optimize timing.
13. Keep designs clean.
14. Remove cold leads.
Slide 10
Uses of Email Marketing:
1. Affiliate Marketing
2. Blogging
3. Customer Relationship Management (CRM)
4. Newsletter Circulation
5. Transaction Notifications
6. Information Dissemination
7. Gathering Feedback
8. Selling Courses
9. Selling Products/Services
Read Full Article:
https://digitalsamaaj.com/is-email-marketing-effective-in-2024/
The Jewish Trinity : Sabbath,Shekinah and Sanctuary 4.pdfJackieSparrow3
we may assume that God created the cosmos to be his great temple, in which he rested after his creative work. Nevertheless, his special revelatory presence did not fill the entire earth yet, since it was his intention that his human vice-regent, whom he installed in the garden sanctuary, would extend worldwide the boundaries of that sanctuary and of God’s presence. Adam, of course, disobeyed this mandate, so that humanity no longer enjoyed God’s presence in the little localized garden. Consequently, the entire earth became infected with sin and idolatry in a way it had not been previously before the fall, while yet in its still imperfect newly created state. Therefore, the various expressions about God being unable to inhabit earthly structures are best understood, at least in part, by realizing that the old order and sanctuary have been tainted with sin and must be cleansed and recreated before God’s Shekinah presence, formerly limited to heaven and the holy of holies, can dwell universally throughout creation
How to Store Data on the Odoo 17 WebsiteCeline George
Here we are going to discuss how to store data in Odoo 17 Website.
It includes defining a model with few fields in it. Add demo data into the model using data directory. Also using a controller, pass the values into the template while rendering it and display the values in the website.
How to Show Sample Data in Tree and Kanban View in Odoo 17Celine George
In Odoo 17, sample data serves as a valuable resource for users seeking to familiarize themselves with the functionalities and capabilities of the software prior to integrating their own information. In this slide we are going to discuss about how to show sample data to a tree view and a kanban view.
Beyond the Advance Presentation for By the Book 9John Rodzvilla
In June 2020, L.L. McKinney, a Black author of young adult novels, began the #publishingpaidme hashtag to create a discussion on how the publishing industry treats Black authors: “what they’re paid. What the marketing is. How the books are treated. How one Black book not reaching its parameters casts a shadow on all Black books and all Black authors, and that’s not the same for our white counterparts.” (Grady 2020) McKinney’s call resulted in an online discussion across 65,000 tweets between authors of all races and the creation of a Google spreadsheet that collected information on over 2,000 titles.
While the conversation was originally meant to discuss the ethical value of book publishing, it became an economic assessment by authors of how publishers treated authors of color and women authors without a full analysis of the data collected. This paper would present the data collected from relevant tweets and the Google database to show not only the range of advances among participating authors split out by their race, gender, sexual orientation and the genre of their work, but also the publishers’ treatment of their titles in terms of deal announcements and pre-pub attention in industry publications. The paper is based on a multi-year project of cleaning and evaluating the collected data to assess what it reveals about the habits and strategies of American publishers in acquiring and promoting titles from a diverse group of authors across the literary, non-fiction, children’s, mystery, romance, and SFF genres.
How to Configure Time Off Types in Odoo 17Celine George
Now we can take look into how to configure time off types in odoo 17 through this slide. Time-off types are used to grant or request different types of leave. Only then the authorities will have a clear view or a clear understanding of what kind of leave the employee is taking.
Lecture_Notes_Unit4_Chapter_8_9_10_RDBMS for the students affiliated by alaga...Murugan Solaiyappan
Title: Relational Database Management System Concepts(RDBMS)
Description:
Welcome to the comprehensive guide on Relational Database Management System (RDBMS) concepts, tailored for final year B.Sc. Computer Science students affiliated with Alagappa University. This document covers fundamental principles and advanced topics in RDBMS, offering a structured approach to understanding databases in the context of modern computing. PDF content is prepared from the text book Learn Oracle 8I by JOSE A RAMALHO.
Key Topics Covered:
Main Topic : DATA INTEGRITY, CREATING AND MAINTAINING A TABLE AND INDEX
Sub-Topic :
Data Integrity,Types of Integrity, Integrity Constraints, Primary Key, Foreign key, unique key, self referential integrity,
creating and maintain a table, Modifying a table, alter a table, Deleting a table
Create an Index, Alter Index, Drop Index, Function based index, obtaining information about index, Difference between ROWID and ROWNUM
Target Audience:
Final year B.Sc. Computer Science students at Alagappa University seeking a solid foundation in RDBMS principles for academic and practical applications.
About the Author:
Dr. S. Murugan is Associate Professor at Alagappa Government Arts College, Karaikudi. With 23 years of teaching experience in the field of Computer Science, Dr. S. Murugan has a passion for simplifying complex concepts in database management.
Disclaimer:
This document is intended for educational purposes only. The content presented here reflects the author’s understanding in the field of RDBMS as of 2024.
Feedback and Contact Information:
Your feedback is valuable! For any queries or suggestions, please contact muruganjit@agacollege.in
Beginner's Guide to Bypassing Falco Container Runtime Security in Kubernetes ...anjaliinfosec
This presentation, crafted for the Kubernetes Village at BSides Bangalore 2024, delves into the essentials of bypassing Falco, a leading container runtime security solution in Kubernetes. Tailored for beginners, it covers fundamental concepts, practical techniques, and real-world examples to help you understand and navigate Falco's security mechanisms effectively. Ideal for developers, security professionals, and tech enthusiasts eager to enhance their expertise in Kubernetes security and container runtime defenses.
Credit limit improvement system in odoo 17Celine George
In Odoo 17, confirmed and uninvoiced sales orders are now factored into a partner's total receivables. As a result, the credit limit warning system now considers this updated calculation, leading to more accurate and effective credit management.
NLC English 7 Consolidation Lesson plan for teacher
Pharmaceutical Complaints
1. UNIT IV
Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF PHARMACEUTICAL SCIENCES AND
RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY ASSURANCE
2. COMPLAINTS
• Despite all the precautions taken, some
problems may occur in a given drug
product.
• The customer finds the faults in the
product.
• And the dissatisfaction is conveyed in the
form of a COMPLAINT.
• Complaints are then investigated and
corrective actions are taken.
3. DEFINITION
• Complaint is defined as statement that is
something wrong or not good enough,
which shows customer dissatisfaction
about the company and the product.
• Example: complaining about the drug
product or the packaging materials etc.
• All complaints concerning defective
products should be carefully reviewed
according to written procedures.
4. NEED FOR COMPLAINT HANDLING
• Gives the company an opportunity to improve
the quality of the product.
• Helpful to maintain cGMP.
• Maintains committed relationship between the
customer and company.
• Reduce costs and improve production
schedules.
• Reduce employee confusion.
• Improve safety and performance of devices.
5. CLASSIFICATION OF COMPLAINTS
A. CRITICAL COMPLAINTS
• Individual defects which can be critical and require the
company to take in need of attention action by all
reasonable resources, whether in and out of company
hours.
Example: microbial contamination of a sterile product.
B. MAJOR COMPLAINTS
• These complaints will possibly put the patient at a little
hazard but are not life threatening and will require
product recall within a few days.
example: any labelling/leaflet misinformation.
C. MINOR DEFECTS
• Complaints which present only a significant risk to patient.
Example: readily visible inaccessible packaging/closure faults.
6. STEPS TO HANDLE COMPLAINTS
Good Complaint Handling Procedure are
implemented by steps which are divide into
four.
1. Receiving Complaints
2. Technical Investigation
3. Corrective and Preventive Actions(CAPA)
/ Feedback to Customers.
4. Trend Analysis / Monthly Reports
7. RECEIVING COMPLAINTS
• Complaints must provide open channels
through which customers can arise their
complaints
• The company must appoint a person who
will be responsible for receiving the
complaint, and documenting it as per
company requirements.
• The most flexible channels are toll-free
numbers and chat-rooms.
9. TECHNICAL INVESTIGATION
Once the complaint has been received, a
complaint investigation form should be
prepared with the following information:-
• Name and contact details of complainant.
• Details of the drug product on which
complaint has been raised – product name,
manufacturing batch number, lot number,
manufacture and expiry dates, quantity of
product where problem is seen
• Details of the nature of complaint – what
exactly is wrong and has been complained
about.
10. Product complaint data sheet details include:-
• Serial number of complaint
• Complaint details
• Name and address of the complainant.
• Date of receiving the complaint
• Name of the person who received the complaint.
• Details of the product – name, strength, batch number
• Size of sample obtained from the complainant.
• Complaint evaluation report.
• Name and sign of the investigators with date.
• Action taken report
• Copy of written response sent to complainant.
11. • All this information is sent to the Quality
Assurance department to start investigation. A
QA officer is appointed as Complaint Officer
to oversee the next stages.
• Two phases of investigation will follow:-
1. Document Based investigation
2. Laboratory Analysis
12. DOCUMENT BASED INVESTIGATION
This involves review of :-
• Complaint files to see how many previous
complaints of a similar nature have occurred,
and how the complaints were handled.
• Batch manufacturing and packaging records
to check for any incidents of non-
conformance during that particular batch’s
processing.
13. LABORATORY ANALYSIS
• This phase involves analysis by the Quality
Control laboratory. The samples received
with the complaint as well as the samples
that have been retained by the manufacturer
must be tested and the results are
documented.
The Complaint Officer compares the results of
the laboratory analysis and the document
based investigation and prepares a report that
may result in one of the conclusions:-
• Confirmed complaint
• Non – Confirmed complaint
• Counterfeit/ Tamper Suspicion
14. • Confirmed Complaint – when out of specification
(OOS) results are seen in both complaint and
retained or in only complaint samples. For e.g. if
both samples of tablets showed discolouration, o one
tablet is missing from blister pack.
• Non Confirmed Complaint – when both retained and
complaint samples test results comply with
specifications, or if complaint samples show OOS
results. For e.g. tablets in complaint sample are
discoloured but not in retained samples.
• Counterfeit/ tamper suspicion – when retained
sample meets specifications but complaint samples
are OOS, with no possible reason to explain the
deviation. For e.g. if packing material of complaint
sample is different from the retained – counterfeit
drug. Or if colour of complaint sample is totally
different from retained – tampered drug.
15. The Complaint Officer investigates if the
complaint involves any unexpected or
serious adverse drug reaction.
After complaint of investigation,
generally within 30 days of receiving the
complaint, the report is prepared and
signed by Complaint Officer and QA
manager.
the complaint file must be maintained for
at least 1 year following the expiry date of
the productive batch.
16. QA
COMPLAINT
OFFICER
Quality Assurance
department to start
investigation. The
Complaint Officer
investigates if the
complaint involves any
unexpected or serious
adverse drug reaction.
STEP 2
1.DOCUMENT
BASED
INVESTIGATION
2.LABORATORY
ANALYSIS
COUNTERFEIT/
TAMPER SUSPICION
NONCONFIRMED
COMPLAINT
CONFIRMED
COMPLAINT
17. CORRECTIVE & PREVENTIVE ACTIONS/
FEEDBACK TO CUSTOMER
• In case of confirmed complaints, company must
implement corrective actions depending on the
severity of the problem.
A team of representatives from Production, QC, QA
and higher management areas is put together for
launching CAPA
• In case of non confirmed complaints, that may have
originated from improper handling , company sends a
written response to the complainant, including
information on the corrective method adopted. Also a
free replacement is sent to the customer.
• In case of therapeutic complaints or ADR, the
company may decide for a product recall, if they see
a risk in sale of drug.
18. CORRECTIVE ACTION
•Depend on nature of complaint
•Training
•CAPA procedures
•Product recall
STEP 3
FEEDBACK TO THE CUSTOMER
•Explanation letter to customer about the results
and reason.
•Delivery of free product as reimbursement.
19. TREND ANALYSIS/MONTHLY
REPORTS
• Monthly reports should be elaborated in order
to evaluate the amount and the nature of
complaints received and to perform a trend
analysis of these complaints.
• The monthly report must answer the
following:-
How many complaints did the company
receive in the period?
How many were confirmed, nonconfirmed
or counterfeit/tamper suspicion?
20. • Graphic methods of displaying data are important
adjuncts to data analysis and presentation.
• The report must be readily available mainly during
GMP inspections.
STEP 4
TREND ANALYSIS
•Number of reports :- category, nature, segment,
batches
•Identification and implementation of corrective
actions.
•Sharing of report with all departments.
21. DOCUMENTATION OF FINAL
REPORT ONCOMPLAINTS
• Nature of the complaint:- ____________
• Date:- __________
• Complaint:- _________________
• Originator of the complaint& title:- _____________
• Distributor contact person & title:- __________
• Method of notification:- ______________
• Name:- ____________
• Phone No:-________ P.O - ______
• Date shipped:- __________ Invoice:-_______
• Product name:-__________ Control No.:-____
• Expiry date:__________ Quantity involved:-____
22. • Total quantity shipped- ________
• Reason for complaint return request-_________
• Evaluation of complaints: -
physical characteristics
sign of deterioration
other observation
• Quality control findings:-
returned sample
returned sample re assay
initial data
quality control comments & suggestions
• Packaging or labelling or inserts evaluation.
23. Resultant action taken:
1. Method, date of customer notification & authorized:-
_________
2. Comments:- ___________
3. Completion date for action taken:-___________
4. Quality assurance evaluation:-_____________
CUSTOMER COMPLAINT RECORD BOOK
REPORT
NO.
DATE
RECEIVED
PRODUCT
NAME
RECEIVED
BY
PRODUCT
LOT NO.
DATE
INVESTIG
ATION
STARTED
DATE
INVESTIG
ATION
ENDED
24. REGULATORY GUIDELINES
• A SOP should be available giving full details about
how to handle products complaints and necessary
records about complaints should be maintained.
• A person should be designated for handling the
complaints and deciding the measures to be taken
• Person should be normally be from quality
management department.
• All decisions and measures taken as a result of a
complaint should be recorded
• If product defect is suspected in a batch, other batches
should also be checked in order to determine whether
they are also affected.
• Written records shall be maintained for at least 1 year
after the date that the complain was received.