COMPLAINTS
TOPIC COVERED
1.Definition
2.Principle
3.Need for complaint handling system
4.Objectives
5.Responsibility
6.Type of complaints (CRITICAL,MAJOR ,MINOR)
7.Key for handling complaint
8.Content of product complaint data sheet
9.Steps involved in handling of complaint
10.Recordings of complain
The document provides standard operating procedures (SOPs) for handling complaints and recalls at a pharmaceutical company. It defines complaints, outlines the need for a complaint handling system, and describes procedures for receiving, investigating, and responding to complaints within defined timelines. It also provides templates for documenting complaint investigations and reports. The document similarly describes procedures for identifying, evaluating, and executing a recall of defective medical products in compliance with regulatory authorities.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
The document discusses product complaints and recalls in the pharmaceutical industry. It defines a complaint as customer dissatisfaction about a product and outlines four types of complaints. It details the four-step process of handling complaints, which includes receiving, investigating, implementing corrective actions, and reporting. The document also defines a recall as removing a product from distribution due to quality, safety or efficacy issues. It describes the reasons and types of recalls, as well as the classification, levels and timelines involved in an effective recall system.
Unit 4 Document maintenance in Pharmaceutical Industry.pptxAshwiniBhoir2
The document discusses the importance of documentation in the pharmaceutical industry. It states that documentation provides evidence of activities and ensures quality assurance. Good documentation includes specifications, procedures, and information to ensure manufacturing processes are followed correctly. It also discusses the types of documents needed like batch production records, master formulas, standard operating procedures, distribution records, and emphasizes that documents must be properly designed, approved, distributed and updated to ensure compliance.
1. Returned goods and recovered materials from pharmaceutical products need to be evaluated and may be reprocessed, retested, repackaged and resold if they meet specifications.
2. Complaint handling procedures include classifying, investigating, reporting on complaints, maintaining records for regulatory compliance and continual improvement.
3. The complaint handling process involves receiving complaints, conducting a technical investigation which includes documentation review and laboratory analysis, determining corrective actions, and reporting trends to management.
COMPLAINTS
TOPIC COVERED
1.Definition
2.Principle
3.Need for complaint handling system
4.Objectives
5.Responsibility
6.Type of complaints (CRITICAL,MAJOR ,MINOR)
7.Key for handling complaint
8.Content of product complaint data sheet
9.Steps involved in handling of complaint
10.Recordings of complain
The document provides standard operating procedures (SOPs) for handling complaints and recalls at a pharmaceutical company. It defines complaints, outlines the need for a complaint handling system, and describes procedures for receiving, investigating, and responding to complaints within defined timelines. It also provides templates for documenting complaint investigations and reports. The document similarly describes procedures for identifying, evaluating, and executing a recall of defective medical products in compliance with regulatory authorities.
Document Maintenance in Pharmaceutical IndustryNAKUL DHORE
Document Maintenance in Pharmaceutical Industry.
By_ NAKUL DHORE
❖ Introduction
❖ Batch Formula Record
❖ Master Formula Record
❖ SOPs
❖ Quality Audit
❖ Quality Review & Quality Documentation
❖ Reports & Documents
❖ Distribution Records
❖ MCQs
Quality Assurance
As per B.PHARM 3rd Year Semester-6
(PCI Syllabus New)
The document discusses product complaints and recalls in the pharmaceutical industry. It defines a complaint as customer dissatisfaction about a product and outlines four types of complaints. It details the four-step process of handling complaints, which includes receiving, investigating, implementing corrective actions, and reporting. The document also defines a recall as removing a product from distribution due to quality, safety or efficacy issues. It describes the reasons and types of recalls, as well as the classification, levels and timelines involved in an effective recall system.
Unit 4 Document maintenance in Pharmaceutical Industry.pptxAshwiniBhoir2
The document discusses the importance of documentation in the pharmaceutical industry. It states that documentation provides evidence of activities and ensures quality assurance. Good documentation includes specifications, procedures, and information to ensure manufacturing processes are followed correctly. It also discusses the types of documents needed like batch production records, master formulas, standard operating procedures, distribution records, and emphasizes that documents must be properly designed, approved, distributed and updated to ensure compliance.
1. Returned goods and recovered materials from pharmaceutical products need to be evaluated and may be reprocessed, retested, repackaged and resold if they meet specifications.
2. Complaint handling procedures include classifying, investigating, reporting on complaints, maintaining records for regulatory compliance and continual improvement.
3. The complaint handling process involves receiving complaints, conducting a technical investigation which includes documentation review and laboratory analysis, determining corrective actions, and reporting trends to management.
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.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
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.
A COMPLETE STUDY ON COMPLAINTS, DRUG RECALL, RETURNED PRODUCTS, AND WASTE DIS...Teny Thomas
a detailed study on complaints, drug recall, returned goods and waste disposal is studied here in the presentation for the students of sixthe semester b.pharm following the PCI syllabus.
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 discusses organization and personnel responsibilities in the pharmaceutical industry. It outlines that each employee should have a clear written job description that details their responsibilities. Key personnel include the heads of quality control, production, and quality assurance departments. Their responsibilities include approving materials and processes, ensuring training, and monitoring compliance. The document also covers personnel hygiene, training programs, and the purpose of maintaining personnel records.
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.
Purchase specifications & Maintenance of stores For Raw materialsYash Menghani
This document discusses the purchase specifications and maintenance of stores for raw materials. It defines raw materials as all materials used in manufacturing finished products. Purchase specifications provide guidelines that define operational, physical and chemical characteristics and quality of items to be acquired. Maintaining proper stores is important, requiring inspection centers, storage at appropriate temperatures, and clear labeling of materials with names, batch numbers, and expiration/retesting dates.
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
This document outlines good warehouse practices for storage and distribution of pharmaceutical products. It discusses 12 key areas: premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt of incoming goods, assembling orders and issuing goods, packing for transportation, transport, and records. The document provides details on requirements for each area to ensure proper storage conditions and distribution of medicines.
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.
This document discusses the qualification of UV-visible spectrophotometry. It begins by defining qualification as an act or process to ensure something complies with conditions, standards, or requirements. There are four types of qualification: design, installation, operational, and performance. UV-visible spectroscopy is concerned with the ultraviolet and visible regions ranging from 200-780 nm. The document outlines parameters for acceptance procedures and performance qualification of a UV-visible spectrophotometer, including wavelength accuracy, stray light, resolution power, noise, baseline flatness, stability, photometric accuracy, and linearity.
The document discusses Batch Manufacturing Records (BMR) and Master Formula Records (MFR) for pharmaceutical manufacturing. A BMR documents each batch production run and includes the batch number, materials used, production steps, yields, and test results. An MFR is the master document that provides the standard procedure for a product and is referenced when creating individual BMRs. It includes the product name, ingredients, batch size, packaging details, and authorization. Proper documentation with BMRs and MFRs is necessary for quality control and batch traceability in pharmaceutical manufacturing.
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.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
The document discusses the qualification and validation of various analytical techniques used in pharmaceutical quality control including UV-Visible spectrophotometry, Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and high performance liquid chromatography (HPLC). It provides details on the design qualifications, installation qualifications, operational qualifications, and performance qualifications required for each technique. The key steps include instrument calibration, determination of accuracy and precision, evaluation of limits, and verification that the instruments are operating as intended over time.
This document provides guidelines on product recalls, including:
- Defining a product recall as withdrawing or removing drugs from distribution or use due to quality, efficacy, or safety issues.
- Describing the different types and levels of recalls, from compulsory recalls ordered by authorities to voluntary recalls initiated by manufacturers.
- Outlining the classification of recalls from Class I recalls for products that could cause serious health issues to Class III for minor issues.
- Providing steps for conducting an effective recall, including developing a recall strategy, recovering and storing products, notifying consumers, and evaluating the recall's effectiveness.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
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.
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.
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.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
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.
A COMPLETE STUDY ON COMPLAINTS, DRUG RECALL, RETURNED PRODUCTS, AND WASTE DIS...Teny Thomas
a detailed study on complaints, drug recall, returned goods and waste disposal is studied here in the presentation for the students of sixthe semester b.pharm following the PCI syllabus.
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 discusses organization and personnel responsibilities in the pharmaceutical industry. It outlines that each employee should have a clear written job description that details their responsibilities. Key personnel include the heads of quality control, production, and quality assurance departments. Their responsibilities include approving materials and processes, ensuring training, and monitoring compliance. The document also covers personnel hygiene, training programs, and the purpose of maintaining personnel records.
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.
Purchase specifications & Maintenance of stores For Raw materialsYash Menghani
This document discusses the purchase specifications and maintenance of stores for raw materials. It defines raw materials as all materials used in manufacturing finished products. Purchase specifications provide guidelines that define operational, physical and chemical characteristics and quality of items to be acquired. Maintaining proper stores is important, requiring inspection centers, storage at appropriate temperatures, and clear labeling of materials with names, batch numbers, and expiration/retesting dates.
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
This document outlines good warehouse practices for storage and distribution of pharmaceutical products. It discusses 12 key areas: premises, security, temperature and humidity control, equipment, personnel, sanitation, receipt of incoming goods, assembling orders and issuing goods, packing for transportation, transport, and records. The document provides details on requirements for each area to ensure proper storage conditions and distribution of medicines.
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.
This document discusses the qualification of UV-visible spectrophotometry. It begins by defining qualification as an act or process to ensure something complies with conditions, standards, or requirements. There are four types of qualification: design, installation, operational, and performance. UV-visible spectroscopy is concerned with the ultraviolet and visible regions ranging from 200-780 nm. The document outlines parameters for acceptance procedures and performance qualification of a UV-visible spectrophotometer, including wavelength accuracy, stray light, resolution power, noise, baseline flatness, stability, photometric accuracy, and linearity.
The document discusses Batch Manufacturing Records (BMR) and Master Formula Records (MFR) for pharmaceutical manufacturing. A BMR documents each batch production run and includes the batch number, materials used, production steps, yields, and test results. An MFR is the master document that provides the standard procedure for a product and is referenced when creating individual BMRs. It includes the product name, ingredients, batch size, packaging details, and authorization. Proper documentation with BMRs and MFRs is necessary for quality control and batch traceability in pharmaceutical manufacturing.
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.
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
The document discusses the qualification and validation of various analytical techniques used in pharmaceutical quality control including UV-Visible spectrophotometry, Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and high performance liquid chromatography (HPLC). It provides details on the design qualifications, installation qualifications, operational qualifications, and performance qualifications required for each technique. The key steps include instrument calibration, determination of accuracy and precision, evaluation of limits, and verification that the instruments are operating as intended over time.
This document provides guidelines on product recalls, including:
- Defining a product recall as withdrawing or removing drugs from distribution or use due to quality, efficacy, or safety issues.
- Describing the different types and levels of recalls, from compulsory recalls ordered by authorities to voluntary recalls initiated by manufacturers.
- Outlining the classification of recalls from Class I recalls for products that could cause serious health issues to Class III for minor issues.
- Providing steps for conducting an effective recall, including developing a recall strategy, recovering and storing products, notifying consumers, and evaluating the recall's effectiveness.
The document discusses batch manufacturing records (BMRs) and master formula records (MFRs) for pharmaceutical products. It notes that BMRs should include complete information about manufacturing and quality control for each batch, and that line clearance is important before starting a new batch to ensure all remnants of the previous batch are removed. MFRs should provide detailed instructions for each product and batch size. Both BMRs and MFRs are important quality documentation that allow for full traceability of the manufacturing process.
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.
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.
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.
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.
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.
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
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.
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 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.
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.
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.
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.
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 provides guidance for good manufacturing practices regarding complaints, quality defects, and product recalls for medicinal products. It emphasizes applying quality risk management principles when investigating issues and making risk-reducing decisions such as recalls. Manufacturers should have procedures to properly handle complaints and investigations, identify root causes, and implement corrective actions. Recalls should be managed through established written procedures and competent authorities should be notified of quality defects that could require a recall.
This document provides guidance for investigating complaints and potential quality defects in medicinal products, and making decisions about product recalls when necessary. It emphasizes applying quality risk management principles to investigations and decision making. Manufacturers should have procedures to properly handle, assess, and investigate complaints, including determining the root cause. If a quality defect could result in a product recall or supply restriction, manufacturers must notify the relevant authorities and marketing authorization holder in a timely manner.
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.
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.
Similar to Product Complaints and Recall: Quality Assurance (20)
ICH P B Jadhav International Conference of Hormonisation.pptxPRASHANT JADHAV
The International Conference on Harmonization (ICH) was established in 1990 by a committee representing the pharmaceutical industry and regulatory agencies. The ICH aims to improve new drug development and registration through harmonized guidelines. It involves regulators and industry from the US, EU, and Japan. The ICH structure includes a Steering Committee, Secretariat, and working groups that meet twice yearly to develop guidelines on quality, safety, efficacy, and multidisciplinary topics.
The skeletal system consists of bones, joints, cartilage, ligaments and tendons. The skeletal system is divided into the axial skeleton which includes the skull, vertebral column, and rib cage, and provides protection and support. The appendicular skeleton includes the bones of the limbs and girdles that connect the limbs to the axial skeleton. Bones are classified by their shape as long, short, flat or irregular. The skeletal system functions to support the body, protect organs, allow for movement, store minerals, and produce blood cells.
Pharmaceutical Incompatibility : Mr. P. B. JadhavPRASHANT JADHAV
This document discusses drug incompatibilities, which occur when undesirable changes take place in the properties of a medication when two or more ingredients are mixed together. It classifies incompatibilities into three types - physical, chemical, and therapeutic. Physical incompatibilities involve changes in properties like color, odor, or viscosity due to insolubility or other interactions. Chemical incompatibilities show immediate effects like decomposition or color change from reactions. Therapeutic incompatibilities modify a drug's intended effects, such as from overdose, wrong dosage, or drug interactions that antagonize each other. Examples are provided for each type of incompatibility.
This document provides an overview of web technologies including HTML, CSS, and JavaScript. It discusses how websites are built from web pages created using HTML, which contains text, images and other multimedia. CSS is used to style and lay out elements on web pages for consistency. The document also lists common client-side and server-side technologies and provides examples of basic HTML tags and structures like headings, paragraphs, lists and tables.
PHARMACEUTICAL QUALITY ASSURANCE : Mr. Prashant JadhavPRASHANT JADHAV
The document discusses quality assurance and good manufacturing practices in the pharmaceutical industry. It defines quality assurance according to WHO as activities that provide confidence that quality requirements are being met. Quality assurance is part of quality management and includes planned activities to ensure products and services meet quality standards. Good manufacturing practices are regulations and guidelines for manufacturing drugs, medical devices, and foods to minimize risks that cannot be eliminated through testing. GMPs help ensure drug products are safe, pure and effective.
Philippine Edukasyong Pantahanan at Pangkabuhayan (EPP) CurriculumMJDuyan
(𝐓𝐋𝐄 𝟏𝟎𝟎) (𝐋𝐞𝐬𝐬𝐨𝐧 𝟏)-𝐏𝐫𝐞𝐥𝐢𝐦𝐬
𝐃𝐢𝐬𝐜𝐮𝐬𝐬 𝐭𝐡𝐞 𝐄𝐏𝐏 𝐂𝐮𝐫𝐫𝐢𝐜𝐮𝐥𝐮𝐦 𝐢𝐧 𝐭𝐡𝐞 𝐏𝐡𝐢𝐥𝐢𝐩𝐩𝐢𝐧𝐞𝐬:
- Understand the goals and objectives of the Edukasyong Pantahanan at Pangkabuhayan (EPP) curriculum, recognizing its importance in fostering practical life skills and values among students. Students will also be able to identify the key components and subjects covered, such as agriculture, home economics, industrial arts, and information and communication technology.
𝐄𝐱𝐩𝐥𝐚𝐢𝐧 𝐭𝐡𝐞 𝐍𝐚𝐭𝐮𝐫𝐞 𝐚𝐧𝐝 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐚𝐧 𝐄𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫:
-Define entrepreneurship, distinguishing it from general business activities by emphasizing its focus on innovation, risk-taking, and value creation. Students will describe the characteristics and traits of successful entrepreneurs, including their roles and responsibilities, and discuss the broader economic and social impacts of entrepreneurial activities on both local and global scales.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
THE SACRIFICE HOW PRO-PALESTINE PROTESTS STUDENTS ARE SACRIFICING TO CHANGE T...indexPub
The recent surge in pro-Palestine student activism has prompted significant responses from universities, ranging from negotiations and divestment commitments to increased transparency about investments in companies supporting the war on Gaza. This activism has led to the cessation of student encampments but also highlighted the substantial sacrifices made by students, including academic disruptions and personal risks. The primary drivers of these protests are poor university administration, lack of transparency, and inadequate communication between officials and students. This study examines the profound emotional, psychological, and professional impacts on students engaged in pro-Palestine protests, focusing on Generation Z's (Gen-Z) activism dynamics. This paper explores the significant sacrifices made by these students and even the professors supporting the pro-Palestine movement, with a focus on recent global movements. Through an in-depth analysis of printed and electronic media, the study examines the impacts of these sacrifices on the academic and personal lives of those involved. The paper highlights examples from various universities, demonstrating student activism's long-term and short-term effects, including disciplinary actions, social backlash, and career implications. The researchers also explore the broader implications of student sacrifices. The findings reveal that these sacrifices are driven by a profound commitment to justice and human rights, and are influenced by the increasing availability of information, peer interactions, and personal convictions. The study also discusses the broader implications of this activism, comparing it to historical precedents and assessing its potential to influence policy and public opinion. The emotional and psychological toll on student activists is significant, but their sense of purpose and community support mitigates some of these challenges. However, the researchers call for acknowledging the broader Impact of these sacrifices on the future global movement of FreePalestine.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
This presentation was provided by Racquel Jemison, Ph.D., Christina MacLaughlin, Ph.D., and Paulomi Majumder. Ph.D., all of the American Chemical Society, for the second session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session Two: 'Expanding Pathways to Publishing Careers,' was held June 13, 2024.
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
Making of a Nation.
From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
2. Statement that is something wrong or not good
enough, which shows customer dissatisfaction about
the company and the product
Example: Complaint about packaging materials, Concerning about
the product etc.
COMPLAINT
2
3. It gives the company an opportunity to improve the quality of
the product
It is helpful to maintain cGMP
It maintains committed relationship between the customer and
company
It is the regulatory obligation.
Aid in implementing solutions to these quality problems
Reduce costs and improve production schedules
Reduce employee confusion
Improve the safety and performance of devices
3
Reasons
4. Identify poor performance in the overall quality system,
particularly faulty design of devices, and faulty manufacturing
processes
Verify confidence and improve the performance of the
quality system
Improve customer relations by reducing the frequency of problems,
complaints, and recalls
4
5. Quality complaints: Originate at consumer level and
concern with physical, chemical and biological properties
or condition of labeling and /or packaging of the product.
Adverse reaction complaints: Due to allergic reactions of
any other untoward reaction or fatal reaction .
Other medically related complaints: Include complaints
such as lack of efficacy or clinical response.
5
Types of Complaint
6. Step 1: Receiving Complaints
It is important to have open channels with customers in order
to receive their suggestions, doubts and complaints. Generally,
these channels are toll-free numbers, e-mails, chat-rooms and
P.O. boxes. Whatever the channel, it is necessary to have a
person in charge of receiving the complaints and in putting
them into an appropriate investigation form that shall be
addressed to the Quality Assurance (QA) unit for
investigation.
Steps Involved in
Handling of Complaints
6
7. customer
Make a complaint
through toll free no., E-
mails, P.O. Box
Company's
contact Person
•Open the investigation, including
information about the customer
and about the complaint(product
name, lot no., mfg & expiry date
and complaint description.)
• Ask the customer to return the
product for analysis.
QA
Complaint
Officer
7
8. Step 2: Technical Investigation
Upon receipt of the investigation form, the QA unit is able to start the
investigation, which can be divided in two phases:
Technical investigation
Documentation-based
Checking if this complaint
Occurred previously in the
same lot or if any
nonconformance was found
in the lot during its
production
Laboratory analysis phase
Requesting QC laboratory to analyze
both samples (complaint & retained).
If the customer did not send the
complaint sample for analysis, the
lab.
8
9. Step 3: Corrective Actions and Feedback to
Customers-
9
o Corrective actions can range from a simple and quick training to some
employees to a formal Corrective Action and Preventive Action (CAPA)
handling.
The criteria for choosing appropriate action depend on the nature of
the complaint, and the complaint incidence.
If a CAPA is opened, a multidisciplinary team consisting of
representatives of QA, QC, Regulatory Affairs and Production
Management must be established.
o As feedback to the customer, the company must write a response letter to
the complainant to explain the investigation approach taken, the results
obtained and any implications, in case the quality problem was
confirmed.
10. o The customer should be sent a free replacement product together
with the response letter, since the customer returned the product
(the “complaint sample”) to the company for analysis and a
quality problem was found.
o Concerning non-confirmed complaints originating from misuse or
inadequate handling of the drug product, even if there is no need
for internal corrective actions, corrective measures should be
implemented to provide orientation to the customer.
11. Step 4: Monthly Reports and Trend Analysis- Monthly
reports should be elaborated in order to evaluate the amount and the
nature of the complaints received and to perform a trend analysis of
these complaints.
11
The monthly reports must answer the following questions:
How many complaints did the company receive in the period?
How many were confirmed?
How many were non-confirmed or were counterfeit/tamper
suspicion?
12.
Serial number assigned to the complaints.
Exact nature of the complaints.
Name of the complainants.
Address of the complainants.
Date of complaint received.
If verbal, name of the person who received the complaint.
Name of the product, strength and batch number of the product.
Reference to analytical record number.
12
Product Complaint Data Sheet
13. Quantity involved in the complaint.
Size of sample obtained from the complainant.
Evaluation of complaint by QC department.
Materials and records used to perform evaluation.
Other possible effected materials, products and results of their investigation.
Name and signature of the investigator(s) and date.
Action taken by the company.
Copy of reply sent to complainant.
13
14. Name and address of complainant;
Name (and, where appropriate, title) and phone number of person
submitting the complaint;
Complaint nature (including name and batch number of the bulk product or
Medicinal Product/Drug);
Date complaint is received;
Action initially taken (including dates and identity of person taking the action);
Any follow-up action taken;
Response provided to the originator of complaint (including date
response sent); and
Final decision on bulk product or Medicinal Product/Drug batch or lot.
14
Complaint Record
15. Report Date Product Received Product Date Date
no. received name by lot no. investiga investiga
tion tion
started ended
15
Customer Complaint Record Book
16. A SOP should be available giving full details about how to handle
products complaints and necessary records about complaints handled
should be maintained.
A person should be designated for handling the complaints and deciding
the measures to be taken together with sufficient supporting staff to assist
him. This person should normally be from quality management
department, with sufficient knowledge and experience in related work.
16
Regulatory Guidelines
17. If product defect is suspected in a batch, other batches should
also be checked in order to determine whether they are also
affected.
All decisions and measures taken as a result of a complaint
should be recorded.
A file regarding such drug products complaints shall be
maintained at the factory site.
Written records involving a drug product shall be maintained
until atleast 1 year after the expiration date of the drug product
or 1 year after the date that the complaint was received.
17
18.
1.0 OBJECTIVE:
To layout the procedure for investigation and reporting the market
complaints.
2.0 RESPONSIBILITY:
The quality assurance manager along with manager of the complaint
related department.
3.0 ACCOUNTABILITY:
The Head, Q.A / Q.C / Regulatory shall review the investigation report,
suggest corrective actions and approve the complaint report.
18
SOP on Complaint Handling
19. 4.0 PROCEDURE:
19
1.Market complaint may be received from any of the following sources:
Physicians , Pharmacist , Warehouse, Patients, Regional Offices, Hospitals
Regulatory affairs, Wholesale Traders, Actual users
2.Complaints shall be classified in following categories to facilitate
investigation:
- Product quality complaints (non therapeutic).
- Packaging complaints (shortages and packaging error).
- Medical complaints (therapeutic problems).
3.As a company policy even verbal complaints shall be formalized and
investigated.
4. All written and oral complaints to be forwarded to Head,
QA/QC/Regulatory or his nominee for investigation
5.All the Product Quality Complaints shall be investigated jointly with
QA/F and D/Manufacturing within 5 days of the receipt of the complaint.
20. 6.Medical complaint investigations shall be carried out jointly by Medical
department, QA, Production, F and D and Marketing Department within
3 days of receipt of complaint
7.Packaging complaints and Quality complaints shall be jointly
investigated by QA, F and D and Manufacturing department within 10
days of receipt of complaint.
8.The investigator shall investigate the complaint by referring to the
Batch Manufacturing Record, SOP, machine log tables, retain samples,
storage conditions used and prepare the Product Complaint Report
(PCR)
9.The PCR (Annexure I) shall include the product details, details of the
complainant, quantity involved, enclosed complaint sample (if any),
details of investigation actions taken and recommended corrective actions
to prevent such recurrences in future. Each PCR shall be approved by
Head/QA/QC/Regulatory or his nominee.
20
21. 10.Incase of the Head/QA/QC/Regulatory finds that investigation is not
necessary, such written records shall be maintained including reasons for
not conducting the investigation.
11.Each report shall be assigned a specific PCR number, which will be a 3
digit number starting with “001”in continuous sequence prefixed with
“PCR” and suffixed with the last two digits of the year. For example, the
first market complaint for 2006 shall have the number PCR/001/06
12.If product defect is established or suspended in a batch,
Head/QA/QC/Regulatory will decide for checking other batches in order
to determine weather they are also affected.
13.Incase of medical complaints, if Head, /QA /QC /Regulatory and
Medical Advisor feels that the product will put the public at risk, he shall
advise immediate recall of the batch. The depth of recall is dependent on
the seriousness of the complaint.
21
22. 14.Complaint Record shall be maintained at least one year after
expiration date of medicine.
15. Complaint Record shall be reviewed and a monthly summary shall
be prepared for the management.
16.A Register is maintained having the complete details of complaint for
future reference.
ABBREVIATIONS: QA/QC : Quality Assurance/ Quality Control
PCR : Product Complaint Report
F and D : Formulation and Development
REFERENCES: NIL
22
25. Recall is an action taken to withdraw/remove the drugs
from distribution or use including corrective action for
which deficiencies are reported in quality, efficacy or
safety.
Recalls also include drugs prohibited under the Provisions
of Drugs & Cosmetics Act and also those products for which
product licenses are suspended/cancelled
25
Recall
26. Products which are already distributed or sold, may require at
times to be recalled from market for various reasons.
e.g. - substandard quality detected after the product was
distributed
- damage of goods during transit.
Such recalled products should be clearly identified and stored
separately in a secure area until a decision is taken on their
force.
Such decision should be made as soon as possible.
Recall applies a;
Total ban or Permanent removal
Temporary ban or Temporary removal
Recalled Products
26
27. FDA authorities may order a recall for substandard quality of
the finished product or for any other justified reasons
Manufacturer himself may find problems with the product such
as:
- substandard quality
- problems related to the stability of the product
- based on the market complaint received from a customer or
physician
Accidental damage of the consignment may also happen
during transportation
In such case product quality may not be questionable, but
packages may get damaged and cannot be sold or distributed
as such in the market, and hence required to be recalled.
27
Reasons
28.
Types of Recall
28
Compulsory Product
Recall
Industries do not take the
responsibility of recalling
the product voluntarily.
Commission conducts a
“Compulsory Product
Recall”
Voluntary Product
Recall
Industries voluntarily recall
the products in consultation
with ICCC
Encouraged by the
commission where suppliers
recall a product as soon as a
defect is found that makes a
product hazardous or unsafe
for use or consumption.
29. CLASS I RECALLS
Class I is a situation in which there is a reasonable probability
that the use of, or exposure to, a violative product will cause
serious adverse health consequences or death.
• Examples of Class I Recalls
•Pathogens in ready-to-eat food: Salmonella, Listeria monocytogenes,
E. coli, Clostridium
•High levels of sulfites
•High levels of heavy metals
•Choking hazards for susceptible populations
33
Recall Classification
Reference:www.fda.gov
30. CLASS II RECALLS
Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is remote.
• Examples of Class II Recalls
•Foreign objects that pose a physical hazard
•Pathogens: Shigella, hepatitis A, Cyclospora, Cryptosporidium
30
31. CLASS III RECALLS
Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health
consequences.
• Example of Class III Recalls
An example might be bottles of aspirin that contains 90 tablets
instead of the 100 stated on the label.
31
32.
Based on the category of risks involved, a time
line of :
Within 24 hours up to a maximum of 72 hours for Class I
recall
For Class II recall up to a maximum of 10 days and
For Class III recall up to a maximum of 30 days is allowed.
32
Time Lines For Effective
Recall System & Rapid Alert
33. WHOLESALE PRODUCT RECALL (Distributor)
wholesale, distribution Centre's and importers
RETAIL PRODUCT RECALL (Dealer)
supermarkets, stores, hospitals, restaurants and major retail outlets
INDIVIDUAL CONSUMER RECALL
individual consumer
Level of Recalls
33
34.
1. Product Recall Process
Product is likely to cause injury/adverse health effect to a person,
the Supplier should identify & take the necessary steps required to
recall the product, control the risk and coordinate the recall
process.
2. Level of Recall
A product can be recalled at 3 levels; wholesale, retail, individual
consumer or combination of any two or three levels.
Determination of the level of recall is dependent of how far the
product has penetrated the market from the supplier.
34
How to Recall the Product?
35. 3. Recall Strategy
35
Supplier should develop recall strategies for various levels of recall
as specified.
Supplier should consider the following:
Notification mechanism to stop distribution and sale of
product.
How to effectively and efficiently remove potentially unsafe
product from market place
Isolation and safe storage of recovered product
Disposal of product or return of product to market
Availability of resources for remedial action.
36. 4. Product Recovery, Storage and Disposal
36
Methods of product recovery: product may be recovered by being returned to the
supplier, supermarkets, wholesellers or retailers.
Methods of product storage: recovered products must be stored in
an area that is isolated and separated from any other products.
Methods of corrective actions or product disposal:
Food products– destroyed by burial, denatured through retort and incinerated under
supervision by the relevant or appointed officers Product for general or consumer use–
returned to the manufacturers or destroyed through the appropriate industrial practices.
5. Remedial Actions by the Supplier
The Supplier’s notification to its distribution chain and clients should include
advice on how to settle for the returned products at the wholesale, retail and
consumer level.
The notification should be clear and concise to ensure no distribution
chain and client business operations are affected severely.
37. 6. Monitoring the Effectiveness of the Product Recall
The measurement standard is the total number of products
recovered against the total number of products being issued.
37
Supplier must have a scale of measurement for measuring the
effectiveness of the recall.
7. Post Recall Reporting
One month after the termination of recall process, the Supplier is
required to furnish the recall coordination unit with a final report
on the recall.
The report should contain the following information with details;
a. Copy of letter to customers
b. Circumstance leading to the recall
c. Actions taken by the supplier including copies of media statement
d. Method of disposal
e. Proposed action to avoid future recurrence
f. Difficulties experienced in conducting the recall
g. Forms of assistance from government agencies and industries.
38.
Public Notification
Through media coverage system
38
The media coverage system covers radio broadcast, television,
newspapers, TV news and current affairs programs.
Media Release
Short, concise, clear and written in simple language.
Should contain the product recall detail, problem or hazard,
actions to take, remedial action, names, address, phone numbers
and email address of people.
How To Notify The
Consumers?
39. Publicity Material
39
a. Product information
b. Clear identification of supplier
c. Statement of hazard and associated risk
d. Actions consumers should take to avoid injury
e. Contact telephone numbers
f. Advice that the recall is at the expense of the supplier
41. A detailed SOP should be available and records of recall
should be maintained by the manufacturer.
A person should be designated as responsible for execution
and coordination and should be supported by sufficient staff
to handle all aspects of the recall with the appropriate degree of
urgency. This person should normally be independent of the
sales and marketing organisation.
Recall procedure should be capable of being initiated promptly
and at any time.
41
Regulatory Guidelines
42. All competent authorities of the countries to which the product
might have been distributed should be informed promptly if
products are intended to be recalled because these are being
defective (or suspected of).
The distribution records should be readily available to the
person responsible for recalls, and should contain, sufficient
information on wholesellers and directly supplied customers,
including those for exported products and medical samples.
Recalled products should be identified and stored separately
in a secured area while awaiting decision on its fate.
The program of the recall process should be recorded and a
final report issued including a reconciliation between the
delivered and recovered quantities of the product.
42
43. The effectiveness of the recall procedure should be evaluated
from time to time by a dummy recall.
A detailed check-list may be designed by the manufacturer to
recall a product.
43
44. • 1.0 OBJECTIVE:
• To specify a method of operation that will ensure the prompt and effective removal of any
medicines for which XYZ Pharmaceuticals Ltd. Is the manufacturer and which may represent a health
hazard to the consumer or user from the market.
1. RESPONSIBILITY
• General manager (QA/QC, Regulatory): General Manager
(Manufacturing):
• In case of adverse event a committee evaluates the crisis. It consists of following individuals:
- GM/QA/QC, Regulatory
- GM Manufacturing
- V.P-Marketing
- V.P – International Marketing
- GM, Formulation and Development - V.P – Technical Operations
- Medical advisor
SOP on Product Recall
48
45. All available members of the crisis committee shall review the crisis and take appropriate action.
45
3.0 ACCOUNTABILITY
Vice President
1. DEFINATION
1. “Violation Medicine” means any medicine for which XYZ Pharmaceuticals Ltd is the
manufacturer and,which is reported to be causing serious adverse health reactions-not include in
the package insert and/or
2. With regard to which reports of serious adverse health reactions described in the package
insert are being received with unacceptable frequency, and/ or
3. which has a material formulation error, or other errors, and/ or,
4. Which has a material labelling error, or other errors, and/or,
5. Which has a result of on going stability studies, is found not to comply with the release
specifications.
46. 4.2 PROCEDURE
46
1.Any employee of XYZ Pharmaceutical Ltd becoming aware of “Violative medicine” immediately
notifies the GM, QA/QC/Regulatory or in his absence GM, Manufacturing.
2.If the GM, QA/QC/Regulatory or GM, Manufacturing, is of opinion that the violation is of a sufficiently
serious nature to possibly warrant a medicine recall, he shall immediately quarantine existing in-house
stocks of the relevant medicines and obtain the following information :
a) The product name, strength, packs size, batch number,
Manufacturing Date and Expiry Date.
b) The total number of units released for sale.
c) The Date on which distribution commenced.
d) The total number of units distributed.
e) The number of units still in stock in factory and with stockiest(s)
through the Market.
f) The nature of reported violation.
The above information is recorded on the attached document “Medicine Recall Control document”
under “Product Information” (Annexure- 2)
47. 3.In the light of above information GM-(QA/QC/Regulatory) or GM- (Manufacturing) or GM-
(Formulation and Development) evaluates the health hazard presented by the medicine and documents
this evaluation
on the attached document “Medicine Recall Control Document” under
Health Hazard Evaluation (Annexure-3).
4.Taking into consideration the available information as well as the health hazard evaluation the GM-
(QA/QC/Regulatory) formulates a proposed recall strategy. The recall strategy specifies the nature of
communication to be used (phone, fax, telegram, letters, telemail, etc.) as well as the level in the
distribution chain to which recall is extended.(wholesalers, retailers, general public, etc.)
5.The GM-(QA/QC/Regulatory) or GM-(Manufacturing) informs concerned Regulatory Authorities
in India and other countries as appropriate to the distribution of the medicine. Relevant records shall
be submitted to Regulatory Authorities together with proposed plan of action.
47
48. 6.If the proposed plan of action meets with the Regulatory Official’s approval, or if a modified recall
strategy has been decided upon in conjunction with the Regulatory Official’s, the GM-
(QA/QC/Regulatory) or GM-(Manufacturing) documents the recall strategy on the attached
document “Medicine Recall Control Document” under Recall Strategy
(Annexure 4).
7.The GM-(QA/QC Regulatory) or GM-(Manufacturing) implements recall without delay.
8.The GM-(QA/QC Regulatory) or GM-(Manufacturing) prepares an interim reconciliation report
after 30 days and submit a copy to concerned Regulatory Official’s.
9.The GM-(QA/QC Regulatory) or GM-(Manufacturing) prepares a final reconciliation report after 90
days and submits a copy thereof to the concerned Regulatory officials for information as a final
reconciliation and verification of the success of recall (Annexure-5). Relevant records shall be filed.
48
49. 4.2.10 Prior to termination or completion of Medicine Recall the following points
shall be given due consideration:
- Method of destruction of the product in field.
- A designed area to receive returned medicines.
- Inventory of the returned medicine.
- Destruction authorization.
11.The Medicine Recall will be terminated when the GM, QA/QC
Regulatory or GM Manufacturing are assured that recall has been
reasonably completed and a “medicine recall status report” (Annexure-6)
is completed.
12.Export Products : Recall notifications related to exported products to
relevant Regulatory Authorities, Applicants, Agents and Distributors
loaded in the importing countries shall be informed. GM-
(QA/QC/Regulatory) or GM-(Manufacturing) shall be responsible for
passing on this information.
4.2.13 GM-(QA/QC/Regulatory) or GM-(Manufacturing) shall prepare a
“ Standardized recall letters” and “Press Statement” as given in
(Annexure-7) and (Annexure-8) respectively. 53
50. 4.2.14 After the authorization by GM-(QA/QC Regulatory) or GM-
(Manufacturing), the recalled material along with stock in hand shall be
destroyed. The same shall be indicated in the final reconciliation report
(Annexure-5) with action initiated to avoid recurrence and shall be
forwarded to concerned Regulatory Authorities.
ABBREVIATIONS: NIL
REFERENCES: NIL
54
51. Date Brand Name Product Description Reason/ Problem Company
30 June 2013 Nexus,APP
Benztropine Mesylate
Injection
Glass particles Fresenius Kabi USA
19 June 2013 Rugby
Enteric CoatedAspirin
Tablets,81 mg
May Contain
Acetaminophen 500 mg
tablets
Advance Pharmaceutical
Inc.
13 June 2013
Sagent Pharmaceuticals,
Inc.
Vecuronium Bromide for
Injection
Due to elevated impurity
levels
Sagent Pharmaceuticals,
Inc.
11 June 2013 Bethel Weight Loss Pills
Contains Undeclared
Drug Ingredient
Bethel Nutritional
Consulting, Inc.
10 June 2013 ZyGenerics Warfarin 2 mg Tablets Oversized tablet
Zydus Pharmaceuticals
USAInc.
25 May 2013 Fresenius Kabi USA
Magnesium Sulfate
Injection USP
Glass Particles Fresenius Kabi USA
52. 56
Date Brand Name Product Description Reason/ Problem Company
03 October 2014 Cadolac Ketorolac Due to labelling the Cadila Healthcare
Tromethamine product with Limited
Injection incorect expiration
date
13August 2014 Idarubicine Idarubicine Discovery of red Teva UK Limited
Injection precipitation
28 July 2014 Buccolam Midazolam Chemical ViroPharma SPRL
hydrochloride contamination
oromucosal soln
19 June 2014 Fybogel Isapghula husk Potential risk of Reckitt Benckiser
contamination with Healthcare
metal particles
06 March 2014 Viread Tinofovir Presence of silicone Gilead sciences
disoproxil fumarate rubber limited
(245mg film coated
tablet)
17 Feb 2014 COSOPT Dorzolamide/ Increase in the Merc sharp &
Preservative-Free Timolol eye drops number of adverse Dohme limited
solution events & product
complaints relating
to difficulty in
administration
Drugs Recalled in 2014