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.
According to US FDA it is illustrated here that,
A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.
Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.
21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
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.
According to US FDA it is illustrated here that,
A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.
Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.
21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
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.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
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)
Q.R are planned and documented by an inspections of a review item
The review item may be a product, a group of related products or a part of a product
If the error identified earlier the cost of implication is less and the penalty for failing to conduct adequate reviews.
Pharmaceutical Good Manufacturing PracticesPharmaceutical
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
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)
Q.R are planned and documented by an inspections of a review item
The review item may be a product, a group of related products or a part of a product
If the error identified earlier the cost of implication is less and the penalty for failing to conduct adequate reviews.
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
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
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
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences.
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
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This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
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Model Attribute Check Company Auto PropertyCeline George
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Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
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Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
2. CONTENTS :
Objectives
Complaint Handling Principle
Complaint Procedures
Classification of Defects
Critical Defects
Major Defects
Other Defects
Records of complaint Investigation
Recall definition
Recall process
3. OBJECTIVES :
To recognize the key issues in product
complaint and recall handling
To identify with the specific requirements
for organization, procedures and
resources
To appreciate and develop actions to
resolve current issues applicable to you
4. COMPLAINTS PRINCIPLE :
All complaints and other information concerning potentially
defective products must be carefully reviewed according to written
procedures and corrective action should be taken
Principle should follow bellowing criteria
Manage optimistically and ingeniously reviewed.
Handle by expert staff member.
Methodical investigation of the cause is necessary.
A foremost resource of information and knowledge.
Compulsory actions taken if recall decision
5. COMPLAINTS PROCEDURE – I :
Selected in charge person should have perform
following task
To handle complaint
Decide on quantify to be taken
If not authorized person must advise authorized person
of results
Adequate support staff
Access to records
Written procedure (SOP):
Describes action to be taken
Includes require to consider a recall
6. COMPLAINTS PROCEDURE – II :
Comprehensive investigation:
With individual concentration to set up whether
"counterfeiting" may have been the cause
Cary out Fully recorded investigation – be a sign of all
the details
QC concerned
Caused by product defect (discovered or suspected):
Regard as inspection other batches
Batches containing reprocessed product
7. COMPLAINTS PROCEDURE – III :
Investigation and evaluation should outcome in proper
follow-up actions
possibly will take account of a "recall"
All decisions and manner taken should be recorded
Referenced in batch records
Records reviewed - trends and frequent problems
8. ADDITIONAL ACTION TO BE :
Inform competent authorities in case of serious
quality problems such as:
defective manufacture
Product deterioration
counterfeit
9. CLASSIFICATION OF DEFECTS :
One time defect has been identified or justified ,
company should be dealing with it in a suitable way,
even recall
The following system has been established in some
countries (but it is not a WHO guideline):
A. Critical defects
B. Major defects
C. Other defects
10. A. CRITICAL DEFECTS :
Individuals defects which can be critical and require
the company to take in need of attention action by all
reasonable resources, whether in or out of company
hours
Examples
Product labelled with inaccurate name or
incorrect strength
Imitation or deliberately tampered-with product
Microbiological contamination of a sterile
product
11. B. MAJOR DEFECTS :
Those defects which possibly will put the patient at a
little hazard but are not life-threatening and will require
the batch recall or product withdrawal within a few
days
Examples
Any labelling/leaflet misinformation which
represents a significant hazard to the patient
Microbial contamination of non-sterile products
with some risk for patients
Disobedience to specifications
12. C. OTHER DEFECTS :
Individuals defects which present only a insignificant
risk to the patient — batch recall or product
withdrawal would normally be initiated within a few
days.
Examples
Readily visible inaccessible packaging/closure
faults
Contamination which may cause spoilage or dirt
and where there is least risk to the patient
13. REASONS FOR RECALL :
Patients complaint
Recognition of GMP failure after release
Consequence of an inspection
Result from the in progress stability testing
Identified counterfeiting or tampering
Adverse reaction reporting
Appeal by the national authorities
14. PRODUCT RECALLS: PRINCIPLE
“There should be a system to recall from the market
promptly and effectively, products known or suspected to
be defective.”
15. DEFINITION :
Recall
Removal from the market of specified batches of
a product , may refer to one batch or all batches
of product
16. RECALL PROCEDURE - I :
Designated authorized responsible person
To accomplish and coordinate recalls
Decide on measure to be taken
Adequate support staff
To handle all aspects and necessity of recall
17. SOP FOR RECALL :
Established, written and authorized
Detailed actions to be taken
Regularly reviewed and updated
Capable of rapid operation to required level of
distribution chain, e.g. hospital and pharmacy
level
Store recalled products in a secure, segregated
area
18. DISTRIBUTION RECORDS :
Allocation records on hand to authorized person
and contain enough information on:
Regulatory permit effective recall
Including for clinical tests and medical samples
Batch numbers and quantities
Wholesalers
Direct customers
Export locations
19. PROGRESS OF RECALL :
Supervise and record the progress during the recall
Inform all competent authorities of all countries
where the given product had been distributed
Final report should include reconciliation between
delivered and recovered products
Record of the disposition of the product
Effectiveness of procedure tested and evaluated from
time to time with reference past events.
20. DISCUSSION WITH EXPERT AND STAFF :
Collect 3 examples of complaints or recalls from
your experience
Describe the actions to be taken by the company or
authority and the implications for all interested
parties
Suggest a classification of the complaint or recall into
critical (life-threatening), major or other
21. POSSIBLE ISSUES WITH RECALL PROCEDURE
No response to justified complaints
Response to unjustified complaints
Collapse to recall
Failure to correct common complaints
No capital to investigate
No superior management support
Senior management interference
22. No access to records likewise distribution
information/batch records
Incapacity to contact government during
holidays/weekends
Dissimilarity on harshness of defect
23. REFERENCES :
WHO Module 5, January 2006.
www.authorstream.com
www.wikipedia.com