This document summarizes a seminar presentation on quality audits. It defines quality audits as systematic examinations of quality systems, which are typically performed at defined intervals to verify compliance with good manufacturing practices (GMP). The objectives of audits are to verify that manufacturing and control systems are operating under a state of control. Audits are designed to detect any shortcomings in GMP implementation and recommend corrective actions. Self-inspections involve appointing a team to inspect areas like personnel, facilities, documentation, and more, using a checklist. Inspection reports are reviewed by management to determine necessary improvements.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
Quality Audit in pharmaceutical industryHari Haran
It deals with the understanding and process for auditing
pharmaceutical industries. This covers the methodology involved in auditing process of different in pharmaceutical industries.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Quality Management system in accordance to Vol. 4 EU Guidelines for GMP for Medicinal Products for Human and Veterinary Use Chapter 1 Pharmaceutical QS
ICH Q10/ Q7.
ISO 9001/2015
Introduction types, Objectives, Management of audit, Responsibilities, Planni...Kunal10679
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A quality audit, also known as a quality assurance audit or compliance audit, is a systematic examination and evaluation of processes, systems, and records to determine compliance with established quality standards, regulations, guidelines, and best practices. The purpose of a quality audit is to identify areas of non-compliance, assess the effectiveness of quality management systems, and identify opportunities for improvement. Here are some key aspects of a quality audit
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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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1. M.Pharm, 1st Sem Seminar
Sub - DRA & IPR
Topic - Quality Audit
Presented by - Satyaki Aparajit Mishra
Regd No - 1561611001
School of Pharmaceutical Sciences,
S‘O’A University
2. Definition [1]:-
Quality audit means a systematic examination of
a quality system.
Quality audits are typically performed at defined
intervals.
Any failure in their proper implementation may be
published publicly and may lead to a revocation of
quality certification.
3. Objectives [2] :-
Pharmaceutical manufacturers commonly use audits
as an effective mechanism to verify compliance with
GMP.
Audits can be used to establish a high degree of
confidence to remain under an adequate level of
control by managements.
Audits are intended to verify that manufacturing and
Control systems are operating under a state of control.
4. Designed to detect any shortcomings in
the implementation of GMP and to
recommend the necessary corrective
actions
Performed routinely as well as on
special occasions, e.g. if any complaint
arises or repeated rejections occur
...continued
5. Self Inspection Team [2]:-
Management appoints a team from the
staff or from outside having competent
knowledge to carry out the inspection.
The team can detect any shortcomings
in the implementation of GMP and
recommends necessary corrective
measures.
Generally, people with expertise in the
field of QA/QC, manufacturing and
production parameter, & inventory
control are chosen.
6. Frequency of Self inspection [1]:-
Depends on the basis of the requirement of the
company.
Sometimes, carried out partially or completely
but a complete inspection must be done at least
once a year.
In addition, it is carried out on special events like
product recall, repeated rejections or sudden
announcement of inspection by authorities.
7. Items for Self Inspection[1] :-
• Personnel
• Premises including personnel facilities
• Maintenance of buildings & equipment
• Quality Control
• Documentation
• Sanitation and hygiene
• Validation and revalidation programmes
• Recall procedures
• Complaints management
• Labels control
Inspection of at least following items must be done
as prescribed by the WHO text of GMPs :-
14. Advantages :-
Simple, convenient and
easy to use for any
desired subjected area.
Questions are in logical
order that help auditor
to detect problems.
Report can be prepared
in a minimum amount
of time.
15. Management must review the final reports and
determine what steps need to be taken to eliminate
deficiencies.
Management should sincerely encourage detection of
problems and express appreciation for being able to
improve quality operations.
The audit reports may be shared with manger
supervisor who may discuss finding with employees.
The workers and supervisory personnel should be given
the opportunity to explain their views and ideas about
the audit findings.
Final report to the management [3] :-
16. Reference :-
1. Sharma P.P ; How to Practice GMPs , 6th Edition (2010)
Page 99-114 [1]
2. Pharmaceutical Quality Group; Monograph no :- 5 (revised):
Pharmaceutical Auditing ; IQA2001, ISBN 0906810 68X [2]
3. Provisional Guideline ON the inspection of the
pharmaceutical manufacturers in: WHO Expert committee on
specification for Pharmaceutical Preparations; 32nd report,
Geneva, WHO, 1992, Annex-2 (Who technical report series.
No :- 823) [3]