Accreditation of laboratories is a process through which an authorized body examines and certifies the competence and quality systems of a laboratory based on predefined standards. NABL is India's national accreditation body that specifies the requirements for testing and calibration laboratories to be considered technically competent. The accreditation process involves identifying standards, assessment procedures, training, documentation, internal audits, management reviews, and a final certification audit. Laboratories must prepare for accreditation by training personnel, documenting procedures, implementing quality control, participating in proficiency testing, and addressing any gaps before applying to NABL for assessment.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
The PPT explain about the NABL and accreditation process according to the ISO 17025. And how you will get benefited with the NABL/ISO 17025 accreditation for your Lab.
GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORI0ES (NABL)SAM VIVEK
NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence and satisfaction.
Savings in terms of time and money due to reduction or elimination of the need for re-testing .
Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.
NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORI0ES (NABL)SAM VIVEK
NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence and satisfaction.
Savings in terms of time and money due to reduction or elimination of the need for re-testing .
Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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.
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
The Indian economy is classified into different sectors to simplify the analysis and understanding of economic activities. For Class 10, it's essential to grasp the sectors of the Indian economy, understand their characteristics, and recognize their importance. This guide will provide detailed notes on the Sectors of the Indian Economy Class 10, using specific long-tail keywords to enhance comprehension.
For more information, visit-www.vavaclasses.com
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Basic phrases for greeting and assisting costumers
NABL accreditation
1. Prepared By:- Ms. Mali Sunayana M.
Asst.Professor
Subject:-Pharmaceutical Quality Assurance
Sahyadri College Of Pharmacy, Methwade,
Sangola
UNIT-I TOPIC-
VI
2. INTRODUCTION:
Laboratory studies form an important part of
assessing the quality of products.
For results to be accepted at national and
international levels, the must be proven to be reliable.
DEFINITION:-
Accreditation of laboratories is a process through
which an authorized, independent agency examines
and certifies the competence and quality systems of a
laboratory based on particular predefined standards.
2
Prof. Mali Sunayana
3. Accreditation provides formal recognition of the
technical competence of a laboratory for particular
measurements or tests based on results from a third
party assessments.
Identify the authoritative body
Adopt necessary standard
Establish Assessment mechanism
Fig.1 : Accreditation Process
3
Prof. Mali Sunayana
4. What is NABL ?
NABL is an autonomous society providing Accreditation
(Recognition) of Technical competence of a testing,
calibration, medical laboratory & Proficiency testing
provider (PTP) & Reference Material Producer (RMP).
NABL specifies the general requirements for the
competence to carry out tests and calibrations,
including sampling. It covers testing and calibration
performed using standard methods, non-standard
methods, and laboratory-developed methods.
4
Prof. Mali Sunayana
5. • NABL is an autonomous body under the aegis of Department of
Science & Technology, Government of India, and is registered under
the Societies Act.
• NABL stands for National Accreditation Board For Testing And
Calibration Laboratories.
• NABL has agreements with ILAC (International Laboratory
Accreditation Conference) and APLAC (Asia Pacific Laboratory
Accreditation Cooperation).
5
Prof. Mali Sunayana
6. Benefits of Accreditation:
Potential increase in business due to enhanced customer confidence
and satisfaction.
Savings in terms of time and money due to reduction or elimination
of the need for re-testing .
Better control of laboratory operations and feedback to laboratories
as to whether they have sound Quality Assurance System and are
technically competent.
6
Prof. Mali Sunayana
7. Increase of confidence in Testing / Calibration data and personnel
performing work.
Customers can search and identify the laboratories accredited by
NABL for their specific requirements from the directory of Accredited
Laboratories.
Users of accredited laboratories will enjoy greater access for their
products, in both domestic and international markets, when tested
by accredited laboratories.
7
Prof. Mali Sunayana
8. Types Of Laboratory Can Seek
Accreditation:
Laboratories undertaking any sort of testing or calibration in
the specified fields.
Private or government laboratories.
Small operations to large multi-field laboratories.
Site facilities, temporary field operations and mobile
laboratories.
8
Prof. Mali Sunayana
10. Step Approach To Accreditation:
Awareness Training
Quality Policy & Objectives Finalization
Gap Analysis
Documentation / Process Design
Documentation / Process Implementation
Internal Audit
Management Review Meeting
Shadow Audit
Corrective –Preventive Actions
Final Certification Audit
10
Prof. Mali Sunayana
11. STEP 1:- AWARENESS TRAINING
CAB applies in the prescribed form in triplicate and
attach two copies of their quality manual describing
their management system as per ISO OR IEC
guidelines as applicable.
Separate training sessions for top management,
middle management and junior level management.
Creates a motivating environment throughout the
organization for ISO 17025 implementation.
11
Prof. Mali Sunayana
12. STEP 2:-QUALITY POLICY &
OBJECTIVES
Work shop with top management on development
of quality policy.
Work shop with top management and middle level
functional management on development of quality
objectives.
12
Prof. Mali Sunayana
13. Step 3:-Gap Analysis
Understanding of all the operations of the
organization.
Development of process map for the activities of the
organization.
Comparing existing operations with requirements of
ISO 17025:2005 standard.
13
Prof. Mali Sunayana
14. Step 4:-Documentation / Process
Design
Quality Manual
Functional Procedures
Work Instructions
System Procedures
Formats
14
Prof. Mali Sunayana
15. Step 5:-Documentation / Process
Implementation
Work–shop on process / document implementation
as per ISO 17025 requirements.
Departmental / Individual assistance in
implementing the new processes / documents.
15
Prof. Mali Sunayana
16. Step 6:-Internal Audit
Internal Audit Training & Examination (Optional).
Successful employees / we carry out internal audit
of the organization covering all the departments
and operations.
Suggest corrective and preventive actions for
improvements in each of the audited departments.
16
Prof. Mali Sunayana
17. Step 7:-Management Review Meeting
Quality Policy & Objectives
Results of internal audit
Results of supplier evaluation
Results of customer complaints
Results of customer feedback etc.
17
Prof. Mali Sunayana
18. Step 8:-Shadow Audit
A replica of final certification audit.
Finds degree of compliance with ISO 17025
standard.
Gives an idea to the employees about the conduct
of the final certification audit.
18
Prof. Mali Sunayana
19. Step 9:-Corrective –Preventive
Actions
On the basis of shadow audit conducted in the last
step, all the non-conformities will be assigned
corrective and preventive actions.
A check will ensure that all the NCs are closed and
the organization is ready for the final certification
audit.
19
Prof. Mali Sunayana
20. Step 10:-Final Certification Audit
Upon completion of various stages of accreditation
audit, the audit, your organization will be awarded
accreditation.
20
Prof. Mali Sunayana
21. Obtain NABL documents from the NABL Secretariat to get
familiar with the assessment process and details required
for the application.
Ensure training of one person by NABL on quality
Management System and Internal Audit.
Prepare a quality manual in keeping with the standards.
For each test / investigation done in the laboratory,
prepare a SOP
.
Calibrate instruments and equipment used in testing.
Preparing for Accreditation:-
21
Prof. Mali Sunayana
22. Train Personal on documentation aspects.
Check the status of current technical competence and quality
system by comparing with NABL Standards and address
deficiencies encountered.
Prepare a quality manual and all other documents required by
NABL.
Include Internal Quality Control(IQC) in sample analysis.
Take part in External Quality Assessment Schemes(EQAs)
Evaluate compliance with IQC and EQAs; take corrective actions
where necessary.
Perform internal audit and management review to assess
preparedness for NABL assessment.
After everything is satisfactory, apply for accreditation to NABL
with the prescribed fees.
22
Prof. Mali Sunayana
23. 1) Define the terms ‘Accreditation ‘ and ‘NABL’.
2) Write a note on NABL Accreditation in INDIA.
3) Describe how a laboratory must prepare for
NABL Accreditation.
REVIEW QUESTIONS
23
Prof. Mali Sunayana
24. REFERENCE
1) A Text book of Pharmaceutical Quality Assurance by the
author Anusuya R.Kashi, Bindu Sukumaran, And Veena
P. Nirali Prakashan. Page No.6.1-6.5
2) www.slideshare.com
3) www.google.com
24
Prof. Mali Sunayana
