This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
This presentation aims to elaborate the regulatory & compendial requirements of Visual inspection in Pharmaceutical parenteral manufacturing and the methodology of carrying out the testing.
This presentation is basic knowledge about the aseptic processing and media fill validation in pharmaceutical industry and media fill procedure. How to validate aseptic process in the powder drug products , data guidance and record for media fill validation.
Aseptic / sterile - “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Validation of aseptic process should be designed to provide assurance through appropriate testing that all phases and activities of the process remain sterile and it is controlled within the predetermined parameters.
Drug product, container, and closure are subject to sterilization separately, and then brought together.
Visual Inspection of Parentetal Drug Products in Pharmaceutical Quality testingKarishmaRK
This presentation aims to elaborate the regulatory & compendial requirements of Visual inspection in Pharmaceutical parenteral manufacturing and the methodology of carrying out the testing.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei
Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT.
PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT.
In this webinar, you will learn:
• How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective
• How improved process understanding affects risk assessment
• How improved final fill assembly design simplifies PUPSIT
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Aseptic / sterile- “ A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product”
Watch the presentation of this webinar here: https://bit.ly/3tDy8Ei
Recent PDA/BioPhorum publications outline risks for PUPSIT in sterilizing filtration. This webinar will summarize the key points and best practices for implementing PUPSIT.
PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT.
In this webinar, you will learn:
• How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective
• How improved process understanding affects risk assessment
• How improved final fill assembly design simplifies PUPSIT
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
Autoclave
Principle of Autoclave
Construction of Autoclave
Working of Autoclave
Qualification of Autoclave
Installation Qualification
Operational Qualification
Performance Qualification
References
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Max Neeman International is India’s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies.
Verification looks at the HACCP system to ensure that it is set up in the correct way and that the business is following the HACCP plan, in particular ensuring that the CCPs are under control. Very simply, verification involves performing tests, checking that procedures are being adhered to and reviewing the HACCP system to ensure that the food being produced is safe.
Main points covered:
• Verification activities for pre-requisites programs
• Verification of HACCP Plan
• Method of verification
• Analysis of verification results
Presenter:
Sheryl Anderson is Managing Director of Quality Systems Solutions & Initiatives (QSSI), which is a consultancy organization that offers training, implementation and audit services in ISO 22000, ISO 9001 and HACCP. She is an ISO 9001 Lead Auditor and a certified trainer for HACCP, ISO 9001, ISO 22000 and other quality improvement courses.
Link of the recorded session published on YouTube: http://www.slideshare.net/PECBCERTIFICATION/verification-planning-of-food-safety-system
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
Hello guys,
Welcome to my profile.
Practice School Report
Yh practice school report B.Pharm ke 7th semester me bnayi jati hi, jo bhi aap school training me sikhte ho wahi sb is report me mention krna hota hai.
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Quality assurance and quality management concepts.pptxGayatriBahatkar1
UNIT – I
Quality Assurance and Quality Management concepts: Definition and concept of Quality
control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
Understanding and implementing quality management system in medical laboratoriesPathKind Labs
QMS is essential to run a good laboratory, but the various requirements pose a big challenge. Once you understand the reason for these requirements compliance may be easier.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2.
OHSAS 18000 is an international occupational health and safety
management system specification.
Originally developed in early 1990’s as BS8800.
Revised in 1999 by BSI to be more compatible with ISO 14001.
It comprises two parts, 18001 and 18002 and embraces BS8800 and a
number of other publications.
17 elements designed in parallel to ISO 14001 and allows third-party
certification/registration.
Krupanidhi college of Pharmacy (Quality Assurance)
3.
An international standard like ISO 9001or ISO 14001.
An international guideline as ICH.
Not prescriptive –no absolute requirements; very similar to ISO 14001.
OHSAS 18001 was created via a concerted effort from a number of the worlds
leading national standards bodies, certification bodies, and specialist consultancies.
Krupanidhi college of Pharmacy (Quality Assurance)
4.
BS8800:1996 Guide to occupational health and safety management systems
DNV Standard for Certification of Occupational Health and Safety Management
Systems(OHSMS):1997
Technical Report NPR 5001: 1997 Guide to an occupational health and safety management system.
Draft LRQA SMS 8800 Health & safety management systems assessment criteria
SGS & ISMOL ISA 2000:1997 Requirements for Safety and Health Management Systems
BVQI Safety Cert: Occupational Safety and Health Management Standard
Draft AS/NZ 4801 Occupational health and safety management systems Specification with guidance
for use
Draft BSI PAS 088 Occupational health and safety management systems
UNE 81900 series of pre-standards on the Prevention of occupational risks
Draft NSAI SR 320 Recommendation for an Occupational Health and Safety (OH and S)
Management System
Krupanidhi college of Pharmacy (Quality Assurance)
5.
National Standards Authority of Ireland.
Standards Australia.
South African Bureau of Standards.
British Standards Institution.
Bureau Veritas Quality International.
Det Norske Veritas.
Lloyds Register Quality Assurance.
National Quality Assurance.
SFS Certification.
SGS Yarsley International Certification Services.
Asociaci?spa? de Normalizaci? Certificaci?r .
International Safety Management Organisation Ltd.
Standards and Industry Research Institute of Malaysia.
International Certification Services .
Krupanidhi college of Pharmacy (Quality Assurance)
6. OH & S policy
Planning.
Implementation and operation.
Checking and corrective action.
Management review.
Continual improvement.
Krupanidhi college of Pharmacy (Quality Assurance)
7.
Clearly states overall OH&S objectives.
Authorised by top management.
Appropriate to nature & scale of OH&S risks.
Documented, implemented, and maintained.
Communicated to all employees.
Available to interested parties.
Reviewed periodically.
Krupanidhi college of Pharmacy (Quality Assurance)
8. OH&S Policy Commitments
•
Improve health & safety performance*
•
Continual improvement.
•
“at least” comply with current applicable .
•
OH&S legislation and other requirements.
* Performance: measurable results of the OH&S management system,
related to the organization’s control of health and safety risks, based on
its OH&S policy and objectives.
Krupanidhi college of Pharmacy (Quality
Assurance)
9. OH&S Planning
•
Hazard identification, risk assessment, and risk control.
•
Legal and other requirements.
•
Objectives
•
OH&S management program(s)
Krupanidhi college of Pharmacy (Quality
Assurance)
10. Hazard Identification, Risk Assessment & Risk
Control
•
Conceptually similar to environmental aspects and impacts –target of
management program(s)
•
Much more detailed than 14001 approach
•
Assessment must address:
– routine and non-routine activities
– all personnel, including contractors and visitors
– facilities at the workplace, whether provided by the organization or
by others
Krupanidhi college of Pharmacy (Quality Assurance)
11. Hazard Identification, Risk Assessment & Risk
Control
•
Methodology must be proactive
– in advance of process/equipment changes
– allow engineering of hazard controls during design
– implementation of controls as change occurs
•
Success requires strong Management of Change (MOC) procedure
Krupanidhi college of Pharmacy (Quality Assurance)
12. Hazard Identification, Risk Assessment & Risk
Control
•
Process overview
– identification of hazards
– evaluation of risks under current controls
– evaluation of the tolerability of residual risk
– identification of needed additional controls
•
People are involved
– significant risks must be controlled
– individual behaviour is a significant factor
Krupanidhi college of Pharmacy (Quality Assurance)
14. Implementation & Operation
•
Structure and responsibilities
•
Training awareness and competence
•
Consultation and communication
•
Documentation
•
Document and data control
•
Operational control
•
Emergency preparedness and response
Krupanidhi college of Pharmacy (Quality Assurance)
15. Structure & Responsibilities
•
Documented roles, responsibilities, authorities, and accountability
•
Management appointee responsible for implementation
•
Resources
•
Managers must demonstrate commitment to continual improvement
Krupanidhi college of Pharmacy (Quality Assurance)
16. Training, Awareness & Competence
•
Ensure employee awareness and competence
•
Take into account differing levels of:
– Responsibility
– Ability
– Literacy
– Risk
•
Much of required training driven by regulation
Krupanidhi college of Pharmacy (Quality Assurance)
17. Consultation & Communication
•
More internally focused than ISO 14001
•
Employee involvement and consultation
– in development/review of policies and procedures
– about changes that affect workplace safety or health
– ensuring representation in OH&S matters
•
Buy-in, ownership, motivation
•
Insights of shop floor perspective
Krupanidhi college of Pharmacy (Quality Assurance)
18. Documentation & Data
•
Documentation of core elements
– aids employee awareness.
– shows how the various system relate.
– extremely valuable during certification process.
•
Document and data control procedures
– critical documents are available
– obsolete documents and data are removed
Krupanidhi college of Pharmacy (Quality Assurance)
19. Operational Control
•
Identify operations and activities where risk requires further control
•
Plan these to ensure that
– documented procedures are developed
– operating criteria specify key steps and requirements
– procedures addressing risks related to contractor goods and services
– establish design procedures to reduce/eliminate source of risks
Krupanidhi college of Pharmacy (Quality Assurance)
21. Emergency Preparedness & Response
•
Emergency response procedures to address
– identifying potential for incidents and emergencies.
– preventing and mitigating resultant illnesses and injuries.
– responding to incidents and emergencies when they occur.
Krupanidhi college of Pharmacy (Quality Assurance)
23. Checking & Corrective Action
•
Performance measurement and monitoring.
•
Accidents, incidents, non-conformances and corrective and preventive
action.
•
Records and records management.
•
OH&S management system audit.
Krupanidhi college of Pharmacy (Quality Assurance)
24. Performance Measurement & Monitoring
•
Monitoring the achievement of objectives.
•
Quantitative and qualitative measures.
•
Proactive and reactive methods.
•
Records to facilitate corrective and preventive actions.
•
Calibration of monitoring equipment.
Krupanidhi college of Pharmacy (Quality Assurance)
25. Quantitative & Qualitative
•
Direct Quantitative Measures
– number of lost work days following an injury.
– decibel levels of noise in a work area.
•
Indirect Qualitative Measures
– review of inspection logs.
– observation of a task.
– Interviews.
Krupanidhi college of Pharmacy (Quality Assurance)
26. Proactive & Reactive Measures
•
Proactive monitoring of compliance
– routine basis, independent of any event.
– monitoring may be required by regulations
• daily equipment checks.
• periodic review of hot-work permits.
•
Reactive monitoring of accidents or incidents
– in response to an event or trigger
• accident investigation.
• monitoring in response to a complaint.
Krupanidhi college of Pharmacy (Quality Assurance)
27. Accident, Incidents, Non-conformances & Corrective
and Preventive Action
•
Handle, investigate, mitigate
– Accidents.
– Incidents.
– non-conformances.
•
Corrective and preventive actions.
•
Review action plans through risk assessment process.
Krupanidhi college of Pharmacy (Quality Assurance)
28. Accident, Incidents & Non-conformances
•
Handle = immediate action
– Notification.
– emergency response.
– recordkeeping to facilitate investigation.
•
Investigation process.
– team and procedures.
– root cause analysis.
•
People are involved
– human elements.
Krupanidhi college of Pharmacy (Quality Assurance)
29. Corrective and Preventive Action
•
Correct immediate problem.
•
Mitigate consequences.
•
Eliminate or control root cause.
•
Prevent recurrence.
•
Review action plans through risk assessment process.
•
Communicate results and monitor.
Krupanidhi college of Pharmacy (Quality Assurance)
30. Records & Record Management
•
Identification, maintenance, and disposition
•
Records must be:
– Legible.
– Identifiable.
– traceable to the activities involved.
– easily retrievable.
– protected from damage, deterioration, or loss.
– held for specified and documented retention times.
Krupanidhi college of Pharmacy (Quality Assurance)
31. OH&S Management System Audit
•
Determine if OH&S-MS:
– conforms with planned arrangements.
– is properly implemented and maintained.
– is effective in meeting policy and objectives.
•
Results provided to top management.
•
Audit program and schedule reflect risks and previous audit results.
Krupanidhi college of Pharmacy (Quality Assurance)
33. CONCLUSION
Essentially, OHSAS helps in a variety of respects... it helps: minimize risk to
employees/etc; improve an existing OH&S management system; demonstrate
diligence; gain assurance; etc. The benefits can be substantial.
Krupanidhi college of Pharmacy (Quality Assurance)
34. THANK YOU
Krupanidhi college of Pharmacy (Quality
Assurance)