This document discusses the requirements for facilities under Good Laboratory Practice (GLP) regulations. It states that test facilities must be of appropriate size and construction to minimize disturbances that could affect study validity. There must be adequate separation of different activities through physical or organizational means. Specific facility requirements are outlined for housing test systems, handling test and reference items, storing records and samples, and disposing of waste. Calibrated apparatus must be maintained and suitable computer systems validated.
Food safety and standard act, 2006 fssaiRavish Yadav
complete learning on the topic of food safety and standard act, used in day to day life, fssai hallmark everyone can see in food items , so here is the detail study on fssai
Food safety and standard act, 2006 fssaiRavish Yadav
complete learning on the topic of food safety and standard act, used in day to day life, fssai hallmark everyone can see in food items , so here is the detail study on fssai
Schedule M, M1, M2, M3 are parts of Drugs And Cosmetics Act. Schedule M to M3 Contains Good manufacturing requirements for Drugs. This are formulated to ensure that Drugs intended for human consumption and diagnosis have required safety and efficacy.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
Schedule M, M1, M2, M3 are parts of Drugs And Cosmetics Act. Schedule M to M3 Contains Good manufacturing requirements for Drugs. This are formulated to ensure that Drugs intended for human consumption and diagnosis have required safety and efficacy.
Good Laboratory Practices (GLP)
History
Reason behind GLP created
Advantages and disadvantages of GLP
Objectives of GLP
Practice of GLP
b pharma 6th sem
pharmaceutical quality assurance
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
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.
Analysis of Raw materials…..
This topic comes under Quality Control and Quality Assurance…….
This is useful for M.Pharm (Pharmaceutical Quality Assurance) Students who studying in Fist year sem I......
This Presentation Contain following...
#Definition
#Purchase Specification
#GMP & WHO guidelines for handling of raw materials
#Control on Raw Materials
#Sampling of Raw Materials
#Raw Materials Testing
Thanks for Help and Guidance of Dr. F. A. Tamboli Sir and Dr.Mrs. N.M.Bhatia Madam
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The Principles of Good Laboratory Practice (GLP) are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived). The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms.
The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities, Organization and Personnel, Facilities, Equipment,
Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory
Study, Records and Reports, Disqualification of Testing Facilities
Good Laborarory Practices. Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.
Quality management systems: Good Laboratory Practice (QMS GLP)Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to GLP
2. Definition of GLP
3. Fundamentals of GLP
4. GLP Principles
5. Aim of GLP
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.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
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.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
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.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
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.
2. INTRODUCTION
Good Laboratory Practice(GLP) regulations became part of
regulatory landscape in the latter part of the 1970s in response
to malpractice in R&D activities by pharmaceutical companies.
3. GLP is a quality system concerned with the organizational
process and the conditions under which non-clinical health and
environmental safety studies are planned , performed ,
monitored , recorded , achieved and reported
In 1981,the Organization for Economic Cooperation and
Development(OECD) also published GLP Principles.
To date 30 countries have signed an agreement binding them to
OECD GLP Principles.
The intent of the GLP is to regulate the practices of scientists
working on the safety testing of prospective drugs.
4.
5. OBJECTIVES
The GLP regulations set out the rules for good practice and help researchers perform their work in
compliance with their own pre-established plans and standardized procedures.
All GLP texts, irrespective of their origin, stress the importance on following 5 points:
1. Resources: Organization , personnel , facilities and equipment.
2. Characterization: Test items and test systems.
3. Rules: Study plans and written procedures.
4. Results: Raw data, final report and archives.
5. Quality Assurance
The training programme of the WHO covers each of these five fundamental points and explains
the requirements of GLP in each case.
6. QUALITY ASSURANCE PROGRAMME
General Provisions:
The test facility should have a documented Quality
Assurance Programme to assure that studies
performed are in compliance with these Principles of
Good Laboratory Practice.
The Quality Assurance Programme should be carried
out by an individual or by individuals designated by
and directly responsible to management and who are
familiar with the test procedures.
This individual(s) should not be involved in the
conduct of the study being assured.
7. TEST FACILITY ORGANISATION
Each test facility management should ensure that these Principles of Good
Laboratory Practice are complied with , in its test facility.
It should ensure that a sufficient number of qualified personnel, appropriate
facility, equipments and materials are available for the timely and proper conduct
of the study.
It should ensure that a statement exists which identifies individual(s) within a test
facility who fulfill the responsibilities of management as defined by these
principles of Good Laboratory Practices.
Ensure the maintenance of the master schedule.
Establish procedures to ensure that computerized systems are suitable for their
intended purpose , and are validated , operated and maintained in accordance
with these principles.
8. Principal Investigator’s Responsibility:
She/he will ensure that the delegated phases of study are conducted in accordance
with the applicable principles of GLP.
Study Director’s Responsibility:
Has study control and responsibility for the overall control of the study and for its
final report.
Ensure that all raw data generated is fully secured and documented.
Ensure that the computerized systems used in study have been validated.
Study Personnel Responsibilities:
All personnel responsible for the conduct of study must be knowledgeable.
They are responsible for recording raw data promptly.
9. PERSONNEL
GLP requires that the overall organization of the
test facility be defined.
This is usually done through an organization
chart.
This is often the first document requested by
inspectors to obtain an idea of how the facility
functions.
Sometimes the organization chart forms part of a
quality manual or other document that describes
the nature of the institution and the way in which
it operates.
10. These are high level documents. They are
supplemented by more detailed
information which may be incorporated
into following documents relating to each
individual:
1. Curriculum vitae
2. Training records
3. Job description
Together these three documents meet
the GLP requirement.
11. In a CV , it is usual to include:
Name and age of the person,
Education including diplomas qualifications awarded
by recognized institutions,
12. Languages spoken,
Membership of associations,
Any publications,
Professional experience earned both within the
institution and before joining it.
All staff should have a CV.It is a good practice to have
the CV signed and dated by the person concerned.
13. CURRICULUM VITAE(CV)
A procedure should ensure that the CV’s:
Exist for all personnel in a standard
approval format.
Are kept up-to-date.
Exist in required languages(local and
sometimes English for local submission)
Are carefully achieved to ensure
historical reconstruction
14. TRAINING RECORDS
Training complements CV.
Job competence depends largely on internal and external
specialized training.
GLP requires that all personnel should understand the meaning
of GLP , its importance , and the position of their own tasks
within GLP activities.
Training must be formally planned and documented.
New objectives and activities always involve some training.
Training systems are usually SOP based.
The training system will have elements common to all GLP
management systems i.e.it is formal , approved , documented
to a standard format , described in a SOP.
15. JOB DESCRIPTION
All systems of quality management are based
on making people responsible for their actions.
Having job descriptions with clear definition of
tasks and responsibilities is essential for
everyone.
The contents of job description should
correspond to the qualifications described in CV.
Annual reviews of job descriptions help
management ensure that their organization is
coherent.
16. Responsibilities of QA Personnel:
They should maintain the copies of all approved
study plans and Standard Operating Procedures in
use in the test facility and have access to an up-to-
date copy of the master schedule.
All personnel involved in the conduct of the study
must be knowledgeable in those parts of the
Principles of Good Laboratory Practice which are
applicable to their involvement in the study.
It is their responsibility to comply with the
instructions given in these documents.
Any deviation from these instructions should be
documented and communicated directly to the Study
Director, and/or if appropriate, the Principal
Investigators.
17. All study personnel are responsible for recording raw
data promptly and accurately and in compliance with
these Principles of Good Laboratory Practice, and are
responsible for the quality of their data.
Study personnel should exercise health precautions
to minimize risk to themselves and to ensure the
integrity of the study.
They should communicate to the appropriate person
any relevant known health or medical condition in
order that they can be excluded from operations that
may affect the study.
Verify that the study plan contains the information
required for the compliance with these Principles of
Good Laboratory Practice. This verification should be
documented.
18. Conduct inspections to determine if all studies are
conducted in accordance with these Principles of Good
Laboratory Practice.
Inspections should also determine that study plans and
SOPs have been made available to study personnel and
are being followed.
Inspections can be of three types as specified by QA
Programme SOPs:
o Study-based
o Facility-based
o Process-based
Inspect the final reports to confirm that the methods ,
procedures , and observations are accurately and
completely described , and that the reported results
accurately and completely reflect the raw data of studies.
19. FACILITIES
General:
The test facility should be of suitable size,
construction and location to meet the
requirements of the study and to minimize
disturbance that would interfere with the
validity of the study.
The design of the test facility should provide
an adequate degree of separation of the
different activities to assure the proper
conduct of each study.
20. TEST SYSTEM FACILITIES
The test facility should have a sufficient number of rooms or
areas to assure the isolation of test systems and the isolation of
individual projects , involving substances or organisms known to
be or suspected of being bio-hazardous.
Suitable rooms and areas should be available for the diagnosis ,
treatment and control of diseases in order to ensure that there is
no unacceptable degree of deterioration of test systems.
There should be storage rooms or areas as needed for supplies
and equipment.
Storage rooms or areas should be separated from rooms or areas
housing the test systems and should provide adequate
protection against infestation , contamination or deterioration.
21. BUILDINGS:
GLP required that the test facilities be of appropriate
size , construction and location to meet the
requirements of study and minimize disturbances
that would interfere with the validity of study.
They should be designed to provide an adequate
degree of separation between the various activities
of the study.
The purpose of these requirements is to ensure that
the study is not compromised.
Minimizing disturbances by separation can be
achieved by :
o Physical Separation.
o Separation by organization.
22. o Physical Separation: This can be achieved
by walls, doors or filters or by the use of
isolators. In new buildings or those under
transition and renovation , separation
will be part of design.
o Separation by Organization: By the
establishment of defined work areas
within a laboratory carrying out different
activities in the same area at different
times.
23. o Size:
The laboratory must be big
enough to accommodate the
staff working in it and allow
them to carry their own work
without risk of interfering in
each other’s work.
Each operator should have a
separate working station
sufficiently large to be able to
carry out operation efficiently.
There should be physical
separation to avoid mixing up
of materials.
The dose mixing area is
sensitive zone and access to it
should be restricted.
24. o Construction:
The laboratory should be built of materials that allow
easy cleaning and prevent cross-contamination.
There should be proper ventilation system with filters.
o Arrangement:
There should be separate areas for:
Storage of control and test items.
Storage of vehicles.
Handling of volatile materials.
Weighing operations.
Storage of prepared doses.
Changing room.
Cleaning equipment.
Office and refreshment rooms.
25. o Animal House Facility:
To minimize the effects of environmental variables
on the animal , the facility should be designed and
operated to control selected parameters.
This facility is provided to prevent animals from
coming in contact with the diseases.
The buildings and room should provide sufficient
space for animals and studies , allowing the
operators to work efficiently.
Design should allow easy and thorough cleaning of
the surfaces of walls , doors , floors and ceilings.
There should be no gaps or ledges where the dirt
may accumulate.
26. A typical Animal house should have separations maintained by provision of
areas for:
Different species
Different studies
Quarantine
Changing rooms
Receipt of materials
Storage of materials
Necropsy
Waste Disposal
27. Facilities for Handling Test and
Reference Items
To prevent contamination or mix-ups , there
should be separate rooms and areas for receipt
and storage of the test ad reference items , and
mixing of the test items with a vehicle.
Storage rooms or areas for the test items should
be separate from rooms or areas containing the
test systems.
They should be adequate to preserve identity ,
concentration , purity and stability and ensure
safe storage for hazardous substances.
28. Apparatus , including validated computerized systems
, used for the generation , storage and retrieval of
data , and for controlling environmental factors
relevant to the study should be suitably located and
of appropriate design and adequate capacity.
Apparatus used in the study should be periodically
inspected , cleaned , maintained and calibrated
according to SOPs. Records of these activities should
be maintained. Calibration should , where
appropriate , be traceable to national or international
standards of measurement.
Apparatus and materials used in a study should not
interfere adversely with the test systems.
29. Archive Facilities:
Archive facilities should be provided for the secure
storage and retrieval of the study plans , raw data ,
final reports , samples of test items and specimens,
Archive design and archive conditions should protect
contents from untimely deterioration.
Waste Disposal:
Handling and disposal of wastes should be carried
out in such a way as not to jeopardise the integrity
of studies.
This includes provision for appropriate collection ,
storage and disposal facilities , and decontamination
and transportation procedures.