2. Regulatory Bodies here is discussed with
respect to the wide range samples received
in the chemical testing Laboratory . The
regulatory bodies mentioned are :
1. Food and Drugs Administration
(FDA)
2. National Accreditation Board for
testing and Calibration Laboratories
(NABL)
Wednesday, May 18, 2016 2
3. Basics of Regulatory Bodies :
1. Food and drugs administration are in
accordance with “The Drugs and
Cosmetics Act,1940” (Specifically
Schedule L-1 ; discusses about GLP)
2. NABL is in accordance with ISO
17025:2005 – general requirements for
the competence of testing and
calibration laboratories .
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4. Why we need Accreditation ?
• To provide a means for third-party certification
to perform specific type(s) of testing and
calibration.
• Formal recognition of competent laboratories
from a regulatory body .
• Enhances customer confidence in accepting
testing / calibration methods .
• Potential increase in business due to enhanced
customer satisfaction.
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5. Fundamentals of FDA
• FDA stands for “Food & Drug Administration”.
• A key organization for consumer protection
and customer confidence .
• It is a Trusted agency that specifically impose
on “The Drugs and cosmetics Act , 1940”
• Third Amendment on “The Drugs and
cosmetics Act , 1940” done in 2008 discusses
about SCHEDULE-L (L For GMP & L-1 For GLP)
Wednesday, May 18, 2016 5
6. Fundamentals Of NABL
• NABL stands for “National Accreditation Board
for Testing and Calibration Laboratories” .
• It is an autonomous body shaped under the
guidance of Department of Science &
Technology, Government of India .
• The accreditation services are provided for
testing, calibration and medical laboratories in
accordance with International Organization
for Standardization (ISO) Standards.
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7. Differences Between FDA & NABL
FDA
• Regulatory for protecting
the public health .
• Follows GLP
• Human and veterinary
drugs, and vaccines and
other biological products
and medical devices
intended for human use are
safe and effective
NABL
• Accreditation provider in
agreement with ISO
17025:2005 .
• Accreditation are given in
various field like Biological,
Chemical, Mechanical
,Thermal , Clinical ,
biochemical , Microbiology
etc
• Testing and calibration can
be done .
Wednesday, May 18, 2016 7
8. Technical Similarities
between FDA & NABL
FDA
• Calibration of instrument is
required at regular
intervals.
• Any food , drug or health
related samples can be
analyzed that are
mentioned in the Indian
Pharmacopoeia e.g. Drugs ,
Sterility testing , Heavy
metal contents etc .
NABL
• Calibration must be up to
date before analysis .
• Any kind of samples can be
analyzed (Including DRUGS)
as per scope .
• Standard References are
followed including Indian
Pharmacopoeia(for drugs) .
Wednesday, May 18, 2016 8
9. Quality System Similarities
between FDA & NABL
FDA
• Requires a Goods
Laboratory (GLP) Manual .
• Study Director / Technical
Manager / Quality Manager
• Documentation is necessary
• Need for Replicate Testing &
ILPT .
• Standard Methods are only
employed .
NABL
• Requires a Quality Manual
• Study Director / Technical
Manager / Quality Manager
• Documentation is necessary .
• Need for Replicate Testing &
ILPT .
• Standard Methods are only
employed .
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10. Responsibilities of Management
• Laboratory or Organization must be legally
recognized .
• Laboratory must carry out Testing and Calibration
to meet the requirements of International
standards .
• Carry out Testing and Calibration at permanent
site .
• Must be a bridge between laboratory and
Organization or Parent organization .
• Protection to customers confidentiality .
• Policy to avoid any involvement in any other
activities that would harm the integrity of the
laboratory .
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11. Responsibilities of Management
• Must Appoint Quality Manager & Technical
manager .
• Prepare a Quality manual .
• Clear procedure for Document Control i.e.
issuance , modification, review , approval of
documents related to the laboratory required
for the compliance as per GLP Schedule L-1 or
ISO 17025:2005
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12. Responsibilities of Management
• Procedure for request for tenders , contracts
etc
• Procedure for services and supplies related to
the chemicals , reagents , solvents , salts , raw
materials etc by checking the genuineness of
the chemicals.
• Procedure to handle complaints and rectify it .
• Procedure to handle any non-conformance in
testing or calibration if any .
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13. Responsibilities of Management
• Procedure for Improvement in services
(Feedback).
• Procedure for any corrective Action for non
conforming work identified .
• Procedure for any preventive Action for non
conforming work identified .
• Record Maintenance (Audits & Technical)
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14. Technical Requirements
• Sufficient education, training, and/or
experience
• Current summary of training and experience
• Sufficient number of personnel
• Wear appropriate clothing
• Report any illness that may affect the study
• Have access to protocols and SOP’s
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16. Environmental conditions and Facility
• Suitable size and construction
• Separation of activities
– Test system
– Test system supplies
– Test material handling
– Laboratory operations
– Specimen/data storage
• Cleanliness
• Temperature and Humidity control
• Prevent Cross-contamination
Wednesday, May 18, 2016 16
17. Test Method and Validation
• Standard Methods must be used .
• In-house methods can be developed if
standard method is not available .
• In-house methods before using must be
VALIDATED .
• Must have knowledge of statistical techniques
for Validation of New method / In-house
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18. VALIDATION
• Accuracy
• Precision
• Specificity/Selectivity
• Detection limit /Limit Of Detection
• Limit of quantization
• Linearity
• Range
• Ruggedness/Robustness
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19. Control Of Data
Standard Operating procedures
• Sample Handling
• Storage
• Analysis method
• Instrument Operation
• Instrument Calibration
• Use and storage of Reference standards
• Replicate Testing & ILPT
• Personal Protective / Safety
• Preventive and Maintenance measures
Wednesday, May 18, 2016 19
20. Common SOP Deficiencies
• Not followed
• Don't exist
• Not current
• Not immediately available to staff
• Unclear
• Unauthorized versions found
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21. Basic Documentation Rules
Sign/initial and date all entries/pages.
Do not sign for work you did not do!
If more than one person is responsible for the entries
on a page, the data must indicate who was
responsible for which entries.
Sign/initial, date, and explain all corrections and
changes.
Never obliterate original entries. Never use White
Out!
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22. Equipment
• Well trained analyst
• Training Record
• Calibration Procedure
• Safety Measures
• Preventive Measures
• Appropriate Computer
systems(compatible to
instrument )
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• Raw Data
• Instrument Usage
(Log Book)
• Routine instrument
check .
• Basic Instrument
Information
• Instrument
Maintenance plan
23. Common Equipment pitfalls by analysts
• Failure to calibrate
• Failure to explain maintenance and repairs
• Failure to have SOP’s
• Failure to go through the instrument manual
supplied by the manufacturer .
• Failure to follow preventive and Maintenance
measures .
Wednesday, May 18, 2016 23All rights reserved
24. Handling of Test and Control Materials
Standard Operating Procedures :
Sample receipt
Storage of sample and standards.
Analysis procedure
Intra-laboratory distribution
Retention of sample
Sample disposal
Wednesday, May 18, 2016 24
25. Related Items with respect to
Standards and solutions
• Reference standards & its records
• Solubility
• Mixtures with Vehicle/Carriers and check
Uniformity, Homogeneity, Concentration,
Stability etc
• Show expiration date
Wednesday, May 18, 2016 25
EXPIRES
24/03/2013
27. Common reasons for deficit in
analyzing sample
• Inexperienced approach towards sample
• Poor knowledge
• Calibration not carried off
• lacking understanding
• Training not conducted for the analyst
• Using non standard , non validated procedure
Wednesday, May 18, 2016 27
Method or
magic
28. Final Report
A final report shall be prepared for each
laboratory Analysis
The final report should reflect the data,
methodologies, results and conclusions if
required
Shall be signed and dated by the Technical
Manager and appropriate personnel (analyst
that performed test )
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29. Relationship Between Study Records
Protocol- Says what we will do
Methods/SOPs- Says how we will do it
Raw data- Says what we did and how we did
it
The raw data prove we followed the protocol,
methods, and SOPs
Final report- Reflects the raw data, and
includes the study director’s conclusions for
the study
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30. CONCLUSION
• Technical manager & Quality Manager are
the key personnel in the laboratory .
• All work has to be recorded directly,
promptly, and legibly in ink.
• All raw data must be maintained! (even if
recorded on the following items: paper
towel, sticky, or a glove.) and stick in the
regular records if required
• All data must be signed and dated.
Cotd…..
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31. CONCLUSION
• Changes must not obscure original entry.
Provide proper justification if required .
• Footnote, sign and date all correction
changes.
• Never obliterate original entries. NEVER USE
WHITE OUT or WHITENER OR REMEDY .
• All raw data generated during a study must be
archived, when the study is finalized.
Wednesday, May 18, 2016 31
33. DISCLAIMER
Views Expressed and errors , if any are attributable
to author Anand Pandya . If you rely on the above
views without a personalize opinion or study and if
you have benefits you are free to keep it for yourself
without any ACKNOWLEDGEMENT !!!! Its just a
nutshell presentation for understanding purpose
thus If you wholly rely on the above views , without
referring to the standard copy and suffer loses and
you may sue me for negligence , I RESERVE NOT
ONLY MY RIGHTS TO RECOVER COSTS !!!!!!! But also
raise a new bill on you for relying upon these views .
Wednesday, May 18, 2016 33