Expectations from regulatory authorities

Expectations from Regulatory
Authorities
Wednesday, May 18, 2016 1
By
Anand Pandya,
Quality Assurance Analyst,
JRF Global ,Vapi

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)

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 .

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.

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)

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.

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 .

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) .

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 .

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 .

• 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

• 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 .

• 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)

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

Personnel

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

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

VALIDATION
• Accuracy
• Precision
• Specificity/Selectivity
• Detection limit /Limit Of Detection
• Limit of quantization
• Linearity
• Range
• Ruggedness/Robustness

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

Common SOP Deficiencies
• Not followed
• Don't exist
• Not current
• Not immediately available to staff
• Unclear
• Unauthorized versions found

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!

Equipment
• Well trained analyst
• Training Record
• Calibration Procedure
• Safety Measures
• Preventive Measures
• Appropriate Computer
systems(compatible to
instrument )
• Raw Data
• Instrument Usage
(Log Book)
• Routine instrument
check .
• Basic Instrument
Information
• Instrument
Maintenance plan

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

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

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
EXPIRES
24/03/2013

Common Reagent Labeling
Deficiencies
• Not properly labeled
• Expired
• Not properly stored

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
Method or
magic

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 )

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

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…..

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.

References
• ISO/IEC 17025:2005
• Drugs and Cosmetics Act 1940, 3rd Amendment –
2008
• www.who.int/prequal/trainingresources/pq.../Gen
eral-personnel.ppt
• www.isoiec17025.com/uploads/shoq17025.ppt
• www.who.int/prequal/.../pq_pres/.../Sampling-
analysis-reporting.ppt
• http://www.nabl-india.org/

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 .

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