The document discusses the qualification and calibration of analytical instruments like electronic balances and UV-Visible spectrophotometers. It provides details on the various tests and parameters to be checked during qualification of these instruments to ensure they meet performance requirements. These include tests for baseline flatness, wavelength accuracy, transmittance, absorbance, emission lines, stray light, resolution and photometric linearity. The document also outlines the recommended frequency of qualification and calibration.
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
QUALIFICATION OF MANUFACTURING EQUIPMENTSANKUSH JADHAV
it gives the information about qualification of various manufacturing equipment which is used into the pharmaceutical labs. (only for information purpose)
In this slide contains definition and details of Qualification Of HPLC
Presented by: KHALID KUWAITY (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur
In this slide contains details about Pharmaceutical validation of water system
Presented by: K VENKATSAI PRASAD (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur
CLEANING VALIDATION for M.pharm and industry personabhishek pandey
YOU CAN EASY WAY TO UNDERSTAND A PROCESS AND ANLYTICAL METHOD OF CLEANING VALIDATION
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the active pharmaceutical ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes.[1] All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination and as a GMP requirement.
The U.S. Food and Drug Administration (FDA) has strict regulation about the cleaning validation. For example, FDA requires firms to have written general procedures on how cleaning processes will be validated. Also, FDA expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required. FDA also require firms to conduct the validation studies in accordance with the protocols and to document the results of studies.The valuation of cleaning validation is also regulated strictly, which usually mainly covers the aspects of equipment design,cleaning process written, analytical methods and sampling. Each of these processes has their related strict rules and requirements. Regarding to the establishment of limits, FDA does not intend to set acceptance specifications or methods for determining whether a cleaning process is validated. But some limits that have been mentioned by industry include analytical detection levels such as 10 PPM, biological activity levels such as 1/1000 of the normal therapeutic dose and organoleptic levels.[2][3][4]
Cleaning Validation in the context of Active Pharmaceutical Ingredient manufacture may be defined as: "The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels".
Validation of utility system (water system)ShameerAbid
these slides talked about the validation of utility systems in pharmaceutical industries
with special emphasis on the water system
helpful for pharmaceutical student
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
Validation of utility system (water system)ShameerAbid
these slides talked about the validation of utility systems in pharmaceutical industries
with special emphasis on the water system
helpful for pharmaceutical student
This presentation explains about qualifications of HPTLC, types of qualifications, design qualification , installation qualification ,operational qualification, performance qualification ,documentation of qualification .
Qualification of Dissolution Test Apparatus and Validation of Utility System this presentation will help to enhance your knowledge in validation and qualification area.
In this slide contains Introduction, levels of cleaning, mechanism, sampling method of cleaning validation.
Presented by: P. VENKATESH (Department of pharmaceutical analysis).RIPER, anantapur
QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETER, FTIR, DSC, HPLCAnupriyaNR
Analytical method qualification consists of a simplified evaluation of a subset of validation characteristics with a goal to demonstrate that an analytical method is scientifically sound and suitable for its intended use. In contrast to validation, analytical method qualification is performed without predefined acceptability criteria. Qualification may be performed as a prerequisite to method validation, or when an assay for product knowledge has not yet been established as a test for a critical product quality attribute. Qualification of equipment is pre-requisite for validation of the process in which the equipment is being used. Many types of equipment have measuring devices on them. Calibration of measuring devices is a part of qualification. Calibration of measuring devices is important, as the data is often collected through them. If the data collected is not from measuring devices that have been calibrated, the data cannot be relied upon. Thus the whole validation exercise can be questioned.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with qualifications of HPLC which is the " High Performance Liquid Chromatography".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Calibration is the activity of checking, by comparison with a standard, the accuracy of a measuring instrument of any type. It may also include adjustment of the instrument to bring it into alignment with the standard
Levelwise PageRank with Loop-Based Dead End Handling Strategy : SHORT REPORT ...Subhajit Sahu
Abstract — Levelwise PageRank is an alternative method of PageRank computation which decomposes the input graph into a directed acyclic block-graph of strongly connected components, and processes them in topological order, one level at a time. This enables calculation for ranks in a distributed fashion without per-iteration communication, unlike the standard method where all vertices are processed in each iteration. It however comes with a precondition of the absence of dead ends in the input graph. Here, the native non-distributed performance of Levelwise PageRank was compared against Monolithic PageRank on a CPU as well as a GPU. To ensure a fair comparison, Monolithic PageRank was also performed on a graph where vertices were split by components. Results indicate that Levelwise PageRank is about as fast as Monolithic PageRank on the CPU, but quite a bit slower on the GPU. Slowdown on the GPU is likely caused by a large submission of small workloads, and expected to be non-issue when the computation is performed on massive graphs.
Chatty Kathy - UNC Bootcamp Final Project Presentation - Final Version - 5.23...John Andrews
SlideShare Description for "Chatty Kathy - UNC Bootcamp Final Project Presentation"
Title: Chatty Kathy: Enhancing Physical Activity Among Older Adults
Description:
Discover how Chatty Kathy, an innovative project developed at the UNC Bootcamp, aims to tackle the challenge of low physical activity among older adults. Our AI-driven solution uses peer interaction to boost and sustain exercise levels, significantly improving health outcomes. This presentation covers our problem statement, the rationale behind Chatty Kathy, synthetic data and persona creation, model performance metrics, a visual demonstration of the project, and potential future developments. Join us for an insightful Q&A session to explore the potential of this groundbreaking project.
Project Team: Jay Requarth, Jana Avery, John Andrews, Dr. Dick Davis II, Nee Buntoum, Nam Yeongjin & Mat Nicholas
Adjusting OpenMP PageRank : SHORT REPORT / NOTESSubhajit Sahu
For massive graphs that fit in RAM, but not in GPU memory, it is possible to take
advantage of a shared memory system with multiple CPUs, each with multiple cores, to
accelerate pagerank computation. If the NUMA architecture of the system is properly taken
into account with good vertex partitioning, the speedup can be significant. To take steps in
this direction, experiments are conducted to implement pagerank in OpenMP using two
different approaches, uniform and hybrid. The uniform approach runs all primitives required
for pagerank in OpenMP mode (with multiple threads). On the other hand, the hybrid
approach runs certain primitives in sequential mode (i.e., sumAt, multiply).
2. • Validation of an analytical procedure is the process
by which it is established, by laboratory studies, that
the performance characteristics of the procedure
meet the requirements for the intended analytical
applications.” (Definition of Validation: USP)
• Qualification is part of validation but the individual
qualification steps alone do not constitute process
validation
• Qualification deals with components or elements
of a process
• Validation deals with the entire manufacturing
process of a product
3. QUALIFICATION OF BALANCES
“Qualification of Equipment”, which together should
be used when planning, performing and
documenting the qualification process of balances
• The core document contains the introduction and
general forms for Level I and II of qualification, which
are common to all types of instruments.
4. AIM AND SCOPE OF THE GUIDELINE
This guideline describes the requirements for balances
(electronic - digital) used in chemical and biological
tests in OMCLs. The following types of balances are
considered in this guideline
Type Ordinary name No.of digits after
decimal
position(g)
Accuracy class
1. Ultra micro
balance
7 I
2. Micro balance 6 I
3. Semi-micro
balance
5 I
4. Analytical balance 4 I
5. Precision balance 1 TO 3 II
6. Technical balance 0 TO 1 III
5. CONSIDERATIONS FOR LEVEL I AND II OF
EQUIPMENT:
QUALIFICATION At Level I of the qualification of
balances (selection of instruments and suppliers), it
is recommended to select a manufacturer of
balances that can satisfy the needs of the laboratory
and works under ISO 9001 certification. At Level II of
the qualification of balances (installation and release
for use), it is recommended to check all the
requirements set during the selection of the
instrument and calibration should be performed
before putting into service by an accredited external
service supplier, or internally by appropriately
qualified personnel, using certified reference weights
according to an approved procedure.
6. 4. REQUIREMENTS FOR BALANCE USE
Location of the Balance
The accuracy and precision of weighing
results are closely associated with the location of the
balance. OMCLs should ensure that the balance can
work under optimal conditions (weighing
room/laboratory, weighing bench, temperature,
light, air, etc,.)
• It should be ensured that the weighing bench is
stable, no matter from what material it is made. The
weighing bench should not deform when work is
carried out on it and it must be vibration-proof or the
transfer of vibrations must not influence the
weighing process.
7. Temperature
As weighing results are influenced by temperature,
OMCLs should ensure a constant temperature is
maintained in weighing rooms/laboratories. The
deviation should not exceed more than 5 °C per hour.
Atmospheric humidity
The optimum relative humidity (% RH) during a
weighing process is between 40 % to 60 % 80 % in
cases where the accuracy and linearity of
measurements are not affected. Light Balances
should be protected from direct sunlight (heat).
Air
OMCLs should not place balances in the airflow of air
conditioners or devices with ventilators next to
doorways or in areas of high traffic.
8. Weighing vessel
OMCLs must ensure that:
- the smallest possible weighing vessels are used.
- if the materials that the weighing vessel is made of
have a high degree of electrical insulation they are
not electrostatically charged.
9. FREQUENCY OF QUALIFICATION
OMCLs must ensure that qualification/calibration of
balances is done on receipt (i.e. immediately after
delivery) or prior to their first use and after any
repair or move.
The frequency of qualification/calibration depends
on the extent of use of the balances and is at the
discretion of individual OMCLs.
Qualification/calibration must be performed in
accordance with a pre-determined protocol in which
acceptance criteria are defined
• k = correlation coefficient
• SD = standard deviation
• RSD = relative standard deviation
10. Parameter to be checked Frequency Typical tolerance limit
Levelling Every day before weighing
begins
Acceptance limits of the
balance
Internal caliberation Every day before weighing
begins
Automatic acceptance
limits of the balanc
Verification Atleast once a week OMCLs shall define their
own acceptance criteri.
Accuracy Frequency to be defined
by OMCL,typically once a
year
OMCLs shall define their
own acceptance criteri.
Linearity Frequency to be defined
by OMCL,typically once a
year
OMCLs shall define their
own acceptance criteri.
(k= 1±0.0001)
Precission Frequency to be defined
by OMCL,typically once a
year
OMCLs shall define their
own acceptance criteri.
(SD=max 5*d)
Eccentricity Frequency to be defined
by OMCL,typically once a
year
OMCLs shall define their
own acceptance criteri.
(RSD=0.05%)
11. Verification
Verification of the balance is performed by placing a
suitable weight in the centre of the weighing pan
once and comparing the result with pre-defined
acceptance criteria. The same weight should always
be used in these verifications. The acceptance
criteria shall be defined by each individual OMCL.
Accuracy
The accuracy of the balance is checked by weighing
at least three different certified weights that cover
the usual weighing range of the balance. It is
recommended that the weights have approximately
5%, 50% and 100% of the maximum capacity of the
balance depending on the type of balance. It is
recommended that the weighing is repeated at least
5 times for every weight.
12. Linearity
The results obtained from a series of accuracy checks can
be used to calculate the correlation coefficient and to
check for linearity. The correlation coefficient is
calculated by comparing the nominal and measured
masses of the weights. The acceptance criteria for the
correlation coefficient shall be defined by each individual
OMCL.
Precision
The precision of the balance should be verified by
weighing at least 5 times a weight that is equivalent to
approximately 50% of the maximum capacity of the
balance. It is recommended to repeat the test with a
weight that is equivalent to approximately 5% of the
maximum capacity of the balance, if the balance is used
at the lower range (Proposed criterion: SD = max 5*d,
where d = (actual) scale interval (e.g. d=0.1 mg).
13. CALIBRATION OF UV-VISIBLE
SPECTROPHOTOMETER
Tests Performed In UV-Visible
Spectroscopy:
Baseline flatness test
UV region wave length accuracy test
Visible region wave length accuracy
test
%Transmittance of Cuvette
Control of absorbance
Emission lines from deuterium
discharge lamp
Stray Light measurement
Resolution power
Photometric linearity
14. Make,
Soft ware
& Version
Model
type &
Serial No
Beam
type
(single/d
ouble)
INS/
EQP.ID
No.
SOP No Calibratio
n
Frequenc
y
Every six
months
Instrument/Equipment Calibration Record
INS/ EQP Name: UV-VISIBLE spectrophotometer
Department Name: Central Instrumentation Lab
Equipment Details:
15. 1) Baseline Flatness Test:
Measurement configuration parameters:
Reference : No Cuvette
Sample : No Cuvette
Cuvette material : Quartz
Wave length range : 200-800
Lamp : Deuterium lamp
Detector : PDA detector
17. 2) Uv Region Wave Length Accuracy Test:
Measurement configuration Parameters
Reference : Air (Empty Cuvette)
Sample : Benzene
Recording range : 220-270nm
Lamp : Deuterium Discharge
Detector : PDA Detector
WAVE LENGTH (nm) OBSERVED PEAKS AT
WAVE LENGTH (nm)
ACCEPTANCE CRITERIA
220-270 nm 235.9±0.5nm
18. 3) Visible Region Wave Length Accuracy Test:
Measurement Parameters:
Reference : Distilled Water
Sample : 0.01% KMno4
Measuring mode : 300 to 600nm
Lamp : Deuterium
Discharge Detector : PDA Detector
WAVE LENGTH (nm) OBSERVED PEAKS AT
WAVE LENGTH(nm)
ACCEPTANCE CRITERIA
300-600nm 310±1nm
525±1nm
19. 4) %Transmittance Of Cuvette:
Measurement configuration Parameters
Reference : Empty Cuvette
Sample : Empty Cuvette
Cuvette material : Quartz
Measuring mode : 240nm
Lamp : Deuterium discharge lamp
Detector : PDADetector
WAVE LENGTH(nm) %TRANSMITTANCE ACCEPTANCE
CRITERIA
240nm Not less then 80%
20. 5) Control of absorbance:
Absorbance:Visible region
Place dummy Cuvette in sample holder and set %T to
“zero”. Now remove dummy Cuvette, by using fine & coarse
control set a reading exactly 40.0 on the read out. Press
Absorbance push button. If the maximum absorbance
obtained at λ of 485nm is 0.398 ± 0.002, the photometric
calibration of instrument is confirmed to be proper.
To confirm, repeat above steps, and set 10.00 on read out
Press Absorbance button. If the λ at 485 nm is 1.000±0.002
then it is confirmed the photometric performance in the
visible region is proper.
Absorbance:U.V region
Place blank0.1N H2SO4 Cuvette and 60ppm K2Cr2O7 as
sample
Set λ exactly to 257 nm, if the value of Absorbance of
sample at the set λ is 0.864±0.005, the instrument is
measuringAbsorbance properly.
21. 6) Emission Lines From Deuterium Discharge Lamp:
Measurement configuration Parameters:
Reference : No Cuvette
Sample : Empty Cuvette
Recording range : 400-500, 600-700
THEORETICAL
VALUE
OBSERVED
VALUE
DIFFERENCE ACCEPTANCE
CRITERIA
486nm 486±0.3nm
656nm 656±0.3nm
22. 7) Stray Light measurement:
Weigh accurately 1.2g of dried Potassium chloride in
100 ml volumetric flask and makeup to mark with
Double distilled water.
Measure the absorbance at 200 nm.
Acceptance criteria: Tolerance limit NLT 2.0
8)Resolution Power:
Prepare 0.02%v/v solution of Toluene and make up
with Hexane.
Scan the wavelength from 250 to 280nm.
Maximum absorbance is 269 nm and Minimum
absorbance is 266nm
Acceptance criteria: Ratio limit NLT 1.5
23. 9) Photometric linearity:
Weigh accurately 100mg of Potassium chromate in
100ml volumetric flask and dissolve in 0.05N
Potassium hydroxide solution. Make up with the
same solvent.
From the above solution take 20ml and make up
to 500ml with 0.05N Potassium hydroxide solution.
Now prepare dilution of 4,8,16,24,32 µg/ml.
Measure the absorbance at 370nm using blank.
Acceptance criteria: The plot should be linear and
regression coefficient (R2) should NLT 0.999.