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Project On Quality Control in Pharmaceutical Company
Project On Quality Control in Pharmaceutical Company
ON
BY
An IP Station of
DEHRADUN
July, 2010
A REPORT
ON
QUALITY CONTROL
BY
AT
I would also like to thank Dr. S K Joshi, Faculty In Charge, Amber Enterprises,
Selaqui, Dehradun, Internship Programme II, for giving useful knowledge and
clarifying on Quality Control Process and above all for giving me this opportunity
to present my work with this report.
iii.
Table of contents
ACKNOWLEDGEMENT III
ABSTRACT VI
1. Introduction 1
2. History 2
4.1. Sampling
4.3. Approaches 10
4.5.1. Planning
4.5.2. Implementation
4.5.3. Assessment
5.3. Testing
6. Quality Improvement 17
8. Conclusion 48
Abstract:
This report gives an overview on quality control process and its use in the various
pharmaceutical companies.
Quality Control is an integral part of the production process. The main purpose of
quality assurance and quality control (QA/QC) is to identify and implement
sampling and analytical methods and to decrease the errors into
analytical data. Manufactured products and services are tested to determine if they
meet customer standards or not. Quality control is a service to maintain
consistently high standards not for creating the standards.
For the quality control processes companies use control charts, quality control
software according to the ISO: 9000 standard, visual verification, accuracy
verification and real time quality control.
Quality Control process is very useful and the vital and the lifeblood for all the
manufacturing firms.
Signature of Student Signature of IP Faculty
Date: Date:
1. INTRODUCTION
What is Quality Control?
In quality control incoming materials are tested to make sure they meet the
appropriate industry specifications. Quality Control is an integral part of the
production process.
The main purpose of quality assurance and quality control (QA/QC) is to identify
and implement sampling and analytical methods and to decrease the errors into
analytical data. Manufactured products and services are tested to determine if they
meet customer’s standards or not.
For maintaining the standards they follow statistical process control (use of control
charts), sampling, using of ISO: 9000 standard software, manual verification and
many other modern process. Quality Control not only affects the quality of the
product but also the production cost.
1.
2. HISTORY
In the early 1900s, the beginning of Factory Productions, the final products were
inspected for the purpose of accepting or rejecting the same. During these times, in
his list of basic areas of manufacturing management, F. W. Taylor, emphasized on
quality by including Product Inspection into it. Radford’s was of the view of
involving quality consideration early in the product design stage and also to
connect-together Quality, Productivity and Costs.
After this war, in the mid-twentieth century, professionals and engineers in the
industry hugely benefited by the American Universities in terms of training in
quality control. This has seen the emergence of ‘Quality Assurance’ evolved out of
this development taken place around ‘Quality Control’ concept. At about the same
time, Joseph Juran began his `Cost of Quality’ approach, emphasizing accurate and
complete identification and measurement of Costs of Quality, In the mid 1950s,
Armand Fiegen Baum proposed Total Quality Control which enlarged the focus
of Quality Control from manufacturing to include Product Design.
During the 1960s, the concept of “Zero-defects” gained favor. Philip Crosby, who
was the champion of “Zero defects” concept focused on employee motivation and
awareness. In this decade from 1950 to 1960; quality control and management
became synonymous with the growth of Industrial Revolution in Japan.
In late 1980s, Total Quality Management (TQM) gained a lot of popularity even
outside Japan and became the main theme revolving around the concept of Quality
Control. In the twenty first century the concept of quality has been gathering a total
or gross approach in terms of ‘Business Excellence’.
3.
3. PROCESS OF QUALITY CONTROL
Quality Control mainly consists of three processes:
According to the
Quality is not only a mindset, but also a formalized system. Through strict
documentations and procedures, our engineers and operators maintain control of
quality throughout every step of production.
Our division of the quality control process into three separate processes ensures
that specialized expertise is applied to each stage of our operation. This system
also provides the redundancy necessary to prevent any quality problem from
evading detection.
4.
3.1. Incoming Quality Control
It is the job of the IQC process to conduct inspections and handle quality problem
before the assembly process starts.
5.
3.2. In-Process Quality Control
IPQC process governs the quality systems during the assembly process, to detect
and handle problems that may arise as a result of assembly.
6.
3.3. Outgoing Quality Assurance
OQA is the last process before products ship to customers, and hence is every
important to ensure our shipment is defect-free. Numerous redundancies with IQC
and IPQC is performed here to ensure the validity of previous processes.
7.
4. PLANNING & IMPLEMENTATION OF
QUALITY CONTROL
4.1. Sampling:
It is also called as statistics. This sampling plays key role in Quality Control
process. Sampling is called as the process of selecting a suitable
sample for study from the whole lot.
4.1.1. Different sampling parts are there. Below are few examples:
1.Single-Sampling-Plan
2.Double-Sampling-Plan
3.Sequential-Sampling-Plan
Control Charts are used to tell the difference between normal and abnormal
variations of a process. It explains whether the process is
running smoothly or not. Control Charts are used as a Tool in Data Quality
Improvement process. Control Charts gives indicate at a glance of production
process. Control charts are often referred to as statistical process control (SPC).
The types of charts are often classified according to the type of quality
characteristic that they are supposed to monitor: there are quality control charts for
variables and control charts for attributes. Specifically, the following charts are
commonly constructed for controlling variables:
X-bar chart. In this chart the sample means are plotted in order to control
the mean value of a variable (e.g., size of piston rings, strength of materials,
etc.).
8.
R chart. In this chart, the sample ranges are plotted in order to control the
variability of a variable.
S chart. In this chart, the sample standard deviations are plotted in order to
control the variability of a variable.
S**2 chart. In this chart, the sample variances are plotted in order to control
the variability of a variable.
For controlling quality characteristics that represent attributes of the product, the
following charts are commonly constructed:
C chart. In this chart (see example below), we plot the number of defectives
(per batch, per day, per machine, per 100 feet of pipe, etc.). This chart
assumes that defects of the quality attribute are rare, and the control limits in
this chart are computed based on the Poisson distribution (distribution of
rare events).
U chart. In this chart we plot the rate of defectives, that is, the number of
defectives divided by the number of units inspected (the n; e.g., feet of pipe,
number of batches). Unlike the C chart, this chart does not require a constant
number of units, and it can be used, for example, when the batches (samples)
are of different sizes.
Np chart. In this chart, we plot the number of defectives (per batch, per day,
per machine) as in the C chart. However, the control limits in this chart are
not based on the distribution of rare events, but rather on the binomial
distribution. Therefore, this chart should be used if the occurrence of
defectives is not rare (e.g., they occur in more than 5% of the units
inspected). For example, we may use this chart to control the number of
units produced with minor flaws.
9.
P chart. In this chart, we plot the percent of defectives (per batch, per day,
per machine, etc.) as in the U chart. However, the control limits in this chart
are not based on the distribution of rare events but rather on the binomial
distribution (of proportions). Therefore, this chart is most applicable to
situations where the occurrence of defectives is not rare (e.g., we expect the
percent of defectives to be more than 5% of the total number of units
produced).
4.3.Approaches:
*Quality-reviews
* Auto Software assessment and software measurement.
4.5.1.Planning:
4.5.2.Implementation:
• QAPPs
• SOPs
• Data collection
• Assessments and audits
4.5.3.Assessment:
• Data validation and verification
• Data Quality Assessment (DQA)
10.
4.6.Standards for Digital Elevation Models in Quality Control:
11.
5. QUALITY CONTROL SOFTWARE
Software Quality Control is the set of procedures used by organizations (1) to
ensure that a software product will meet its quality goals at the best value to the
customer, and (2) to continually improve the organization’s ability to produce
software products in the future.
5.3. Testing
Unit testing
Integration testing
System testing
12.
5.4. Software used in pharmacy for QC:
12.
Up-to-date statistical tools
MultiQC disregards the old "Westgard rules" formerly brought in as a standard for
clinical laboratories but which turned out to be totally inappropriate to today's
analyzers. Read: Misconceptions in medical laboratory quality control (pdf file 610
KB).
Non
1) Control intervals specified by the reagent maker
statistical
2) Statistics estimated from a reference pool
3) Specified statistics
Univariate
Multivariate
Acceptance 4) Learning mode when a new analyte is started
We need to take a closer look at the manufacturing and service processes and
deploy suitable techniques to enhance process capability. While 'percentage
defects' is a thing of the past, achieving PPM (parts per million) defect levels is the
challenge before today's managers.
It is true that there are many approaches suggested by various quality experts.
Corporations all over the world have been experimenting with one approach after
the other, with little or no success. In this context, choosing a feasible path has
become very important.
Many top management personnel are not aware that relatively simple techniques
like SPC and EPC can be put to use to achieve quantum jumps in quality
improvement and cost reduction.
17.
SPC is a time-tested and effective control scheme used for process capability
analysis and process monitoring. SPC techniques consist mainly of Pareto
Analysis, Scatter Diagram and Regression Analysis, and Statistical Control Charts.
It is perhaps the most useful tool in the early stages of quality improvement
initiatives. It can be deployed to identify the vital few and screen out trivial many.
Let us look at the following data on defect counts, taken from the inspection log of
a garment manufacturing unit:
Missing buttons and improper stitches contribute 80% of total defects. If the
corrective and preventive actions can be focused on elimination of the root causes
of these two dominant defects from the process, we can easily achieve a significant
reduction in overall defect tally.
They are very useful in the study of inter-relationship between a key process output
variable (KPOV) and a key process input variable (KPIV). If there is a significant
relation between the two, the process output can be controlled effectively by
controlling the process input.
There are many practical situations where measurement of product quality is not
easy. For example, in case of mechanical properties of heat-treated steel, by the
time the product is cooled, sample is taken and tested, a lot of production could
have already happened. In case the test piece fails, you have already generated
huge pile of scrap.
In such situations, it is worthwhile to explore whether the product quality (Y) can
be controlled by controlling one/more process parameters (X's).
2 18 8.0 . 12 38 15.5
3 20 8.4 . 13 40 18.9
4 22 9.5 . 14 42 18.5
5 24 11.8 . 15 44 20.6
6 26 10.4 . 16 46 19.8
7 28 13.3 . 17 48 21.7
8 30 14.8 . 18 50 22.8
9 32 13.2 . 19 52 23.6
10 34 14.7 . 20 54 25.4
We can predict the value of Product Characteristic (Y) for various values of
Process Characteristic (X) using the following equation:
Y = -0.5011 + 0.4635 X
Statistical Process Control charts (or simply, SPC charts) are used for monitoring
the process performance and process variations. These charts may be constructed
for monitoring of process parameter or product characteristic.
Control chart has a centre line depicting the average process performance.
It has two control lines, namely, Lower Control Limit (LCL) and Upper
Control Limit (UCL). The control limits are calculated on the basis of
natural (short- term) variations in the process.
When a plotted point falls within the control limits, no action needs to be
taken. But, any point falling outside the control limits requires further
investigation / process adjustment. Control charts can be constructed for
both the variable (say, diameter) and attribute (say, surface defects) data.
The most commonly used variable control charts are the X-Moving Range chart,
Xbar-Range chart, and Xbar-Sigma chart.
Widely used attribute control charts are the p-chart, np-chart, c-chart and u-chart.
Let us consider the following data on weight of tablet, taken from a pharmaceutical
company:
Lower Specification Limit (LSL) = 0.9 gram; Target Value (T) = 1.0 gram
Weight Weight
Sl. No. Time . Sl. No. Time
(Grams) (Grams)
In this case, all the data points are within control limits. Therefore, no process
stoppage / adjustment are required to eliminate any assignable cause of variation.
Engineering Process Control (EPC) is fast gaining popularity these days. While
SPC charts provide a good check against assignable causes of variation, EPC
charts can be used for prediction and run-on-run adjustment of process average.
Consider the data on weight of tablets discussed earlier. You may ask two
interesting questions.
What amount of adjustment is required NOW to bring the process average to target
value?
7. INTEGRATE the standard methods and processes with the product / service
design stage.
The Six Sigma strategy involves extensive use of statistical techniques such as
control charts, design of experiments, response surface methodology etc. in order
to minimize process variations and product / service defects. These techniques
need to be applied in a structured manner.
While reporting the process improvement, Six Sigma teams use certain numeric
values, known as Six Sigma Metrics. The most common metrics are 'Defects per
Million Opportunities (DPMO)', 'Sigma Quality Level', and 'Yield'.
'Defects per Million Opportunities (DPMO)' is the number of critical defects that
the process is estimated to generate per million opportunities (operations or steps).
In shop-floor process control, this is also called defective 'Parts per Million (PPM)'
pieces produced by a single process / operation.
24.
'Sigma Quality Level' is an indicator of process centering and, process variation
viz-a-viz technical tolerance. A process at six sigma quality level is expected to
generate only 3.4 defective Parts per Million.
Based on the quality characteristic under study (variable / attribute data type), one
or more metrics may be used for process monitoring and reporting.
It may be noted that the six sigma metrics are just the indicators of process quality.
Sustaining and improving the process performance require process monitoring and
control schemes such as Statistical Process Control (SPC), Engineering Process
Control (EPC) etc.
Six Sigma initiatives aim at reduction of process variations and defects. SPC and
EPC are two important techniques for achieving these goals. Relatively
inexpensive and easy to understand (requiring minimal support from external
experts), it is a feasible proposition to implement these techniques in any
organization.
25.
7. QUALITY CONTROL IN
PHARMACEUTICAL COMPANY
7.1. Brief introduction about pharmaceutical company:
The pharmaceutical industry develops, produces, and markets drugs licensed for
use as medications. Pharmaceutical companies can deal in generic and/or brand
medications. They are subject to a variety of laws and regulations regarding the
patenting, testing and marketing of drugs.
The earliest drugstores date back to the middle Ages. The first known drugstore
was opened by Arabian pharmacists in Baghdad in 754 and many more soon began
operating throughout the medieval Islamic world and eventually medieval Europe.
By the 19th century, many of the drug stores in Europe and North America had
eventually developed into larger pharmaceutical companies.
Most of today's major pharmaceutical companies were founded in the late 19th and
early 20th centuries. Key discoveries of the 1920s and 1930s, such as insulin and
penicillin, became mass-manufactured and distributed. Switzerland, Germany and
Italy had particularly strong industries, with the UK, US, Belgium and the
Netherlands following suit.
26.
7.2. Quality Control management:
Pharmaceutical companies of all sizes outsource at least some quality control (QC)
testing to contract analytical testing laboratories. Virtual and smaller companies
may not have the staff to conduct such testing; whereas mid- to large-size
companies may outsource testing that they do not wish to perform in-house. In the
relationship between a pharmaceutical company and its outsourcing partner, each
partner has clearly delineated responsibilities, both business and compliance
related. Focus on those of the contractor (contract acceptor), limiting the attention
to responsibilities in the contractee–contractor relationship. Neither discussion
addresses purely business-related concerns such as revenue growth, development
and retention of staff, and shareholder reward.
Quality control essentially deals with designing and producing products as well as
services in a way that they either meet or exceed the requirements of the customer.
Failure testing and assurance in design as well as production are two important
activities of quality control programs.
27.
7.2.2.Quality-Assurance:
This covers providing evidence for supporting the claim that quality has been
established in work, product or service. For this purpose, suitable standard
operating procedures (SOP’s) are to be introduced for defining a standardized
procedure of doing operations in an effective manner. This ensures adherence to
maximum efficiency and safety requirements of the clinical research activities that
have been performed. Such defined procedural information assures auditors and
regulatory inspectors of requirements adherence. These SOPs should be
sufficiently proliferated amongst all the individuals involved in the procedure and
proper training should be provided to them. Such planned implementation of
procedures is in complete concordance with the basic PDCA cycle of quality
control that asks quality implementers to plan, perform, measure and take
necessary actions as per the measured data. For this purpose, SOPs are tailored for
clinical, pre-clinical, pharmacokinetics, bio-analysis, regulatory affairs, data
management, drug safety, project management, vendor management, supply chain
management, change control and crisis management.
7.2.3.Failure-Testing:
Pharmaceutical research involves trying various combinations of ingredients and
individually gauging the effectiveness of each combination. As can be seen, such
combinations can run into millions and hence failure testing becomes an important
part of quality control in pharmaceutical companies. For instance, even if two
ingredients are involved in a medicine, their relative composition can be varied to
the extent limited by available measuring technology, so that the ideal combination
can be found out. Advanced quality techniques like Design of Experiments are
extensively employed in this regard. They greatly reduce the effort involved in the
testing process and the results provided by them are definitely more reliable than
human analyzed results.
Pharmaceutical industries must comply with the highest quality regulations for
winning accreditation and acceptance in the global market. Quality control is an
extremely effective tool in this regard.
28.
7.3. Quality control at pharmaceutical limited:
They have a modern and well-equipped Quality Control (QC) laboratory, which
ensures that our products are pure, safe and effective and are released only after
thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU CGMP, MHRA, WHO,
TGA, etc.
Their QC Lab is a one of its kind laboratory and amongst the first few pharmacy
companies to get the NABL accreditation. It is also the first in India
Pharmaceutical industry to successfully pass the re-accreditation by NABL.
Our QC department has all necessary instruments for analysis of API, finished
products, packaging and related materials used.
29.
The QC department performs following activities:
RM/PM analysis
Finished Products analysis
In-process Checks
Stability Studies
30.
Quality Control for API / PM, Finished Products & In-Process Control is as
follows:
31.
Flow Chart - In process Checks:
32.
7.4. Quality Control at Aglowmed Pharmacy:
33.
7.5. Technologies used in pharmacy for controlling the quality:
7.5.1. Recording Powder Flow meters (RPF) have received relatively little
attention in the literature. This paper reports on a modified RPF which utilizes a
Metter PR-1200 electronic balance rather than the traditional specifically
fabricated flow meter. The versatility of this modification is discussed as a cost
effective modification. This modification provides for the use of RPF's in many
areas of pharmaceutical technology. The reproducibility of RPF data with its
sensitivity to processing and formulation variables has been investigated.
Suggestions for the application of RPF data in quality control, reformulations and
other research areas of pharmaceutical manufacturing.
7.5.2. As a leading pharmaceuticals company, Taisho is constantly striving for strict
quality assurance and working to deliver world standard products for the safety of
consumers.
In 1980, Taisho formulated its Good Manufacturing Practice (GMP), a set of group
wide standards for manufacturing and quality assurance, and immediately set about
establishing a standards-compliant manufacturing structure.
Taisho established its Production Technology Laboratories in April 1999, with the
aim of conducting specialized research in comprehensive technologies relating to
prescription pharmaceuticals. In December 2001, the Company stepped up efforts
to bolster quality maintenance and at the same time enhanced efficiencies by
consolidating the quality assurance and manufacturing technology functions. As
OTC medicines are products comprised of a various number of ingredients,
consumer safety is paramount. To meet this need, Taisho has installed the most
comprehensive testing equipment used in Japan's pharmaceuticals industry. Other
measures adopted by the Company include testing for the presence or absence of
minute faults in product containers through the use of X-ray irradiation.
Alpha Biotech:
The Cobra 148 is a range of non-contact nano dispensers with dispense volumes of
50nl-5ml.
Brandel plate sealers offer a quick and easy way to seal plates of almost any size.
Dr.Schleuniger-Pharmatron:
8M: universal tablet tester for manually fed measuring of weight, thickness,
diameter and hardness.
36.
8M: versatile with quick-change system for all tablet types and shapes.
8M hardness tester extended with modular HS8 handling system for semi-
automatic measuring.
AUTOTEST 4: reliable processing and testing of all tablet types including round,
capsules and oblong shapes.
37.
Ellab :
The TrackSense® Pro Sky system is used for real-time process monitoring.
The Testo Saver is data logging system offers an extensive range of radio and
Ethernet probes, making it a truly flexible temperature and humidity monitoring
solution for a wide range of pharmaceutical applications.
The 810 is ideal for air and surface temperature infrared measurement with 1-point
laser spot marking and 6:1 optics.
The Testo 720 is a high accuracy thermometer for use as a reference standard
against working instruments in a wide range of laboratory and pharmaceutical
applications.
With a memory of up to 16,000 readings, the Testo temperature data logger range
is the ideal solution for continuous monitoring of air temperatures.
The Testo 206 pH meters with built-in temperature probes are versatile, easy-to-
use instruments for fast measurement checks on liquids.
Micromeritics
Metrohm :
41.
850 Professional IC with 858 Professional Sample Processor: an intelligent ion
chromatography system for parallel determination of anions and cations in
pharmaceutical products.
Labtech Machinery
The CM-30 tablet coating machine ensures that an even coating is created.
42.
M-Tech Diagnostics:
The Pro Line challenge device is inserted into the mid-point of tubing run to
demonstrate sterilization conditions have been achieved during the cycle.
Nanoceram® Alumina filters are available in flat membrane, syringe, capsule and
pleated membrane cartridge format.
Whirl-Pak® sample bags provide a quick, reliable and convenient way to collect
liquid, semi-solid and solid samples.
43.
Mesa Laboratories
The Data-Trace MPIII system offers a wide variety of logger’s ideal for real-time
process monitoring and validation.
The Data-Trace Radio Frequency (RF) system allows for wireless and accurate
data collection, monitoring and validation during pharmaceutical processes.
The DTRF software package allows for fast and easy set-up, allowing for up to 250
loggers of any model or type to be synched together for accurate and efficient
reporting.
Mesa Laboratories' thermal barriers can be utilized with the Data Trace MPIII
loggers for monitoring processes involving extreme heat.
44.
JASCO
The model DT-810 Dissolution Tester is fully automated and designed for
flexibility to provide dissolution testing of up to 8 samples.
45.
7.5.4. Process Analytical Technologies (PAT):
The term "Process Analytical Technologies (PAT)" has been used to describe "a
system for designing and controlling manufacturing through timely measurements
(i.e. during processing) of critical quality and performance attributes for raw and
in-process materials and also processes with the goal of ensuring final product
quality". The PAT initiative focuses on building quality into the product and
manufacturing processes, as well as continuous process improvement.
Cost control, resulting partly through more efficient production processes, and
partly through the minimization of the necessity of final discard (or reprocessing)
at the QA final test point, is an important justification for exploring PAT.
47.
8. CONCLUSION
Quality Control is an important part of any manufacturing operation. It is the
lifeblood and vital for all manufacturing process. Quality control process affects
both production cost n the product quality.
The quality control statement of the company is to produce and distribute defect
free products, reduce waste, reduce variation in the manufacturing process, and
establish policies and procedures that will provide for continuous improvement of
its products and services.
In many companies there are quality control departments which controls the
production cost, quality of product, employee’s efficiency and daily work. Many
companies are hiring employees as a quality control manager, supervisor etc. So
the scope of jobs in this department is very good.
Nowadays there is much software for quality controlling is available in the market
which reduces the manual work of control process and companies are using them
frequently.
48.
9. LIST OF REFERENCES
This article incorporates public domain material from the General Services
Administration document "Federal Standard 1037C" (in support of MIL-
STD-188).
Godfrey, A. B., Juran's Quality Handbook, 1999. ISBN 007034003.
Pyzdek, T., Quality Engineering Handbook, 2003. ISBN 0824746147.
Clapp, Judith A, Software Quality Control, Error Analysis, and Testing,
1995 William Andrew In.
http://www.sqa.net/softwarequalitycontrol.html
Wesselius, Jacco, "Some Elementary Questions on Software Quality
Control"
http://satc.gsfc.nasa.gov/assure/agbsec5.txt
Deming, W E (1975) "On probability as a basis for action." The American
Statistician. 29(4), pp146–152
Deming, W E (1982) Out of the Crisis: Quality, Productivity and
Competitive Position ISBN 0-521-30553-5.
Mandel, B J (1969). "The Regression Control Chart" Journal of Quality
Technology. 1 (1), pp 1–9.
Oakland, J (2002) Statistical Process Control ISBN 0-7506-5766-9.
Shewhart, W A (1931) Economic Control of Quality of Manufactured
Product ISBN 0-87389-076-0.
Shewhart, W A (1939) Statistical Method from the Viewpoint of Quality
Control ISBN 0-486-65232-7.
Wheeler, D J (2000) Normality and the Process-Behavior Chart ISBN 0-
945320-56-6.
Wheeler, D J & Chambers, D S (1992) Understanding Statistical Process
Control ISBN 0-945320-13-2.
Guidance for Industry. PAT — A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance.
http://www.fda.gov/cder/guidance/6419fnl.htm
Weinberg Sandy “Process Analytical Technology-An Emergent Biomedical
Regulatory Methodology”.
vii.
10. BIBLIOGRAPHY
1. www.google.com
2. www.aglowmed.com
3. www.novartispharma.com
4. www.torrentpharma.com
5. www.statsoft.com/textbook/qualitycontrolchart.htm
6. www.rajeshtimane.com
7. www.multiqc.com
8. http://www.globalqualityvillage.com/spc.php
9. http://en.wikipedia.org/wiki/Talk:Software_quality_control
10. www.aristopharamaltd.com
11. www.lotsofessays.com
12. http://www.allbusiness.com/3470945-
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13. http://www.indiamart.com/company/1943270/aboutus.html
14.
http://www.sgs.com/search.htm?query=quality+control&lob=&x=10&y=4&q=qua
lity%20control
15. www.pharmainfo.net/pat
viii.