How do I get a job in QA & QC department in Pharmaceutical Industry
How do I get a job in QA & QC
department in Pharmaceutical Industry
The
pharmaceutical sector is famed for its ability to recognise and reward true
talent. Manufacturing, quality control, quality assurance, drug regulatory
affairs, intellectual rights, technology transfers, research and development,
formulation and development, analytical labs, clinical research,
pharmacovigilance, sales and marketing, and so on are all part of the
pharmaceutical industry. When you first emerge as a newcomer, it appears like
breaking through is difficult. However, practically every company has open
positions for a single or several divisions at any one time while we track a
record. In reality, there are several work opportunities, but you must first
grasp how to obtain employment in the pharmaceutical business.
To
make the best professional choice, you must be job-ready and dynamic. It's
possible that you'll have to apply for a few different jobs before you locate
the one that's ideal for you. There are numerous ways to obtain employment in
the pharmaceutical business, and we are here to provide solutions.
INSTRUMENT PIC: LCMS
Examine the following job-related websites: First and foremost, you have the option of visiting several job websites. Different websites display various career chances, and visiting a reliable website can provide you with accurate job information at the right time. There are numerous such job sites that provide job information, and Pharma Tutor is one of them. You can always sign up for free email alerts by registering.Join
Pharma Groups: We live in the internet age, so you're probably familiar with
social networking sites like Facebook, Twitter, LinkedIn, and WhatsApp. Many
organisations are actively watched by pharmacists and provide you with free
information not only about recruitment but also about honing your professional
abilities and techniques. Joining such groups on various social media sites and
apps is a good idea.
Make
Use of Referrals: Although it is not always essential, receiving such
suggestions for interviews is beneficial to you. References may or may not help
you land a job, but they will at least get you an interview. You can readily
obtain recommendations from your seniors or classmates who are currently
employed in the field. There is nothing to be shy or
feeling small to ask for help.
Participate
in additional skill-based courses: what we learn in our textbooks is vastly
different from what we must do in the pharmaceutical sector. The pharmaceutical
sector is a skill-based profession in which you must be specialised in your
work, whether it be sales or R&D. You can participate in any practical
training that will help you in your profession. Additionally, candidates with
additional knowledge and training will be given precedence by human resource
and technical departments. Furthermore, several of these colleges offer job
guarantees or at the very least keep you informed about job interviews. And
that is your chance!
Create
a LinkedIn profile: HR professionals are becoming increasingly astute, and they
may be able to trace you down on social media sites, which can provide a
picture of the real you. A well-managed LinkedIn profile can help you project a
professional image. You can use LinkedIn to promote your abilities, make new
connections, engage with others, and share content that is relevant to your
professional interests.
Also, ensure sure there are no spoon-feeding techniques in the
pharmaceutical industry. You must learn it on your own. If you want to
understand something, you must ask. You will also be expected to have a basic
understanding of procedures learned during your college or university courses.
Your compensation will rise in tandem with your increased knowledge and skills.
Because of the ever-changing nature of the pharmaceutical sector, it's
no surprise that it's a top priority for many people looking for the best
science careers.
When it comes to the particular skill set that is required to fill any
given job, there are several variables. Nonetheless, there are a few desirable
abilities that are virtually universally in demand by pharmaceutical firms.
Employers will spend the majority of their time reviewing your CV looking at
your work experience and education, so make sure these data are correct.
The first step in the pharmaceutical industry should be to learn the
fundamentals. Define your skill sets and ask yourself questions that will help
you in your job search. Consider what you're strong at, what you enjoy doing,
and what areas you'd like to expand into. Consider the main abilities you
possess and how transferable they will be. Second, you must create an excellent
CV that is tailored to the application or industry, particularly the
pharmaceutical industry. Highlight any vital talents that you have and have
earned, such as biology skills, supervising skills, and analytical abilities.
If you're a graduate, make a list of any skills you learned at university and
anything you've worked on in terms of the fundamentals. Any of those skills
that you picked up on any project that you worked on can be included.
Depending on their level of responsibility and specific field, the
pharmaceutical industry expects a wide range of essential talents. The skillset
includes everything from the basic abilities required for the work to the generic
skillset that is useful in any field. Here are the top skills and abilities
that will make you a valuable employee.
Keen researcher, Compiling
and analyzing reams of data
·
Problem solver
·
Strong analytical skills
·
Attention to detail, Diligence is part and parcel of every project you
undertake.
·
Specialist skills for roles such as chemical engineering, you have a
relevant degree to back it up.
·
Ability to effectively interact with peers and leaders.
·
Strong attention to detail, organizational skills
·
Empathy
·
Quality-oriented
·
Strong oral and written and interpersonal communication skill
·
Product and industry knowledge
·
Basic computer literacy
·
Ability to work in a challenging and fast-paced environment and
multitask effectively.
·
Reliable and goal-oriented
·
Ability to handle the pressure
·
Creative problem-solving and strategic thinking
·
Awareness of industry trends and Business skills
·
Teamwork and conflict resolution
·
Understanding of legal and regulatory matters
·
Relationship-building and communication
The Job Role and Responsibilities
Entry-level staff in
pharmaceutical can get absorbed in any of the following divisions:
·
Research and Development
·
Production and Quality Control
·
Distribution
·
Analytical Chemist
·
Clinical Research Assistant
·
Clinical Research Associate
·
Pharmacist
·
Pharmacologist
·
Research Scientist
·
Product/Process Development Scientist
·
Science Writer
·
Product Specialist
·
Pharmaceutical Sales
Competencies and
Skills Required
Being a niche and knowledge-driven sector,
pharmaceutical companies look for professionals with the right academic
background to understand the process and add key inputs. From one division to
another, the skills required would differ but apart from the core competencies
to manage job duties, strong ethics are another major quality pharma companies
seek in candidates, as keeping data and sensitive information secure is vital.
Some key competencies required for different profiles are:
1. Specializations
Let’s step back in time a moment. The
first and foremost skill you must concentrate on is specializing in a
particular area if you haven’t already. Clearly, this decision is mainly about
what interests you, but it’s worth knowing just how much employers value
particular talents. If you are still studying, industrial experience during your
holiday can prove to be a real bonus.
2. Accuracy
When it comes to the pharmaceutical
industry, attention to detail is literally a matter of life and death – and
there is no room for error.
3. Project Planning Skills
Excellent project planning skills are
required. Project planning in this industry usually involves the task of
identification and resource allocation, an in-depth understanding of user
client issues, and cost estimation.
4. Transferable Skills
There is no doubt that specialized skills
can help you to stand out amongst job applicants, but they aren’t the only
skills that recruiters seek. Ranging from professional communication to
emotional intelligence, there are many transferable soft skills that are sure to come in handy
throughout your career.
The importance of professional communication skills cannot
be overstated no matter whichever industry you are working. You need to have
basic sales skills. To hone your sales
skills, you don’t have to be working in the sales department. In
fact, in virtually every career on the planet, the ability to sell comes in
handy. Do you know your product? Can you use it well enough to teach someone
else how it works? For any employee, this is important knowledge. The ability
to speak clearly and empathetically is another
invaluable job skill. Finally, become a great listener. During conversations, this is the only way
you’ll be able to speak and ask intelligent follow-up questions. Emotional intelligence is not an
easy skill to hone, but once you can use it, you will instantly become more
valuable as an employee and improve the overall quality of your life. This form
of intelligence requires that you recognize not just your own emotions, but the
emotions of your co-workers and customers as well the ability to wear multiple
hats while on the job are great, but the ability to step into someone else’s
shoes is magical.
5. Management Skills
The pharmaceutical industry includes risk analysis, problem-solving, and decision
making. As a worker within this industry, you should also have effective time management skills and delegation techniques. You might
also have to work with team
members in remote locations. This is something the applicant should
be prepared for, as there is quite a lot of travel involved in the industry. Writing skills and having a
comprehensive understanding of the regulatory issues within the pharmaceutical
industry is also an important asset. Great organization skills to keep lists of your in-progress
and upcoming projects would serve handy.
6. Creative problem-solving and strategic
thinking
Decision-making and strategic thinking are
valuable skills in any work environment. This is particularly true in the
pharmaceutical industry. To make complex projects successful, you must
constantly innovate and plan far in advance in this industry. Employees who are
quick to solve problems are valued and heavily relied upon in the
pharmaceutical industries.
7. Business skills and awareness of
industry trends
The Pharmaceutical industries are highly
innovative and evolve rapidly. If you want to be successful in this industry,
you must learn to stay abreast of key business trends, including regulatory and
financial changes influencing each industry sector. Candidates who have the
ability to predict trends that might affect an organization’s bottom line,
manage budgets and timelines, and make financial projections are valued by the
industry employers. Similar to a secondary effect of a molecule you’re working
on, you must be able to recognize global trends as well as business
opportunities.
8. Teamwork and conflict resolution
As you might have done during your postdoc
or Ph.D., you cannot work by yourself with the sole aim of getting more data
when you are working in a research lab, or even in industry. Compared to academic
environments, industrial environments are often more collaborative. As such,
industry employers consider teamwork and conflict resolution as very important
job skills. You will need to develop diplomatic skills, interpersonal
skills, communication skills in order to work as a part of a team. The
individuals on the team will often have a difference of opinion and hence
working with a team can be challenging and thus learning to be a good team
member is essential.
9.
Understanding of legal and regulatory matters
You’ve
learned to follow the rules and regulations while working in academia, the
rules related to the use of instrumentation, reagents, and the reporting of
results and data. However, in industry, you must be aware of rules and
regulations beyond those related to scientific research. In innovation-based
sectors, this is especially true where your everyday work life can be affected
by compliance and intellectual property laws. Bodies such as the FDA heavily
monitor many companies, and, you must be aware of the regulatory laws affecting
your organization as an industry employee.
10.
Communication and Relationship-building
Without
efficiently interacting with others, it’s impossible to be successful in the
industry. Major factors in your career progress
would be how you deal with differences in opinion, share responsibilities, and
communicate with your colleagues.
·
Experience working in a
similar role
·
Length of time in the same
role
·
Qualification in a relevant
scientific discipline
·
Languages
·
Which therapeutic areas and
phases of study you have worked in
Breaking
into the pharmaceutical industry may feel like a monstrous challenge, but with
a few bright tips to boost your application, there’s no reason why you can’t
stand out as a candidate entering this fascinating sector.
For
working in this sector, the applicants must understand the goals, structure,
and scope of the pharmaceutical industry as a whole.
Many
skills that were impressive just a few years ago are now sadly outdated.
Technology is changing every day. In any career, to have the ability to
recognize when the skills are updated or new skills are required is invaluable.
While you’re gobbling up information on the latest tech and marketing trends
don’t forget that professional skills aren’t everything, outside of work,
discover practices that inspire the creativity and mindfulness you need to do
your job well. Flexibility and the ability to go with the flow without
compromising quality is invaluable in any career. As long as there are plans
there will be wrenches to mess them up but as long as you’re flexible you can
keep plugging along with confidence roll.
“Schooling
doesn’t assure employment, but skill does.”
― Wealth
of Words
Get
into action now! Work on yourself and acquire these skills and those who
already have these skills, just improve them a bit to get better opportunities
at the industrial level.
Key skills for Pharma
Industry Jobs:
·
Analytical skills.
·
Ability to think critically.
·
Strong numerical skills.
·
Attention to detail.
·
Problem-solving.
·
Observation skills.
·
Communication and social skills.
Instrument Pic: Stability Chamber
Pharmaceutical Quality Control
& Quality Assurance Interview Questions & Answers
Below are some Interview Questions and
answers which can help the fresher’s as well as experience personnel for
interview preparation so please Read and share if you think it useful.
General
Quality Assurance Interview Questions in pharma industry:
·
Introduce yourself.
·
Tell me about yourself.
·
Your strength and weakness.
·
Why do you want to join us?
·
How long will you stay with our company?.
·
Your achievements.
·
Are you planning for further studies?
·
Do you know anyone in this company?
1.
What is Quality Control:
The
term quality control refers to the sum of all procedures undertaken
to ensure the identity and purity of a
particular pharmaceutical product. It involves in chemical, physical
and sometime microbiological testing of a pharmaceutical product.
Quality
control involves testing of pharmaceutical products against the
specifications.
The
other responsibilities of Quality Control are sampling of Raw & packing
material, testing of raw material, packing material, in process, finished
product& Stability batches, Sampling & testing of water, Calibration of
Instruments, Preparation of Specification of Raw, Packing, in process &
Finished products, Preparation of Standard Test procedure of Raw, Packing, in
process & Finished products and reporting of result after analysis &
preparation of COA.
2.
What is Disintegration Test:
It is
the time required for the Tablet / Capsule to break into particles, the
disintegration test is a measure of the time required under a given set of
conditions (Temperature) for a group of tablets/capsules to disintegrate into
particles.
Cycle
of shaft holding the tube basket limit is 29-32 cycles per minutes and distance
covered by shaft basket is 50-60 mm and beaker temperature is 35 to 39 º C.
Disintegration
is to be Performed to determine whether tablets or capsules disintegrate within
the prescribed time when placed in a liquid medium at the experimental
conditions.
3.
What are the Disintegration Time of tablets:
·
Uncoated Tablet 15 min as per
BP
·
Uncoated Tablet 30 min as per
USP
·
Sugar Coated Tablet 60 min as
per BP
·
Film Coated Tablet 30 min as
per BP
·
Plain Coated Tablets DT in
specific medium for 30 min as per USP
·
Enteric Coated Tablets DT
in simulated gastric fluid (0.1 M HCl) for 1 hr and then in simulated
intestinal fluid (Phosphate buffer 6.8 pH) until disintegrate as per USP.
·
Dispersible Tablets 3 min (15-
25º C) as per BP.
·
Effervescent Tablets 1 tablet
in 200 mL water for 5 min (15- 25º C)
·
as per BP
·
Buccal Tablets 4 hrs as per
USP.
·
Soluble Tablets 3 min (15- 25º
C) as per BP.
·
Chewable Tablets are not
requiring to comply with test
4. What
are the Disintegration Time of capsules:
·
Gastro resistant
capsule DT 2 hrs without disk in 0.1 M HCl and phosphate buffer pH
6.8 for further 60 min as per BP.
·
Hard and Soft gelatin
capsule DT 30 min as per BP & USP.
5. What is Friability Test of Tablet &
friability calculation:
Friability
is defined as the percentage of weight loss of powder from the surface of the
tablets due to mechanical action and the test is performed to measure the
weight loss during transportation.
Friability (%) =W1– W2/W1X100
Where,
W1 = Weight of Tablets (Initial / Before Tumbling) &
W2 = Weight of Tablets (After Tumbling or friability)
Limit: Friability
(%) = Not More Than 1.0 %
Tablets
with individual weight equal to or less than 650 mg then take the sample of
whole corresponding to as near as 6.5 gram equivalent and tablets with
individual weight more than 650 mg then take sample of 10 whole tablets to
perform friability test. Tablets must be de-dusted prior to and after use.
6.
What is Incident:
Any
unplanned or uncontrolled event in the form of non-compliance to the designed
systems or procedures at any stage of testing, and storage of drug product due
to system failure or equipment breakdown or manual error.
A
laboratory Incident is an event in the laboratory that occurs for two primary
reasons either due to analyst error or instrument error.
7. What is Calibration:
The
demonstration that a particular instrument or device produces results within
specified limits by comparison with those produced by a traceable standard over
an appropriate range of measurements.
8. What is Qualification:
The
action of proving that any equipment or process work correctly and consistently
and produces the expected result. Qualification is part of, but not
limited to a validation process, i.e. Installation Qualification (IQ), Operation
Qualification(OQ) and Performance Qualification (PQ).
The
act of planning, carrying out and recording the results of tests on equipment
to confirm its capabilities and to demonstrate that it will perform
consistently as intended use and against predefined specification.
9. What is Deviation:
Any
unwanted event that represents a departure from approved processes or
procedures or instruction or specification or established standard or from what
is required. Deviations can occur during manufacturing, packing, sampling and
testing of drug products.
Examples
of Deviations: Temperature and RH of
area goes out of limit during manufacturing, Typographical error observed in
approved documents, Standard operating procedure not followed, Breakdown of
equipment, Spillage of material during unloading, Instrument calibration
results goes out of limit etc. Deviations are of three types Minor, Major and
Critical
10. What is Change Control:
It is
an Approved Procedure which is taken to change in any documents, Standard operating
procedures, Specification, Process parameters and change in batch size etc.
Change control is raised by user department as per requirement and finally the
change control is approved by Quality assurance. Change control can be raised
through software or through manually.
After
Final approval of change control the changes can be made in documents and
change control can be closed after completion of required action plan which is
mentioned in the Change control form.
Change
controls are of two types i.e Major and Minor.
11. Corrective action & Preventive
action:
Corrective
action:
An
action taken to eliminate the cause of the existing deviation, incident or
problem in order to prevent its recurrence (occurring again).
Preventive
action:
An
action taken to eliminate the cause of potential deviation, incident or problem
in order to prevent its occurrence (an incident or event).
12.
What is Chromatography:
Chromatography
is an analytical technique commonly used for separating a mixture
of chemical substances into its individual components, so that the
individual components can be thoroughly analysed.
Chromatography
is a laboratory technique for the separation of a mixture. The
mixture is dissolved in a fluid called the mobile phase, which
carries it through a structure holding another material called the stationary
phase and the separation is based on differential partitioning
between the mobile and stationary phases.
The
key difference between stationary and mobile phase is
that stationary phase does not move with the sample
whereas mobile phase moves with the sample. Stationary
phase and mobile phase are two important terms in chromatography,
which is a technique of separation and identification of the components in
a mixture.
14.
What is Column in Chromatography:
A Chromatography
column is a device used in chromatography for the separation of
chemical compounds. A chromatography column contains the stationary phase,
allowing the mobile phase to pass through it. The columns are mostly
made of borosilicate glass, acrylic glass or stainless
steel.
15.
Which gas is used in Gas Chromatography:
In GC
Nitrogen, Helium and Hydrogen are considered to be suitable
carrier gases but Helium is most widely used due to safety concerns associated
with hydrogen and also the fact that nitrogen is much less efficient.
16.
What is HPLC in Chemistry:
High-performance liquid
chromatography (HPLC) is a technique in analytical chemistry which
is used to separate, identify, and evaluate each component in a mixture.
17.
What is System suitability:
Before
start of analysis of the Chromatographic system like HPLC &GC system
suitability has to perform to know that the system is working properly or to
know the performance.
System
suitability criteria may include such factors as plate count, tailing,
retention, and/or resolution and the above factors are most important as
they indicate system specificity, precision, and column stability.
18.
What is RT & RRT in HPLC:
The
amount of time it takes for the compound to pass through the column is
the retention time (RT). The relative retention time (RRT)
is the comparison of the RT of one compound to another.
19.
Types of HPLC Pumps:
There
are 3 main types of HPLC Pumps: Reciprocating pump, Displacement (or syringe)
pump and Pneumatic (or constant pressure) pump.
20.
What is Trailing factors:
The tailing
factor is a measure of peak tailing. It is defined as the distance
from the front slope of the peak to the back slope divided by twice the
distance from the centre line of the peak to the front slope, with all
measurements made at 5% of the maximum peak height.
21.
What are the different Types of HPLC Columns:
The
different Types of HPLC Columns are Normal phase, Reverse Phase, Ion Exchange
and Size Exclusion columns.
22.
What is Good Laboratory Practice (GLP):
Good
Laboratory Practice contains a set of principles that provides a framework
within which laboratory studies (Activities) are planned, performed, monitored,
recorded, reported and archived. GLP help assure regulatory authorities that
the data submitted are a true reflection of the results obtained during the
study and can therefore be confidence upon when marking risk/safety assessment.
Good
Laboratory Practice contains different principles which are designed to
ensure and promote consistency, quality, safety, reliability and integrity of
chemicals during non-clinical and laboratory testing.
23.
What is Working & Reference Standard:
A reference
standard is the traceable, raw material standard (usually in
crystallized form) that we dissolve and volumetrically dilute to make
our working standard. The working standard is what we use to “do
our work.” and this information makes it traceable and is recorded in the
preparation notebook.
A reference
standard is prepared for use as the standard in an assay,
identification, or purity test and should have a quality appropriate for its
use.
24.
Why is Dissolution Test Required:
Dissolution
tests are performed to establish drug (Active Pharmaceutical Ingredient)
release characteristics of solid oral products, such as tablets and capsules.
The rationale for conducting these tests is that for a product to be
therapeutically effective, the drug must be released from the product and
should generally be dissolved in the fluid of the gastrointestinal (GI) tract.
The API in solution form facilitates the absorption of the drug from the GI
tract into the systemic (blood) circulation to reach its desired target (site
of action) to exert its effect.
25.
How dissolution test is Performed:
The
drug is placed within the medium in the vessels after it has reached sufficient
temperature and then the dissolution apparatus is operated. Sample
solutions collected from dissolution testing are commonly analysed by
HPLC or Ultraviolet–visible spectroscopy.
26.
What is Q Stands for in Dissolution:
‘Q’ is
the amount of dissolved active ingredient specified in the monograph which is
required to be released in the stated time, expressed as a percentage of
labelled strength, then the batch of the tablet or capsules is acceptable, if
each unit is not less than Q + 5 %.
If the
initial sample analysis, known as S1 or stage 1 testing fails to meet the
acceptable value for Q, then additional testing known as stage 2 and 3 testing
is required. S3 testing is performed only if S2 testing fails in Q parameter.
If there is a deviation from the acceptable Q values at S3, then an OOS (Out of
Specification) investigation is generally initiated.
27.
Which tablets are used in Calibration of dissolution Apparatus:
Non
disintegrating (Salicylic Acid) and disintegrating (Prednisone) tablets are
used in the calibration of dissolution test apparatus.
28.
What is Gas Chromatography:
Gas
Chromatography is a common type of chromatography which is used for separating
and analysing compounds that can be vaporized without decomposition. Particular
uses of GC include testing the purity of a particular substance, or separating
the different components of a mixture and in some situations, GC may help in
identifying a compound.
In gas
chromatography, the mobile phase is a carrier gas, usually an inert gas such as
helium or an un reactive gas such as nitrogen.
29.
What is Karl Fischer Titration:
Karl Fischer titration is a classic titration method in chemical analysis that uses coulometric or
volumetric titration to determine trace amounts of water in a
sample. It was invented in 1935 by the German chemist Karl Fischer.
30.
What is KF Reaction: The Karl
Fischer Titration is a titration method for measuring water content in
basically all types of substances. The Karl Fischer Titration is
based on an iodine / iodide reaction and the water reacts with iodine.
The
endpoint of the titration is reached when all the water is consumed and
the process uses an organic base (B), sulphur dioxide, iodine and an
alcohol.
31.
What is Infrared Spectroscopy:
The
infrared spectrum of a sample is recorded by passing a beam of infrared light
through the sample and when the frequency of the IR is the same as the
vibrational frequency of a bond or collection of bonds, absorption occurs.
Examination of the transmitted light reveals how much energy was absorbed at
each frequency (or wavelength). This measurement can be achieved by scanning
the wavelength range using a monochromatic.
32.
What is the use of Incubator:
An incubator is
a device used to grow and maintain microbiological
cultures or cell cultures. The incubator maintains
optimal temperature, humidity and other conditions such as the
CO2 and oxygen content of the atmosphere inside. Incubators are
essential for a lot of experimental work in cell
biology, microbiology and molecular biology and are used to
culture bacterial cells.
33.
What is Out of Specification:
Out of
Specification (OOS) means the test result that falls outside the specifications
or acceptance criteria which has been specified in the official monographs or
the Blend, In process, Raw material, packing material, Stability and finished
product specification.
During
analysis if any OOS observed then it should be investigated to find out the
root cause and required Corrective & preventive actions shall be taken to
avoid the reoccurrence.
There
are two phases of Investigation Laboratory investigation and production process
investigation.
34.
What is Out of Trend:
Out of
Trend (OOT) means the test result that is within the specification limit or
acceptance criteria as mentioned in the Blend, In process, Raw material,
Packing material, Stability and finished product specification but outside the
trend of previously tested batches.
Suppose
X Product has the Specification limit 95 to 105 % & we have tested many
batches of product X and the trend result shows is 98 to 102 %. Suppose X
Product current result is 97.5 % so in this case it is called OOT.
35.
What is Stability Study:
Stability of
a pharmaceutical product means how long it can maintain its original
form for the duration of the shelf life assigned to it and should comply the
specification without any visible changes under the influence various
environmental factors like temperature and humidity.
The pharmaceutical
industry conducts this testing to develop a new product and
establish the shelf-life of a product.
36.
What is Bracketing in Stability Testing:
The
design in which only the extremes are tested at all-time points e.g., strength,
pack size, container fill etc. are tested.
Bracketing
is applicable if the strength is identical or very closely related in
composition (e.g. for a tablet range made with the different compression
weights of similar basic granulation, or a capsule range made by filling
different plug fill weight of the same basic composition in to different size
capsule shells. Bracketing can be applied to different container sizes or
different fills in the same container closure system).
37.
What is Shelf Life:
The
period of time during which a drug product, if stored correctly, is expected to
comply with the specifications determined by stability studies on a number of
batches of the product. The shelf life is used to establish the expiry date of
each batch.
38.
In stability how many conditions are there:
There
are Three Stability Condition Long term or Controlled Room Temperature (CRT),
Accelerated and Intermediate
39.
What is Significant changes in Stability Study:
At
long term and intermediate condition: Failure
to meet the specification is considered as significant change.
At
accelerated condition: Following changes are
considered as “Significant change”.
A 5%
change in assay from its initial value, any degradation product exceeding its
acceptance criterion. Failure to meet the acceptance criteria for appearance,
physical attributes. Failure to meet the acceptance criteria for dissolution.
40.
What is limit of detection (LOD):
The
detection limit of an individual analytical procedure is the lowest amount of
analyte in a sample which can be detected but not necessarily quantitated as an
exact value. Several approaches for determining the detection limit are
possible.
Based
on visual evaluation the detection limit is determined by the analysis of samples
with known concentrations of analyte and by establishing the minimum level at
which the analyte can be reliably detected.
41.
What is limit of Quantification (LOQ):
The
quantification limit of an individual analytical procedure is the lowest amount
of analyte in a sample which can be quantitatively determined with suitable
precision and accuracy. The quantification limit is a parameter of quantitative
assays for low levels of compounds in sample matrices, and is used particularly
for the determination of impurities and/or degradation products.
Based
on visual evaluation: The detection limit is determined by the analysis of
samples with known concentrations of analyte and by establishing the minimum
level at which the analyte can be quantified with acceptable accuracy and
precision.
42. What is SOP in pharma company?
For everyone working in the
Pharmaceutical Industry, standard
operating procedures (SOP) are a routine part of day to day
operations. An SOP as defined by Wikipedia is a set of step-by-step instructions
compiled by an organisation to help workers carry out complex routine
operations.
43. What is the difference
between QA and QC?
Although QA and QC are closely related
concepts, and are both aspects of quality management, they are fundamentally
different in their focus: QC is
used to verify the quality of the output; QA is the process of managing
for quality.
Beautiful campus of Torrent Pharmaceuticals, UNIT 1 & 2, Sikkim
So much information in one place . Great
ReplyDeleteIt was really informative sir. I think it will help us to understand about the particular topic in our pharmacy field with some theoretical knowledge.
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