Month: May 2021

What is a Fishbone Diagram


The fish bone diagram or Ishikawa  diagram is a cause-and-effect diagram that helps to identify many possible causes for an problem and it can be used as a Investigation tool.

It can be used in case of any Deviation, Market Compliant, Out of specification to identify the possible root cause for the problem.

The diagram looks just like a fish’s skeleton with the problem at its head and the causes for the problem feeding into the spine. Once all the causes that underlie the problem have been identified, the investigator can start looking for solutions to ensure that the problem doesn’t become a recurring one.

Fish bone diagrams help us to determine the variables that may enter the equation. They allow us to make our plans so that we know how to deal with them in such a way that the quality of our final product is still up to standard and without significant variation.

Background :

Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa , who pioneered quality management processes in the Kawasaki  shipyards, and in the process became one of the founding fathers of modern management. In the 1920s it was seen as an important quality control tool.

Fishbone Diagram

Disintegration Test Apparatus Questions and Answers


Hi in this Topic I have provided some questions and answers of Disintegration Test Apparatus which will be useful to freshers as well as experience personnel to gain some knowledge. Always i have tried to provide good and quality contents for my viewers or readers or followers. So pl read and provide your feedback

For Dissolution Test Apparatus interview questions and answers please refer https://pharmaceuticalupdates.com/2021/05/25/dissolution-test-most-important-interview-questions-and-answers/

Dissolution Test most important Interview Questions and Answers


Hi this is Chandrasekhar Panda and welcome to all my readers and followers. As you know that previously i have updated some interview questions and answers regarding dissolution Test. Always i have tried to provide good contains for my readers and i hope this topic will be useful to the persons working in Quality control and Quality Assurance department to gain good knowledge on dissolution Test Apparatus.

You can read the Dissolution test Apparatus Questions and Answers

https://pharmaceuticalupdates.com/?p=2968

How To Start A Medical Store in India


So thinking about “How to open a medical store”? Let me tell you this, the pharmacy business is an evergreen business in India that is not affected by economic cycles or even in pandemic situation. So, if one has minimal capital investment and space, the pharmacy store is ideal for many businessmen across India. It will be easy if you are having experience in medical store and Hospital as a Pharmacist. 

Q. Who can start a medical shop?

Ans- Anyone who has a Pharmacy Licence is eligible to open a medical store. For becoming a qualified pharmacist you need to acquire a Diploma in pharmacy (D.Pharm) or degree of B. Pharm or M. Pharm.

Q. Is chemist shop a profitable business?

Ans- Any chemist business or medical store is profitable just like the pharmacy business. Most prescribed drug-related businesses are incurring good profits in the market. Even OTC (over-the-counter) drugs or patent medicine store is decently profitable.

Q. How much is needed to open a medical store?

Ans- To open a medical store in the suburbs a minimum of 3 to 4 lakh rupees is needed. While to open the same in a metropolitan city would easily cost you around 7-8 lakh rupees. You could either be a wholesaler or a specific hoarder. Small businesses can easily apply to avail business loan for medical store.

Q. What are the requirements to open a medical shop?

Ans- To open a medical store you will need the following-

  1. Rental Agreement/Ownership Proof
  2. Premises proof ranging at least 10 square meters
  3. If clubbed into retail then a minimum of 15 square meters is required

Q. What is the procedure to open a medical store?

Ans- Below are some of the mandatory things needed before thinking

about how to open a medical store in India-

  1. Ownership proof of premises
  2. Business constitution and registration proof
  3. Affidavit of non-conviction of proprietor or partners or directors under the Drug and Cosmetics Act of 1940.
  4. Registered pharmacist affidavit
  5. Equally competent full time working employees affidavit

Q. Is Cold storage facility required in medical store?

Ans- Yes Most importantly, the store must have a refrigerator on the premises.
This is because, according to the labeling specifications of certain drugs like vaccines, Sera, Insulin Injections, etc., are required to be stored in the refrigerator.

Q. Is Digital system required in medical store for billing?

Do not stick to the old and inefficient method of operating a pharmacy. Do business the smarter way! Managing  like billing, inventory, bookkeeping single-handedly or with a bunch of people is challenging and can result in a lot of manual work without the use of technology.

Q. How much profit does a medical store make?

Ans- Any retail medical store profit will range from 5% to 30% every month. Different products will incur different types of margins like-

  • OTC (over-the-counter) medicines
  • Branded Prescription products
  • Generic Medicines
  • Trapped Products
  • Brand-specific discounted items

Q. Can Doctor run a pharmacy?

Ans- No, doctors aren’t officially allowed to run a pharmacy shop based on Medical ethics. Any of the Drug License for the hospital is allotted in the name of a Pharmacist and not the Doctor or even the Hospitals owner!

Q. How many years is a Diploma in Pharmacy?

Ans- Diploma in Pharmacy is a 2 years full-time course. It consists of the following subjects-

  1. Human Physiology
  2. Disease
  3. Therapeutic Compounds & drugs in use
  4. Their pharmacology & formulations
  5. Basics on drug store management
  6. Pharma Jurisprudence

Q. Is a pharmacist a medical professional?

Ans- Pharmacists, in general, are extremely trained health professionals who specialise in a comprehensive spectrum of services like-

  1. Conducting Health And Wellness Testing
  2. Managing Chronic Diseases
  3. Performing Medication Management
  4. Administering Immunizations

Q. Can I open a medical store after D Pharma?

Ans- The official requirement to open a medical store in India is becoming a registered pharmacist. So after the completion of your D.Pharm, you have to register yourself at your state pharmacy council and obtain official certification that’ll take around 45 days after the registration process, and then you can start a medical shop.

Advice :

Firstly, avoid renting/owning the shop where there are already Multiple medical stores to avoid unnecessary competition and if required try to search Rural areas to set up your business.

It will be better if you can always network with a doctor/Hospital so that you can tie-up with them.

Before set up your own medical store it will be better to gain some experience by working in any medical store or Hospital or under any doctors

For betterment you can refer the CIMS Drug books or 1 mg.com or Netmeds to know the name of drugs, their substitutes, dosage, indication and uses etc. You can use the APP or can download the same and can read to gain some better knowledge.

Use SMS alert system i.e automatically patient can get the SMS to refill their medicines and record the patients history in your data bank and if required you can think for Home delivery of medicines at doorstep.


 
  

Ultra Violet Visible spectroscopy Principles


Introduction:

 UV-Visible spectroscopy is a mature and well-established analytical technique used extensively in many industry sectors including Environmental Analysis, Pharmaceutical Testing, Food and Beverage Production etc.

Spectroscopy is the measurement and interpretation of electromagnetic radiation absorbed or emitted when the molecules or atoms or ions of a sample moves from one energy state to another energy state.

UV spectroscopy is type of absorption spectroscopy in which light of ultra-violet region (200-400 nm) is absorbed by the molecule which results in the excitation of the electrons from the ground state to higher energy state.

Principle:

UV-Visible Spectroscopy is based on the Lambert-Beer principle which states that the absorbance of a solution (A) is directly proportional to its path length (l) and its concentration (c) when the wavelength of the incidence light remains fixed.

Basically, spectroscopy is related to the interaction of light with matter.

As light is absorbed by matter, the result is an increase in the energy content of the atoms or molecules.

When ultraviolet radiations are absorbed, this results in the excitation of the electrons from the ground state towards a higher energy state.

Molecules containing π-electrons or non-bonding electrons (n-electrons) can absorb energy in the form of ultraviolet light to excite these electrons to higher anti-bonding molecular orbitals.

The more easily excited the electrons, the longer the wavelength of light it can absorb.

The absorption of ultraviolet light by a chemical compound will produce a distinct spectrum which aids in the identification of the compound.

If there is no absorption of the light passing through the solution, the transmittance is 100%.

Apparatus:

The UV-Visible Spectrophotometer is the analytical instrument used for the UV-Vis spectroscopic analysis. Spectrophotometers are available in different configurations however most can be categorized into either single beam, split beam or double beam types depending on the design of their optical system. Such types of instrument comprise the following components in their constructions:

1. Light Source :

  • Tungsten filament lamps and Hydrogen-Deuterium lamps are most widely used and suitable light source as they cover the whole UV region.
  • Tungsten filament lamps are rich in red radiations; more specifically they emit the radiations of 375 nm, while the intensity of Hydrogen-Deuterium lamps falls below 375 nm.

2. Monochromator :

  • Monochromators generally is composed of prisms and slits.
  • Most of the spectrophotometers are double beam spectrophotometers.
  • The radiation emitted from the primary source is dispersed with the help of rotating prisms.
  • The various wavelengths of the light source which are separated by the prism are then selected by the slits such the rotation of the prism results in a series of continuously increasing wavelength to pass through the slits for recording purpose.

3. Cell Compartment :

  • One of the two divided beams is passed through the sample solution and second beam is passé through the reference solution.
  • Both sample and reference solution are contained in the cells.
  • These cells are made of either silica or quartz. Glass can’t be used for the cells as it also absorbs light in the UV region.

4. Detector :

  • Generally two photocells serve the purpose of detector in UV spectroscopy.
  • One of the photocell receives the beam from sample cell and second detector receives the beam from the reference.
  • The intensity of the radiation from the reference cell is stronger than the beam of sample cell.

5. Signal Processing System :

  • Most of the time amplifier is coupled to a pen recorder which is connected to the computer.
  • Computer stores all the data generated and produces the spectrum of the desired compound.

This absorption spectroscopy uses electromagnetic radiation between 190 and 800 nm and is divided into two regions

1. UV (190–400 nm)- Deuterium lamp

2. Visible (400–900 nm) – Tungsten lamp

Because the absorption of UV or visible radiation by a molecule leads to transition among electronic energy levels of the molecule, it is also often called electronic spectroscopy.

UV-Visible Analysis is Suitable For,

  1. Analytes that can be dissolved in solvents like water, ethanol and hexane.

  2. The analyte need to absorb UV or Visible light.

  3. With UV /Vis we can do quantitative measurements a single analyte in solution(or more than one analytes om solution provided that do not interfere with each other).

Not Suitable For,

1. Analytes that have a photochemical reaction at the wavelength range of interest.

2. Partially dissolved, unclear or colloidal samples.

The UV-Visible spectrum shows the absorbance of one or more sample component in the cuvette when we scan through various wavelengths in the UV/Vis region of the electromagnetic spectrum.

System suitability in HPLC Analysis


System suitability is to prove that system is working perfectly before the analysis on HPLC, GC, TOC analyser or any other system. It is required to done before every sample analysis. HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture.

HPLC chromatographic technique is used in pharmaceutical industries for analysis. System suitability testing limits are acceptance criteria that must met before starting the analysis.

There are some System suitability parameters which can be used to check the system before starting the sample analysis are listed below.

1.    Retention time

2.    Resolution

3.    Repeatability

4.    Plate Count

5.    Tailing Factor

6.    Signal-to-noise ratio

7.    Pressure

Retention Time:

In liquid chromatography and gas chromatography, the retention time, tR, is defined as the time elapsed between the injection of the sample and the appearance of the maximum peak response of the eluted sample zone. tR may be used as a parameter for identification. Chromatographic retention times are characteristic of the compounds they represent but are not unique. Coincidence of retention times of a sample and a reference substance can be used as a partial criterion in construction of an identity profile but may not be sufficient on its own to establish identity. Absolute retention times of a given compound may vary from one chromatogram to the next.

 Resolution (Rs):

Resolution is a measure for the ratio of the distance of two adjacent peak maxima and their widths. For complex sample mixtures Rs should be determined for the critical pairs of components to characterize their separation.

Resolution is calculated by following formula,

RS = 2(tR2 − tR1) / (W1 + W2)

Where, tR2 and tR1 are retention times of two compounds, W2 and W1 are the corresponding widths at the bases of the peaks obtained by extrapolating the relatively straight sides of the peaks to the baseline.

Repeatability/Precision:

Replicate injections of a standard preparation are used to demonstrate the system performance when it gets exposed to some specified column usage, environment, and plumbing conditions. Data from five or six replicate injections are used if requirement of relative standard deviation is less than 2%.

Plate Count/ Column Efficiency:

The Column Efficiency is measured by following formula,

N = 16(tR/W)2

Where tR is the retention time of the substance, and W is the peak width at its base, obtained by extrapolating the relatively straight sides of the peak to the baseline. The value of N depends upon the substance being chromatographed as well as the operating conditions, such as the flow rate and temperature of the mobile phase or carrier gas, the quality of the packing, the uniformity of the packing within the column, and, for capillary columns, the thickness of the stationary phase film and the internal diameter and length of the column.

Tailing Factor/Symmetry Factor:

Tailing Factor is calculated by following formula,

AS = W0.05/2f

where W0.05 is the width of the peak at 5% height and f is the distance from the peak maximum to the leading edge of the peak, the distance being measured at a point 5% of the peak height from the baseline.

Signal-to-noise ratio:

This parameter is used for the lower-end calculation of the performance of the system. 

Noise: It is measured between two specific lines that bracket the baseline. 

Signal: It is measured starting from the baseline’s middle and ending to the peak’s top.

Once calculating both these factors, the ratio can be measured by dividing the signal value by the noise value. With this, generally, the noise value has to be reduced using one of the following methods:

  • Signal Averaging
  • Reagent and Solvent Purity
  • Column Flushing and Sample Clean-Up
  • Temperature Control
  • Additional Pulse Damping and Mixing

The signal-to-noise ratio (S/N) is a useful system suitability parameter. The S/N is calculated as follows:

S/N = 2H/h

where H is the height of the peak measured from the peak apex to a baseline extrapolated over a distance ≥5 times the peak width at its half-height; and h is the difference between the largest and smallest noise values observed over a distance ≥5 times the width at the half-height of the peak and, if possible, situated equally around the peak of interest

System Pressure:

System suitability tests must be performed under controlled pressure limit. Monitor the pressure variation throughout the analysis.

Conclusion: The above mentioned system suitability parameters are not must. These parameters and acceptance criteria are performed during the method validation and fixed based on the method development outcome results. But system suitability should meet the acceptance criteria before starting the sample analysis.