Thursday 26 June 2014

ADVANTAGES AND DISADVANTAGES OF CONDUCTOMETRY IN CHEMISTRY

Conductometry: Let us discuss advantages and disadvantages of Conductometry. This method is also called as conductometric titration method. Types, mobility, concentration of ions and temperature affects the electrochemical conductivity

Some of the advantages of conductometry are as follows:

  1. In this method as coductance  is measured by conductivity meter , indicator is not required.
  2. Conductometric titration works for coloured solution.
  3. Accurate results can be obtained by conductometry.
  4. It is suitable for both weak base as well as weak acid.
  5. This method is also suitable for turbid solution.

Some of the disadvantages of conductometry are as follows:

  1. Sometimes the salt level increases in the solution which masks the conductivity and do not gives accurate result.
  2. Sometimes high concentration of ions masks the conductivity and hence do not give accurate results.

Applications of Conductometry

Some applications of conductometry are discussed here, conductometry in analytical chemistry is used to measure the progress of chemical reactions. Conductometric titration is carried out in order to measure the  electrical conductivity of the reaction mixture. This type of titration gives a sharp end point for the colored solution.

  • This type of titration is used to check water pollution in lakes as well as rivers.
  • It is also used to check the alkalinity of the fresh water
  • Salinity of the sea water can also be checked by this method.
  • It is also used to trace antibiotics.
  • Used for tracing microorganism in food microbiology
  • To check the solubility of sparingly soluble salts.
  • Purity of distilled water and de ionised water can determined.


Wednesday 25 June 2014

Vitamin C: Seven Advantages of Vitamin C

Some important Vitamin C points

Wednesday, 25 June, 2014

Seven Advantages of Vitamin C

Vitamin C has significant advantages over others and is very helpful to cure disease and to keep body healthy.

The Advantages of Vitamin C are:
  1. Vitamin C in skin protection
  2. Vitamin C protects the skin from free radicals which can be generated during exposure of sunlight. The antioxidant present in Vitamin C protects the body skin from harmful ultraviolet radiation during sunlight exposure.
  3. Vitamin C to loose fat
  4. One of the most significant advantages of Vitamin C is it reduces body fat , vitamin C obtained from fruits are very useful to loose body fat. Doctors says that As Vitamin C lowers the insulin so instead of storing sugars into body and converting into body fat , it uses it as a fuel to reduce fat in the body.
  5. Vitamin C in hair loss
  6. Vitamin C keeps free radical away which may generate during food intake. The antioxidant property of Vitamin C removes free radical which may cause damage to hair by making it rough, brittle etc and ultimately prevents hair loss.
  7. Vitamin C in common cold
  8. Vitamin C controls the common cold and reduces the severity of the symptoms which are caused by the common cold. Vitamin C also controls the allergy caused by cold.
  9. Vitamin C dilates blood vessels
  10. Vitamin C also ensure the proper dilation of the blood vessels and keeps a body free diseases such as atherosclerosis, chest pain, high cholesterol, heart pain etc.
  11. Vitamin C in healing wounds
  12. Vitamin C helps to heal wounds, It replaces the tissue which are damage and improves healing property, If Vitamin C deficiency is observed then wound will heal slowly
  13. Vitamin C makes skin Beautiful
  14. There are tiny blood vessels in the skin which contains oxygen and nutrients, Vitamin C provides enough oxygen and nutrition and keeps the skin healthy and beautiful
Because of the Vitamin C, many disease can be prevented by eating citrus fruits and vegetables, apart from discussed points it has various other applications which keeps body healthy and beautiful.

chromatography: Seven Advantages Of Chromatography

Some important Chromatography points

Wednesday, 25 June 2014

Seven Advantages of Chromatography

Chromatography has significant advantages over other methods that makes it suitable for identification of unknown component from a mixture.

The advantages of Chromatography are:
  1. Chromatography is quick method
  2. Chromatography is quick method for the separation of various components from a mixture of  various compounds which are difficult to separate.
  3. Chromatography is simple
  4. Chromatography is simple method and even a single person can operate the instrument or an equipment.
  5. Chromatography is accurate
  6. One of the most significant advantages of Chromatography is its ability to separate the sample mixture easily and gives accurate results.The ability to separate even complex mixture of compounds effectively, chromatography is widely used method and has applications in various fields.
  7. Chromatography is continuous process
  8. Chromatography also supports continuous operation for a large scale batch.This Chromatography method is capable to run the sample at various operating parameters and multiple sample analysis at a time.
  9. Chromatography is robust
  10. Robust means reliability. Chromatography puts a lot of emphasis on easy and early detection of given product accurately by checking all possible components, as Chromatography detects wide varieties of samples as a result lots of commercial industries started using it.
  11. Chromatography is multithreaded
  12. Multithreaded is the capability for an equipment to perform various task simultaneously within a program.In Chromatography, several operating parameters can be operated smoothly and no any extra efforts are required.
  13. Chromatography is secure
  14. Chromatography provides security to an individual with password protection system. The Chromatography equipment, is provided with various password levels among manager, executive and operators.
Because of Chromatography's robustness, easy handling, accurate results, quick results, separation of solid liquid or gaseous samples, it has become popular and widely acceptable method for component separation.

Tuesday 24 June 2014

APPLICATIONS OF BIOTECHNOLOGY

 Biotechnology applications and uses also know as (Biotech) are discussed here. As we know that biotechnology is used in various fields such agriculture , food industry, medicine, pharmaceutical industry and much more. Today various products are prepared using this technology. Various techniques such as genetic engineering, gene therapy , genetic testing are used with the help of biotechnology. Various hybrids of plants, animals, poultry with high nutritional value can be produced with this technique. Various disease can be diagnosed as well as treated with the help of this method So let us discuss different uses of biotechnology one by one.
Applications of Biotechnology

Biotechnology uses in Food industry

Various types of food products are prepared using biotechnology such as bread, beer and wine. Cheese and other products of cheese are also prepared using this technique. It is also used to prepare fruit and vegetables juices.

Biotechnology uses in medicine

Some of important uses are their in medicine using this technology, Various disease can be treated and diagnose with the help of this technique, Genetic information can also be tested in parents and children to treat disease.Various pharmaceutical products are prepared such as hormones, different enzymes or some chemicals can be prepared with this method. Different drugs can be prepared with the help of this method in order to treat disease, Enzyme which is prepared by this method acts as catalyst and in various chemical reactions.

Biotechnology uses in agriculture

Biotechnology also used in agriculture, It helps to produce disease resistant crops which are also tolerance to some herbicides. This technology is also used to produce crops which are resistant from environmental stress such as heat and cold.

Biotechnology uses in environment

Some of the biotechnology technique is also used to keep environmental clean. It helps to produce some useful microorganisms which are used to reduce or break industrial waste and hence keeps the environment clean.

Biotechnology practical uses

It is used in various practical fields which improves the life style of living organisms. It is used in agriculture, environment, and also useful for various plants and animals. It also helps to keep the living organisms disease resistant.

Other Articles:

These are some of the uses of Biotech which are discussed here so find other other articles on these blog to know more about about biotechnology.

Applications of Biotechnology in agriculture

Applications of biotechnology in agriculture: There are many uses of biotechnology in various fields such as medicine, food industry, pharmaceutical industry and more. Out of this, It also plays in important role in agriculture. So let us check it out some of the applications of biotechnology in agriculture which are as follows.

  1. Diseases resistant crops can be made using biotechnology.
  2. Plant which are grown using biotechnology are used in production of various biopharmaceuticals to treat various disease.
  3. Plants are also used to create antibiotics which can be used for both animals and humans.
  4. Plants can be made which are resistant to various environmental stresses such as cold, heat or drought.
  5. Improves yield of crops by introducing various genes which are resistant to insects and are tolerance to herbicides.
  6. Nutritional value of plants can be increased by biotechnology.
Other useful article: Applications of Biotechnology

Practical Applications of Biotechnology

Practical applications of biotechnology, There are many uses of biotechnology which are used in various different fields such as agriculture, medicine, pharmaceutical industry, food industry, etc. Biotechnology is widely growing field now a days, so let us check is out some of the practical applications of biotechnology which are as follows.

  1. Bio processing technology in which using whole cells or the part of cells or the component of cells desired products can be made.
  2. An example of whole cell such as yeast or bacteria are used to prepare various products.
  3. Most components which are used such as enzymes which acts as catalyst and increases chemical reaction.
  4. Cells which are isolated from the animals or plants are used to make desired products.
  5. Using genetic engineering various information of genes can be studied.
  6. Genetic testing is used to detect disease in children or their parents.
  7. Agriculture application of biotechnology for better crops and improved animal health.
  8. Some medical and the health care applications for vaccines, medicines and new tests. 
Recommended Article: Applications of Biotechnology

Environmental Applications of Biotechnology

Environmental applications of biotechnology, As we know that now a days biotechnology is widely used in various fields such as agriculture, food industry, pharmaceutical industry, medicine and much more. Out of this biotechnology also plays an important role to protect environment. Some of the environmental applications of biotechnology are as follows.

  1. Biotechnology produces enzymes which is used in laundry detergents.
  2. Genetically modified microorganisms are made using biotechnology which are used to break industrial waste.
  3. It improves manufacturing of products and reduces the waste products.
  4. Biotechnology develops bio degradable products.

Applications of Biotechnology in Food Industry

Applications of biotechnology in food industry: It is used in various fields such as medicine, pharmaceutical industry, agriculture etc., Biotechnology also plays an important role in food industry. So let us check it out some of the application of biotechnology in food industry which are as follows.

  1. Use of yeast is industries which can be used for production or preparation of alcohol which is the first product made by using biotechnology.
  2. Wine can be prepared by using biotechnology.
  3. Fruit and vegetable juices can be prepared by biotechnology.
  4. Biotechnology can be used to prepare cheese and other cheese products.
  5. Biotechnology can be used to prepare bread.

Applications of Biotechnology in medicine

Applications of Biotechnology in medicine: As we know that biotechnology plays a very important role in various fields such as agriculture, food industry etc., In medicine also biotechnology is widely used, Different types of diseases can be diagnosed by biotechnology. Some of the applications of biotechnology in medicine are as follows.

  1. Gene therapy is one of the application of biotechnology which is used to diagnose and treat diseases like cancer and Parkinson.
  2.  Through various genetically modified animals and plant scientist are trying to make various Biopharmaceuticals to treat various disease.
  3. Pharmacogenomics is one of the applications in which the genetic information of an individual is studied. Using this genetic information the behavior of certain drugs on body can be studied. So that according to the genetic information favorable drugs can be prepared.
  4. Genetic testing is also an important application in which the genetic disease in children and parents can be identified.
  5. Many hormones , chemicals and enzymes for pharmaceuticals industries are produced using biotechnology.
  6. The gene of interest can be introduced into the body using genetic engineering and recombinant DNA technology.
  7. With the help of biotechnology various antibiotics are developed and are used.
  8. Production of vaccines for animals and humans.
Recommended article: Applications of Biotechnology

Applications of Biotechnology

The Applications of Biotechnology are discussed here which  is applied in various fields now a days such as agriculture, medicine, Food industry, Pharmaceutical industries etc, Let us define what is biotechnology. With the help of genetic engineering (Biotechnology) using various living organism or their parts or components , different types of products which are used at commercial level are made. Such as Crops which are pest resistant, hybrid animals with high nutritional value are made with the help of biotechnology.. Some of the applications of biotechnology are as follows.
  1. Biotechnology can be used to grow better crops, hybrid crops can be made which gives high yield and disease resistant.
  2. Value added product of plants or crops can be made with the help of biotechnology.
  3. Crops yield can be improved by introducing specific genes into the plants using biotechnology, this genes are resistant to insects, resistant to environmental stress such as (heat, cold, drought) and tolerance to herbicides.
  4. Tolerance from virus can be done with biotechnology.
  5. Genetically engineered poultry can be done with biotechnology.
  6. Genetically engineered plants can be grown.
  7. Some of the genetically engineered microorganism can be made which can be used as pesticides.
  8. Genetically engineered insects can be made which are used in agriculture.
  9. Nutritional value in plant can be improved with this technology.
  10. Productivity of crops can be improved with biotechnology.
  11. Gene therapy is also available which is used in diagnosis of Parkinson and Cancer disease.
  12. Using genetic testing we can study if there is any disease in children or parents.
  13. Biotechnology is used in making beer.
  14. Biotechnology is used in making bread.
  15. Biotechnology is used in making fruit and vegetable juices.
  16. Biotechnology is used in making cheese and other cheese products.
  17. Various enzymes can be made which are used as catalyst in various chemical reaction.
These are some of the applications of biotechnology which are used directly of indirectly to improve lifestyle or health of living organisms.

Monday 23 June 2014

Principle of FTIR Spectroscopy

Basic principle of FTIR Spectroscopy are as follows:-


  • FTIR spectroscopy is used to identify the functional group which is present in certain molecules.
  • FTIR is one of the widely used method which is also know as Fourier Transform Infrared Spectroscopy.
  • In this method of infrared spectroscopy , radiation (Infra red) is passed through the sample.
  • Some of the radiation is absorbed by the sample while some of the radiation is transmitted.
  • Now spectrum which is produced , represents molecular transmission and molecular absorption creating molecular fingerprint of a sample.
  • The fingerprint region is unique for also samples, no two samples have same fingerprint region.
  • The fingerprint region shows different absorption peaks with different vibration frequency between bonds of an atoms in the sample.
  • Hence with this property unique molecule can be identified.
Please visit other articles on this blog to know more about this topic:
Recommended Articles : Advantages and disadvantages of FTIR 
Some more information about: What is FTIR    

Advantages and Disadvantages of FTIR Spectroscopy

Advantages of FTIR are:-

  • FTIR stands for Fourier Transform Infrared Spectroscopy is highly sensitive and quick method to achieve high quality spectrum.
  • This spectroscopy gives better signal to noise ratio compared to the dispersive instrument.
  • With FTIR, spectrum can be obtained very quickly and saves time.
  • Gases, solids as well as liquid can be analysed with FTIR.
  • By using FTIR no external calibration is required and gives accurate results.
  • FTIR is non-destructive technique.
  • Organic compounds and Inorganic compounds can be identified easily using fourier transform infrared spectroscopy.
  • Mechanical breakdown is less compared to other instruments because the mirror which is attached in the interferometer is the only moving part in FTIR.
  • Simultaneous analysis can be done for multiple gaseous compounds.
  • FTIR can identify even small concentrations of contaminants.
  • FTIR has a laser beam which keeps the FTIR instrument accurately calibrated.
  • It generally completes a scans within 1 to 2 seconds.
  • High resolution.

Disadvantages of FTIR are:-

  • FTIR instrument have only single beam while , dispersive instrument generally have a double beam.

To know more about this topic please visit other articles on this blog:
Recommended article: What is FTIR






Sunday 22 June 2014

Some Uses of chromatography in Industries

Let us see some of the Uses of Chromatography in Different industries. There are different types of chromatographic methods which are used to separate  and identify the components present in a mixture. Chromatography methods such High performance liquid chromatography (HPLC), Thin layer chromatography, Paper Chromatography, Liquid chromatography, Solid Chromatography and Gas chromatography. The list of the uses of chromatography are as follows:

Some of the uses of chromatography in different industries are:-

  1. Chromatography is used in pharmaceutical industries to identify and separate drug products at various stages.
  2. Chromatography is used in food industry to identify additives present in the food product.
  3. In petroleum and petrochemical industries chromatography is also used.
  4. Chromatography is used to identify fats, oils, vitamins, steroids and alkaloids.
  5. Chromatography is used to identify pesticides and fungicides.
  6. It can also be used in cosmetic industry.
  7. Chromatography is used to identify radioactive isotopes.
  8. Chromatography is used to identify toxins present in environment.
Related articles:




What are uses of chromatography in crime investigation

There are many uses of chromatography in crime investigation so let us check it out one by one. As we know that chromatography is the method of separation of components from a mixture based on the chemical properties, the samples which are collected at the spot of crime are sent to forensic department , and are detected using chromatography technique which directly or indirectly helps to find the person who has committed crime. So let us check it out some of the uses of chromatography which are as follows.

Uses of chromatography in crime investigation are:-

  1. Blood sample can be detected by using chromatography.
  2. Chemical sample which is found at the crime spot can also be identified  by the use of chromatography.
  3. Sample mixture of gas as well as liquid or solid can by identified by various methods such as gas chromatography, liquid chromatography, solid chromatography or thin layer chromatography.
  4. Forensic department takes item from the seen and by use of chromatography they match the DNA in records and if matched then criminal can be identified.
Related Articles:

Saturday 21 June 2014

What are USES of Chromatography in Pharmaceutical Industry?

There are many uses of chromatography in pharmaceutical industries, As we know that chromatography is a method used to separate various components present in a mixture based on the chemical properties of a mixture. Various types of chromatography are used in pharmaceutical industry such as Gas chromatography (GC), High performance liquid chromatography (HPLC), Thin layer chromatography and solid chromataography. There are many advance chromatographic methods in pharma industry such as combination solid liquid chromatography, liquid liquid chromatography, head space analyzer and so on. So let us check it out some of the uses of chromatography in pharma industry one by one.

Uses of chromatography in pharmaceutical industry are:-

  1. Chromatography is used in research and development in preparing medicine.
  2. Chromatography is used in analytical laboratory.
  3. Different chromatography methods such as HPLC, GC are used in various stages in drug production in pharma industry.
  4. Quality control and R&D department uses chromatography methods.
  5. During new drug molecule development chromatography is used.
  6. During testing of various chemicals on animals chromatography is used.
Related articles:-





DIFFERENT USES OF CHROMATOGRAPHY

Uses of Chromatography are listed here, So before going into detail let us check it out  principle of chromatography. The main use of chromatography  is to separate and to identify the components present in the mixture. There are different types of chromatography such as gas chromatography, paper chromatography, liquid chromatography, gas liquid chromatography, and thin layer chromatography. There are two phases in all types of chromatography, one is stationary phase and other is mobile phase. Now chromatography works on the principle of partition, here the compounds with high affinity with mobile phase will travel further and separated first. There are many uses of chromatography in our day to day life , so let us check  it out one by one.


Some of the uses of chromatography are:-

  1. Chromatography is used in medicine.
  2. Use of the chromatography in analytical laboratory.
  3. Use of chromatography in pharmaceutical industry.
  4. Chromatography is also used in food industry.
  5. Out of many uses of chromatography it is also used in forensic science.
  6. Chromatography is also used in daily life or everyday life.
  7. Chromatography  is used in crime investigations.
  8. Alcohol level  in patient can also be detected using chromatography in hospitals.
  9. Some environmental agencies also uses chromatography in detecting pollutants.
  10. Chromatography is also used to purify water.
  11. In food industry chromatography is used to identify additives.
  12. In pharmaceutical industry at various stages drugs which are made are checked by different chromatography methods.
  13. Oils, fats, vitamins, alkaloids, steroids are identified with the help  of chromatography.
  14. Blood samples are checked with the help of chromatography.
  15. Chromatography also plays an important role in cosmetic industry.
  16. Pesticides and fungicides are also checked by chromatography.

Some of the related questions are also explained such as , What are uses of chromatography in crime investigation or forensic science , or What are Uses of Chromatography in pharmaceutical industry as well as Some of the uses of chromatography in industries, So find out other articles on this blog.

Thursday 19 June 2014

4 Different types of Dissolution Apparatus As Per USP

Let us see some of the types of dissolution apparatus as per USP. But before knowing that let us check it out what is dissolution apparatus. It is used to test dissolution profile of drugs in pharmaceutical industry, drug release profile of oral solid dosage form such as capsules, tablets etc which  is generally checked for quality control and to assess batch to batch consistency.There are four different types of dissolution apparatus as per USP which are as follows.

Four different types of dissolution apparatus as per USP are as follows:-
  1. Basket type - USP Dissolution apparatus - Type 1
  2. Paddle type - USP Dissolution apparatus - Type 2
  3. Reciprocating Cylinder - USP Dissolution apparatus - Type 3
  4. Flow Through Cell - USP Dissolution apparatus - Type 4
These are the four main types of dissolution apparatus as per USP among all type 2 is widely used. TO know other types of dissolution apparatus such as per USP, IP, BP etc please visit other articles on Dissolution apparatus.

Wednesday 18 June 2014

5 different Types of Air Pollution


Let us see some of the types of air pollution. But before knowing that let us check it out definition of pollution. As we all know that pollution is as unwanted material or something which is added to the environment which causes harmful effect on human beings, animals or all living organism. There are five different types of air pollution which are classified and listed below.

Five different varieties or types of air pollution are as follows:
  1. Industrial air pollution which may arise from thermal power plants, food industry, pesticides, fertilizers and pharmaceutical industry. Due to cement, steel, paper or sugar industry. Air also pollutes due to textile related industries or due to atomic units.
  2. Transportation causes pollution in which vehicles liberates smoke and pollutes surroundings, it may due to all forms of terrestrial transport, urban transport or due to other modes of transport.
  3. Accidental air pollution which may arise due to fires in forests, by accidents of petroleum carrying vehicles or may be due to leakage or a blast in certain industries.
  4. Smog formation, pollution may arise, in which smoke from different industries released in to the environment and then mixes with the fog present in air which is known as Smog.
  5. Pollution by Green house effect in which several important gases are released and combine with air, which rises upward and combine with the atmosphere and return back to the earth and destroy crops, human lives, animals ,plants and livestock etc. 
These are some of the main types of air pollution which are well known. There are other types of pollution such as Water pollution, Soil pollution and much more. please check other articles on this blog.

Friday 30 May 2014

Quality Audit Frequency and Audit Schedule

Depth And Duration Of Quality Audit: It usually depends on the following parameters.

  • Objectives status and history of organization.
  • Complexity and size of organization.
  • Number of audit criteria.
  • Amount of human and financial resources.
  • Amount of time and expertise of auditors.
Frequency of Quality audit:
  • To optimize the control of significant quality aspects.
  • High risk areas are audited more frequently.
Quality Audit Schedule:
  • It clearly identifies objectives, criteria, scope etc.
  • It contains audit details, site information, date and duration of audit, proposed activities documents required etc.
  • Resulting in greater chances of audit to become more valuable and cost effective.
Notification of Audit:
  • Announcement encourages the organizational units to correct many things in advance on their and set their house in order. Units are noticed in advance so that it may be likely that performance of the audit smoother and fruitful.

Difference between Internal quality audit and External Quality Audit

Difference between Internal Quality Audit and External Quality Audit are As follows , So let us check it out one by one.

  • Internal: Is examination of quality system and procedures in organization "First party audit"
  • External: Is an evaluation of suppliers, contractors etc., "Second or Third Party Audit"
  • Internal:Performed by team drawn from different departments i.e, production , QC, QA etc. is put together design.
  • External: Performed by consultant professional test implement the associations and of course regulatory who are not party to supplier or customers.
  • Internal: Employees may or may not contribute new information and knowledge.
  • External: Contribute lot of information to employees.
  • Internal: Conducted at reasonable internal with covering all areas of function / operations and hence it is very effective to determine non complying activities.
  • External: Conducted infrequently with examine small parts of Productions, Operations and hence ineffective to determine all non complying activities.
  • Internal: Carried Out by people within organization, they are likely to miss out most obvious mistakes.
  • External: Outsider with fresh approach for inspection , they are less likely to miss out most obvious mistakes.

Types of Quality Audit

Adequacy Audit or Document Review:

  • System or management audit.
  • Determine the extent to which document system represent by the quality manual and procedures meets the requirements of applicable standards.
Compliance Audit or Onsite Audit:
  • Seeks to establish the extent to which the documented system is implemented and observed by workforce.
External Audit:
  • Performed by company on its own suppliers.
  • It may be an adequacy or compliance report.
Internal Audit
  • Most important and requires to look on own system, procedures and activities in order to ascertain whether it is adequate and complied with it.
  • It provides management with information whether their policies are meet or not.
  • It provide line of communication throughout the company.

Quality Audit Objectives

Objectives of Quality Audit Is:

  • To determine conformity or non conformity of quality system elements with specified requirements. 
  • To suggest corrective actions and also to permit regular review of status of implements in an impartial manner in order to encourage and improve the quality of work in all the areas of manufacturing in order to meet standards laid down by regulatory agencies.
  • Also to determine effectiveness of implemented quality system in meeting specified quality objectives.
Scope of Quality Audit Is:
  • All operations directly or indirectly connected with manufacturing are covered thus personnel, premises,  Warehousing, Dispensing, production, packaging, quality control, engineering, environment, personnel safety and document should be covered.
Principles of Quality Audit:
  • Ethical Conduct
  • Fair presentation
  • Due professional care
  • Independence
  • Evidence based approach

What is Quality Audit

Quality Audit can be defined as : "A systematic and independent examination to determine or check whether the quality activities which are performed and the related results comply with the planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives."

The main objective of audit is that it checks the compliance with planned arrangement and implementation.

It is one type of an information gathering activity by the auditors for making improvement and corrective action.

The audit which is performed may be Internal or External and do not necessarily have to cover the whole system at once but it may cover some of the elements of the system.

The first party audit is an audit carried out by an organization itself which is known as Internal Audit.

A second party audit by one organization , working on its own behalf , on another i.e, audit on supplier by a customer

Third party is an audit by independent organization on supplier.

Wednesday 21 May 2014

Quality Audit

Quality Audit can be defined as systematic, independent and documented examination by quality auditor which may be internal or external.

What is quality Audit?

Quality Audit can be defined as Systematic, independent and Documented Examination.

Why quality Audit is Required?

The reasons quality audit is required are as follows , so let us check it out one by one.
  • To ensure that quality systems are maintained.
  • To achieve the consistency between manufacturing and testing facilities.
  • To ensure the customers requirements are understood and met.
  • To improve processes going on in the industry.
  • Also done to reduce the risk of failure.
  • Regulatory requirements and for Business benefits.
  • To check the cGMP compliance with the company's standard procedure.

Types of Audits

Generally the audits are divided into major two types, 1) Internal Audits and 2) External Audits. Let us check it out one by one  and the importance of each audits and why is is performed.?

Internal Audits: 

  • Internal audits  is carried out by the own organization on its own facilities, systems and the procedure going on in the company.
  • To check whether they are following GMP as per ISO9000 and other guidelines or not.
  • Reason for the audit should be the business benefits by building quality into the process and system.

Internal Audits Sub Category:

  1. The audit is performed by the staff of department by themselves i.e., individual from the same department will do the audit..This audit is for short duration which checks the documentation and housekeeping etc
  2. Second type of audit is performed by QA Department, comprising staff independent of the department being audited. The focus is more on system than housekeeping.
  3. Third types is carried out by corporate compliance group or they will ask other external consultant to carry out the audit.

External Audits:

  • External audits is carried out by the company on its vendors or its contractors
  • There will be an initial evaluation audit to access the capability and general suitability of the vendor.
  • Regular audit assess the compliance with agreed contractual standards.
  • Frequency depends on audits and vendor history.
  • Audit leader is with wide experience of GMP & Quality System auditing.
  • Audit team depends on the size of the facilities.
  • The audit report which is generated is circulated within the company and to the vendor

Regulatory Audits: 

  • Regulatory audit is carried out by the regulatory bodies , audit is against regulations of manufacture and supply of pharmaceuticals.
  • Also carried out by National Regulatory bodies. Example., Therapeutic Goods Administration (TGA) in Australia, Medicines control Agency (UK) etc.,
  • Failure causes restrictions and withdrawal.
  • After audit a formal report is received.

Audit Methods: 

The audit methods are divided into three category, let us have a look on all the different sub categories.
  1. Input-Process-Output: It breaks what is seen into input, process and output. For example in laboratory process ( Input=sample, Process=analysis and output=result).The quality of the output depends on the control over the input and the process. The output of process is often the input of another process.
  2. Trace Forward & Trace Back: Trace forward follows the process starting with the inputs, then looking the process and finally finish with the outputs. while in Trace Back it starts with output then process and finally finish with the Input by which they produced.
  3. Product and Process: 1)Product:over here Auditor may choose particular product and then look at the process which is being followed. While 2): Auditor will choose particular process and select different products, to see how this process is put into practice.

Selection and training of Auditor and Auditee

Auditor Skills

To be a better auditor following qualities or skills must be present in the auditor.
  • Open minded and mature.
  • Possess sound judgement, analytical skills and tanicity.
  • Ability to perceive situations in realistic way.
  • Understand complex operations broadly.
  • Understand the role of individual units within the overall organization.
  • Diplomatic, honest, Professional etc., 

Auditor Training

Some information on auditor training and some of the skills required are as follows.

General Audit Skills

This skills over here includes the following.
  1. Audit management skills such as Planning , direction and communication.
  2. Assessment Techniques such as Examination, recording and reporting.
  3. Inter personal skills such as differ best from the rest.

Specific Technical skills

 Skills over here are as follows:
  1. Depending on the process to be audited  for example., procedure for the ethylene oxide sterilization process. Purification of water etc., 

Auditee Skills: 

  • Generally the training requirement will depend on their involvement in the audit.
  • General awareness training for the all staff.,(Responsibilities, Behavior , Answering-Questions)
  • Training for those likely to meet the auditors (Security, Reception, Note taker, Information Retrievers)
  • For most likely to meet the auditor(Experts, technical staff with technical and inter-personal skills)

Audit policy and program management

  1. Document Date checking
  2. Document Type Checking
  3. Document Title Checking
  4. Document Title spell Check
  5. Names checking etc.,

Audit Policy

  • Policy states the auditing activities required by the organization.
  • Expected demands arising from the audits by regulators, customers or certification bodies
  • Some of the key elements of the audit policy includes: 
  • Responsibilities for the management
  • Types of audits to be managed
  • Required frequency of audits
  • Standards to be used (ISO, GMP, CFR etc.,)
  • Conduct and reporting of the audit process, Frequency of the review of the audit program.

Audit Program Management

 Responsible person should ensure that...
  • Adequate numbers of auditors are available.
  • Adequate time is allowed for audit from preparation to closeout.
  • Audit program is frequently reviewed and modified.
  • Overall target and goals of the audit policy are met.
  • Evidences are active and well managed eg., Documentation during regulatory Act.
  • System for analyzing audit deficiencies also be active eg., reviewing, strengths and weakness of the auditor.

Preparation for specific audit

Auditor Perspective.

Selection of Personnel

  • On technical and general audit skills.
  • Health and safety considerations
  • Audit leader to a team of auditors
  • Experts when team lacking technical knowledge                 

Audit Standards

  • Aware of the Standards and Regulations (ISO, GMP FDA)
  • Audit policy already define the standards  required.       

Scope of the Audit

  • Should be clearly define to both.
  • Audit program will provide to auditor with the scope i.e, internal audit of warehouse, distribution, facilities, procedure and general requirements.      

Agreements

  • Audit of vendors subject to various agreements due to business transactions.eg., supply, commercial, technical and confidentiality agreements.
  • Establish and review relevant agreement to the scope
  • Be aware of any limitations which affect the conduct of audit. eg., restriction of access of certain facilities.      

Information

  • Made available at opening meeting., procedure list, licenses, Organization charts, 
  • Audit reports, quality reports, failure reports helpful to identify areas for review.
  • Brochure, financial and establishment inspection report (EIR) requested from auditee.
  • Questionnaires are useful information gathering tool
  • Adequate supporting documents to be supplied eg., Quality manual, SOP, Specific records.      

Audit Plans And Checklist

  • Produce audit plan with estimate of time required.
  • Objective of the audit is not compromised.
  • Consider the working days and the time of the auditee
  • Use checklist as an aid to the conduct of an audit.
  • As with questionnaire should be concise and should not be irrelevant.     

Auditee's Perspective

  1. Selection of personnel: Team should meet the expected needs of the auditors. Substitute should be planned.
  2. Audit Standard and Scope: Fully aware, Aware of any limitation.
  3. Information: Identify the document required by the auditor. Previous audit report be reviewed to verify that the are addressed. Provide auditor with dossier which explain quality system and organization.
  4. Audit Scheduling: To ensure that audit can be conducted, key personnel are available and other audits are not at the same time. Once scheduled communicate the necessary information with all the person involved.
  5. Pre audit: Period between notification and start of the audit. For deficiencies corrective action to be take and close out prior to the audit.
  6. Domestic arrangements to be confirmed eg., Meeting rooms, facilities for the auditors etc 

Conducting an Audit

How to conduct an audit is explained in brief let us check it out one by one.

From auditors perspective


  • General Conduct


    • Auditor be punctual for the appointment and work as per agreed program
    • Views and comments restricted to matters related to the audit.
    • Adhere with company rules and working arrangement.
    • Points raised during examination not be answer by auditors or escorting personnel.
    • Interviewing of personnel also be done.     

    Opening meeting

    • Held with auditor and principal members of the auditee
    • Business cards are exchanged and outline of roles is provided.
    • Auditors should reiterate the audit purpose style, standard use, acceptance criteria, anticipated time scales.
    • Normal working day conditions will exist through the duration of the audit.
    • Closing meeting should be scheduled.
    • Restrictions to the information or areas should be discussed.
    • Auditee may present an overview of company structure, operations and details of changes taken place.       

    Audit Technique

    • Check the documented procedure and compliance with regulations.
    • Aware of time available to complete the audit.
    • Audit leader assigned to direct the team.
    • Maintain mutuality between auditors and auditee
    • Findings and queries be discussed and resolved.
    • Show deficiencies to auditee before processing.
    • Standard not met be specifically referred.
    • Make specific record of documents reviewed to answer.
    • While reviewing , confidentiality should be respected.
    • Point may come where apparent that the necessary standards will not met.   

    Closing meeting

    • Time be made available to the auditors to discuss finding to the audit 
    • Findings should be presented to the key auditee personnel.
    • Presenting both good and bad points in courteous and professional manner.
    • Agreements of the facts be established, corrective actions, and their time-frames agreed.
    • Discuss method of follow-up before conclusion of audit.
    • Finally do not forget to thanks to auditee.

    From auditee perspective


  • General Conduct


    • Designated auditee will be accompanied with auditor at all  times(for nothing unavailable information, arrangement to provide it early etc.,)
    • Do not answered readily to auditors questions.
    • Undue stalling for time must be avoided.
    • Ensure that auditor adhere to companies policies and procedures.     

    Opening meeting

    • Made available the information as a pre-audit arrangements to auditor.
    • Limitations to be brought to attention.
    • Auditee established the final audit agenda.       

    Audit Technique

    • Appoint an employee to make notes.
    • Organization be prepared to provide responses to the questions.
    • Understand the issues and agreed observations.
    • Think carefully before answering.
    • Documents provided to auditor should be noted and stamped.
    • For audits more than one day review its progress.
    • Auditee should not attempt to guide the auditor in a specific direction.      

    Closing Meeting

    • Allow auditors to discuss finding in private prior to closing meeting.
    • Conduct an overview of points raised during audit.
    • Decide the staff to be present.
    • Do not respond too quickly to the points made.
    • Time frame for corrective actions, reports and responses to be discussed.
    • Arrangements for follow-up should be discussed.
    • Do not forget to thank the auditor.

    After an Audit

    Publication and Audit Report

    • Auditor should prepare formal written report and send it to the auditee within agreed period of time.
    • Along with covering letters.
    • Contents as discussed earlier.
    • For External Audit completed reports are to be send to all affected customers.
    • For Internal Audit report being sent to an agreed set of internal management.
    • For Regulatory Audit, Auditee will receive the copy of audit findings in a style of the individual regulatory authorities.

    Formats and contents of audit summary

    • Header 
    • Background
    • Approach
    • Report Format
    • Summary of results
    • Future work

    Auditee response

    • Ensure that identified observations are agreed.
    • Review the observations.
    • Carryout agreed action plan with proposed completion date, to rectify the defects.
    • Response document forwarded to the auditor as a follow up to the audit activities
    • Applied equally to all audits.

    Progress on audit issues

    • Its joint responsibility to to ensure compliance.
    • But prime responsibility if of auditee for implementing corrective actions.
    • Auditor has to review and monitor action plans for closing out.
    • Auditor contact auditee if the completion date is slipping.
    • Audit is said to be complete only after successful completion of all actions.
    • All the successful outcome will be communicated with all.

    Conclusion

    1. To assess the effectiveness of the quality system and to ensure that the requirements of GMP are be met, audits must be perform.
    2. A good quality audit is that, assess the quality system against the current and anticipated future needs.
    3. Always established the root cause rather than quick fixes to isolated parts.

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