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VALIDATION OF ANALYTICAL PROCEDURES: A COMPARISON OF ICH Vs PHARMACOPOEIA Vs FDA


About Authors:
Kataria Sahil,Middha Akanksha, Sandhu Premjeet
Seth G. L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA

ABSTRACT
Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability, and consistency of analytical results; it is an integral part of any good analytical practice. When extended to an analytical procedure, depending upon the application, it means that a method works reproducibly, when carried out by same or different persons, in same or different laboratories, using different  reagents,  different  equipment etc.  In  this  review  article  we  discussed  about  the  strategy  and  importance  of  validation  of  analytical  methods.

Reference ID: PHARMATUTOR-ART-1172

1. Introduction
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals and of the GMP regulations for medical devices and therefore applies to the manufacture of both drug products and medical devices.9

*  According to USP General chapter <1225> “Validation is the process of providing documented evidence that the method does what it is intended to do” In other words the process of method validation ensures that the proposed analytical methodology is accurate, specific, reproducible and rugged for its intended use 2

*  According to the FDA Guidelines on General Principles of Process Validation, process validation is defined, ‘‘ as establishing documented evidence, which provides a high degree of assurance, that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.’’ The process for making a drug product consists of a series (flow diagram in logically defined steps) of unit operations (modules) that result in the manufacture of the finished pharmaceutical.9

*  The elements “Quality control system” and  “Validation and process Validation” of Schedule M to the drugs and cosmetic rules provide as under

“16.12 All instruments shall be calibrated and testing procedures validated before these are adopted for routine testing. Periodical calibration of instruments and validation of procedures should be carried out”

“26.1 Validation studies should be an essential part of GMP and shall be conducted as per the predefined protocols. These should include validation of Processing, testing and cleaning procedures”

* In WHO GMP under the element “Qualification and Validation”. Validation of analytical test methods, automated systems and cleaning procedure has been emphasized. It reads as under

It is of critical importance that particular attention is paid to validation of analytical test methods, automated systems and cleaning procedures” 12

In International Pharmacopoeia the guidelines are directed primarily to the examination of chemical and physiochemical attributes, but many of the general principles are also applicable to microbiological and biological procedures16

According to ICH Guidelines Validation of an Analytical procedure is to demonstrate that it is suitable for its intended purpose 8

Guideline History

ICH Q2A :- Text on Validation of Analytical Procedures

ICH Q2B : - Guideline on Validation of Analytical Procedures: Methodology  [ICH Q2(R1)]

ICH Q2R1 :- Q2A+Q2B 15

2. WHY VALIDATE ANALYTICAL PROCEDURES

There are many reasons for the need to validate analytical procedures. Among them are regulatory requirements, good science, and quality control requirements. The Code of Federal Regulations (CFR) 311.165c explicitly states that “the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented.”Of course, as scientists, we would want to apply good science to demonstrate that the analytical method used had demonstrated accuracy, sensitivity, specifi city, and reproducibility. Finally management of the quality control unit would definitely want to ensure that the analytical methods that the department uses to release its products are properly validated for its intended use so the product will be safe for human use.1

Analytical methods need to be validated, verified, or revalidated in the following instances:

  • Before initial use in routine testing
  • When transferred to another laboratory
  • Whenever the conditions or method parameters for which the method has been validated change (for example, an instrument with different characteristics or samples with a different matrix) and the change is outside the original scope of the method.7

Furthermore revalidation may be necessary in the following circumstances:
- Changes in the synthesis of the drug substance;
- Changes in the composition of the finished product;
- Changes in the analytical procedure15

3. CYCLE OF ANALYTICAL METHODS
The analytical method validation activity is not a one - time study. This is illustrated and summarized in the life cycle of an analytical procedure in Figure

An analytical method will be developed and validated for use to analyze samples during the early development of an active pharmaceutical ingredient (API) or drug product. As drug development progresses from phase 1 to commercialization, the analytical method will follow a similar progression. The final method will be validated for its intended use for the market image drug product and transferred to the quality control laboratory for the launch of the drug product. However, if there are any changes in the manufacturing process that have the potential to change the analytical profile of the drug substance and drug product, this validated method may need to be revalidated to ensure that it is still suitable to analyze the API or drug product for its intended purpose. 6

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Anonymous (not verified)
Pharma Graduate

Dear All,

With respect to the current scenario of the Indian pharma graduate and outlook of the government and the industry, we need to address the following problems with the demands as mentioned below for the pharma graduate:-

1) To ensure there are quality graduates coming out of the colleges as there are poor quality of the students coming out from the universities.

2) Our Indian degrees should be recognized all over the world and registered pharmacist in India should be able to register in any European or American Countries without much hassle.

3) As per the regulation of the price of the essential drugs in the DPCO, the salary provided to the pharma graduate should be also be regulated per the pay commission.

4) PIC (The Great Pharmacy Council of India) should work proactively for the maintaining the high standards of the pharma profession by making the employment of the pharma graduate compulsory in the production area and not allowing the other graduates including the Msc and Bsc in working in the company.

5) The DPharm graduation should be phased out immediately as there should not be any advantages or disadvantages for both the B or the D graduate.

6) The PharmD should not start as there is no scope for the further learning after Bpharm, as per the syllabus for the PharmD there is no scope for any specialization and may have no effect on any job performance. Eventually he will be standing behind a pharmacy counter which even a D pharm would be able to stand and dispense the medicine as prescribed by the doctors.

7) New Colleges having such courses should be stopped with immediate effects, as more graduates are eventually been fooled for the course and no happiness is gained by being a graduate of Pharm.

8) For Marketing Jobs, also they should be reserved only for the trained person like Dpharm or BPharm, no other untrained person should be selling the pharma products.

9) More Government Employment schemes for the further progress of the pharma profession and national strength. And allowing the Pharma graduate to have better roles in research.

For the above demands if completed, provide a perfect healthy and fairly competitive environments for the level playing of the pharma graduate. But how make the government listen to your demands, how will the bloody buggers will answer to the questions which are pertinent to their activities which are corrupt enough.

There is a solution to this question. I can make this thing happen, I require only 50 persons who can help me. The only things required:-
1) Incurring expense of rupees 50Rs (This is No payment to me)
2) Time to post an application.

If you are interested in participating in the movements, please contact me at hvk159@hotmail.com

Regards,

manav2229
Offline
Joined: 2011-11-24
GOOD WORK

I WANT TO CONGRATULATE TO ALL OF U.U ALL HAVE DONE A NICE JOB.I AM WORKING AS Sr. OFFICER VALIDATION SECTION IN MACLEODS PHARMA IN ARD FROM LAST THREE YEARS. Its A GOOD ARTICLE CAN U SEND A COPY OF THIS ON MY MAIL ID;manav2229@gmail.com. so i can read it thoroughly and give u some good suggestions.

GOOD LUCK.

Anonymous
Hi

Very Informative article. Keep it your hard work

Dr Tushar Lokhande

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