AN UPDATED & MODERN CONCEPT OF VALIDATION

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ABOUT AUTHORS:
Somsubhra Ghosh1*, B. V. V. Ravikumar2, B. Mahanti1
1Bharat Technology, Banitabla, Uluberia, West Bengal
2Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha
som_subhra_ghosh@yahoo.co.in

ABSTRACT
Validation is a very important tool in GMP. Main aim & objective of GMP to all Pharmaceutical agencies are to provide a good & reasonable quality of Pharmaceutical products to people. To get that desired quality Validation is great support to all Pharmaceutical & other industry people. Validation is also a very important tool to save money, time, labourer, waste material etc. There are different types of Validation used all over the world by which we can achieve our goal very easily. In this review it is briefly described scope, importance, objectives & types of Validation as per international norms. Now days it became so important that without validation any process, method or instrument are not accepted globally.

REFERENCE ID: PHARMATUTOR-ART-2340

PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 3, Issue 6

Received On: 23/01/2015; Accepted On: 20/03/2015; Published On: 01/06/2015

How to cite this article: S Ghosh, BVV Ravikumar, B Mahanti; An Updated & Modern Concept of Validation; PharmaTutor; 2015; 3(6); 16-20

INTRODUCTION[1]
Quality is designed and built into the process/method/premises functionality, consistency and repeatability is confirmed by Validation.

Validation is documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes.

The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.

After the requirement for each aspect is determined, the responsible l engineers complete the design and it is again reviewed by the validation team. After the approved designs are constructed and/or installed, the validation cycle continues with the preparation and execution of the validation documents.

Scope of Validation[2]
Pharmaceutical validation is a vast area of work & it practically covers every aspect of pharmaceutical processing activity.

However it will point out at least the following areas of for pharmaceutical validation.

Analytical, Instrument calibration, Process utility services, Raw material & packaging material, Equipments, Manufacturing operation, Facilities, Product design, Cleaning, Operator.

Objectives of validation[2]
· Is to form a basis for written procedures for production and process control.
· Which are designed to assure that the drug products have the identity, strength, quality and purity they are represented to possess.
· According to the FDA, the goal of validation is to: “establish documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

Reasons / purpose of validation
- Enable scientist to communicate scientifically & effectively on technical matter.
- Cost saving, reducing testing, & elimination of product retesting.
- Useful for comparison of results compliance to cGMP/GLP.
- For addressing analytical problem to proper form.
- Assurance of Quality
- Safety

Classification of validation

Depending on time when it is performed relative to production it can be classified as:

A. Process validation[2]:
The goal of manufacturing organization is to make the same product reproducibly over the life cycle of the product.Process validation is the total activity which shows that the process will do what it is purported to do.Process validation is a QA tool because Quality standard of a process is established by validation of that particular process.

Objectives of process validation:

The 3 main objectives of process validation are:
· To demonstrate control over the process and finished product.
· To demonstrate that the process will consistently produce product which meets all specifications and quality attributes.
· To generate a knowledge base for the product as well as accommodate any further business needs.

Types of process validation:

1. Prospective validation: Also called as premarket validation.Carried out prior to distribution of  new product  or  existing product made under a revised manufacturing processes where such revision may affect  product specification or quality characteristic

This is employed when historical data of the product is not available or is not sufficient & in process & furnished product testing are not adequate to ensure reproducibility.

Such validation is conducted prior to release of either  new product or product made under revised  / new manufacturing  process.

2. Retrospective validation: Conducted for a product already being marketed, and is based on extensive Historical data accumulated over several lots and over time.

Some essential elements of retrospective validation:
- Batches manufactured for a defined period
- Batch size/ strength/ manufacturer/ year
- Master manufacturing/ packaging documents
- Current specifications for active materials/ finished products

3. Concurrent validation: Study is carried out during a course of normal production.It gives assurance of present batch being studied and offer limited assurance regarding consistency of quality from batch to batch.

4. Revalidation: Revalidation means repeating the original validation effort or any part of it, and includes investigative review of existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Possible reasons for starting the revalidation process include:

  • The transfer of a product from one plant to another.
  • Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
  • The necessity of periodic checking of the validation results.
  • Significant (usually order of magnitude) increase or decrease in batch size.
  • Sequential batches that fail to meet product and process specifications.

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