Stratified Sampling Approach in Process Validation
Pharmaceutical manufacturing is a perfectly systematic process that primarily relies on quality control to produce quality products. The goal of quality control is to reduce batch failures and defects during manufacturing by taking steps at every manufacturing stage. Therefore, the sampling of the intermediate ...
Process Validation FAQs
How many types of validation are there in pharmaceuticals?
There are four types of validation in pharmaceutical industry: Prospective validation, Concurrent validation, Retrospective validation & Revalidation
What are the stages of process validation?
As per FDA, there are three stages of process ...
Process Validation in Pharma Industry
Process validation is an important part of pharmaceutical product manufacturing. Where a scientific evidence is to be established that the process is capable of consistently delivering quality product.
As per FDA,
Process validation is the collection and evaluation of data, from the process design stage ...
Types of process validation
The guidelines on general principles of process validation mentions four types of validation:
A) Prospective validation (or premarket validation)
B) Retrospective validation
C) Concurrent validation
D) Revalidation
A) Prospective validation (or premarket validation)
Establishing documented evidence prior ...
Stages of Validation
Validation study activities can be classified into three phases:
Phase 1: Process Design
This step is where the process of building and capturing knowledge and understanding takes place. At this stage the preliminary design of the process and experiment should be done. It covers all activities related ...
Process Validation
= The selection of number of batches for process validation shall be defined in individual protocol. All protocols shall be as per the Format given in Annexure.
= A validation team shall be consisting of multi-disciplinary team of personnel primarily responsible for conducting and or supervising validation ...
Basic Concept of Process Validation
=>> Calibration, verification and maintenance of process equipment.
=>> Prequalification or revalidation.
=>> Establishing specifications and performance characteristics.
=>> Selection of methods, process and equipment to ensure the product meets specifications.
=>> Qualification or validation of process ...
General Considerations for Process Validation
In all stages of the product lifecycle, good project management and good archiving that capture scientific knowledge will make the process validation program more effective and efficient. The following practices should ensure uniform collection and assessment of information about the process and enhance ...
Basic Requirements for Process Validation Exercise
Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at the lowest possible cost. In order to maintain the quality of a drug product and to ensure its safety, manufacturing process validation has to be done. It is the ...
