Validation in Pharmaceutical manufacturing process is a vital step at different stages to ensure all quality prospectives.
It is a documented evidence which show that each step, during R&D, manufacturing, testing, packaging and storage, should perform according to protocols (SOP’s) or not and also results after product development should meet its pre decided specifications or not.
Validation is a key process for effective quality assurance.
Validation is established document evidence which provides a high a degree of assurance that a specific process ,method, instrument or equipment will consistently produce a product or results meetings its pre-determined specifications and quality attributes.
Objectives of Validation
The primary objective of Validation is that to produce specifications and fundamental rules as in written procedures for manufacturing and process control which are construct to assure that products which go through with these standards should have identity, strength, quality and purity.
Quality, efficacy and safety must built and design into the drug products. Each and every step of production must perform under control to maximise the probability for finished products as they meets all design and quality specifications.
Types of Validation
PROSPECTIVE - Basically, this is a pre-production activity. Prospective validation involves different applications which apply before a new product is introduce and when there is a production process changes are there which can affect the product's characteristics. Validation program must be documented in a proper way and design accordingly and also after conduct of the validation, obtained results must be documented and maintained properly.
CONCURRENT- Concurrent validation is basically utilises to built documented evidence for equipments and utilities to ensure that performance of those are intended, according to information generated during actual use of the process. Concurrent validation is generally perform during the process.
RETROSPECTIVE- Retrospective validation is a type of validation is for products which are already in distribution and it is based on accumulated production, testing and control data.
Phases of Validation
1. Design qualification (DQ)-
DQ, Design qualification are essential when manufacturer or user involve in purchase of utilities or equipment from vendors. Pharmaceutical manufacturers should prepare user requirement document (URD).
This document is necessary to discussed and share with vendor of equipment and utilities which manufacturer wants to purchase so vendor easily can provide utilities according to manufacturer’s need.
Equipment’s design should be in such a manner that cleaning of that equipment and also its maintenance should be easy.
Design equipment in such a way that it will not allow matter like coolants, lubricants, other impurities to interact with any in-process material.
In Equipment design, it is necessary to have indicating system for malfunctioning of equipment.
All other specific requirements according to the process for which equipment is design and utilises should take in considerations.
2. Installation Qualification (IQ)- Installation Qualification (IQ) is perform to check that designed equipment or utility which manufacturer obtained is install properly or not. It needs a systematic and formal checking for all newly installed or sometime modified utilities, equipments or premises. This involves inspections in different levels as-
Inspections of documents related to delivery of the equipment or utility.
Inspection of packaging of equipment or utility to check if any visible physical damage is there.
In case of major equipments, unpacking should be assist in the presence of vendor’s representative.
Inspection of availability of all other accessories with equipment.
Installation of equipment- Firstly position the equipment in a logical area and then install according to the manufacturers instructions, electrical testing also perform if necessary to check the power cut off effects.
Calibration- Confirmation of calibrating equipments and devices with references to national standards ( e.g. National physical laboratory for physical parameters in India).
Preventive maintenance schedule and manuals.
Prepare SOP’s (Standard operating procedures) for cleaning, calibration, maintenance, sterilisation if necessary should prepare.
3. Operational Qualification- After successful implementation of Installation Qualification, Operational qualification is conducted. This is perform to check that euipempents and utilities which installed show their specified operations or not. It involve tests those are developed from knowledge of system, equipment and processes. These are the tests which includes conditions with lower and upper operating limits.
4. Performance Qualification- After successful implementation of IQ and PQ, the next level is Performance Qualification (PQ). This is perform to check the performance of equipment or device in different stages. It provides the demonstration to inspect the effectiveness and robustness of the process by equipment and device.For different equipments and devices various SOP’s are generated to perform Performance qualification according to their uses and parameters involve in that particular equipment.
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