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Process Validation

Process Validation Types Revalidation

Fourth type of process validation is Revalidation. It is performed to check the performance of the various process parameters, some of the points regarding revalidation are as follows. So let us have a look on revalidation:

Any part of process or entire process parameters are validated in order to check the performance of the process parameters.

To maintain the validated status of equipment, facilities, or manufacturing process , revalidation if often carried out.

Process Validation Types Concurrent validation

Third type of process validation is concurrent validation which is also performed. Some of the points about concurrent validation are as follow , so let us see one by one:

Concurrent validation is performed based on the data which is generated at the time of production.

Validation carried out on the bases of the actual report generated during production.

Critical process parameters and the end products are monitored during concurrent validation.

The process parameter are checked for each and every ongoing batch.

Process Validation Types Retrospective validation

Retrospective validation is the second type of process validation, some of the points regarding the retrospective validation are given below , so let us check it out one by one:

Retrospective validation is the documented evidence in which the process validation is carried out based on the historical data.

Validation of facilities, process, or processes are carried out based on the available historical data or reports.

This type of approach is rarely used today.

Process Validation Types Prospective validation

Types of Process validation:Out of four types prospective validation is one of them. Some points regarding prospective validation are as follows , so let us check it out one by one:

In prospective validation process the validation is carried out based on the pre planned protocols.

Prospective validation is carried out at new process at new manufacturing facility.

Before pharmaceutical production at commercial level, prospective validation is carried out.

During prospective validation the input resources are clearly defined and specified.

Process Validation Types

Types of Process Validation: There are mainly four types of process validation. Following are some of the types of process validation so let us see all types one by one:

Prospective process validation

Retrospective process validation

Concurrent process validation

Revalidation

Prospective process validation: "Documented evidence - Validation carried out based on the pre-planned protocol"

Retrospective process validation: "Documented evidence - Validation carried out based on the analysis and review of the historical data"

Process Validation parameters

Parameters of Process Validation for successful validation of any process are discussed here. Some of the key parameters in process validation are as follows, so let us check it out one by one.

The knowledge and the information about the product and the process is very necessary.

Understanding of the source of variation is required for successful process validation.

One must be aware about the impact of the variation on the process and ultimately on the products which is being manufactured.

Process Validation stages continued process verification one

About Process Validation, the third stage is continued process verification, Some more information about process validation in continued process verification are as follows:

The variation in the continued process verification can be detected by assessment of various documents.

By complaints of any defects.

By checking out of specification records or process parameters.

Checking deviation reports.

By observing variation in the process yield.

By checking batch records.

Checking records of incoming materials.

Process Validation stages continued process verification

Third stages in Process Validation is Continued Process Verification, Some points in process validation during continued process verification are as follows, So let us see one by one all the points:

The main goal of continued process verification in process validation is to ensure that the process remains in a state of control during manufacturing of commercial products.

The data is collected and evaluated in order to determine process variability.

Process Validation Stages process qualification report excution

In Process Validation the execution of process qualification begins after the approval of the protocol, Following are some of the points regarding execution and preparation of report during process qualification.

Execution will start of begins after the approval of the protocol.

All points mentioned in the protocol are to be followed.

If the points mentioned in protocol is not followed then proper justification is required.

Follow the commercial manufacturing process and the routine procedures.

Process Validation Stages process qualification protocol

During Process Validation the protocol of process qualification is also prepared, following are some of the points which are included into protocol of process qualification, so let us check it out some points:

The manufacturing condition including processing limits, the operating parameters as well as the components used such as raw materials are included in protocol.

The sampling plan with complete details of the number of sampling points, frequency of sampling of each unit are to be mentioned in protocol.

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