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Process Validation Stages process qualification two

In the Process Validation during second stage that is process qualification some more points are taken into account which are  discussed below. So let us see some points one by one:

During process performance qualification the actual facilities, utilities and equipment are checked whether they are qualified or not.

The personnel operating various equipment are trained or not is checked.

The  procedure which are performed are as per standard procedure is verified and checked.

The components which are going to use for the commercial manufactured are also checked and verified.

Performance qualification confirms process design.

Overall level of product and the understanding of process is necessary during performance qualification.

Data from lab, pilot and commercial batches are studied.

Previous experience of similar batches and products are also taken into account.

Higher level of sampling is required during this stage.

Additional testing is done if required.

Adequate measure are taken out to achieve adequate quality of product.

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Process Validation Stages process qualification

During Process validation: The second stage is process qualification Some of the points which are discussed during process qualification are as follows , so let us check it out points one by one.:

The main aim of process qualification is to determine whether the process which is designed is capable of reproducible commercial manufacture or not.

Design of the utility and the qualification of the equipment are taken into account during process qualification.

Process performance qualification in this stage.

Process Validation Stages process qualification one

In Process Validation the second stage that is process qualification , the design of the facilities and the qualification of the equipment and the qualification of the utilities are very important. Some of the points regarding design and qualification are as follows:

During the qualification of th utilities and the equipment, the construction materials, the operating principle and the performance characteristics are very important.

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.

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 design one

In Process Validation as we know that first stage is process design, Some of the points which are discussed during the process design are as follows , so let us check it out one by one.

Use Design of experiment (DOE) to develop the process by different factors such as :

By Revealing relationship between the various variable inputs such as characteristics of components or process parameters  and between the resulting outputs such as process material, intermediate or the final product.

Process Validation Stages process design

In Process Validation the first stage out of three stages is Process Design. Following are some of the points which are taken into consideration during process design. So let us check it out one by one:

To design process follow good manufacturing practices.

Uses scientific principles as well as scientific methods.

Conduct the internal review , the document decisions and the justification of the controls.

Find out critical quality attributes during process design.

Critical material attributes are defined.

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

Process validation: It can be defined as the documented evidence which provides a high degree of assurance that the process which is going to be performed will consistently produce a product , meeting its pre determined specifications and all the quality attributes.

Process Validation is classified into four types which are as follows:

Prospective Validation

Retrospective Validation

Concurrent Validation

Revalidation

Process Validation is divided into three stages which are  as follows:

Process Design - Stage I

Process Validation Stages process design two

In Process validation the first stage that is Process design stage have some points which are taken into account. Some of them which are taken into consideration are as follows:

Process control should address variability such as:

During the process design the control to reduce the input variation and the control to adjust for input variation are taken into account during manufacturing.

Controls may also consist of about the equipment monitoring at significant processing point and also control on material analysis.

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

Process Validation is divided into three stages, So let us check it out one by one. Following are the three stages.

Stage I - Process Design: With the knowledge of Scale up studies and the prior knowledge which is gained through development, The commercial manufacturing process is defined during this stage of process design.

Stage II - Process Qualification: After defining process design, it is evaluated in this stage to determine whether the process is capable of reproducible commercial manufacturing or not.

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 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 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 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

Process Validation points - Some types of process validation are as follows. So let us see types of the process validation one by one to know more about process validation.

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 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.

Line Clearance

Line clearance is the permission taken from the authorized QA person before starting actual production (Manufacturing, Filling and Packaging). 

The line clearance includes:

Manufacturing Area

Filling Area

Dispensing or packaging Area

Purpose and Importance

In line clearance the procedures have been established to prevent mix - up of containers, products, labels and mistakes in documents. MIx up and mistakes occurs when GMP are not followed.

Particular take should be taken:

When starting a new operation

At change of shift