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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 Qualification - Stage II

Continued Process Verification - Stage III

The Process Validation which is going to be performed only starts after the qualification of equipment or instruments and the qualification of facilities.

Examples of some of the process parameters are:

Temperature

Pressure

Flow rate

Vacuum

Cooling rate

Agitation speed

Time (Duration)

Quantities of materials.

Construction of equipment or instrument

Order of addition of materials

Sequence of unit operations.

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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 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 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 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 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 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.

  • 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 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 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

    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 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 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 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 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.

  • Processes involved in Recycling materials

    There are mainly four types of process involved in recycling materials. So let us check it out each process take place during recycling of any materials or products

    The first step is to collect recyclable materials such as paper, glass, aluminium, cans, plastic from communities. The recyclable materials are placed into separate bins and the bins also have the recyclable symbol on it. 

  • Examples of Recycling materials

    Some Examples of recycling materials are as follows. So let us check it out some points of recycling to know more about recycling materials.

    Material which can be recycled are : Plastic drink bottels, chipboard, newspaper, corrugated cardboard, glass bottels, beverage cans, magazine, plastic, aluminium, paper, glass, trash etc., Find out more on advantages and disadvantages of Recycling.

    Example 1: We can reuse plastic bags when we go to supermarket to buy household products.

  • How Recycling Saves Energy?

    When we manufacture new products from virgin materials, more energy is consumed. Other natural resources such as fossil fuels (Oil , Petroleum, Natural gas, Coal) are also used during manufacturing of products. But when we make products out of recycled materials we can reduce the use of energy sources. The steps in the process of manufacturing of recycled product is reduced which helps to save energy.

  • What are environmental benefits of Recycling ?

    There are several environmental benefits of recycling. Let us check it out some of the points of recycling to know more about recycling.

    The process of recycling helps to reduces noxious waste in landfills. Recycling also helps to promote environments sustainability. By this entire process it is possible to diminish the demands of raw materials. Ecological degradation can also be prevented by the process of recycling, 

  • Incineration

    Incineration is one of the waste management technique  and disposal method to treat waste materials. Combustion of waste in the presence of oxygen is carried out by thermal treatment process. The waste is then converted into water vapour, carbon dioxide and ash, with he help of incineration treatment the quantity of waste products or garbage can be reduced significantly.

  • Benefits of Recycling

    Recycling is a process of waste management in which waste materials of plastic, paper, metal, aluminium, glass etc., are collected and are used to make new products. Recycling helps to protect the environment and saves energy and resources. 

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