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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.

The number of the samples should be adequate in order to provide sufficient statistical data.

The description of the statistical method to be used should be mentioned in protocol.

Design of facilities and the qualification of the utilities and equipment must be available.

Training records of personnel during handling or operating of the equipment must be present.

Verification of materials in use.

Status of the validation of the analytical methods should be available.

Review and approval of the protocol.

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  • 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 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 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 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 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

    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 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 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 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 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 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 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 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 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.

  • 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. 

  • Importance of Sustainable Development in Points

    Check out Importance of Sustainable Development in Points which are discussed below. So let us find out some important points on importance to know more about sustainable development.

    Importance of sustainable developement are :

    Sustainable Development is a continuous Process

    Sustainable development helps in developing eco-friendly culture.

    Sustainable development considers the needs for future generation

    Freedom of speech and freedom of choice in sustainable development.

    Improves economic growth as well as national wealth.

  • Medicinal Uses of Aloe Vera in Points

    Check out Medicinal Uses of Aloe Vera in Points which are discussed below. So let us find out some points on Medicinal uses to know more about Aloe vera.

    Medicinal uses of aloe vera are :

    Aloe vera helps to reduce high blood pressure and also lowers high cholesterol.

    It helps to protect the body from stress and prevents kidney stones.

    Aloe Vera supports immune system and also stabilizes blood sugar level.

    Aloe vera helps in cooling and repairing sunburn skin and it also hydrates the skin.

  • Advantages and disadvantages of Advertisement in Points

    Check out Advantages and Disadvantages of Advertisement in Points which are discussed below. So let us find out some points on advantages and disadvantages to know about advertisement.

    Advantags of Advertisement in points are :

    Advertisemet can be used to build brand Loyalty.

    Advertisement creates ground for personal selling.

    Advertisement helps to communicate information to the people.

    It also helps to educate people.

    Advertisement creates image for the products of services in the market.

    It helps to build goodwill.

  • How to find 10 percent of a number ?

    Let us see how to find 10 percent of a number. Some information or method explaining how to calculate percent of number are as follows.

    In order to find 10 percent of any number you need to divide number by 10. For example 10 percent of 100 = 100/10 =10

    Example 2 : 10 percent of 200 = 200/10 which means 20

    Example 3: 10 pecent of 333 = 333/10  and the answer is 33.3

    This is very simple , you just need to divide the number by 10 .

  • Medicinal Uses of Amla Plants in Points

    Check out Medicinal Uses of Amla plants in Points which are discussed below. So let us find out some points on Medicinal uses to know more about Amla Plants.

    Medicinal Uses of Amla Plants are :

    Amla Plants can be used to stimulate Appetite.

    Amla plants can also be used for diarrhea, dysentry and hemorrhage.

    Amla plants can be used as an antioxidants as it contains vitamin C and polyphenols

    They are also good for heart , eyes and brain

    Amla also improves immunity and gives physical strength

  • Medicinal Uses of Mint in Points

    Check out Medicinal Uses of Mint in Points which are discussed below. So let us find out some points on Medicinal uses to know more about Mint. It is also know as pepperming.

    Medicial Uses of Mint are :

    Mint helps to promote digestion and also improves oral health.

    Mint is an effective and quick remedy for nausea.

    Mint helps to clear up congestion of throat, nose and lungs.

    Mint is a natural stimulant and helps to give relief from depression and fatigue.

    Mint also helps to prevent cancer.

  • Medicinal Uses of Tulsi Plant in Points

    Check out Medicinal Uses of Tulsi plant in Points which are discussed below. So let us find out some points on Medicinal uses to know more about Tulsi Plant.

    Medicinal Uses of Tulsi Plant are :

    Tulsi has ability to cure many types of fever because tulsi has very potent anti-bacterial, germicidal,antibiotic and fungicidal properties which are great for resolving fevers.

    Tulsi plant is also helpful to enhance the immune power of the body.

    Tulsi helps to maintain normal body temperature of the body.

  • How to find 20 percent of a number ?

    Let us see how to find 20 percent of a number. Some information or method showing how to calculate 20 percent of a number are follows:

    In order to calculate 20 percent of number you need to follow two simple steps.

    Step 1: Divide number by 10 for example if number is 100 then you have to divide 100/10 so answer is 10

    Step 2: Multiply answer with 2, so in this case we have answer 10 so 10x2= 20

    So 20 percent of 100 is 20

    Example 2: What is 20 percent of 22

    Answer 22/10= 2.2 now you have to multiply 2.2 with 2 so 2.2x2=4.4 

  • 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.

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