You are here

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

When additional components are needed

After maintenance part way through the process.

Manufacturing Area

During Line clearance all equipments and area should be clean. 

Checking of all raw meterials are properly weighed or not.

The Batch manufacturing record entries are done properly or not is checked

Mixing time, granulation time , compression time etc., are checked in BMR record.

The cleaned labels of equipment should be attached in BMR

The cleaned label is attached for all the equipments which are used in production.

Filling Area

In line clearance empty bottle inspection is carried out. Wash water sample is checked. 

Clarity and pH

Filled volume

Status label

To verify whether the previous product packaging material are removed or not.

"Under use" label should be there on each equipment.

Explore more Information

  • 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 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 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 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 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 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 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 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 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 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.

  • Full Form of MICR,GPRS

    Magnetic Ink Character Recognition (MICE) is widely used in banking industry for clearance of cheques and other similar documents.(Other full form of MICR and meaning are also available) So check it out other articles related to the given term.

    GPRS : General Packet Radio Service (Packet oriented mobile data service for mobile communication).

  • How does the FAX Work ?

    Fax machine is used to send as well as receive documents, so there are two parts one is sending part and other is receiving part. 

    The sending part is just like a computer scanner which scans one line of a document at a time.

    Phone line is attached between sending part and the receiving part which transmits the information instantly to a fax machine.

    Within few minutes a copy of a document is received to a fax machine.

    Also read full Form of a fax machine

  • 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 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

    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.

  • 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.

  • 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.

  • Full Form of CCTV Camera

    Full Form : CCTV is a technology in which a set of monitors and video cameras are arranged.

    It is used to watch the area of interest  to prevent crime and to keep that area safe for any misuse.

    Its full form is closed circuit television.

    Visit other similar articles to know more about it.

  • BET to CEP terms

    The list of Abbreviations used in Pharmaceutical Industry

    Check out useful information on related terms.

    In the Second Chapter on List of abbreviations used in pharmaceutical Industry find out more informations of the useful terms. Some of them are given below so check it out one by one.

  • 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.

  • 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. 

  • 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

WHAT OTHERS ARE READING

Full Form of DNA

Deoxyribonucleic Acid (DNA)  is a molecule which helps to carry most of the genetic instructions or information in functioning, development and reproduction of almost all kinds of living organisms which is present in nearly all living organisms. DNA can be said as a carrier of genetic information. (Other full form related to DNA such as RNA and other similar terms are also available.)

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.