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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.

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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 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 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.

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 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 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.