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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.
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.
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.
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 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
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"
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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: 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:
Process Validation is divided into three stages which are as follows:
Process Design - Stage I
Line clearance is the permission taken from the authorized QA person before starting actual production (Manufacturing, Filling and Packaging).
The line clearance includes:
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
Full form - MBA is the post graduate degree in the business administration.
MBA stands for Master of Business Administration.
Finance, Banking, Marketing, Information technology, Human resources, Accounting are some of the subjects which are studied in MBA.
During tablet coating Orange peel defect is observed due to inadequate spraying or spreading of the coating solution.
Before the drying this coating solution causes bumpy or orange peel effect on the coating.
It is caused due to high spray rate and high pressure.
This defect can be prevented by thinning of the polymer solution and adding additional solvents.
During Tablet coating , color variation defect is observed sometimes.
This defect is caused by improper mixing on the tablets, or by insufficient coating and also caused by uneven spray pattern on tablets.
After coating the migration of soluble dyes or any additives during drying may give tablet a spotted and mottled apperation.
Due to this defect color variation is observed.
List of some tablet coating defects which may affect the tablet formulation and bioavailability of drug are as follows.
(1) Picking and Sticking,
(2) Color variation,
(3) Orange peel effect,
(5) Capping and lamination,
(6) Mottled color,
(8) Hazing or Dull film
(15) Peeling and frosting.
Various applications of polymers are there for different industries which are very useful. Let us see some applications of polymers which are discussed as follows:
Polymers are used in packaging, surgical sutures, bottles, electrical components, contact lenses, adhesives, medical supples such as blood bag, bone cement etc.
Used if plastic bags, pipes, rubber, fabrics, automative parts, paints, also used in houseware products such as plates, cups etc.,
Polymers nanofiber applications:
Polymers are used in
Biodegradable polymes are having wide range of applications in different fileds such as pharmacy, medicine , dermatology etc
.Let us check it out some of the biodegradable polymers.
Polymers obtained from biomass products are knows as agropolymers such as polysaccharides, proteins, starch, ligno cellulose products etc.
Polymers obtained from microorganisms by extraction such as PolyHydroxy Alkanoats (PHA) .
Polymers applications is also available in biomedical engineering.
The structure of polymers are used to determine the utilization of polymers is various medical fields such as surgery, ophthalmology,pharmacy, dermatology etc.
Preparations of popular thermoplastic polymers for biomaterials like teflon, nylon, PVC, polyolefin etc.,.
Popular thermosetting polymes like butyl rubber, natural rubber, silicon rubber etc.
Polymers have many properties which is very important for different applications of various polymers in different fields.
Some of the propeties are:
(1) Electrical properties: Dielectric constant, leakage current, breakdown voltage, dielectric strength.
(2) Mechanical properties: Tensile strength, modules and elongation.
(3) Thermal properties: Themal stability, Tg, CTE, stress, thermal oxidative stability, Themal conductivity.
(4) Other properties: viscocity, water absorption, moisture permeability, adhesion, chemical resistance, surface finish. etc.
Polymers additives is one of the applications in polymers to improve the mechanal property, durability or processability.
Fillers such as carbon black or silica gel are added to polymers to improve tensile strength, abrasion resistance and toughness.
Plasticizers are added to reduce the glass transition temperature.
Stabilizers contain antioxidants and UV protectants.
Lubricants are added to allow easier processing.
Other additives like colorants and flame retardants are also added in polymers.
Polymers have many applications in various fields as well as in everday life.
Let us check it out some uses of polymers.
Polymers are used in clothing, oil recovery, food and flavours, agriculture, packaging, consumer items like clothing, toys, skin care
Polymers also used in automative parts, pipes, parts, additives etc.
Also used in electronics as well as in medicines such as in formulation of proteins, antibiotics, gel caps or in coating of tablets.
Definition - Polymers are large molecules which are made of repeating units of molecules which are called as monomers.
There are lots of applications of polymers in day to day life.
The term polymer is derived from the greek work , In Greek terminology poly means many and meros means parts.
To form polymers, the monomers are connected to each other with the help of covalent bonds and this process is called polymerization.
Polymers is made up of either same type of monomer or different types of monomers.