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Biopharmaceutical Process Validation Research Assignment
Essay Instructions:
the assignment divided into 3 parts:
Part-1: Elaborate in detail on a typical sequence of process validation activities for a
biopharmaceutical product, and suggest a process validation workflow.
Part-2: Explain why a process validation program should include study protocols on the
following items: a. Viral clearance b. Impurity clearance (Nucleic acid, Immunogenic,
Pyrogenic, etc.) c. Process consistency (conformance lot validation) d. Process intermediate
stability e. Process solution stability f. Drug substance fill, freeze, thaw, and storage g.
Mixing studies (product and process solutions) h. Chromatography resin and reusable filter
membrane lifetime validation.
Part-3: Explain why complete characterization of the cell line is an important process
validation study, going all the way back to the origin of the cell line: phenotyping, antibiotic
resistance, identity and stability monitoring, testing for adventitious agents, retroviruses,
retroviral activity markers, and tumorgenicity.
Essay Sample Content Preview:
Biopharmaceutical Process ValidationNameCourseTutorDate
Part 1: Sequence of Process Validation Activities
Process validation can be defined as the procedure that is followed in the collection of data and the evaluation of the collected data. The process begins at the design stage and goes through the commercial production process, and then a scientific evidence is established that the process that a certain product has gone through is capable of delivering a quality product that is fit for consumption CITATION WHO13 \l 1033 (WHO, 2013). As such, we can view process validation as a series of activities that takes place over the lifecycle of the product that is being produced and the whole process. There are three main stages of the process validation process for pharmaceutical products.
Stage One- Process Design
At this stage, the commercial manufacturing process is defined. It mainly depends on the knowledge that has been gained through the development of scale-up activities. Most of the early process design experiments do not need to be performed under the CGMP conditions that are used for the drugs that are used in the commercial distribution. However, the fact that they are not performed under the CGMP conditions does not mean that there should be a compromise of the sound and scientific principles that are involved. Good documentation process should be carried out and it should be consistent with the Pharmaceutical Quality System requirements and practices CITATION WHO13 \l 1033 (WHO, 2013).
The designing of an efficient process control approach depends on the process knowledge and the understanding that is obtained. The designing of experimental studies can play a great role in developing the process knowledge by revealing the relationships between the variable inputs and the outputs. In this case, the variable inputs can be the component characteristics and the various process parameters. On the other side, the resulting outputs can be the materials used in the process and the final product of the whole process CITATION EMA16 \l 1033 (EMA, 21st November 2016). The risk analysis tools can be used to screen the potential variables for the design of the experiment so as to minimize the total number of the experiments that are performed while at the same time maximizing the knowledge that is obtained.
There are other activities such as experiments and demonstrations that play a great role in the evaluation of certain conditions and provide a prediction of the performance of the commercial process. Such activities can also be used as a good source of information to be used to model and at the same time simulate the commercial process that is taking place at that particular time. Simulations that are done by the help of the computer on the unit operations provide a good understanding and can help to avoid problems that arise as a result of commercial sales.
As a manufacturer, there are various gauges that can be used to establish a proper process control for each of the units that are used in the operation. However, you need to remember that proper knowledge and understanding is the basis for all the strategies that you will undertake in your operations. The policies can be designed in such a way to reduce the input variation during the whole process of manufacturing and as such the impact that it will be having on the output or at the same time you can use a combination of both processesCITATION USD11 \l 1033 (Health, 2011). The process controls will address the variability and also assure the consumers of the quality of the product. A manufacturer should also make early and regular risk assessments so that they can make decisions that regard the type and the extent of the process controls.
Stage Two- Process Qualification
At this stage, the process design is evaluated to determine whether it is capable of being reproduced as part of the commercial manufacturing. The stage has got two main elements. One of the elements is the design of the facility and the qualification of the equipment and its utilities. The second essential stage is the performance process requirement.
1 Facility Design and Qualification of Utilities and Equipment.
There is the need for the proper design of a manufacturing facility so that it can meet the CGMP regulations and requirements of building and facilities. It is therefore very essential that the activities that are performed to assure the proper facility design and the commissioning procedures that are involved. The activities that are undertaken should be aimed at demonstrating that the utilities and the equipment are suitable for the intended use and that they perform properly.
There are some activities that are involved in the process qualification utilities and
Equipment.
* You should select the utilities and equipment construction materials based on their operating principles and the performance characteristics. The equipment and building materials that are chosen should be appropriate for the specific use upon which they are intended.
* A manufacturer should also verify the utility systems and equipment to make sure that they have been built and installed according to the design specifications that were set out.
* There is the need to verify that the unity systems and equipment carry out their operations by the process requirements. It should also include challenging the system functions of the equipment.
2 Process Performance Qualification (PPQ)
It is the second element of stage 2, and it combines the actual facility utilities and the equipment, the actual facility, trained personnel within the given commercial training process, the control procedures that are involved and the components that are used in the process of producing the commercial badges. A successful PPQ will be a confirmation of the process design, and it will at the same time demonstrate that the commercial manufacturing process will perform as expected. Success at this stage will signify a major milestone in the lifecycle of the product.
In most of the cases, PPQ has a higher level of sampling, additional testing and greater scrutiny of the performance process that will be typical of a routine commercial production. It is important to know that the level of the testing and monitoring process should be sufficient enough to confirm the product quality throughout the batch. The increased level of testing, scrutiny, and sampling continue throughout the process verification stage.
Stage 3- Continued Process Verification
During this stage, ongoing assurance is gained during the routine production process as it remains in a state of control. Under this stage, the collection, evaluation of information and data about the performance process is very essential. It will allow the detection of the undesired process variability. It is also a requirement that the process should adhere to the CGMP requirements. As part of evaluating the performance process, you should be able to identify the problems and determine whether the action to be taken is used to correct, anticipate and prevent problems so that the process will remain in control.
A manufacturer should establish an ongoing program that will be used in the collection and analysis of the processed the data that will relate to the product quality that is established. As part of the data that is collected, one should include related process trends and the quality of the incoming materials or components, the in-process material, and the finished products. A trained personnel should do all this.
Before the distribution of the commercially produced batch of products from the manufacturer to the consumer, as a manufacturer, you need to gain a higher degree of assurance in the performance of your manufacturing process. It will make you know whether you have the ability of consistently producing APIs and drug products that meet all the attributes relating identity, strength, quality, purity and potency. Such an assurance can be obtained from objective information and data from the various laboratory and commercial studies that have been carried out. The information and data that you receive should demonstrate the fact that the commercial manufacturing process that your products are going through has the capability of producing acceptable quality goods within the industrial manufacturing process.
For a process validation process to be successful, one must have adequate information and knowledge about the product and the process development of that product. The knowledge and understanding of the product provide a basis for the establishment of an approach to control the process of manufacturing that will result in the production of products that have the desired attributes. As a measure, the manufacturers should take the following into mind:
1 There is the need to understand the source of variation during the manufacturing process.
2 It is advisable for the manufacturer to detect the presence and the degree of the evaluation that is carried out on the commercial products that he/she has manufactured.
3 The manufacturer should also control the variation in a manner that corresponds with the ris...
Part 1: Sequence of Process Validation Activities
Process validation can be defined as the procedure that is followed in the collection of data and the evaluation of the collected data. The process begins at the design stage and goes through the commercial production process, and then a scientific evidence is established that the process that a certain product has gone through is capable of delivering a quality product that is fit for consumption CITATION WHO13 \l 1033 (WHO, 2013). As such, we can view process validation as a series of activities that takes place over the lifecycle of the product that is being produced and the whole process. There are three main stages of the process validation process for pharmaceutical products.
Stage One- Process Design
At this stage, the commercial manufacturing process is defined. It mainly depends on the knowledge that has been gained through the development of scale-up activities. Most of the early process design experiments do not need to be performed under the CGMP conditions that are used for the drugs that are used in the commercial distribution. However, the fact that they are not performed under the CGMP conditions does not mean that there should be a compromise of the sound and scientific principles that are involved. Good documentation process should be carried out and it should be consistent with the Pharmaceutical Quality System requirements and practices CITATION WHO13 \l 1033 (WHO, 2013).
The designing of an efficient process control approach depends on the process knowledge and the understanding that is obtained. The designing of experimental studies can play a great role in developing the process knowledge by revealing the relationships between the variable inputs and the outputs. In this case, the variable inputs can be the component characteristics and the various process parameters. On the other side, the resulting outputs can be the materials used in the process and the final product of the whole process CITATION EMA16 \l 1033 (EMA, 21st November 2016). The risk analysis tools can be used to screen the potential variables for the design of the experiment so as to minimize the total number of the experiments that are performed while at the same time maximizing the knowledge that is obtained.
There are other activities such as experiments and demonstrations that play a great role in the evaluation of certain conditions and provide a prediction of the performance of the commercial process. Such activities can also be used as a good source of information to be used to model and at the same time simulate the commercial process that is taking place at that particular time. Simulations that are done by the help of the computer on the unit operations provide a good understanding and can help to avoid problems that arise as a result of commercial sales.
As a manufacturer, there are various gauges that can be used to establish a proper process control for each of the units that are used in the operation. However, you need to remember that proper knowledge and understanding is the basis for all the strategies that you will undertake in your operations. The policies can be designed in such a way to reduce the input variation during the whole process of manufacturing and as such the impact that it will be having on the output or at the same time you can use a combination of both processesCITATION USD11 \l 1033 (Health, 2011). The process controls will address the variability and also assure the consumers of the quality of the product. A manufacturer should also make early and regular risk assessments so that they can make decisions that regard the type and the extent of the process controls.
Stage Two- Process Qualification
At this stage, the process design is evaluated to determine whether it is capable of being reproduced as part of the commercial manufacturing. The stage has got two main elements. One of the elements is the design of the facility and the qualification of the equipment and its utilities. The second essential stage is the performance process requirement.
1 Facility Design and Qualification of Utilities and Equipment.
There is the need for the proper design of a manufacturing facility so that it can meet the CGMP regulations and requirements of building and facilities. It is therefore very essential that the activities that are performed to assure the proper facility design and the commissioning procedures that are involved. The activities that are undertaken should be aimed at demonstrating that the utilities and the equipment are suitable for the intended use and that they perform properly.
There are some activities that are involved in the process qualification utilities and
Equipment.
* You should select the utilities and equipment construction materials based on their operating principles and the performance characteristics. The equipment and building materials that are chosen should be appropriate for the specific use upon which they are intended.
* A manufacturer should also verify the utility systems and equipment to make sure that they have been built and installed according to the design specifications that were set out.
* There is the need to verify that the unity systems and equipment carry out their operations by the process requirements. It should also include challenging the system functions of the equipment.
2 Process Performance Qualification (PPQ)
It is the second element of stage 2, and it combines the actual facility utilities and the equipment, the actual facility, trained personnel within the given commercial training process, the control procedures that are involved and the components that are used in the process of producing the commercial badges. A successful PPQ will be a confirmation of the process design, and it will at the same time demonstrate that the commercial manufacturing process will perform as expected. Success at this stage will signify a major milestone in the lifecycle of the product.
In most of the cases, PPQ has a higher level of sampling, additional testing and greater scrutiny of the performance process that will be typical of a routine commercial production. It is important to know that the level of the testing and monitoring process should be sufficient enough to confirm the product quality throughout the batch. The increased level of testing, scrutiny, and sampling continue throughout the process verification stage.
Stage 3- Continued Process Verification
During this stage, ongoing assurance is gained during the routine production process as it remains in a state of control. Under this stage, the collection, evaluation of information and data about the performance process is very essential. It will allow the detection of the undesired process variability. It is also a requirement that the process should adhere to the CGMP requirements. As part of evaluating the performance process, you should be able to identify the problems and determine whether the action to be taken is used to correct, anticipate and prevent problems so that the process will remain in control.
A manufacturer should establish an ongoing program that will be used in the collection and analysis of the processed the data that will relate to the product quality that is established. As part of the data that is collected, one should include related process trends and the quality of the incoming materials or components, the in-process material, and the finished products. A trained personnel should do all this.
Before the distribution of the commercially produced batch of products from the manufacturer to the consumer, as a manufacturer, you need to gain a higher degree of assurance in the performance of your manufacturing process. It will make you know whether you have the ability of consistently producing APIs and drug products that meet all the attributes relating identity, strength, quality, purity and potency. Such an assurance can be obtained from objective information and data from the various laboratory and commercial studies that have been carried out. The information and data that you receive should demonstrate the fact that the commercial manufacturing process that your products are going through has the capability of producing acceptable quality goods within the industrial manufacturing process.
For a process validation process to be successful, one must have adequate information and knowledge about the product and the process development of that product. The knowledge and understanding of the product provide a basis for the establishment of an approach to control the process of manufacturing that will result in the production of products that have the desired attributes. As a measure, the manufacturers should take the following into mind:
1 There is the need to understand the source of variation during the manufacturing process.
2 It is advisable for the manufacturer to detect the presence and the degree of the evaluation that is carried out on the commercial products that he/she has manufactured.
3 The manufacturer should also control the variation in a manner that corresponds with the ris...
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