In previous article we understood what is pharmaceutical validation study and scope (phase)of validation. We also saw the history of validation concept.
In this article we are going to understand the definition of process validation as per various regulatory agencies, type of process validation and objective of process validation along with it’s advantages.
Definition of Process validation:
ICH (International Conference on Harmonization): In 2000, ICH defines definition of process validation in cGMP Guidance document ICH Q7 that “Process Validation (PV) is the documented evidence that the process, operated within established parameters, can perform effectively and reproducible to produce an intermediate or API meeting its predetermined specifications and quality attributes.”
WHO (Word Health Organization): The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to expected result.
USFDA: In 2011, “The collection and assessment of data, from the process design stage all the way through production, which establishes logical indication that a process is capable of consistently delivering quality products.
European Commission: In 2000, Documented evidence that the process, operated within established Parameters, can perform effectively and reproducible to produce a Medicinal product meeting its predetermined specifications and quality attributes.
Stages of process validation:
This stage is the combination of all three phases of validation, i.e. Phase-I (Process design), Phase-II (Process qualification) and Phase-III (Continuous process verification).
Stage-I (Process Design):
When we talk about Process design Part, it explains process / product development activities. This is very important stage, as without understanding the process / product to work on Qualification of process would be worthless.
Hence, it is important to understand the process / product right from development stage. This stage gives knowledge gained during the process / product development activities and scale-up activities. This is the stage where acceptance criteria’s and its establishment are being taken, called as process control strategy to get the desired product.
Stage-II (Process Qualification):
This is the execution phase of process validation, wherein execution of the process is being done with the knowledge gained via stage-I (process design).
Establishment of the process, acceptance criteria’s has been done in stage-I now to prove consistency, accuracy and efficiency this stage is being applied to complete the approach of process validation.
In other words “Process qualification is the heart of the Process validation concept”. Approaches being selected around the globe inline to regulatory expectations are explained in this article. Sometimes it is also known as Process Performance Qualification i.e. PPQ approach.
Stage-III (Continuous process verification):
As we have established a process and validated it, so maintenance of process is also required to get the desired product with consistency of the quality.
This is the stage which is used for the on-going assurance of the process taken during execution, to prove that process remains in state of control.
“A fruitful validation program lay on the leg of Knowledge, Understanding, execution and approach to control the process” and this all being obtained via execution of all above three stages of process validation.
Type
of process validation (Process performance qualification)
Validation is documented proof to prove that established parameters will perform effectively and reproducible to supply a product meeting its established specifications and quality attributes. There are three types / approach of process validation;
1] Prospective process validation:
This is the approach / type of validation usually conducted prior to the distribution of either a new product, or product made under amended manufacturing process, where the revisions may affect the product’s characteristics. (FDA) Validation carried out before routine production of products intended for sale.
Basic concept of prospective validation is that batches those are considered under the validation study shall be released to market for the purpose of commercialization only after execution of all the validation batches and its quality inspection. Any exception in in this must be justified, reviewed and approved by Quality assurance.
2] Concurrent process validation:
This approach of validation is being carried out during routine production of products intended for sale. It is identical to the prospective approach of validation, except in this approach manufacturer can sell the product during the execution of validation activity.
This approach is being selected usually for recapitulation of the process which is already validated under prospective approach of validation. Execution of this approach is taken in condition when there is change in the already validated equipment / plant or its site location.
3] Re-validation:
This stage is the repetition of the process validation to provide an assurance that changes in the process/equipment introduced in accordance with change control procedures do not adversely affect process characteristics and product quality.
This approach is also taken in the case of sequential batches that do not meet established specifications. Various changes that may trigger the re-validation likewise change in the key starting material / raw material and change in its source of manufacturing, change in the process variables (drying temperature, batch size etc.) or variation revealed by trend analysis.
In simple word if we say this is all about the Confidence building and assurance on established manufacturing process. To achieve main principal of cGMP i.e. Manufacturing of Pharmaceutical product with high quality that meet global standards, with consistency and with the principal of Quality, safety, efficacy and reproduce-ability.
Advantage of validation includes; enhancement of data evaluation capabilities for a product / process. process validation also gives an assurance that particular process will produce the desired product with the consistency of the quality as per predetermined specification.
In other words process validation helps to establish a process in such way, any process can be executed right first time and contributes in cost reduction as well. Process validation also helps to optimize the equipment, facility and system associated with the process. It also reduces failure cost.
I hope this article helps you to refreshing your knowledge bucket; other useful articles may uplift the information stock of the mind…..
Learn More.....
What is Validation Study: Basic overview
Product Lifecycle management: An Overview
Pharmaceutical regulatory authorities All over the world
Pharmaceutical Quality Management system: An overview
What is quality management system for pharmaceutical industry?
Elements of Quality management system: An overview
0 Comments
If you have any doubts, Please contact us