- Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result
- Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics
- Obtaining and documenting evidence to demonstrate that a method can be relied upon to produce the intended result within defined limits
- Action to verify that any process, procedure, activity, material, system, or equipment used in manufacture or control can, will, and does achieve the desired and intended results.
1.1 Justification of Validation
Validation is basically good business practice. The objective is to achieve success
in the first production of a new product.
- Government regulations: Current good manufacturing practices (GMPs) have been established all over the world. The GMPs basically serve as guidelines but do not provide step-by-step directions on how to achieve them. However, the validation master plan and associated SOPs exactly define responsibilities: who, when, where, and how much is sufficient to demonstrate.
- Assurance of quality: Validation provides confidence in the quality of products manufactured as the over quality of a particular process cannot be established due to the limited sample size. Validation leads to less troubleshooting within routine production. As a result, it reduces the number of customer complaints and drug recalls.
- Cost reduction: Processes running at marginal levels often cause costs because of necessary re-inspection, retesting, rework, and rejection. Validation leads to the optimization of processes and results in minimization of those expenses.
- Retrospective Validation
- Prospective Validation
- Concurrent Validation
- Revalidation
2.1 Retrospective Validation
This approach is rarely been used today because it’s very unlikely that any existing product hasn’t been subjected to the Prospective validation process. It is used only for the audit of a validated process.
2.2 Prospective Validation
2.3 Concurrent Validation
A combination of retrospective and prospective validation. Performed against an approved protocol but product is released on a lot-by-lot basis. Usually used on an existing product not previously validated or insufficiently validated.This approach involves monitoring of critical processing steps and end product testing of current production, to show that the manufacturing process is in a state of control.
2.4 Revalidation
To validate change in equipment, packaging, formulation operating procedure, or process that could impact product safety, efficacy, or potency. It is important to establish a revalidation program for critical equipment to maintain validity. Possible reasons for starting the revalidation process include:
- The transfer of a product from one plant to another.
- Changes to the product, the plant, the manufacturing process, the cleaning process, or other changes that could affect product quality.
- The necessity of periodic checking of the validation results.
- Significant (usually order of magnitude) increase or decrease in batch size.
- Sequential batches that fail to meet product and process specifications.
- The scope of revalidation procedures depends on the extent of the changes and the effect upon the product.
3. Importance of Validation
- Increased throughput
- Reduction in rejections and reworking
- Reduction in utility costs
- Avoidance of capital expenditures
- Fewer complaints about process-related failures
- Reduced testing in-process and in finished goods
- More rapid and reliable start-up of new equipment
- Easier scale-up from development work
- Easier maintenance of equipment
- Improved employee awareness of processes
- More rapid automation
For more information see also:
1) Component Of Master Validation Plan
2) Cleaning Validation And Its Importance In Pharmaceutical Industry
Very well written.As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
The whole article gave a clear path where and how to start.
I thank the moderator for sharing such a good article.- See more at:
equipment validation
labview programming
software validation
Written cleaning procedures should be established. Attention should be addressed to dedicate certain equipment to specific products,
such as fluid bed dryer bags and to residue originating from the cleaning detergent or solvent themselves.
By packaging equipment I am referring to primary packaging equipment.
equipment validation
Standard person can validate the Equipment through calibration order.
They will check every the parameters,
Place Heat,humidity & additionally the components changed by maintenance and others.
writing is simply great,thank you for the blog.
equipment validation
we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that
critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.
equipment validation
The ability of prerequisites to streamline the execution of a qualification,
with the added bonus of the ways that they benefit a quality system,
demonstrates the value of incorporating prerequisites into an equipment qualification.This service saves you time and money,
as you can review these digital representations.
equipment validation
Focuses on the validation of laboratory equipments used in the production of pharmaceutical products.
Determination the requirements of the end user,
which are often defined in the User Requirements Specifications.equipment validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.
equipment validation
well explained:-)