The following process validation definition.
"Process validation is establishing documentary evidence to provide a
a high degree of assurance that the specific process (eg manufacturing of the pharmaceutical dosage form) will consistently produce a product meeting
its intended specification and quality characteristics." According to FDA, product quality assurance comes from careful And some important factors to the system's attention, including: selection
The quality of parts and materials, adequate product and process design as well
(Statistical) control process through process and end product testing.
So it is through careful design (qualification) and validation Process and its control system, you can establish a high degree of confidence
A given batch or inheritance for all individual manufacturing units it is acceptable to meet the specifications of the batch. According to FDA's current Good Manufacturing Practices (CGMP) 21CFR 211.110 a:
Control procedures for monitoring outputs and verification should be established Performance may be responsible for the manufacturing process Causing changes in the properties of the material and the drug during processing product. Such control procedures shall include but are not limited to the following, when appropriate .
1. Change in tablet or capsule weight
2. disintegration time
3. Mix thoroughly to ensure uniformity and uniformity
4. Dissolution time and rate
5. The clarity, completeness, or pH of the solution
The first four items listed above are directly related to manufacturing And solid dosage forms. Items 1 and 3 are usually associated There are changes in the manufacturing process, while items 2 and 4 are usually By the choice of ingredients in the product formulation. versus Respect for content consistency and unit performance control (item 3), adequacy Mixing to ensure uniformity and uniformity are considered to be of high concern. The routine quality control procedures for finished product testing include
Three basic steps:
1. The establishment of normative and performance characteristics
2. Select the appropriate method, equipment and instrument
To ensure that the product is tested in accordance with specifications
3. Final product testing, using proven analysis and testing
Make sure that the finished product meets the specifications.
With the emergence of the concept of pharmaceutical process validation, the following
Added four additional steps:
4. Qualification of processing facilities and equipment
5. Qualification and verification through appropriate manufacturing processes
6. Key steps in auditing, monitoring, sampling or challenging
The process conforms to the process and the final product specifications
7. Re-verify when the product has significant changes
Or its manufacturing process.