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Process Validation in Pharmaceutical industry

Process Validation is the method used to ensure that a manufacturing or production process consistently produces a product that meets its predetermined specifications and quality attributes.

Key Aspects of Process Validation:
1. Definition: It is a documented evidence that a process will consistently produce acceptable results.
It is critical in regulated industries such as pharmaceuticals, medical devices, and food manufacturing.

2. Purpose: 
To ensure product quality and compliance.
To identify and mitigate risks in the process.
To reduce variability and improve efficiency.

3. Stages of Process Validation (as per FDA and ICH guidelines):
Stage 1: Process Design – Development and understanding of the process.
Stage 2: Process Qualification – Demonstrating the process works as intended using production-scale equipment and facilities.
Equipment qualification (IQ, OQ, PQ)
Performance qualification (PQ)

Stage 3: Continued Process Verification – Ongoing assurance during routine production that the process remains in a state of control.

5. Key Components:
Validation protocol (plan)
Acceptance criteria
Data collection and analysis
Validation report
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