How to prepare validation protocol ?
Please clarify your question precisely. Which validation protocol are you referring from given below?
- Process validatin
- Cleaning validation
- Analytical method validation
- HVAC Validation
- Purified water system validation
- Water for Injection generation system validation
- Purified steam generation validation
- Other utilities validation
- Equipment validation (IQ/OQ/PQ)
- Software validation / Computerized system validation
How to prepare process validation protocol
Please note that following guidelines on Process validation protocol,
Validation should be done in accordance with process validation protocols. A written protocol is essential for this stage of process validation.
The protocol should include or reference at least the following elements:
■ the manufacturing conditions, including operating parameters,
processing limits and component (raw material)inputs;
■ the data to be collected and when and how they will be evaluated;
■ the type of testing or monitoring to be performed (in-process,
release, characterization) and acceptance criteria for each significant
■ the scientifically justified sampling plan, including sampling points, number of samples and the frequency of sampling for each unit operation and attribute;
■ the number of batches for which additional monitoring is proposed;
■ status of the validation of analytical methods used in measuring the process, in-process materials and theproduct;
■ a description of the statistical models or tools used;
■ review and approval of the protocol by appropriate departments and the quality unit;
■ a description of the manufacturing process;
■ details of the equipment and/or facilities to be used (including measuring or recording equipment) together with its calibration status;
■ the variables to be monitored, with appropriate justification;
■ the samples to be taken
■ “who”, “where”, “when”, “how”, “how many” and “how much”
■ the product performance characteristics or attributes to be monitored,
together with the test methods; (Critical Process Parameters-CPP and Critical Quality Attributes- CQA)
■ the acceptable limits; (Acceptance criteria)
■ personnel responsibilities;
■ details of methods for recording and evaluating results, including statistical analysis. Data should be collected and reviewed against predetermined acceptance criteria and fully documented in process
For Analytical Method Validation Protocol Please refer the ICH guidelines.
The link for the same is:
For Process Validation Protocol Please refere the FDA guidelines.
The link for the same is:
Can anybody provide the links related pharma guidelines