How to prepare validation protocol

Quality Assurance
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How to prepare validation protocol ?

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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

Please clarify…

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How to prepare process validation protocol

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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
processing step;
■ 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”
(sample size);
■ 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
validation reports.

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For Analytical Method Validation Protocol Please refer the ICH guidelines.
The link for the same is:
https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf

For Process Validation Protocol Please refere the FDA guidelines.
The link for the same is:
https://www.fda.gov/files/drugs/published/Process-Validation–General-Principles-and-Practices.pdf

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Can anybody provide the links related pharma guidelines

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Purified water system validation

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