Process Validation Protocol in Pharma

  A document describing the activities to be performed in a validation, including the acceptance criteria, Critical process parameters for the approval of a manufacturing process or a part there of for routine use.

The validation protocol shall be approved before the execution

As a minimum the protocols should include the following information:

- Purpose

- Scope

- Pre requisite

- Site of the study

- Where the manufacturing activity performed , if in manufacturing site two plants are available  for the manufacturing of the same product then separate process validation shall be performed for  each plant and site or plant name shall be mentioned ) — the type of validation

- the responsible personnel

- Preparation of protocol,

- Organizes the validation activity,             

- Conducts the validation activity as defined in the protocol, for all activity     

- responsibility shall be mentioned

- Presentation of the entire process and  flow diagram, criteria steps/risks

 - List of SOPs  and documents to be followed (List of different SOP which will follow to complete the proc )

- List of Equipment to be used  and its calibration status in manufacturing process;

- List of raw material to be used

- The manufacturing process, including operating parameters, processing limits, and Tests to be performed (in-process, release, characterization) and acceptance criteria for each significant processing step.

- Method of analysis of in process and finished product

- The sampling plan, including sampling points, number of samples, and the frequency of sampling for each unit operation and attribute.

 - The number of samples should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. The confidence level selected can be based on risk analysis as it relates to the particular attribute under examination. Sampling during this stage should be more extensive than is typical during routine production.

- Criteria and process performance indicators that allow for a science- and risk-based

- Methods/procedures, list of manufacturing methods, SOPs, and written procedures, as applicable  and testing procedures, acceptance criteria (detailed description of, or reference to, established procedures, as described in pharmacopoeias)

- Stability schedule and condition

- If any deviation is found.