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Get Form-725 Raw Material Evaluation Form - Pharmaceutical Quality ...
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How to fill out the Form-725 Raw Material Evaluation Form - Pharmaceutical Quality online
The Form-725 is a critical document used for evaluating raw materials in pharmaceutical quality management. This guide provides a step-by-step approach to successfully fill out the form online, ensuring all necessary information is accurately captured.
Follow the steps to complete the Form-725 online.
- Click ‘Get Form’ button to access the Form-725 and open it in the designated editor.
- Start by filling out the procurement section, including current and proposed material details such as trade name, classification, manufacturer, and shelf-life.
- In the compliance section, assess the affected markets and provide comments on any specifications for the current and proposed materials.
- Complete the stability assessment by verifying ongoing stability study requirements and documenting relevant stability protocol numbers.
- Move to the quality assurance section and indicate whether the supplier has been audited. Provide details such as audit rating and report number.
- Proceed to the third-party contract manufacturing quality assurance group to confirm if the proposed material is used by any third-party manufacturers.
- In the quality control raw materials lab section, indicate if the proposed material has been tested and if it meets all required specifications.
- Fill out the environmental health and safety considerations, detailing any hazards associated with the proposed material.
- Complete the validation and technical services section, specifying any qualifications or validations needed for the product.
- Finalize by reviewing the recommendations and conclusion sections, ensuring that all evaluations are documented correctly.
- Save your changes, and download a copy for your records, or print the form for submission.
Encourage users to complete their documents online for a streamlined and efficient process.
1. What is raw material testing? Before manufacturing a drug or food product, each of its raw material is tested individually. This is called raw material testing, and it is compulsory as per the terms of the FDA to establish the materials' identity, purity, safety, and quality.
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