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ASEAN GUIDELINES ON PROCESS VALIDATION Page 1 of 7 Guidelines ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION 1. Introduction Process Validation is a means of ensuring
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Start by carefully reading the entire guideline to familiarize yourself with the requirements and recommendations provided.
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Identify the specific process or validation activities that your organization needs to undertake. Make note of any unique considerations or requirements that may apply.
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Determine the appropriate sections or forms within the guideline that correspond to your specific validation activities. Pay attention to any references or cross-references provided.
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Complete each section or form in accordance with your organization's processes and procedures. Provide accurate and detailed information, ensuring that all relevant fields are properly filled out.
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Organizations involved in the development, manufacturing, or distribution of products that require process validation.
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The annex10casean process validation guideline2july-adopted outlines the requirements and procedures for validating processes in a specific industry.
Companies within the industry specified in the guideline are required to file the annex10casean process validation guideline2july-adopted.
The annex10casean process validation guideline2july-adopted should be completed following the instructions provided in the document.
The purpose of the annex10casean process validation guideline2july-adopted is to ensure that processes within the industry are properly validated to meet regulatory requirements.
The annex10casean process validation guideline2july-adopted may require information such as process parameters, validation results, and protocols.
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