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Regulatory Consulting: |
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| cGMP Validation helps companies develop and implement sound GMP compliance strategies. cGMP Validation can assist your firm with FDA pre and post approval inspections, QA/QC documentation review, regulatory interpretation, and submissions. |
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Quality Systems: |
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| cGMP Validation can assist your group in the development of GMP Quality Systems including Standard Operating Procedures (SOPs), batch records, change control, revalidation, documents management, complaints management, and annual product reviews. |
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Commissioning: |
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| During commissioning and start-up of a new facility, documentation critical to the validation effort should be compiled and organized. Poor commissioning negatively impacts the validation effort and can result in persistent compliance problems. cGMP Validation assists in many activities related to commissioning and start-up of new facility such as preparation of specifications and engineering turn over packages (ETOPs). |
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Training: |
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| cGMP Validation offers on-site training. Common topics include validation protocol generation and execution, FDA pre and post approval inspections, QA / QC program development, and Part 11 compliance. cGMP Validation also can develop internal training procedures. |
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Auditing: |
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| cGMP Validation offers supplier/vendor audits, contract laboratory audits, and general GMP compliance auditing. Audits are tailored to meet the specific needs of your company. |
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To learn more about our company, please explore our request info and contact us areas. |
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