#122, Sri Lakshmi apartments
Bangalore-560109.
Documentation
We help in preparation following documentation for regulatory approval
- Quality manualS/Policies : A global company document that describes, in paragraph form, the regulations and/or parts of the regulations that the company is required to follow.
- Standard operating procedures (SOPs): Step-by-step instructions for performing operational tasks or activities.
- Batch manufacturing records: These documents are typically used and completed by the manufacturing department. Batch records provide step-by-step instructions for production-related tasks and activities, besides including areas on the batch record itself for documenting such tasks.
- ANALYTICAL Test methods: These documents are typically used and completed by the quality control (QC) department. Test methods provide step-by-step instructions for testing supplies, materials, products, and other production-related tasks and activities, e.g., environmental monitoring of the GMP facility.
- Specifications: Documents that list the requirements that a supply, material, or product must meet before being released for use or sale. The QC department will compare their test results to specifications to determine if they pass the test.
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+91 8197988275
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