” QUANTUM” help in preparation following documentation for regulatory approval

  1. Quality manual: A global company document that describes, in paragraph form, the regulations and/or parts of the regulations that the company is required to follow.

  2. Policies: Documents that describe in general terms, and not with step-by-step instructions, how specific GMP aspects (such as security, documentation, health, and responsibilities) will be implemented.

  3. Standard operating procedures (SOPs): Step-by-step instructions for performing operational tasks or activities.

  4. Batch 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.

  5. 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.

    Test methods typically contain forms that have to be filled in at the end of the procedure; this is for documenting the testing and the results of the testing.

  6. 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.

  7. Logbooks: A bound collection of forms used to document activities. Typically, logbooks are used for documenting the operation, maintenance, and calibration of a piece of equipment. Logbooks are also used to record critical activities, e.g., monitoring of clean rooms, solution preparation, recording of deviation, change controls, and its corrective action assignment.

Incredible documentation is a crucial piece of a quality assurance system and is needed in essentially all aspects of pharmaceutical manufacturing. It plans to give a genuine degree of assurance that the manufacturing framework and the quality-related activities are finished in the equivalent manner as they are organized and embraced. It gives framework or the point-by guide information in respects toward the most well-known approach to manufacturing to the personnel stressed over the manufacturing and assurance that the staff knows how to get when do. It furthermore ensures the transparency of the record and data required for validation, review, and statistical analysis. Suitable records permit to keep track of the manufacturing of explicit packs, starting from the receipt of crude parts, to the final product release.