The process starts with a BOM, which lists all the items and quantities needed for a particular production batch. This is essential for ensuring that the kit includes all the necessary components.

All components are sourced according to the BOM. This could involve coordinating with different suppliers to procure APIs, excipients, packaging materials, etc.

Upon receipt, each component is subjected to rigorous quality control to ensure they meet the necessary specifications and regulatory requirements. This may include testing for purity, potency, and safety.

Before kitting begins, a pre-assembly inspection might be conducted to make sure that all components are accounted for and that they meet the required standards.

Kitting often takes place in a controlled environment, such as a cleanroom, to prevent contamination. Workers wear protective clothing, and the air quality is tightly controlled.

The items are then assembled into kits. This process can be manual or automated, depending on the scale of the operation and the complexity of the kit.

Each kit is labeled with information such as lot numbers, expiration dates, and tracking information. The kit also includes the necessary documentation, such as batch records, formulation details, and instructions for use.

Finished kits are inspected by quality assurance to ensure they are complete and that no errors have been made during the kitting process.

Kits are then inventoried and stored under appropriate conditions until they are needed for production.

Kits are delivered to the production floor just in time to be used, reducing the need for storage space and handling.

Throughout the kitting process, compliance with regulatory standards such as Good Manufacturing Practices (GMP) is essential. Traceability is also crucial in case of recalls or audits, so detailed records must be kept for each kit.