Frequently Asked Questions

A BMR must contain: product name and batch number, dates and times of commencement and completion of significant intermediate steps and the final processing, identification (initials) of the operator who performed each significant step, in-process control records, a record of any deviation from the approved procedure with written justification, and the quantity of all materials including lot numbers.

Standard Operating Procedures must be reviewed at least once every two years. However, they should also be updated whenever there is a change in process, equipment, materials, or regulations that affects the procedure. All revisions must go through the formal change control process and be approved by the QA department.

A Deviation is a departure from an approved procedure, standard, or specification during manufacturing. It can be planned (authorized in advance) or unplanned. An OOS result specifically refers to a test result that falls outside the established acceptance criteria during quality control testing. Both require formal investigation and documentation, but OOS investigations have a specific 30-day completion timeline under Revised Schedule M.

A Master Formula Record is an authorized document that specifies the starting materials with their quantities and packaging materials, along with a detailed description of the manufacturing procedure and precautions. It serves as the template from which individual Batch Manufacturing Records (BMRs) are prepared. Any changes to the Master Formula must go through formal change control.

A formal documented change control system is required for evaluating, approving, and recording changes to validated systems, processes, equipment, or materials that may affect product quality. Changes must be initiated through a written proposal, risk-assessed, approved by QA, implemented with proper documentation, and verified for effectiveness. All change records must be maintained.