PART X: Guidelines for Keeping Batch Production Records

Introduction
Keeping accurate and professional records of all batch production is an important component to being in compliance with cGMP. These documents may be reviewed by staff, clients or government officials, so the collection and documentation process must be precise and strategic. These guidelines were established for the manufacturer and distributor to be able to track product batches in future reference.

The following information must be included in all batch production records:

Assignment of a batch, lot, or control number of the finished batch of dietary supplement.

Documentation of the equipment and processing lines used in producing the batch.

The dates and times of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch.

The unique identifier assigned to each component (or when applicable, to a product you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used.

The identity and weight or measure of each component used. It also must include a statement of the actual yield and a statement of theoretical yield at appropriate phases of processing.

Results obtained during any monitoring operation.

Results of any testing or examination performed during the batch production, or cross-reference to such results.

Documentation that the finished dietary supplement meets all specifications.

Documentation, at the time of performance, of the initials of the person performing each step in the master manufacturing record.

Documentation must be completed and included in the batch record, at the time of performance, of the packaging and labeling operations. Documentation of packaging and labeling operations must include the unique identifier you assigned to packaging and labels used, and, when label reconciliation is required.

Quality control personnel to document at the time of performance the review of the batch production record.

Documentation at the time of performance, of any required material review and disposition review.

Documentation, at the time of performance, of any processing.