PART XI: Guidelines for Keeping the Master Manufacturing Record

Introduction
Establishing the principal requirements for your company’s Master Manufacturing Records is of great importance to maintaining a procedural guide for anyone involved in the manufacturing of dietary supplements. This two-part installment of the cGMP’s will assist you in maintaining important product documents for current and future references.

The following information is the requirements to establish a Master Manufacturing Record:
Prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch.

The master manufacturing record identity specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

The master manufacturing record establishes controls and procedures to ensure that each batch of dietary supplement you manufacture meets the specifications identified.

Make and keep master manufacturing records in accordance with subpart P (the requirements for records and recordkeeping).

The following information must be included in all Master Manufacturing Records:
The name of the dietary supplement to be manufactured and the strength, concentration, weight, or measures of each dietary ingredient for each batch size.

A complete list of components to be used.

An accurate statement of the weight or measure of each component to be used.

The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement.

A statement of any intentional overage amount of a dietary ingredient.

A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made.

A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label.

Written instructions for specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Written instructions for procedures for sampling, and cross-reference to procedures for tests or examinations.

Written instructions for specific actions necessary to perform and include written instructions for specific actions necessary to perform and verify each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Instructions for special notations and precautions to be followed.

Written instructions for corrective action plans for use when a specification is not met.