Une récente "Warning Letter" rappelle quelques règles relatives aux "Master Batch record" et à leur identification

Cette mise en demeure adressée à une société japonaise de production d'API mentionne l'écart suivant :

4.    Failure to prepare adequate batch production records and failure to identify produced batches with a unique batch identification number.

Batch Record (b)(4) Lot (b)(4), reviewed during inspection, was not controlled or reviewed by your firm prior to the release of API for distribution. Your firm failed to ensure that batch records were completed in their entirety or that they specified the equipment used during API manufacturing.  At least one executed batch record was observed to have no associated lot number. 

We also noted that your firm has no written procedure for assigning lot numbers to API products and failed to ensure that lot numbers were unique identifiers.   While firm officials stated that certain unwritten rules are followed in creating batch numbers, application of these rules appeared to be inconsistent.  For example, while firm officials stated that the (b)(4) signify the date of manufacture, our inspection found that lot number (b)(4) was actually manufactured on March 9, 2011.

In response to this letter, please include a copy of your written procedures for the preparation and review of master production instructions and the issuance, review, approval or rejection, and archiving of executed batch records. Also include your written procedure for unique lot number assignment. During the review of your documents, obtained from the FDA inspection, we observed your firm’s inconsistent use of terms such as batch, batch record, and lot.  Please include definitions of these terms within your submitted procedures.

Ainsi qu'un autre écart sur les règles d'attribution des délais de péremption et/ou de recontrôle :

5.    Failure to have an API stability program to monitor stability characteristics of your firm’s APIs, and failure to set an expiry or retest date for APIs based on the evaluation of data derived from stability studies. 

The inspection documented that the label for API (b)(4), lot number (b)(4), provided a (b)(4) expiration date.  Your firm failed to provide stability data to support the expiration date provided on the label for this product.  Furthermore, representatives from your firm stated that the firm has no stability program for any of the API products manufactured at your facility.

In response to this letter, include a copy of your stability data to support any assigned expiry or retest dates.  In addition, provide a copy of the written procedures by which you plan to monitor the stability of your APIs on an ongoing basis.   Provide a summary of the validation of the analytical methods used in your stability program and describe how you have demonstrated that these methods are stability-indicating.