Bulk active chemical Post approves changes (BACPAC)

 

BACPAC

Bulk active chemical Post approves changes

 

The guidance provide recommendation to holders of new drug application, abbreviated new drug application (ANDA), new animal drug application (NADA), abbreviated new animal drug application (ANADA) drug master files (DMF), veterinary masters files (VMF), who intend during the post approval period, to change site, site of manufacture, scale of manufacture, equipment, specification. & manufacturing process of intermediates in the synthetic pathway lending to the drug substance.

Post approval includes site of manufacture, scale of manufacture, equipment, specification, manufacturing process of intermediates in synthetic pathway leading substance.

The act provides for 4 reporting categories as

1.   Prior approval supplement

2.   Supplement-changes being effected in 30 days

3.   Supplement-changes being effected

4.   Annual report

The repeating category for a change is based to have on the potential for the change to have an adverse effect on the identity, Strength, quality purity or potency of the drug product as these factors may relate to the  Safety or effectiveness the drug product.

The guidance applies to synthetic drug synthetic drug substances and synthetic step involved in the preparation of semisynthetic drug. 

Post approval changes affecting the  following are not addressed in this document:-

1.   synthetic peptides

2.   oligonucleotides.

3.   Radiopharmaceuticals

4.   Non synthetic steps for semi-synthetic drug substances

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