PROCEDURE FOR PREPARING, ISSUING, MOVEMENT, RETENTION AND DESTRUCTION OF BATCH HISTORY RECORD IN STERILE MANUFACTURING SITE

B. K. Yashas* and S. Hemanth Kumar

ABSTRACT

Batch history record (BHR) is any written statement or proof of any activity in pharmaceuticals. BHR is to define the manufacturer's system of information and control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history. In this article it is clearly described on how a batch history record is Prepared and what are the prerequisites to be followed. Regulatory views on batch history records and the basic necessary checklist viewed during the development of the documents. This states to have an information or general procedure for Preparation, Approvals, and Maintenance of these records in the most of the pharmaceutical industry. These Documents are a mirror to show an actual image of any pharmaceutical company. Control of this document is also an important part of Good Documentation Practice (GDP) to reduce error and misuses of any documents. Every document should have an effective date, review date, and revision number. This record needs to be established for each Transitional and API/formulation and should consist of entire picture pertaining to exhibit, validation, and commercial batch.

Keywords: Good Documentation Practice, Batch History Record.