US FDA to train Gujarat FDCA inspectors on system based drug batch manufacturing records to address data integrity issues

In order to ensure quality and integrity of APIs, US FDA regulatory team would be training Gujarat Food and Drug Control Administration (FDCA) inspectors on system based drug batch manufacturing records (BMR) and Electronic Common Technical Document (ECTD) through a series of workshops to address data integrity issues. The workshops is a wake up call on issues related to API impurities like in cases of N-nitrosodimethylamine (NDMA) impurity in APIs like ranitidine and losartan which according to regulatory experts require information technology (IT) intervention at the level of production. NDMA has been termed as a probable human carcinogen. This comes close on the heels of the recently concluded workshop on Current Good Manufacturing Practices (cGMP) compliance and API manufacturing by US, EMA and EDQM experts in quality and compliance. “Pharmaceutical industry is a knowledge based industry and requires consistent upgradation in terms of regulatory knowledge in line with global regulatory harmonisation. US FDA will be guiding Gujarat FDCA on Schedule U compliance of Drugs and Cosmetics (D and C) Rules which contains various regulations and requirements for record keeping,” explains Gujarat FDCA Commissioner Dr H G Koshia. Schedule U (Rules 74,74-A, 74-B, 78 and 78-A) stipulates following to be clearly shown in manufacturing records like name of the product, reference of master formula records, Lot/batch size, Lot/ batch number, date of commencement of manufacture and date of completion of manufacture and the assigned date of expiry, name of all ingredients, specifications quantities required for the lot/Batch size and quantities actually used. It also stipulates that all weighings and measurements shall be carried out by a responsible person and initiated by him and shall be counter-checked and signed by the competent technical staff under whose personal supervision the ingredients are used for manufacture. It also includes control numbers of raw materials used in the formulations, date, time and duration of mixing, details of environmental controls like room temperature, relative humidity, date of granulation, wherever applicable, theoretical weight and actual weight of granules/powder blend, records of in-processes controls (Periodically whenever necessary), uniformity of mixing. Schedules U also specifies for moisture content of granules/powder in case of tablet/capsules, pH of solution in case of liquid, weight variation, disintegration time, hardness, leak test in case of strip packing, filled volume of liquids, quantity of tablets/capsules in the final container and content of ointment in the filled containers.

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