Specifications of drug substance, finished drug products and excipients are prepared as per the monographs available in the different Pharmacopoeias like IP, JP, BP, Ph. Eur., USP, etc. These monographs are updated by the regulatory bodies as per the latest development. Also, new monographs are introduced as per new drug discovery and advancement. Similarly, addition/ deletion of the general chapters is also done in these pharmacopoeias as a part of continuous improvement. Change management in pharma is very critical.
It is a regulatory requirement to address these modifications in pharmacopoeias by the pharmaceutical industries, where the affected products are manufactured. Impact on the products due to modifications in pharmacopoeias shall be taken into the consideration for evaluation as a part of cGMP and implemented within 6 months.
To digitalize and simplify this process of handling pharmacopeial changes, we have come up with a solution called Pharmacopoeia change management, where pharmaceutical companies can handle the pharmacopeial changes in electronic system. Pharmacopeial change management software is fully compliant to the regulatory requirements as per 21 CFR part 11, EU annex 11 and ISO 9001: 2015 standards.
Handling of pharmacopeial changes is very critical, as these changes need to be done in the stipulated time frame. Further, plenty actions are taken to address a single pharmacopeial change. Any skipped or delayed action may lead to unexpected delay in implementation of change. Therefore, proper impact assessment and identification of activities to implement the change is very important. These identified activities shall be tracked and monitored for timely completion.
Pharmacopeial change management software has the provision to create a schedule of activities for proper planned execution. Pharmacopeial change management software tracks the series of activities as per the predefined schedule and escalates the delayed actions. Activities are automatically assigned to dedicated person and upon completion of all the activities, reviewer is notified for closure of the change control. Collaboration of external parties is also manageable in the system as and when required.
All the pharmacopeial changes can be maintained in a presentable manner and trended as and when required.