Scanning the news headlines at my favorite news website, I found something – something really interesting.
“Wockhardt to recall drugs from plants with US import alert” – Due to cGMP violation as the root cause.
The Mumbai-based Wockhardt is recalling the remaining batches of drugs in the US that were made before the Food and Drug Administration (FDA) there issued import alerts on its Waluj and Chikalthana plants in Maharashtra. The company said US patients currently using these drugs were at no risk. It is recalling 13 drugs from the US.
Following the announcement on Tuesday, Wockhardt shares fell 11 per cent in intraday trade and closed at Rs 1,243 apiece, down 6.52 per cent on the BSE exchange. On Monday, the share had dropped 18.31 per cent to close at Rs 1,330.05 on BSE. [Source: Business Standard]
Now, being a part of a leading ERP for Process Manufacturers company, the news compelled me to think—“Would Wockhardt have to face the same situation if they would have used BatchMaster?” And, I started my research.
Consulting our highly skilled consultants, the persons with in-depth knowledge of the product as well as industry, I concluded the answer is NO. Using BatchMaster, the situation would have been better at their end.
Let’s see how BatchMaster helps you comply with cGMP:
Meeting the on-going current regulatory compliance is quite easy with BatchMaster. Along with ensuring that product is fully compliant, accurate, as per stringent regulatory standards; it also ensures to help you easily adopt new laws. Empowering you the capability to generate real-time regulatory documents, calculate hazardousness, gather data to comply SARA reporting, define, store and report QC test groups with specific test ranges and target values to report while auditing, formula versioning control with e-signatures; BatchMaster helps you easily meet FDA’s 21 CFR Part 11 and cGMP standards and audit trails.
Also, time spent in typing a Certificate of Analysis (CoA) or writing a compliance specification is time wasted. BatchMaster eliminates the need for manually generating these documents. Moreover, it supports bi-directional traceability, connecting the dots of materials receipt into production to finished goods shipped.
BatchMaster contributes maximum when it comes to quality. It maintains quality checks for finished goods as well as raw materials at every required junction. And, ensures that no raw material should undergo production run without passing the assigned quality test. The product also facilitates sample testing.
BatchMaster ensures all formula records undergo a complete multi-level approval process at the time of their creation, modification or deletion. This, in turn, ensures accurate checking of a formula from quality, compliance, cost, feasibility aspects. Result: a better, compliant and cost-effective product.
Coming to the point
It is not just Wockhardt. Nowadays, the frequent news about pharmaceutical industry is about (every) big organizations failing to face and meet the compliance issues. As a result, more and more pharma companies are getting filed against the legal actions by FDA. This hampers the reputation of a company.
Needless to say, a good ERP solution is essential for pharmaceutical industries in this modern economic scenario. And, what is the better choice than the BatchMaster?