Batches are released for distribution by the QC department only after thorough testing and approval. The warehousing department must maintain systematically systematic records of batches released for distribution. For every batch of products, it is important to maintain distribution records in sufficient detail to be able to trace to which places the product has been sent. This is critical in the event of a problem with the product batch that necessitates a product recall from the market.
Distribution record details:
Some of the important details required include:
• Name of the product, its strength, and description of
dosage form.
• Batch number/lot number of shipped product.
• Name and address of consignee.
• Shipping date and quantity shipped.
• Besides warehouse inventory records, distribution records
also include invoices, receipts from customers, and bills of lading.
The February 28, 2019 edition of Pharma Times Now provides a
review of data collected regarding the “Top 20 Reasons for Drug Recalls in the
USA”. The topmost category cited is the violation of cGMP which was the cause
for the highest number of recalls – 238. In the pharmaceutical industry,
compliance with cGMP is the basic quality requirement that ensures the
production of safe and effective medicines. While there is increasing awareness
of the need to adopt quality systems, the pharmaceutical industry still has a
long way to go to make sure all personnel involved in the manufacturing of drug
products understand the criticality of following practices as laid down in the
written documents of the company.