How Vakils helps pharmaceutical companies avoid product recalls

Governed by FDA validation, stringent quality norms and GMP, minuscule errors can put pharmaceutical companies at risk of product recalls. In this scenario, Vakils helps pharmaceutical companies deliver packaging artwork of the finest quality.

In 2021, the leaflets and cartons of a batch of cold and flu capsules incorrectly stated stated that children aged 12-15 years could take a maximum of upto 12 capsules (3.6 grams of paracetamol) in any 24-hour period, which is correct for adults aged 16 years and over, but not for children aged 12-15 years. This resulted in 11 retailers from the United Kingdom being asked to recall certain batches of the product, which was costly.

If a company mislabels or poorly packages a drug, there are several risks such as:

• Patient safety: Errors in labelling can lead to misuse of the drug, which is the biggest risk.
• FDA compliance problems: FDA has strict standards on packaging for pharmaceuticals. Several items must be on the label for it to be in compliance. If the company does not comply, the FDA may issue a product recall.
• Costs and fines: The cost associated with a drug recall is very high.
• Damage to image: Drug recalls are very public in nature and could have a negative impact on the company’s reputation.
• Time lost dealing with issues: The time spent investigating the cause error is time you could have spent on developing and investing in other drugs.

Some of the most common product labelling errors to look out for:

• Gross errors: These can happen when essential information is not on the label artwork. This sort of error often occurs when FDA regulatory requirements have changed but the drug manufacturer has not changed the artwork in response.
• Context and meaning mistakes: If the label’s artwork information is given in a vague way, a context error can occur.
• Content errors: This includes major errors in the content of the product artwork including the incorrect use of symbols on the label.
• Technical mistakes: Errors in the functional aspects of the artwork, such as the product’s barcode.

Vakils’ extensive knowledge of pharmaceutical requirements and needs results in our clients’ artwork amendments and change requests being completed quickly and accurately. By leveraging the latest technologies, we aim to deliver added value with a focus on getting it right the first time. Our goal is to avoid product recall and remove the need of multiple iterations in artwork, ensuring that products are fully QRD compliant with matching manufacturing manuscripts.