As tablet packaging is a job involving several risk factors that may adversely affect the pharmaceutical company’s credibility, stringent attention is essential during the process.
With the consolidation of tablet manufacturing plants, with the expansion of tablet packaging operations and the increased separation of tablet manufacturing from packaging, come greater probabilities for mix-ups. The risk that foreign tablets and foreign matters could find their way into packaged product is rising. At the same time, product quality is being scrutinized by customers more closely than ever before, and processes are increasingly coming under the review of regulatory agencies.
Now more than ever, manufacturers, packagers and brand owners of OTC and regulated pharmaceuticals need to take every precaution to deliver consistently high quality product. Inspecting the package is clearly not enough, tablets too need to be inspected.
In the past, most manufacturers and packers of tablets have relied on labour intensive manual inspection – because automated systems were expensive and slow. But a new class of automated inspection systems – bulk vision inspection systems – has recently been developed specifically for tablets. The effectiveness of these systems is prompting a new debate on what it means to be diligent in pharma manufacturing and packaging.
Here, we focus on the risks and results of relying on vulnerable verification processes. You will also get an insight of the various inspection practices available to tablet manufacturers and packagers, highlighting both the advantages and disadvantages of each. Lastly, you will find criteria to consider to select the ideal system for your application.
Risks of Vulnerable Inspection
Of course, the ideal Acceptable Quality Level (AQL) is zero defects, but in reality, technological limitations and business practices erode this ideal. The more production lines in the plant and the more ‘touch points’ or distinct steps in the production process, the greater is the risk of both cross contamination and the introduction of foreign matter – both are critical problems.
If a foreign tablet or foreign matter is found in a packaged product, the consequences can be disastrous: At the minimum level, such an incident will erode confidence in the company. More seriously, this could trigger an expensive product recall call, or worse still, a consumer could ingest the foreign tablet and experience an adverse health reaction, which could result in litigation.
But even critical defects that were left in the product that left the manufacturing plant, and were later found by a packager can have a devastating impact. Such an incident will cause the batch to be rejected or worse, product from that batch already packaged will have to be isolated and returned – both costly mistakes that affect a company’s bottom line as well as reputation.
Reducing exposure to such risks is a high priority for quality conscious tablet manufacturers, contract packers and brand owners. It is interesting to note that using effective inspection systems serves a dual purpose. Obviously, it reduces the risk that foreign tablets, foreign matters and defects reach customers. It also illustrates the company’s due diligence, which reduces it’s financial exposure, should an incident occur.
To a lesser extent, even minor defects such as broken tablets, stained or off-colour tablets and tablets with scratched or chipped coatings can be a problem. Although, these issues are not as devastating to a manufacturer, packager or brand owner as the more critical defects (foreign tablets and foreign matters), they are common occurrences that have a negative impact on the perception of the company, which can affect customer loyalty and result in lost sales.
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