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The most Common Calibration related Warnings to Pharma Companies


Calibration in Pharma Company
Testing Lab

We all want to be certain that we can trust the items that pharmaceutical businesses make as their customers. Fortunately, pharmaceutical firms are subject to stringent regulations, and their operations are closely scrutinised. The primary organisation that periodically audits pharmaceutical businesses around the world to verify compliance is the US Food and Drug Administration (FDA).


The FDA issues hundreds of warnings to pharmaceutical companies each year for breaking rules. Then again, not even they are perfect! Some of these alerts are calibration-related, but not the majority. We examined the calibration-related alerts, and in this article we have compiled a list of the most frequent ones. Please keep reading if it seems interesting.


What is FDA?

The FDA is a US government agency protecting public health by ensuring the safety, effectiveness, and security of drugs, biological products, and medical devices.


The FDA conducts inspections of pharmaceutical firms to make sure they are compliant with applicable laws. Despite the fact that the FDA is a US agency, any pharmaceutical business that wants to sell its goods in the US must adhere to its rules and be subject to its auditing procedures. The FDA criteria are therefore universal in practice.


The FDA will issue a form 483, which could result in a warning letter, if the audits reveal evidence of noncompliance. If they discover substantial non-compliance, the FDA even has the authority to shut down a plant.


Warning Letter

As previously indicated, the findings of non-compliance made by an FDA auditor during their investigation of a pharmaceutical company will be recorded on a 483 form. A warning letter may result from them, depending on how serious they are and/or how many observations there are. Following that, the pharmaceutical corporation must respond to the letter and take the necessary corrective action to address the observations.


These warnings are available to the general public and can be found at this URL: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters


On the FDA website, there are presently approximately 3,000 warning letters that date from 2019 to the present.


Most COMMON GENERAL WARNINGS

It becomes difficult to analyze all the letters because there are so many of them, but widely available information lists the following as the most typical causes of warnings:


  • Absence of written procedure, or not following written procedures

  • Data records and data integrity issues

  • Manufacturing process validation – Lack of manufacturing controls

  • False or misleading advertising

  • Issues with environmental monitoring

Many are generally referred as “Failure to meet Good Manufacturing Practices or GMP Practices as we way”.


Most COMMON CALIBRATION RELATED WARNING LETTERS

We investigated all the warnings for the last three years: 2020, 2021, and 2022. There have been almost 2,000 warning letters issued during those three years!


Calibration-related warnings make up a relatively small percentage of total warning letters, as may be seen by counting them up. It appears that calibration-related remarks are included in roughly 2% of the warning letters.


Even though the majority of these businesses are based in the US, there are several from Asia, Europe, and South America.


It goes without saying that calibration may be included in some of the general cautions even though it is not specifically stated. These include problems with maintenance, missing documented procedures, problems with data records, and problems with manufacturing controls, to name a few.


We analyzed all of the warning letters that mention calibration.


The following categories were used to group the calibration-related alerts, and their respective shares are listed in the list below:


  • Inadequate calibration program: 33%

  • Failed to routinely calibrate instruments: 19%

  • Lack of calibration records: 16%

  • Use of non-calibrated calibration instruments: 11%

  • Insufficient calibration to prove required accuracy: 5%

  • Test equipment not calibrated for the required range: 5%

  • All others: 11%


How V CARE IMPEX can help

We have worked and partnered with many of the top pharmaceutical companies for a long time. V CARE IMPEX calibration ecosystem, which is intended to assist customers in achieving their calibration-related goals in compliance with laws like those from the FDA, is utilized by many of the top pharmaceutical and life sciences businesses in the world.


We help our customers in getting their instruments and equipment calibrated on timely basis. We have tied up with some of the best curated NABL Calibration Labs in India. We used their services to not only get our customers instruments and equipments calibrated but also the standard weights that we manufacture.


All our Standard Weights are backed by solid documentation. We have served number of Pharmaceutical and Life Sciences Companies in India and abroad. In short time, VCI PRECI has become a very popular brand for standard weights in Pharmaceutical circle in India.


Should you have any requirements regarding the same or any queries please feel free to reach us on sales@vcareimpex.com

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