Why Instrument Validation is Important for Pharmaceutical Industry?

Products are regularly manufactured and sent to the market for sale. With all of these products, especially the ones that are being used for medical purposes in hospitals, clinics, and the pharmaceutical and drug industries, certain guidelines must be followed before selling them to the public. It is important to determine what is safe and what is not. This is where the need of proper instrument validation comes in. Even the slightest error can result in great harm which in turn can result in some nasty lawsuits. Thus, it becomes critical for these instruments in both manufacturing and laboratory areas to function properly during the pharmaceutical process. It is best for everyone to take the time to calibrate these instruments and just be done with it!

But What Exactly is Instrument Validation?

In a nutshell, Instrument validation (IV) is a documented process that contains a set of independent procedures used to check whether a product is meeting the requirements and specifications of its purpose or not. There are thousands of regulatory agencies around the world that have very strict requirements for performance testing, quality, procedures, safety checks, and more for a myriad of products. There are a lot of pieces of laboratory equipment such as freezers, incubators, balances, furnaces, water systems, thermal cyclers, environmental chambers, spectrophotometers, and cryo-tanks that need installation, operational, and performance validation for the same reasons.

Protocols

There are several protocols that are needed to be kept in mind in order for a successful instrument validation for laboratory and pharmaceutical industries. They are as follows:

  • Utility supply
  • Documentation availability
  • Electrical connections and supply
  • Component and design verification
  • Safety compliance
  • Environmental verification
  • Instrumentation for validation
  • Standard operating procedures
  • Critical instrumentation calibration

Benefits Of Instrument Validation in Pharmaceutical Industry

Whether new lab equipment, used lab equipment, or parts and consumables of these pieces of equipment, need validation at some point in time before they are taken into use. They not only ensure the quality of manufactured products but also help in recognizing certain risks associated with them if there are any present. Here is a list of all the benefits that proper instrument validation provides to you and your lab.

  1. Process parameters and controls can be determined during the validation of instruments and types of equipment.
  2. With the right instrument validation process, a deep understanding of the equipment is made possible.
  3. After the validation, the risk of regulatory non-compliance is minimized.
  4. Instrument validation assists in determining several worst-case scenarios and risks that may arise while producing quality products.
  5. During the manufacturing process, it helps to investigate possible deviations.
  6. It reduces the product’s production costs.
  7. It decreases the possibility of the failure of a batch to be manufactured.
  8. With the right instrument validation, batch to batch variation is minimized.
  9. A fair instrument validation process reduces the requirement of process control and finished product testing.
  10. There is a decrement in rework and rejection which results in the increment of production of the manufacturing facility.
  11. It provides a high rate of customer satisfaction.
  12. These processes highly increase employee’s awareness.
  13. Maintenance of equipment is made easier with them.
  14. Lastly, the validation documents produced during the process can be used as a presentation or a legal proof in case there is a need for inspection from the legal authorities.

The instrument validation process can highly affect the quality of products. Keeping in mind all the benefits that it provides, all the new instruments and equipment pieces should be validated before using them in the commercial production of products and finally in the clinics and laboratories. Moreover, it is a regulatory requirement of the FDA, TGA, and other regulatory agencies around the world. They focus on these processes during their regulatory and GMP audits.

Key Takeaways

Instrumental validation is an indispensable part of determining the cGMP requirements of your facility and equipment. Determining why the equipment needs validating starts with finding out the requirements of the end-user. After that, a risk analysis is carried out by paying careful attention to the regulatory requirements. Thus, it is significant for you to always carefully choose your equipment manufacturer that provides a comprehensive validation service program. It should be done by specially trained professionals, calibrated measuring instruments; relevant documentation keeping in mind the GMP requirements and on-site qualification protocols. This will facilitate overall regulatory compliance.

If you are looking for one such qualified equipment manufacturer then you can unquestionably rely on Biotechnical Services Inc. We understand how challenging regulatory compliances can be which makes it crucial for you to ensure the future of your processes and methods with equipment validation services. We have been providing the best instrument validation services in San Diego, Los Angeles, and San Francisco to our clients for more than three decades now. Contact us to know more!

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