In the pharmaceutical industry, manufacturers invest heavily in manufacturing machines and systems for the compliant production process to allow their finished products to compete with their competitors. Secondly, to enable their products to deliver the required results intended its user. Apart from processes and systems, it is also mandatory for the manufacturers to develop and maintain a system that keeps an eye on the product’s production process from the initial stages of raw material selection to final product packaging.
The pharmaceutical industry uses different instruments to maintain a check on the quality of each manufacturing cycle. They are used to inspect every single component of the product, each manufacturing process stage, and post-production product’s quality.
The equipment for pharmaceutical industry is also responsible for proper maintenance such as calibration, validation, and Troubleshooting to keep them in optimum working condition. In addition to this, proper storage and working environment are also necessary for their correct operation.
Every manufacturer is required by regulatory bodies to keep appropriate instruments following their guidelines. Regulator bodies keep a close eye on the manufacturer’s approach towards instrumentation during accreditation and inspection. It can also result in failed accreditation and license cancellation if regulatory find any deviation in compliance.
Areas of Applications
In a pharmaceutical manufacturing plant, instrumentation are commonly used in the following departments
Quality Control Department - QCD
The quality control department is one of the critical departments in a pharmaceutical manufacturing facility. It is used for product development and manufacturing product testing. Following are essential characteristics of instrumentation in a QCD.
· The person performing testing procedures (or analysts) should be an expert in handling and using the instruments. They should be well aware of the basic concept of each instrument and the purpose of each instrument in the pharmaceutical testing cycle.
· Instruments should be appropriately calibrated with regular frequency, with proper record keeping. Calibration record is an integral part of regulatory body inspection qualification. The calibration frequency can be set according to the instrument's usage or the manufacturer's recommendation.
· Every QC lab is responsible for maintaining the usage log. The log indicates the detailed activity of a particular instrument with time, personnel, and type of measurement made.
Quality Assurance Department – QAD
The quality assurance department is responsible for maintaining the product’s quality during the production process, from the initial stages of raw material issuance to final product packaging. Personnel from QAD are deployed on every manufacturing process, and they regularly test samples of products from the different production stages.
Sometimes they perform the test on the instruments installed at the production floor, such as in the in-process lab. Sometimes, QAD has a dedicated lab with all the necessary required instruments.
Production department – In Process labs
Pharmaceutical instruments are also installed on the production floor so that that production personnel can check production process parameters. A dedicated room or space is allocated for the instruments on the production floor, often called the In-Process lab.
The production personnel must measure and record the process parameters during the production process. These records become part of production documentation. In addition to production personnel, Quality Assurance and Control personnel also uses instruments in the In-Process lab.
Instruments used in Pharmaceutical Industry
Let’s look at some instruments commonly used in Pharmaceutical industry
Karl Fischer titrator
Karl Fischer titrator is an instrument used to perform titration on chemicals. Karl Fischer invented this technique, which is named after its invent...
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