Gmp calibration program

However, the calibration program is not a stand-alone program but rather an interface between the calibration department, metrologists, equipment users and the quality assurance department.

The effectiveness of this program relies on cooperation among these groups. This SOP Standard Operating Procedure sets out the responsibilities of all involved parties in an unambiguous manner and defines the main processes of the calibration program.

The SOP Standard Operating Procedure only needs a small amount of site-specific modification before an effective calibration program can be implemented. The SOP can be used in the area of drug, drug substance, medical device and biotech manufacturing and contains 12 pages, including 2 attachments. Table of Content 1. Regulatory Basis, Reference Documents 2. Purpose 3. Scope 4. Responsibilities and Accountabilities 4. Procedure 5. Definitions 7. These activities shall be documented.

A Calibration Management System is the program designated to handle your entire calibration operation. It is used by regulated industries to demonstrate compliance with the calibration requirements.

It will manage the calibration requirements, sections, and calibration records. Moreover, it organizes calibration works, schedules, calibration delivery, grading, records, and history. A calibration management system is a program either manual or electronic intended for the administration, documentation, tracking, and reporting of instrument calibration works.

Some companies use dedicated software for this purpose, other companies handle their calibration management system more manually using handwriting and hard copies.

A CMS manages calibration administration, instrument registration, tracking, effective monitoring, and reporting. In some cases, they are capable to manage financial aspects, including budget forecasting and cost-tracking. Sometimes initial calibration is followed by a requirement of additional recurrent re-calibrations within six months, or perhaps one year later.

Calibration standards are known as reference standard instruments typically with 3 or more times more accuracy than the instruments that will be calibrated with. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards NIST Traceable calibrations. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard.

If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. Calibration records are commonly known as calibration certificates contain the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date. In addition to the calibration certificate, a calibration tag or label is placed or displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

These calibration tags typically contain:. Many federal regulations and company policies require to comply with specific calibration schedules, control of calibration standards, view completion dates, test results, and detailed information such as accuracy, precision, duration of actual calibration time, or frequency.

In some cases, each company establishes its own frequency of instrument recalibration based on a risk assessment. Based on this information, a recurrent calibration date or frequency can be generated, and certificates of calibration completion must be sent and stored in the document control file as per the Calibration Management System.

Calibration is needed whenever an instrument is added or modified in the manufacturing process, procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc. More specifically, a calibration must be considered if you add, modify, or impact any instrument or equipment related to the measurement in the following areas:.

Government regulations require that FDA regulated companies bring calibration to their instruments and equipment to assure their confidence and reliable results.

Some industries work under stricter calibration requirements due to the type of product and process. In addition, the calibration management system serves as a registry log book and tracking system of all calibration in the chronologic order that was done.

It helps to bring the evidence that calibration has been done to each instrument by date during its life cycle. Failure to adhere to proper calibration delivery is considered a violation of US Federal regulations on good manufacturing practices.

As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to bring calibration, and failed to design and implement an effective calibration control program or management system either manual or electronic. In some cases, it may result in an FDA warning observation, product hold, product recall, etc.

Firstly , establish if the gauge needs to be calibrated in the first place. Examples of these are gauges on water systems that are simply indicating that the water is flowing at a certain speed. Quality critical data is recorded by other calibrated gauges at other locations.

Secondly , if the gauge does need calibrating then the frequency needs to be based on a number of factors. These can include:. You could initially, for example, calibrate a gauge every 6 months for its first few years of use. After several years you could look at the data and consider extending that calibration frequency. You should also consider if the usage of the gauge has changed in this period, as this could affect any decision to change frequency to less or more frequent.

Finally, ensure that your calibration activities are suitably recorded. These activities are often outsourced to specialist firms, so do check that they are providing you with calibration certificates that are suitable and will stand-up to regulatory inspection.

To try a free taster of our online courses to see if they are of interest visit this page. The EU and FDA are only setting guidelines and the responsibility is coolly passed on to the manufacturer. Hence, it is the responsibility of the Manufacturer to justify the time limit fixed for the calibration. Longer the period, the risk factors will be very high if calibration goes out.

As mentioned in the discussion, It is better to have 6 month period initially and less frequency after 2 years for critical gauges. Way back as a rookie, I was asked to find out what the FDA meant when indicating that an appropriate statistical method should be used. I managed to get in touch with the author of the guide, and what he told me was that I would have to defend that whatever method I used, it was appropriate.

If the equipment fails the check it is replaced rather than re-calibrated. Many people in many industries try to control measuring equipment that they have no chance of controlling. In many cases, a simple monthly, quarterly or bi-annual check is adequate with a procedure in place to analyze the effect and to re-check recent jobs if that equipment is found to be out of tolerance, is sufficient. Ensure that equipment that is used for indication purposes is easily distinguished from similar equipment that is used for measurement.

Turning the statement around the other would ot work as well as you have to identify equipment that is to be checked so that it can be controlled via the Equipment Checks Records or whatever you call them. Beware the CB Auditor that tries to get you to do things his way, particularly if he has qualifications of previous experience in test labs or testing houses. I believe a good GMP calibration program goes beyond the minimum regulatory requirements.

Aspects such as the criteria for calibration range establishment and relationship between instrument and standard uncertainties must be taken into account to ensure the data generated by those critical instruments are reliable. Posted by Daniel Melo. If there is a management system in place which holds all cal dates and cal due dates taken directly from cal certificates provided , is there a requirement to label equipment as well? This site uses Akismet to reduce spam. Learn how your comment data is processed.

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