GxP compliance and Techcomp Lab Products by Precisa
Key points:
- GxP ensures that accurate, uniform and reliable results are consistently produced
- Whilst it is the lab managers or study directors responsibility to ensure compliance, each individual is responsible for ensuring they are adhering to GxP standards
- Techcomp Lab Products ensures GxP compliance as well as accurate results through various innovative features
What is GxP compliance?
Good practice (GxP) refers to a set of quality guidelines and regulations to ensure consistency, reliability and uniformity within various disciplines. The most common subcategories included are:
- Good laboratory practice (GLP)
- Good clinical practice (GCP)
- Good manufacturing practice (GMP)
Are there differences in regulations for the different subcategories for GxP?
Yes, but they have one common purpose: ensuring data integrity, traceability and accountability.
GLP and GCP are very similar in regulation standards, as they both tend to involve research studies, with GCP having stricter guidelines to ensure both data integrity and sample anonymity. GMP refers to the manufacturing process, and guidelines are set to ensure that manufacturers are meeting a certain standard within the production process.
Why is GxP Compliance important?
To ensure that no fraudulent practices are occurring that could prevent the generation of reliable and accurate data or products.
To ensure standards are being adhered to, an audit will occur every 12 to 30 months, and a compliance breach could result in a huge monetary loss for your company and damage the company reputation. Companies that would adhere to GxP standards include the food, pharma, biologics, medical devices and cosmetics industries.
Who is responsible for ensuring GxP compliance?
Overall, the management team in the relevant facility is responsible for ensuring that GxP standards are met.
However, everyone working within that facility is responsible for ensuring that they adhere to GxP compliance standards. Within a busy laboratory, it takes effort to ensure that every piece of equipment you are using is compliant, and that’s why at Techcomp we have worked to create innovative balances to help make this process easier for you.
How do Techcomp Lab Products by Precisa balances meet GxP requirements?
Various features have been implemented to ensure GxP compliance within your laboratory.
Suitable: The weighing system you are using should be suitable. This means that you use a balance which is within the range of what you are weighing. Whilst it is the user’s responsibility to check that the balance they are using is suitable, in order to provide an extra security measure, Techcomp developed the minimum sample weight (MSW) feature. This ensures that the sample you are weighing is above the minimum required sample weight according to the US Pharmacopeia, meaning that your weighing results will have statistical relevance. The Series 390 and 520PT balances contain the MSW features integrated, and so will inform the user the minimum weight required on the weighing pan to meet these requirements.
Calibrated and levelled: The balance should only be used when it has been calibrated and levelled: if the balance is used when it has not met this criteria, then the results generated will be inaccurate. This is why the Series 390 and 520PT balances provide the user with a visual warning when the balance is not level, to ensure that you are only ever receiving accurate and reliable weighing results. Calibration occurs at the touch of a button, and levelling is simplified, with the balance informing the user which way to turn the feet to be levelled.
User-specific Profiles: Any data generated under GxP should be attributable, and state clearly who performed the action and when. In order to achieve this electronically, balances should have user specific profiles. These user profiles come with the ability to individually set access rights. Access depth is defined, with access to special settings either locked or unlocked depending on the requirement. For the series 390 and 520PT balances, you are able to store 15 different password protected user profiles.
Integrated audit trail and alibi memory: Data generated should have traceability of modifications to generate a comprehensive log of events that cannot be tampered with. An audit trail is the automatic recording of data that has been generated, changed or deleted from the system and can be exported externally. An alibi memory allows the safe storage of weighing results. Both of these systems complement each other and can be exported onto a USB to provide the user with all they require to be GxP compliant.
Techcomp lab products by Precisa: which balance is best for me to ensure GxP compliance?
Which product is best for you depends on the individual user need and application.
Precisa Series 520 balances (1-3) and Series 390 balance (4)
To ensure complete digital compliance with GxP standards, the Series 390 or 520PT balances are the ideal choice, due to their advanced features, which includes:
- User defined profiles – ensures accountability for all measurements
- Integrated audit trail – allows for traceability of data that has been generated, changed or deleted
- Alibi memory – ensures data integrity through storing of weighing results
Alternatively, if you do not require complete digital GxP compliance, a balance which still contains several of these innovative features could be for you, such as the Series 360, which still allows for password protected user profiles to be created, and has the MSW option.
Precisa 360 Balance
To learn more about the Series 390 and 520 balances and its wide range of features, and our other range of products visit;