GMP Environments Require Centrifugation that Supports Compliance  

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Food manufacturers, pharmaceutical companies and biotech firms involved in the manufacture and testing of active raw materials must adhere to the stringent guidelines required of Good Manufacturing Practice (GMP) environments. Countries such as the US, EU and Japan are signatories to the International Conference on Harmonization (ICH) which in 1999 published  ‘GMPs for Active Pharmaceutical Ingredients’.  This also applies to countries such as Australia, Canada and Singapore which also adopt ICH guidelines.

These guidelines are integral to maintaining quality control.  They lay down the minimum requirements that a manufacturer must meet to ensure products are of consistent high quality and do not present any risk to consumers or general public.  The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world. The European Union and the FDA enforces similar requirements to the WHO GMP.

Many manufacturers rely on the high throughput performance of floor-standing ultracentrifuges and high-performance centrifuges to help increase their productivity.  They demand more throughput, faster turns, and greater control over workflow.  However, instruments that are run in GMP environments must also actively support compliance.  Two key compliance features focus on security levels and traceability.  Manufacturers are also looking for high-performance instruments which offer innovative features that support GMP compliance while eliminating much of the burdensome administrative work that compliance entails.  

Bespoke Security Access Restrictions
Relieving the admin burden imposed by GMP compliance is important as regulatory authorities must be certain that the compliance data submitted by manufacturers is a consistent, reproducible and accurate reflection of production.  This is especially important when assessing the hazards and risks to users, consumers and third parties, including the environment.
Controlling access to equipment within a GMP environment is therefore critical. Security levels provide the ability to control the level of access each user has to the centrifuge.  Password protection with an option to select a PIN expiration date provides optimum security. Administrators may require log-in before anyone can use the centrifuge. Being able to restrict operators to running only certain pre-defined programs further limits the potential for errors.  Systems such as Beckman Coulter Life Sciences’ Optima XPN and Avanti JXN Series centrifuges feature password protection for up to 50 unique user profiles. They are then assigned one of three security levels - Administrator, Super User, or Operator.  The latter can be further restricted to run only certain pre-defined programs, limiting the potential for errors.
•    Administrator: Unlimited access
•    Super User: permission to run all programs, manage users, assign programs.  Some             systems like the Optima XPN also enable the Super User to manage the rotor library
• Operator: permission to run assigned programs and change user options.

Crucial Data Logging Parameters for Traceability
Extended traceability is essential to meet the increasingly stringent GMP quality requirements.  Offering a powerful tracking capability helps maintain an audit trail of centrifuge activities by ensuring that data from each and every run is recorded and linked to a specific user. 
To enable manufacturers to build a detailed archive of each run, Beckman Coulter has set down 10 core data logging protocols that customers should expect from ultra and high-performance centrifuges  to support compliance:
 • User information
• Start date and time of the run
• End date and time of the run
• Rotor type
• Program name
• Acceleration and deceleration parameters
• Before run comment
• After run comment
• Detailed information about each step in a run (speed, RCF, time, temp, ω2t)
• Any diagnostics that occurred during the run
• Graph of the run (speed and temperature)
• Electronic signature (if enabled)

The above information should be stored and viewable on the centrifuge itself, and easily
exported to a USB drive, network drive, or printer for archiving.