Category: Regulatory

LIMS can be used used extensively in manufacturing processes to manage, track and report on samples, tests, test results and more at every step from raw material analysis through to the finished product. Meeting regulatory compliance needs such as in Good Manufacturing Practice is an essential requirement for LIMS in a number of industries.

Good Manufacturing Practice

The Good Manufacturing Practice (GMP) principles put forward by the US Food and Drug Administration help ensure quality of manufactured product throughout the manufacturing, processing and packaging stages. They are used to create a quality framework for the manufacture of a wide variety of products including drugs, medical devices, some food, and blood to make sure that the products are safe, pure, and effective. GMP principles (often designated ‘cGMP’ – current Good Manufacturing Practice) address a wide range of issues as varied as record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling, but offer individual manufacturers the flexibility to decide how to implement the necessary controls in the most appropriate way for their particular business. Here we take a look at how the Matrix Gemini LIMS can support 10 key principles of GMP.

1. Defined operating procedures and work instructions to establish controlled and consistent performance

Standard Operating Procedures (SOPs) and work instructions are stored maintained within the integrated document management system. They are available for users to reference directly from the Matrix Gemini.

2. Adherence to written procedures and instructions

SOPs and work instructions are available for users to reference directly from Matrix Gemini. Relevant SOPs can be presented based on the current user task, and visual workflows guide users through the laboratory process. By defining access rights and managing competency records users are only able to carry out tasks relevant to their function and which they have been trained to carry out.

3. Prompt and accurate documentation of work for compliance and traceability

As users complete workflow tasks or actions within the LIMS an Electronic Signature can be created that records who completed the action and when. A reason for the action can also be recorded if necessary. Data entered is recorded directly in the database at the time of entry. Analytical results, and the ID of the instrument used, can be captured automatically removing the possibility of transcription errors and a record of media and reagents used can be maintained. If users can modify data within the system an audit trail can provide access to a complete history of the changes made including who, when, why and the changes made.

4. Prove that the systems do what they should through validation

Matrix Gemini can manage data and information that supports system validation. For example, instrument calibration and sensitivity measurements and records can be managed through LIMS and are easily accessible for validation purposes. QA/QC information has always been a fundamental of LIMS and Matrix Gemini can be used to validate the accuracy of In-Line analyzers and Process Analytical Technology (PAT) processes

5. Properly defined and designed system and equipment

Matrix Gemini can help validate and ensure facility, system and equipment suitability. As an example facilities must be designed to prevent contamination (microbial, particulate or cross contamination). An Environmental Monitoring facility within a LIMS will allow the setup of Sampling Points within a Sample Location, i.e. within a sterile filling facility the air vents, bench tops and the filling machines themselves need to be monitored for contamination. The tests (and associated limits) and testing frequencies required for each sampling can be defined. Results are recorded and alerts triggered for out of specification results, previous results can also be reviewed to identify possible trends.

6. Properly maintain facility and equipment

Matrix Gemini supports instrument and equipment maintenance and calibration schedules. Instruments and equipment can be flagged as unavailable if they are out of maintenance or calibration and it is possible to prevent tests being assigned to specific instruments if they are flagged as unavailable

7. Define, develop and prove job competency

Competency and training records can be maintained within Matrix Gemini, and it is possible to prevent individuals carrying out specific tasks if they do not have a valid training record.

8. Protect products from contamination

Matrix Gemini supports QA/QC testing regimes to help ensure ongoing product quality and Environmental Monitoring functionality is specifically designed to monitor possible contamination at specific location and sampling points on an ongoing basis.

9. Build quality into products

Matrix Gemini supports the standard QA/QC processes used in manufacturing. Raw materials and finished products can be tested against Master Record specifications and release mechanisms implemented for Batches and Lots. Defined workflows help ensure adherence to quality processes and full traceability of actions carried out is supported

10. Perform regular audits to ensure compliance

Matrix Gemini supports the audit process (internal and external) by providing access to required information from a single integrated source. Training records, Instrument calibration and maintenance records, the results of QA/QC testing and other relevant information can be recorded in, and retrieved from, the LIMS data base together with required electronic signatures and audit trail.

The ability of Matrix Gemini to meet these GMP requirements is extremely important since the failure of organizations to comply with GMP regulations can result in very serious consequences including product recall, seizure, fines, and even imprisonment.