GMP
What is GMP?
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
Good manufacturing practices, along with good agriculture practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries.
GMP Benefits
- It also ensures compliance with legal requirements.
In this way, the possibility of encountering any penalty situation is reduced. - Any customer requests for today or in the future can be met more quickly.
Increases awareness of production safety among employees. - The products are produced in the most accurate methods and under the right conditions and delivered to the user.
This, of course, increases the image of the company's reliability in public opinion.
The company creates an advantage in international trade.
Since the system also has quality management system standards, all production stages are followed and the product is provided to reach the user in the most healthy way. - Relevant processes and employees are kept under control in order to prevent various confusion and errors during production.
- It gains competitive advantage in the market against its competitors.
- The motivation of the employees increases and the sense of commitment to the company increases.
GMP Principles:
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 analysers 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.
