A Good Laboratory Practices certificate is a green flag that shows a laboratory is competent for performing non-clinical studies. It indicates that the laboratory follows the good laboratory practices guidelines set by local and international regulatory bodies. Hence, the results it reports will also be high-quality, reproducible, reliable, and consistent. A good laboratory practice certificate holds tremendous value in the pharmaceutical, agricultural, and chemical industries. So, how do you get a good laboratory practice certificate?
Steps to get good laboratory practices certification
Step 1: Understand the requirements for good laboratory practice certification.
Before implementing any changes in the facility or equipment, it is necessary to understand the guidelines. Each company should create a team that will research these guidelines. Good laboratory practice guidelines are often provided by regulatory bodies such as the Food and Drug Administration. Consequently, the team can visit the official websites of these regulatory bodies to obtain complete lists and detailed documents. If not available, the local offices of these regulatory bodies can provide thorough documentation.
Once these documents are obtained, they should be thoroughly read, and the relevant guidelines should be identified. Not all guidelines may be applicable. Hence, the team should determine which guidelines are enforceable based on the types of study the laboratory performs. Additionally, industry-specific guidelines should also be identified.
Step 2: Conduct a gap analysis.
If the laboratory is not set up and a new facility is being built, these guidelines can be used during the design and set-up stages to ensure compliance. However, if the facility is already set up and functional, a gap analysis needs to be performed.
The gap analysis includes a detailed assessment of the current facility, all procedures used, personnel appointed, roles and responsibilities provided, equipment purchased/in use, and safety measures followed. This assessment should be comprehensive and include all aspects of the facility, from the beakers used to the equipment calibration schedule. The results of these assessments should be compared with good laboratory practice requirements to identify non-compliant and compliant areas.
All discrepancies and gaps between current operations and good laboratory practice standards should be identified and documented. This is a crucial step in making any laboratory good laboratory practices-compliant.
Step 3: Develop or update standard operating procedures.
Develop or update standard operating procedures to ensure they cover all portions of the laboratory operation. This includes study design, sample handling, equipment maintenance, data recording and analysis, and reporting. These standard operating procedures should be compliant with good laboratory practice guidelines. Furthermore, they should be well-documented, with all details and notes. The documents should be made accessible to all employees so they can refer to them at any time to make a decision.
The standard operating procedures should be unambiguous and detailed, leaving no room for misinterpretation. Doing this will ensure the employees will not need to “take a call” and choose what they think is best. Furthermore, standard operating procedures should be regularly reviewed and updated according to regulatory requirements. Regular updates and reviews ensure the laboratory does not follow old procedures and risks becoming non-compliant.
Step 4: Train personnel.
All laboratory personnel must be trained once standard operating procedures that comply with good laboratory practice requirements are established. The training should cover all good laboratory practices, their principles, the importance of following these good laboratory practices, and the implemented standard operating procedures. Personnel should also know how to handle data appropriately and any specific requirements related to their roles.
After training, competency assessments should be held to determine whether they understand the requirements. Depending on the results, they may need to be re-trained. Even after training, employees should undergo regular or random assessments to determine whether they are competent in their duties and whether their knowledge is up-to-date.
Step 5: Update facilities and equipment.
First, assess whether the existing laboratory, facility, and equipment meet requirements for good laboratory practice. To this end, analyse whether environmental controls, equipment calibration, safety measures, ventilation systems, etc., comply with the guidelines of good laboratory practices. If they are not compliant, purchase, modify, or upgrade the facilities and equipment. This step may require a sizeable financial investment because equipment upgrades are expensive. However, this step is necessary to obtain a good laboratory practice certificate.
Once all facilities and equipment are set up, they must be calibrated according to appropriate standards. The documents of all changes need to be stored and backed up. Equipment calibration should be performed regularly, even after the laboratory is set up, to ensure the obtained data are reliable.
Step 6: Establish a quality assurance unit.
An independent quality assurance unit should be set up. The unit’s primary responsibility is to monitor laboratory compliance with good manufacturing practice guidelines. The unit will conduct regular audits and inspections of ongoing studies to determine whether they follow standard operating procedures. The results of these assessments should be documented appropriately and comprehensively. The reports should also include any corrective measures recommended. The reports and documents of these audits are stored so they can be referred to in the future.
Step 7: Implement a robust data management system.
Appropriate management systems and procedures should be implemented to ensure the integrity, accuracy, and security of all data in all studies. Data recording, storage, and retrieval processes should be well-defined. Appropriate measures should be taken to ensure data security, such as granting access only to specific people and managing credentials appropriately.
Electronic data systems and management software should comply with good laboratory practice requirements. These requirements include electronic signatures, access controls, audit trials, etc. The security of electronic data systems and software should be thoroughly checked before implementation. Furthermore, licensed software should be chosen and implemented on all computers.
Step 8: Perform internal audits.
Internal audits should be performed before applying for certifications. Internal audits should evaluate the compliance of all laboratories, facilities, and equipment with good laboratory practice standards. The audits should cover all parts of the laboratory, including the software used, data management, and standard operating procedures. Any potential issues should be identified and resolved beforehand.
Step 9: Apply for external audits and certification.
External audits and certification can be pursued once the internal audit yields positive results. Select a local industry-recognized regulatory body. Apply for the regulatory body to conduct the external audit and prepare for the audit by ensuring all necessary documentation (standard operating procedures, training records, equipment logs, etc.) are easily accessible. After conducting the audit, the regulatory body will address any non-compliance issues. If there are no issues, the certificate is awarded.
Step 10: Maintain the certification.
After obtaining the certificate, compliance should be maintained. This includes three things:
Standard operating procedures should be regularly reviewed and updated.
Equipment should be re-calibrated periodically.
Personnel should be provided regular training and upskill courses.
Conclusion
By following these ten steps, any laboratory can obtain a good laboratory practice certificate. This certificate not only ensures regulatory compliance but also enhances the efficiency and credibility of the laboratory, making it a trusted partner for scientific researchers and companies. Good manufacturing practice certification ensures that all operations in the laboratory meet the highest standards of quality and integrity, which boosts the laboratory’s market value and brand image.
