Personnel Training and Development
By Dr. Jayesh Warade | Consultant Biochemistry & Molecular Biology Sr. Quality Manager Meenakshi Labs
Discover how to foster a culture of continuous learning and development at your laboratory. Additionally, gain insights into the best practices for equipment & material management. Our FAQs offer practical solutions to foster a culture of learning and improvement. Learn how to select and validate laboratory tools and materials, manage procurement processes etc.
GCLP or Good Clinical Laboratory Practice provides guidelines for ensuring quality and compliance in clinical laboratories conducting research or diagnostic tests. It ensures that clinical laboratories maintain high standards of quality, accuracy, and consistency in testing and research, which leads to reliable results and safeguards patient safety. It offers guidelines on quality management systems, laboratory infrastructure, personnel, equipment and supplies, data management and documentation etc.
GLP stands for Good Laboratory Practice. It is a set of principles intended to ensure the quality and integrity of non-clinical laboratory studies, particularly those related to the safety of products in areas like pharmaceuticals, chemicals, and cosmetics.
GCLP stands for Good Clinical Laboratory Practice. It combines elements of GLP and GCP (Good Clinical Practice), focusing on ensuring quality and consistency in clinical trial laboratory processes to generate reliable data that supports clinical studies.
The laboratory director must possess the necessary qualifications and expertise to deliver duties and responsibilities competently. A laboratory director should also possess strong decision-making skills to address complex issues in lab operations, resource management, and quality control.
Yes, anyone with the necessary knowledge and training can work as a quality manager. There are no specific educational requirements for this role. However, it's important to ensure that the individual has the appropriate skills and understanding of quality management principles to effectively fulfill the responsibilities of the position.
Make the workplace comfortable, provide competitive pay, and offer career development opportunities to encourage employees to remain loyal to your lab. Implementing policies that promote job satisfaction and work-life balance can also help retain staff.
No, there are no fixed staffing norms. The number of staff required will depend on your laboratory's workload, the complexity of the tests performed, and the volume of samples processed.
Equipment & Materials
While ICMR 2021 guidelines don't explicitly mandate GCLP adherence for all laboratories, it recommends laboratories involved in the testing of clinical trials and research studies adhere to GCLP. Any laboratory in India that handles patient samples or generates data for clinical or research purposes would benefit from adhering to GCLP principles to ensure the quality and reliability of their results.
Laboratories can determine their retention policy for obsolete copies. This might involve keeping them for a specific period (e.g., 1 year, 2 years) or until new copies are available. However, it's important to consider any regulatory requirements from your medical council or Ministry of Health and Family Welfare, which may dictate specific retention periods for certain types of documents.
When transitioning to digital documents, it's crucial to ensure they are well-protected and controlled. The most important part is that there should not be any unauthorized access and unauthorized changes that should be made to the digital document. If you are maintaining a digital copy of the document, then it should use measures like password protection and read-only formats to prevent unauthorized alterations.
Although GCLP suggests an annual review, the frequency can vary. If specific guidelines exist, they should be followed. In the absence of guidelines, you can determine the review frequency based on the document's relevance and your laboratory's needs. Always follow the specified guidelines for SOP reviews to ensure compliance and document relevance.
No, ISO 15189 accreditation is not mandatory in India. It is a voluntary process. Indian medical laboratories and research laboratories are not required by law to obtain ISO 15189 accreditation.