REGULATORY COMPLIANCE

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GLP :

Over the last several years, life sciences industry have failed not due to innovative product or technology being developed but due to improper laboratory management. QMICS Solutions in partnership with Soma Life Science Solutions aims to provide the highest quality training and consulting to life science professionals and industries.
As the global leader in quality life sciences, we offer range of consulting options for professional development in pharmaceutical, medical device, biotech disciplines. We also provide customized training and consulting by conveying content relevant to the needs of life science professional as well as life science organizations.

LABORATORY MANAGEMENT:

Every laboratory to be compliant with regulations has to investigate whether national regulatory standards are being met. A laboratory should always refer to both, a standard and a guideline:

  • a standard sums up the requirements to a quality management system
  • a guideline describes how quality management can be integrated in the laboratory processes

GOOD LABORATORY PRACTICES (GLP) :

Good Laboratory Practices (GLP) is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that support research or marketing permits for products regulated by governing agen-cies. GLP defines a set of quality standards for study conduct, data collec-tion and results reporting. GLP provides an overview of the quality system of management controls for research and development sector of life sci-ence industries. This is important to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety stud-ies. A key element of the GLP is the Quality Assurance (QA) unit that moni-tors the entire study conduct, analysis, and reporting. The purpose of QA is to verify that all written procedures are followed throughout the study. QA verifies procedures and reports to ensure that GLP guidelines have been followed while conducting the study.

As the global leader in quality life sciences, we offer range of consulting options for professional development in pharmaceutical, medical device, biotech disciplines. We also provide customized training and consulting by conveying content relevant to the needs of life science professional as well as life science organizations.

LABORATORY MANAGEMENT

Every laboratory to be compliant with regulations has to investigate whether national regulatory standards are being met. A laboratory should always refer to both, a standard and a guideline:
 a standard sums up the requirements to a quality management sys-tem
 a guideline describes how quality management can be integrated in the laboratory processes

GOOD LABORATORY PRACTICES (GLP)

Good Laboratory Practices (GLP) is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that support research or marketing permits for products regulated by governing agen-cies. GLP defines a set of quality standards for study conduct, data collec-tion and results reporting. GLP provides an overview of the quality system of management controls for research and development sector of life sci-ence industries. This is important to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety stud-ies.
A key element of the GLP is the Quality Assurance (QA) unit that moni-tors the entire study conduct, analysis, and reporting. The purpose of QA is to verify that all written procedures are followed throughout the study. QA verifies procedures and reports to ensure that GLP guidelines have been followed while conducting the study.