Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and cosmetic act. Good Laboratory Practices (GLP) embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. The purpose of this SOP is to describe the Good Laboratory Practices (GLP) to be followed to obtain reliable and reproducible results meeting regulatory standards with effective usage of time, manpower, and resources. This SOP is applicable to all activities which to be performed in the Quality Control Laboratory. To follow the good laboratory practice as described in SOP. To train the Lab assistant/workmen to follow the procedure as described in SOP. To follow the good laboratory practice (GLP) as described in the SOP. To ensure and train the Analyst to follow the procedure as described in SOP. Check the compliance of the SOP for Good Laboratory Practices (GLP).
Follow the good laboratory practice (GLP) procedure as described in SOP. Impart training to all concerned personnel before the implementation of SOP. To review the report and related documentation in case of any discrepancy. To ensure that the procedure is followed as per SOP. To check the SOP. To ensure the implementation of practice is being followed as per SOP. Shall be accountable for the compliance of this SOP. To review and approve the SOP. HPLC: High-Performance Liquid Chromatography. UPLC: MedicGLP Online Ultra Performance Liquid Chromatography. Good Laboratory Practice embodies a set of principles that provides a framework within which laboratory studies (activities) are planned, performed, monitored, recorded, reported, and archived. GLP help to assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessment. Dictated observations or recorded data from automated equipment. Information from Light Emitting Diode (LED) display of any equipment.
The attainment of quality objectives, product quality, efficacy, and safety is the responsibility of senior management but requires the participation and commitment of staff which is vital. There must be comprehensive and effectively implemented Quality Control systems that should be fully documented and its effectiveness monitored. Ensure Quality Control System should be adequately resourced with competent personnel and proper premises, equipment, and facilities to ensure that Quality Control Functioning is effective in meeting the requirements. Written job responsibilities of Quality Control personnel should be laid and followed strictly. The structure of the organization which is fundamental to the satisfactory operation of QC should be appropriately defined including the hierarchies as per the functions. The QC department should be independent of the Production department and warehouse. The QC department should be under the authority of the QC Head who has appropriate qualifications and experience and reports directly to the top quality management. But should effectively involve in decisions, which may concern the Quality of the products.
Quality Personnel should have access to production and warehouse areas for Sampling and investigation as appropriate. Products leading to meet the desired quality standards of marketing authorization such that the delivered products will fit for their intended use and will help in maintain and improving patient’s health. Products should not place patients at risk due to inadequate safety, quality, or efficacy. Follow the concept of continuous improvement and make the best use of management resources in all quality matters. Comply with all applicable laws and regulations. Ensure all-round development of personnel through adequate training. Create a suitable environment for everyone to participate in quality. Ensure that all activities carried out are safe for personnel who come in contact with work. The company is committed to consistently manufacture and deliver Pharmaceutical Products of dependable quality that comply with national and International Quality Standard. The assurance of high quality is by strictly adhering to current Good Manufacturing Practices and Good Laboratory Practices (GLP).
This compliance ensures consistent Quality, Safety, and Efficacy of products. Consistently high-quality standards will be reached through a team effort and with the contribution of trained personnel through ongoing training that results in transparent and effective Quality Management. Installation of sophisticated equipment and building a sound scientific understanding. Every individual has a definite role and responsibility under good laboratory practices (GLP). This role definition ensures that each team member contributes significantly to all aspects of our integrated manufacturing operation. Companies believe and emphasize continuous improvement in all areas of our functioning to achieve excellence. Set achievable and well-defined goals and measure performance periodically against defined standards. The company is committed to providing a safe and secure working environment. The company is committed to better living, it seeks to manufacture and distribute products that result in a better quality of life for the people that world over. Quality Control is responsible for fulfilling the regulatory requirements for product registration. Organogram is to be prepared for the Quality Control department, define the job responsibilities of the individual hierarchy in the laboratory.