GLP SOP is essential for Pharmaceutical Industry in order to maintain Current Good Manufacturing Practices (cGMP). GLP is also known as “Good Laboratory Practices”.
Good Laboratory Practice SOP (GLP SOP)
Herein Good Laboratory Practice SOP (GLP SOP) is provided for guidance purposes. Hence, please go through the below points to improve your knowledge.
GLP SOP Objective
To describe a procedure for following good laboratory practice (GLP) in a Quality Control laboratory.
SOP Scope
The GLP SOP is applicable for the activities carried out at Quality Control Department in <<Pharma Organization>> at the respective location.
Responsibility
- QC-Personnel is responsible to follow the GLP SOP.
- Head-QC/Designee is responsible to implement the SOP.
- Head-QA/Designee is responsible for monitoring the overall compliance of the GLP SOP.
GLP Definition
GLP stands for Good Laboratory Practice, which is a set of principles and guidelines for laboratory studies that are intended to ensure the quality and integrity of non-clinical health and environmental safety studies. The aim of GLP is to promote transparency and reproducibility in research and to provide confidence in the safety assessments of products such as chemicals, pharmaceuticals, and food additives.
Standard Operating Procedure
GLP SOP includes Quality Management, Quality Control Objectives, QC Lab Cleanliness, handling of Chemicals, Instruments, labeling, Personal hygiene, and Laboratory Safety (but not limited to). The procedure elaborates as below.
Quality Management
The below procedure of Quality Management shall be included in GLP SOP. 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 their effectiveness should be monitored.
Quality Control systems should be adequately resourced with competent personnel and proper premises, instrument/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 Quality Control should be appropriately defined including the hierarchies as per the functions.
The Quality Control department should be independent of the Production department and Warehouse. The Quality control department should be under the authority of the Quality Control Head who has appropriate qualifications and experience and reports directly to the top Quality Management.
Quality Control should not be confined only to Laboratory operations but should be effectively involved in decisions, which may concern the Quality of the products.
Quality Control Personnel should have access to Production and Warehouse areas for sampling and investigation as appropriate.
Pharmacopoeia and its supplements or Addendums, Reference Standards, Working Standards, Reference spectra, other Reference materials, technical books, etc. as required, should be available in Quality Control Laboratory.
Quality Control is responsible for fulfilling the regulatory requirements for product registrations.
Organogram is to be prepared for the Quality Control department. Define the job responsibilities of the individual hierarchy in the laboratory.
Quality Objectives of Quality Control
The below procedure of Quality Control objectives shall be included in GLP SOP.
- Ensure that all the products manufactured in the company are analyzed as per their specifications, leading to meeting the desired quality standards of marketing authorization such that the delivered products will fit for their intended use and will help in maintaining and improving patients’ health. Products should not place patients at risk due to inadequate safety, quality, or efficacy.
- To follow the concept of continuous improvement and make the best use of management resources in all quality matters.
- To ensure the all-around development of personnel through adequate training.
- To create a suitable environment for everyone to participate in quality improvement.
- Ensure that all activities carried out are safe for personnel who come in contact with work.
Laboratory Cleanliness
The below procedure of Laboratory Cleanliness shall be included in GLP SOP.
- Maintain the Quality Control Laboratory neat and clean. Keep the workbenches of the laboratory neat and clean. Workbench shall be kept clean and ensure to keep respective analysis samples only. Keep the pathways free from any obstacles to facilitate free movement. Housekeeping personnel shall clean all the instruments and their respective workplaces regularly. QC personnel shall monitor the housekeeping activities regularly and sign in their respective records.
- Maintain all analytical balances on a steady platform, anti-vibration table away from vibrations.
- Use clean spatulas or butter papers for weighing and transferring Samples.
- All temperature and humidity monitoring records shall be recorded and checked regularly.
- Standard operating procedures and instrument logbooks shall be maintained at their respective workplace.
- Protect all documents from spillage of chemicals/ solutions while performing analysis.
Handling of Chemicals, Glassware, Samples, and Instrument
The below procedure of handling of chemicals, samples, and Instruments shall be included in GLP SOP.
Use only Class-A category volumetric glassware for quantitative analysis (Pipettes and Volumetric flasks, etc.).Store all cleaned and dried glassware in a dust-free storage area. Use clean and dried glassware for analysis. While pipetting the low volumes appropriate capacity of pipettes (Bulbs/syringe/Micro pipettes) shall be used to avoid dilution error. Check the glassware for any cracks or dirt before using them. Rinse the glassware before use with the solvent or diluent, which is used in Analysis.
- Fresh gloves shall be used for each product/sample analysis.
- While sample preparation, new gloves shall be worn in case of any other products/impurities are handled/touched.
- Before using the volumetric flasks analyst shall rinse the volumetric flask, Lid with diluent or solvent, which is used for the analysis.
- Use disposable droppers for solution makeup if necessary.
- Remove all used glassware from workbenches and place them in the washing area after completion of the analysis.
- Avoid spillages, and if any spillage occurs initiate necessary action to clean immediately.
- The samplers used for sampling the finished products, Intermediates, and Raw materials shall be stored in a clean and dried place.
- Store all chemicals and reagents appropriately and affix the ‘use before’ label.
- Working standards shall be stored in the desired storage conditions and shall be appropriately labeled.
- Impurities cannot be kept in the sample preparation room after the completion of the activity.
- The volumetric solutions, reagents, indicators, and test solutions shall be placed in their respective storage places.
Labeling and Care
The below procedure of Labelling shall be included in GLP SOP.
- Label all reagents and solutions as per SOP and check the clarity of the volumetric solution and reagent before usage.
- Mobile phases, Diluents, Reagents, Test solutions, and Standard solutions shall be labeled appropriately.
- New vials and caps shall be used for chromatographic analysis i.e for GC and HPLC.
- For sample preparations, sufficient vials shall be taken from the stock boxes only and shall not be taken from the adjacent trays. Keep such vials in a self-sealing cover and then keep the cover in the tray.
- Clean the trays before & after every usage.
- Color code shall be maintained for under-analysis trays for better identification with respective sections wise like HPLC is Cream, GC is Red, and Wet is white.
- Label the vials of HPLC/GC analysis using a legible marker appropriately.
- Before using any equipment/instrument ensure that the instrument/ equipment is properly labeled with their respective identification numbers and is within the calibration due date.
- The instruments/equipment that is ‘Under Installation’ or ‘Under Maintenance’ instruments/equipment shall not be used for analysis.
- All the solid waste shall be accumulated and collected in a separate waste container.
- All the broken glassware shall be suspended in a separate waste bin which is maintained only for broken glassware.
- Ensure that all instrumental analyses (GC, HPLC, UV, IR, etc.) shall be carried out online.
Good Documentation Practices (GDP)
The below procedure of Good Documentation Practices (GDP) shall be included in GLP SOP.
All entries must be written clearly with a ballpoint pen in blue ink only.
Always perform the analysis after reading the respective standard testing procedure and check the review date against their respective controlled copy.
All weighings shall be carried out by using calibrated analytical balances and weight printouts shall be pasted/attached as appropriate.
Before starting the instrumental analysis, ensure the analysis start date and time of the instrument in the laboratory against the analytical test requisition.
All the entries with respect to the analysis shall be performed simultaneously.
Do not use shortcut marks for repetitive entries. Enter the required data completely whenever and wherever required.
Do not leave any space blank. If a page is partially filled, put a line across the blank space with a sign and date.
After the completion of the analysis, the reports shall be printed and duly signed by the QC personnel.
The complete data for analysis shall be sent for checking after the compilation in the respective raw data formats.
Strike out any wrong entries with a single straight line, sign, and date the same. Never overwrite and never use correction fluids or erasers.
Reviewer if any wrong entries are identified during the review, strike out the wrong entries with a single straight line, and the reviewer sign and date the same.
Details of standard, sample, instrument, and test solution preparation shall be documented in the relevant analytical raw data sheets including weights, dilutions, and calculations.
Analysts shall be trained on all related SOPs before performing any operation.
Health and Safety Practices
The below procedure of Health and Safety Practices shall be included in GLP SOP.
Everyone in the Quality control laboratory should wear appropriate personnel protective equipment such as goggles, aprons, nose masks, gloves, etc.
Use chemical-resistant gloves when handling strong acids and alkalis.
Concentrated acids shall be stored separately and opened only in the fuming cupboard area.
Personal Hygiene
The below procedure of Personal hygiene shall be included in GLP SOP.
- All employees should be instructed to report their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken.
- Smoking, eating, drinking, chewing, or keeping food, drinks, and personal medicines and installation/removal of contact lenses should not be permitted in laboratory areas, where they might adversely influence the product quality or may lead to accidents.
- Do not drink water available in the laboratory.
- All employees should come to the workplace in formal dress and not wear jewelry in the workplace.
- All male employees should come to the workplace with clean shaving.
- All employees should cut/her nails frequently at home and ensure before coming to the workplace.
- All employees should maintain good hair craft and should not come with unbound hair.
The above Good Laboratory Practice SOP (GLP SOP) is for reference & information purposes only.
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