1.0) OBJECTIVE
To lay down a standard procedure for implementation of Good Laboratory Practices (GLP) in the Quality Control Laboratory.
2.0) SCOPE
This SOP is applicable to Quality Control Laboratory at
- RESPONSIBILITY
- Officers / Executive – Quality Control shall be responsible for complies of this SOP
- ACCOUNTABILITY
- Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
5.0 ATTACHMENTS
Nil
6.0 PROCEDURE
- GOWNING AND WORK HABITS:
6.1.1 All Department employees shall wear a Laboratory apron and shoes / slippers in the laboratory.
6.1.2 Analysts shall work at the respective workplace and keep them neat and clean (including table and drawers).
6.1.3 Analyst shall wear safety glasses, nose masks and hand gloves, whenever required during the testing.
- QULITY CONTROL LABORATORY PREMISE:
- Quality Control Laboratory function shall be free from dust and other disturbances. Mopping of the floor shall be done twice daily.
- The premise of Quality Control department shall be well ventilated, with proper arrangements of air conditioning. Microbiological areas have independent AHUs to avoid contamination.
- The laboratory plan including its furniture shall be constructed in such a way to facilitate smooth working.
- Working tables shall be smooth and resistant to most of the acids, alkalis and solvents and easily cleanable. Floor and ceilings shall also be easily cleanable.
- INSTRUMENTS:
- Wherever required, instruments shall be kept in controlled temperature and humidity, as per manufacturer recommendations.
- All instruments shall be kept clean every time and serviced regularly as per the Annual Maintenance Contracts and/or paid service plan with the outside agencies or from the In-house resources.
- A record of the service performed on each instrument shall be maintained.
- Instruments shall be calibrated and / or validated as per applicable SOPs. Record of calibration and / or validation shall be maintained.
- Standard operating procedure for each instrument shall be made available separately for its operation and cleaning, calibration.
- All the instruments shall be switched off after use, unless required.
- GLASSWARE:
- All the glassware shall be procured from standard glassware manufacturers.
- Glassware used for quantitative purposes shall be of ‘A’ Grade or Calibrated ‘B’ Grade.
- ‘A’Grade glassware shall be used after reviewing the manufacturer’s certificate, if and only if the certificate is matching the acceptance limit.
- ‘B’ Grade glassware shall be used after the In-house calibration.
- Glassware shall be cleaned properly as per SOP No. SOP/QC-007 after each analysis, and dried before next use. The analyst shall verify the cleanliness of the glassware by visually inspection, before use.
- After completion of analysis, glassware containing hazardous chemicals and poisonous materials shall be emptied immediately into the sink under continuous flow of water, and then shall be kept in the washing trays.
- DOCUMENTAION:
- Current departmental SOPs shall be strictly followed by all employees in the laboratory.
- Properly authorized specifications, Standard test procedure and other required work instructions shall be available in Quality control laboratory for each analysis for each product.
- All the materials shall be analyzed strictly as per the respective current specifications.
- Recording of primary data shall be done in approved test data sheet formats only.
- No change in document shall be allowed unless a written authorization through proper change control procedure is being followed.
- After analysis test data sheet along with supporting raw data, documents, graphs, printouts, samples, report etc. shall be submitted to Head Quality control. It shall be checked, verified and stored along with the respective document file.
- CHEMICALS AND REAGENTS:
- All the chemicals shall be stored as per their properties and hazardous nature viz. inflammable, at the designated place.
- All the chemicals and reagents shall be labeled properly on receipt. Labels on chemicals and reagents shall bear the standard labels.
- All chemicals / reference standards / working standards shall be kept back to their respective designated place after use and should be sealed properly.
- Chemicals and reagents shall not be pipette through mouth. Rubber bulbs shall be used for this purpose.
- Chemicals and reagents taken out for analysis shall not be returned back to the mother container. This shall be discarded.
- Hazardous solutions shall be handled with precaution at the designated area.
- No storage of any solutions (except stock solution with proper labels) in refrigerator or in cupboards shall be done.
- PERSONAL TRAINING:
- Laboratory staff shall be adequately qualified and sufficient in number to perform the assigned analytical work.
- All the personnel shall undergo on-the job training in all Quality Control and Quality Assurance functions.
- Each new recruit shall undergo induction training and training related to the different analysis areas.
- SAFETY:
- An Officer / Executive shall be identified as Safety Officer. The Safety practices followed in the laboratory shall be monitored by the Safety Officer.
- Proper hand gloves, goggles and nose masks shall be used during handling of volatile corrosive chemicals.
- First aid box shall be available in the chemical testing room. Necessary first aid facility shall be available in laboratory, with instant access.
- All the electrical lines and gas lines shall be switched off after use.
- Proper safety precautions, wherever specified, shall be followed during analysis.
- Fire extinguishers and water showers shall be installed /kept for safety purpose.
- HOUSEKEEPING:
- Laboratory shall be neat and clean. The record of its cleaning shall be maintained as per SOP in Quality Control Department.
- Instruments, working tables and drawers shall be kept clean by the analyst.
- MISCELLANEOUS:
- Results of out of specifications (OOS) shall be immediately reported to Head Quality Control in case of any discrepancy sops of OOS shall be followed.
- REFERENCES
In-house
- ABBREVIATIONS
SOP: Standard Operating Procedure.
OOS: Out of Specification
QA: Quality Assurance
QC: Quality Control
AHUs: Air Handling Units
- DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
| Version No. | Date of Revision | Reason for Revision |
