Quality Control

Chemical laboratory safety procedure, how to maintain it?

Chemical laboratory safety procedure; Purpose

Chemical laboratory safety procedure, The tenacity of this SOP is to define the general laboratory safety procedure, which will confirm the safe working condition within the Quality Control Laboratory.

Chemical laboratory safety procedure; Scope

This practice is valid for laboratory operations in the quality control laboratory of XX Pharmaceuticals Limited.

Definition

[] MSDS: Material safety data sheet.

[] PPE: Personal protective equipment.

[] QC: Quality Control.

[] SOP: Standard Operating Procedure.

Responsibilities:

The roles and responsibility is as follows

User/Analyst

[] To use personal PPE [Protective Equipment] as per MSDS [Material safety data sheet].

[] To maintain appropriate procedure for safety.

Manager, Quality Control
  • To confirm that this procedure is kept up to date.
  • To check that SOP reflects required working practices.
  • To organize training on the SOP to all concerned personnel.
  • To confirm implementation of the SOP after training.
  • To achieve the operational control.
  • To confirm the availability of suitable PPE & safety equipment.
Head of Quality Assurance
  • Take initiative to Approval of the SOP.
  • To confirm the overall implementation of the SOP.

Procedure:

Precaution(s):

  • Take a note of material hazard facts from the supplier’s information. Review any relevant hazard data in MSDS.
  • Do not smoke, drink, chew gum, eat, or apply cosmetics in the laboratory.
  • Do not keep food or beverages in the laboratory.
  • Always keep the flammable chemicals away from sources of fire.
  • Try to avoid unnecessary chemical exposure.
  • Never use fume hood for storage.
General procedure
  • Wear laboratory coat and dedicated laboratory shoes, before entering into the laboratory. Keep goggles/ eye protector in the pocket of lab coat and & when necessary. This will give protection against corrosive action of chemicals & contaminations.
  • Check PPE prior to use & attire appropriate protective equipment as processes dictate & when required to avoid chemical exposure.
  • Wear gloves when using any type of hazardous or toxic chemicals & respirator when handling solvents.
  • Wash & clean gloves regularly during a hazardous job. Discard soiled gloves as hazardous waste after use. Remove them before leaving laboratory/at the end of the work.
  • When handling/transferring solid chemicals only from one container to another, wear gloves dust mask and activity to be perform under fume cupboard.
  • Treat anonymous chemicals as hazardous & before starting work, make sure the analysts are familiar with all known hazards of the chemicals & take proper precautions.
  • Reject glass apparatus that is damaged, cracked/even scratched.
  • Examine all glassware before use. Use washed & clean glassware. Always move gas cylinder on cylinder trolley. Gas cylinder when standing upright position should always be appropriately supported.
  • Use fume hood to handle hazardous chemicals, volatile liquid and flammable compounds.
  • If solvent extraction is perform by shaking in a separating funnel, release pressure at frequent intervals by reversing funnel. Point the funnel away from the eyes & naked flames.
  • Avoid pipetting anything by mouth. Use mechanical pipetting device/pipette bulb/ aspirator.
  • Always add the acid to the water when diluting acids; never add water to acid. Add the acid to water slowly.
  • Conduct periodical inspection in laboratory refrigerators & storerooms, correctly label all collected samples.
  • Confirm all electrical wires are properly insulated. Report all electrical faults to the reporting authority/supervisor.
  • Instantly Report all type accidents to the Supervisor/Manager.
  • Confirm that all personnel engage laboratory know about the fire exit from the chemical laboratory.
  • Confirm eye showers & Fire extinguishers are located at easily accessible points.
  • Confirm all personnel/user are aware about the locations & proper use of all safety equipments (e.g. eye shower, First-aid kit, fire extinguishers).
  • Wash hands before leaving the laboratory, in case of chemical handling.
  • Wash the exposed area with large amount of water in case of spillage of any acid, base or irritant material on skin and seek immediate medical support if required.
  • Clearly sealed& labeled the dangerous materials and never leave it on the working bench unattended
  • Visitors to laboratory should be under the direct supervision of a accountable personnel.
Spillages
  • Spillages must be instantly dealt as per SOP for Handling of Spillages in the QC Laboratory.
Disposal of waste
  • Waste must be disposed as per SOP for Waste Management in QC Laboratory.

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Audit Checklist for QC Department

Audit Checklist: Here is the tentative Audit checklist [Internal Audit/Self Inspection Checklist] for Quality Control Department. You may follow the below list at the time of Audit [Internal Audit/Self Inspection] for Quality Control Department-

1. Approved Departmental Organogram.

2. Approved vendor List of Raw and Packaging Materials.

3. Acceptance Record of Raw Material and Packaging Material.

4. Approval or Rejection of Materials and Products.

5. Controlling method of  

  • Purchase
  • Primary Packaging and   
  • Printed Packaging Materials

6. Data Verification based on Logbook and Chromatograms.

7. Document retrieval and achieving Procedure.

8. Collection of retained sample and retrieval system.

9. Certificate of analysis.

  • Primary data
  • Checking of calculations
  • Preservation of primary data

10. Certification of Products for Release.

11. Chemical Reagents consumption records.

12. Calibration Record Keeping for the instruments.

13. Calibration schedule/calendar of instruments.

14. Disinfectant effectiveness testing based on different concentration.

15. Documentation

  • Material receiving report
  • Preservation of original data
  • Final report
  • Communication with related department e.g- Supply chain, Warehouse, Accounts

16. Health checks for all personnel

  • Pre-employment
  • Yearly
  • Record

17. In-process analysis (Specification & method)

  • Currently revised
  • Revision procedure
  • Validation
  • Approval

18. Instruments SOPs of operation, maintenance & calibration

  • Operation Logbook
  • Calibration
  • Servicing
  • Documentation

19. Investigation of Test Failure.

20. Job Responsibilities of all personnel are available.

21. List of Reagents & Solvents.

22. Laboratory Reagents

  • Identified
  • Tested
  • Expiration dated

23. Maintaining of Reference Number for

  • Specification
  • Starting materials (both RM & PM)
  • Finished products
  • Certificate of Analysis

24. Management of HPLC columns.

25. Method for Identification of each starting materials container.

26. Management of Working Standard/Reference Standard.

27. Management of analytical worksheets.

28. Method Validation of Testing Product.

29. Maintain and storage of HPLC Column and column suitability test.

30. Management of Control Sample.

31. Practice and Record keeping of OSS with action plan.

32. Personnel engaged in analytical activity.

  • Personnel Hygiene
  • Lab Coat

33. Prohibited in working area

  • Smoking
  • Chewing tobacco
  • Eating/ Drinking

34. Preparation and record keeping of working standard and volumetric solutions.

35. Record Keeping of

  • Sampling
  • Inspection and
  • Testing procedures

36. Reference Standard

  • Evaluation
  • Maintaining
  • Record Keeping
  • Logbook Entry
  • Storage

37. Receiving Record of

  • Reagents
  • Chemicals
  • Culture Media

38. Retesting procedure

39. Received Material

  • Sampling Plan
  • Sampled Quantity

40. Real Time & On-going Stability Study Calendar/Schedule.

41. Qualification [DQ, IQ, OQ & PQ] records of Oven.

42. Real Time & On-going Stability Study Sample Receiving Record.

43. Real Time & On-going Stability Study Failure Investigation.

44. Real Time & On-going Stability Study Report Evaluation, Recommendations and Conclusion.

45. Safety

  • Fire extinguishers-adequacy
  • First aid-adequacy
  • Possibility of potential electrical hazards

46. SOP on cleaning

  • Glass apparatus
  • General cleaning of department

47. SOP on Material Coding System.

48. SOP on calibration of measurement equipment.

49. SOP on Handling of breakdown of stability chambers.

50. SOP for sampling of

  • Starting Materials
  • Bulk Materials and
  • Finished Products

51. SOP for

  • Label and labeling system
  • Packing Materials handling
  • Handling of the raw material
  • Reanalysis
  • Testing of Market Complaints Sample
  • Testing of Recalled Products
  • Return products

52. Stability study

  • List of products under stability study
  • Stability protocols & reports
  • Temp. % RH monitoring records of the stability chambers

53. Shelf life extension programme based on Real Time Stability Study.

54. Stability Study Record of Primary packaging materials.

55. Standardization of volumetric solution & documentation.

56. SOP for Sampling and Management of Raw Materials, Packaging materials.

57. Sampling of Water System.

58. Specification & Methods

  • Currently revised
  • Revision procedure
  • Validation
  • Approval

59. Standard Lab requirement availability

  • Adequate facilities
  • Trained persons
  • Analyst Validation
  • Approved procedures

60. Standard documented system for

  • Specification
  • Sampling
  • Testing and
  • Release of materials and products

61. Testing

  • Physical
  • Chemical
  • Microbiological/ Biological

62. Tolerance of Electronic balances.

63. Testing of Validation Batch/Scale Up batch Record.

64. Temperature and Relative Humidity Monitoring Record of Oven Humidity chambers.

65. TLC qualifications are document keeping.

66. Validated Excel Sheet for Calculation.

66. Working standards & reference standards.

  • Maintenance
  • Documentation
  • Listing

1. Air Sampling plan of Specific Area .

2. Autoclave validation Record.

3. Autoclave operational Record.

4. Bacterial Endotoxin Test[BET], Sterility Test, Environmental Monitoring Test failure investigation report.

5. Calibration records of equipment’s.

6. Calibration & Recording keeping of Micropipette.

7. Calibration records of measuring devices.

8. Calibration record for heating block for BET.

9. Disposal of microorganism, used culture media, used plates etc.

10. Environmental monitoring records.

11. Growth promotion records of media.

12. Environmental Monitoring and Water Analysis Record.

13. Filter integrity tests record for filters of LAF.

14. Incubators calibration Record.

15. LAF Validation schedule.

16. Microbial culture management.

  • Name of the organisms
  • ATCC/NCTC numbers
  • Sub-culturing of organisms
  • Preservation of microbial culture

17. Master list of SOPs, specifications & methods are updated.

18. Operational Logbooks .

19. Preventive Maintenance schedule for LAF filter cleaning.

20. Record Keeping for Bacterial Endotoxin Test[BET] and Sterility Test.

21. Stock stains available.

22. Testing area.

  • Adequacy of space
  • Adequacy of equipment
  • Cleanliness

23. SOP for

  • Gowning and De-Gowning Procedure Though the Change Room of Microbiology Area
  • Management of Water Sampling and Testing
  • Microbial Disposal of Waste Media
  • Operation of Colony Counter for Microbiology
  • Cleaning and Sanitation of Microbiology Laboratory
  • Operation and Maintenance of Single Door Autoclave
  • Operation, Calibration and Maintenance of Laminar Air Flow Cabinet
  • Operation and Maintenance of Bacterial Incubator
  • Operation and Cleaning Procedure of Oven
  • Preparation and Preservation of Microbiological Media

24. Temperature charts and records of BOD incubators

25. Validation of autoclave machine

26. Validation of LAF

27. Validation Record of BET kit

28. Water monitoring records

This is all about the Audit Checklist [Internal Audit/Self Inspection Checklist] for Quality Control Department [QC & Microbiology Lab] [but not limited to]

Audit Checklist for QC Department Read More »