Follow
Objective: To provide a written procedure to describe good practices to be followed in the Laboratory.
Scope: This SOP shall be applicable for QC and QA personnel working in the Laboratory.
Associated Documents: Not applicable.
Responsibility
1 All QC and QA personnel shall be responsible for ensuring good laboratory practices in the Laboratory.
2 Manager, Quality or his or her nominee shall be accountable for good laboratory practices in the Laboratory.
Abbreviations
1 QCO – Quality Control Officer
2 QAO – Quality Assurance Officer
Precautions: Not applicable.
Procedure
7.1 OBJECTIVES
7.1.1 To understand key issues in quality control / quality assurance.
7.1.2 To understand specific requirements on organization, procedures, processes and resources.
7.1.3 To develop actions to resolve any problems/issues.
7.2 ORGANIZATION
7.2.1 The manufacturing unit shall have a QC/QA Department.
7.2.2 The QC/QA Department shall be independent from Production and other Departments.
7.2.3 Adequate resources shall be available to ensure that all the QC/QA functions are effectively and reliably carried out.
7.2.4 The QC/QA Department shall have an organizational chart.
7.2.5 Under the authority and control of an appropriately qualified and experienced person shall be the following laboratories, such as
> Chemical Laboratory
> Microbiology Laboratory
> QA Laboratory
7.3 Basic requirements of Good Laboratory Practices are as follows:
7.3.1 TRAINED PERSONNEL
7.3.1.1 People in responsible positions shall have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities.
7.3.1.2 Their duties shall be delegated in their absence to designated deputies of a satisfactory qualification level.
7.3.1.3 Personnel working in the laboratories shall have the proper education and experience, strengthened by an in-house training to enable them to perform their assigned functions efficiently.
7.3.1.4 The requirement for training and experience shall be such that each person understands and follows current guidelines and regulations.
7.3.1.5 Personnel shall take necessary sanitation and health precautions to ensure proper conduct of tests.
7.3.1.6 Personnel shall wear protective clothing, eye-protection, mask and gloves, as appropriate to their duties.
7.3.1.7 Personnel shall properly communicate to their superior any deviations from regulations or guidelines, so that corrective actions can be taken.
7.3.2 ADEQUATE FACILITIES
PREMISES
7.3.2.1 The laboratories shall be separate from production areas.
7.3.2.2 The laboratories shall be designed to suit the operations to be carried out in them.
7.3.2.3 The laboratories shall have sufficient size and space to properly conduct the assigned work.
7.3.2.4 Separate rooms shall be required to protect sensitive instruments from vibration, electrical interference, humidity etc.
7.3.2.5 There shall be assigned storage area for different supplies.
7.3.2.6 The laboratory area shall be kept clean and orderly by the personnel working in the laboratory.
7.3.2.7 For the storage of files another area shall be provided with a limited access to authorized personnel only.
EQUIPMENT
7.3.2.8 The laboratories shall be well equipped.
7.3.2.9 The equipment shall have the appropriate range and precision to ensure the quality of generated data.
7.3.2.10 All equipment shall be adequately maintained and cleaned by the laboratory personnel.
7.3.2.11 The equipment used for the measurement and assessment of data shall be adequately tested, calibrated and/or standardized.
7.3.2.12 Written standard operating procedures shall detail the specifics of the routine inspections, maintenance, testing, and calibration and/or standardization of all equipment.
7.3.2.13 These SOP shall be available to all laboratory personnel.
7.3.2.14 Written records shall be kept of all inspections, maintenance, repair, testing, and calibration operations.
7.3.2.15 Defective equipment shall be either removed from QC areas, or at least be clearly labeled as defective.
7.3.3 APPROVED PROCEDURES
7.3.3.1 There shall be “Approved Procedures” for all activities of the Laboratory.
7.3.3.2 The laboratory shall have readily available the following details:
Specifications.
Sampling procedures.
Testing procedures and records (including analytical worksheets and/or laboratory notebooks).
Analytical reports and/or certificates.
Data from environmental monitoring, where required.
Validation records of test methods.
Procedures for and records of the calibration of instruments and maintenance of equipment.
Protocols
7.3.3.3 Accurate records and evidence of all laboratory work, including raw data shall be kept in hard-bound laboratory notebook or if applicable filed away in organized files.
7.3.3.4 All records and evidence of work shall be kept up-to-date and organized.
7.3.3.5 The documents and records shall be retained in such a way that they are readily available.
7.3.3.6 Every person working in the Laboratories shall follow the standard operating procedures.
7.3.3.7 Any document relating to a batch record shall be retained for one year after the expiry date of the batch.
7.3.4 TESTING
7.3.4.1 The analytical methods shall be validated.
7.3.4.2 The tests shall be carried out according to approved methods.
7.3.4.3 The results obtained shall be recorded and checked to make sure that they are consistent with each other.
7.3.4.4 Calculations shall be critically examined.
7.3.4.5 Special attention shall be given to the quality of laboratory reagents, volumetric glassware and solutions, reference standards and culture media.
7.3.4.6 All reagents and solutions in the laboratory shall be labeled to indicate content, concentration, storage requirements, date of preparation and expiration and name of the persons who prepared it.
7.3.4.7 In addition, for volumetric solutions, the last date of standardization and the last current factor shall be indicated.
7.3.4.8 Where necessary, the date of receipt of any substance used for testing (e.g. reagents and reference standards) shall be indicated on the container.
7.3.4.9 The date of opening shall be mentioned in case of all reagents.
7.3.4.10 All reference standards shall be kept in a desiccator /refrigerator.
7.3.4.11 For analytical validations only the appropriate reference standard shall be used.
7.3.4.12 All laboratory areas, including workbenches, desks, shelves and equipment shall be kept in a neat, clean and orderly fashion.
