The purpose of this SOP is to lay down a procedure describes the daily work plan of the laboratory.
This SOP is applicable to routine and non-routine functions in Quality Control Department at manufacturing facility of Pharmaceutical Industry.
- PROCEDURE:
Work shall be allotted to analyst for the day by the Section / Department Head, including the work completed and work pending in daily work plan.
Obtain the green data sheet from the Section Head for the samples to be tested except in the case of all types of samples.
At least twice during the day check and record the temperature and humidity, as applicable, of the main laboratory and instrument room. Make the entries in humidity record, and temperature record for reserve sample room. If the temperature is not within the limit as specified in individual form, immediately inform the engineering department and unit Q.A. for corrective action. Every morning carry out the calibration of the pH meter, and carry out the self calibration of the electronic analytical balance.
Carry out the sampling and testing activities and any other assigned work strictly according to the documented procedures, unless otherwise authorized by the Department Head.
Prepare the composite and reserve samples during sampling and carrying out the tests. Keep the reserve samples in the designated place after making relevant entries in the reserve sample register.
Enter the weights, titers and other observations directly on the Raw data sheet as and when the tests are performed.
Bring to the notice of the Section Head any difficulties faced in carrying out the tests or any unusual observations made either on the samples or in the results of the tests.
Check all the raw data and the results against the specifications and trends (wherever applicable). Dispose off the remaining analytical sample after getting the report checked by the Section Head.
Keep the intimation slip (e.g. GRN, Test Request Slip etc), in the appropriate files or folders, which have been provided, and not on the workbenches, except when they are in use.
After the COA has been approved, file the completed reports in the respective files.
Prepare the appropriate status labels and affix them on the consignments of Raw materials/ Packing materials.
Leave the work place clean after testing is over. Put away the used glassware for washing and put back the specifications on the shelves.
At the end of the day hand over the folder with the completed Test data sheets and other papers to the Head-QC/designee.
Review the Raw data sheets and works of the individual analysts for the previous day’s work and allocate the work for the day to them, on the basis of priorities related to production requirements and any other emergencies.
Discuss promptly with the Department Head if any difficulty experienced in carrying out a test or any result deviating from the specification and take remedial action.
Discuss with the Department Head for any investigation to be done on “OOS” results and prepare report on such an investigation. As a part of investigation, carry out retesting for the same sample. In some cases, if required, resampling can be done.
Carry out analysis of samples, particularly of those involving complex tests or requiring confirmation of doubtful results.
Scrutinize the completeness of A.R. register, Schedule/Programme in order to see if they are up-to-date.
- TRAINING:
As per Employee Training SOP
- DISTRIBUTION:
As per SOP ON SOP
- ANNEXURE:
Annexure I : Daily work Plan
- REFERENCES(S):
Nil