| Handling of Product Failure |
1.0 OBJECTIVE To lay down the procedure for investigation on Handling of Product Failure of any batch. 2.0 SCOPE This procedure is applicable to involved in investigation to be carried out in case of failure of any batch of drug product manufactured. 3.0 RESPONSIBILITY • All concerned department head are responsible for the investigation of any batch failure. 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Failure of any batch of drug product against the laid down specification is defined as batch failure(Handling of Product Failure of any batch). 5.2 Failure: A failure investigation is to be carried out under the following circumstances: 5.2.1 Failure investigation shall be carried out when an in-process, finished product sample does not meet the predetermined specification, failure of procedure, product returned due to quality complaint. 5.2.2 If a GMP deviation or any unusual occurrence that is regarded as sufficiently 5.3 Investigation: Investigations must be carried out thoroughly and promptly, with the objective to identify the root cause(s) of the problem and to take appropriate corrective actions to prevent recurrence. 5.4 Causes of failure: The causes of product failure can be categorized as follows: 5.4.1 Non-Process Related Errors, but not limited to that: • Human error • Equipment failure or malfunction • Contamination from materials of construction of plant equipment, non-process material and product from previous process / batch. • Instrumentation failure To Read this SOP Click here SOP for Handling of Out Sourced Activities. 5.4.2 Process Related Errors, but not limited to that: • Deterioration of input process materials during storage • Process not previously validated 5.5 Whenever the failure is identified, it shall be brought to the notice of Head-QA. 5.6 On receipt of information for the failure of batch against any specification, investigation of same is to be initiated by the Officer or above of QA department. 5.7 Officer or above of QA department has to intimate the Production department to hold the further processing of the batch till the completion of investigation. Same batch is to be kept under quarantine area as “UNDER HOLD”. 5.8 All failed batches must be clearly identified and segregated from other materials under specified storage conditions till final decision on the failed batch / product. 5.9 Officer or above of QA department has to collect the batch documents (i.e. BMR and BPR) of the batch under question for the investigation. 5.10 Officer or above of QA department shall allocate Failure investigation no. to each failure investigation as per prototype PFI/XX/YYY, where PFI stands for product failure investigation XX stands for the last two digits of the current year that is 23 for 2023, 24 for 2024 YYY stands for sequential serial number, starts from 001, 002…. & so on First product failure investigation carried out in year 2023 shall be numbered as PFI/23/001 5.11 Officer or above of QA has to review the batch documents in coordination with Production department for the minimum checkpoints mentioned below: 5.12 Issuance of batch documents is carried out as per procedure. 5.13 BMR and BPR is controlled and issued (with respect to each page of the same) from QA department. 5.14 Line clearance is to be taken during the dispensing. 5.15 Raw material and packing material are dispensed as per the requisition. 5.16 Dispensing tags are available in the BMR and the quantity mentioned in the dispensing tags and requisitions are similar. 5.17 Details of dispensing are to verified against the bin card also. 5.18 Records of dispensing booth of the same are appropriate. 5.19 Calibration records of the balances of the dispensing booth are appropriate. To Read this SOP Click here SOP for Operation and Calibration of Fourier Transform Infrared Spectroscopy (FT-IR). 5.20 All materials issued for the batch are approved from QC department. 5.21 COA of all raw materials issued is appropriate with respect to the specification. 5.22 Manufacturing and packing is carried out as per the instruction mentioned in BMR & BPR, manufacturing and packing activity is to be verified against the equipment usage log books. 5.23 Preventive maintenance records and calibration records of equipments used in the manufacturing and packing are appropriate. 5.24 Environmental conditions during the manufacturing and packing are appropriate. 5.25 Interview of the persons involved during processing of the batch under investigation. 5.26 Upon receipt of approval the destruction of the products is to be carried out as per relevant procedure mentioned below: 5.26.1 Destructions of Liquid Injection / powders. 5.26.2 Tablets shall be de-foiled and collected in a container containing water for soaking. 5.26.3 Soaked tablets shall be sent to effluent treatment plant (ETP) for further disposal. 5.26.4 Powder shall be destroyed by emptying the contents of the individual container of the product in water and sent to effluent treatment plant (ETP) for further disposal. 5.26.5 All the packing material like labels, leaflets, cartons, foils and shippers shall be destroyed and sent to scrap yard for disposal. 5.26.6 All empty containers with paper labels should be collected in a bin containing water, so that the labels are removed and the empty containers cannot be reused by anyone with original label. 5.26.7 Waste Ampoule/vials shall be disposed off into the scrap. 5.26.8 Quality Assurance personnel shall counter check the destruction activity with proper documentation. 5.27 All the batch documents of the batch under question are to be retained in the QA department as per procedures. |
