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SOP for Failure Investigation

Standard operating procedure to investigate the failure of batch in pharmaceutical manufacturing through the investigation of analytical data, cleaning, equipment used, equipment qualification and trend data of the product.


To lay down the procedure for conducting failure investigation of product not meeting acceptance criteria.


This SOP shall be applicable for the quality related failures of product, which do not meet the acceptance criteria.


Head of the Department


Head QA


5.1 Product failures shall be reported in the “Failure Investigation Report” form.
5.2 The “Failure Investigation Report” form shall be issued by QA on request. A “Corrective and Preventive action” form shall be issued along with “Failure Investigation Report” form.
5.3 Before issue the failure investigation report shall be numbered serially in the calendar year with an identification code of department. A typical failure investigation shall be numbered as:
FI: Failure investigation
PRD: Department code
YYY: Serial number commencing at 001 in the calendar year.
Z: Last digit of the calendar year
5.4 The “Failure Investigation Report” number and details of failure shall be recorded in the failure investigation log.
5.5 “Failure Investigation Report” form shall be filled by production.
5.6 The initiator shall fill the details like Department, Name of product, Batch No. and Date on the form, along with the description of the failure and source information.
5.7 The initiator shall sign and forward the form to the Head Production.
5.8 Head Production shall fill the investigation of failure column with details of document review and probable reason and proposed corrective and preventive actions. If required additional sheets can be attached. The department head shall sign and forward the form to Head QA.
5.9 The investigation shall be conducted by production Head in consultation with Head QA. Support from other departments such as Engineering, Warehouse, Research and Development and Quality control as appropriate shall be availed.
5.10 Depending on the nature of the failure, investigators shall check all or some of the following documents, additional data shall be evaluated where necessary.
5.10.1 Batch Manufacturing Records / Batch Packaging Records of the specific batch for critical parameters.
5.10.2 Analytical data
5.10.3 Cleaning records
5.10.4 Equipment logs
5.10.5 Equipment Calibration records
5.10.6 Trend data
Note: The personnel of Production, QC and QA shall carry out the review of the documents

5.11 Head QA shall review the investigation of the failure column with details of document review and the probable reason for failure.
5.12 Head QA shall communicate to Contract giver or other concerned departments, where applicable.
5.13 Based on the investigations Head production shall document the findings, and shall propose Corrective and Preventive actions to correct the failure and to avoid recurrence. The proposed Corrective and preventive actions shall be reviewed by Vice President.
5.14 Head QA shall evaluate all the relevant documents and the impact of failure on associated batches and on existing facility, system, equipment, documentation and suggest the necessary recommendations to correct the failure and to avoid the recurrence.
Head QA shall sign on the form and a copy shall be forwarded to Head Production.
5.15 In case, where experiments are required to be conducted at R&D / QC, necessary samples shall be withdrawn. Data shall be reviewed by QA.
5.16 Head Production shall carry out the implementation of the Corrective and Preventive action by updating required documents and/or system.
5.17 Head Production shall summarize the implementation of Corrective and Preventive actions and send the form to Vice President for comments.
5.18 Vice President shall review the corrective and preventive actions implemented and shall send the filled form to Head QA.
5.19 Head QA shall review and update the related documents, wherever applicable and verify the implementation of corrective and preventive actions taken.
5.20 The failure investigation shall be closed by Head QA after verification of the implementation of CAPA.


6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 QC: Quality Control
6.4 R&D: Research and Development
6.5 CAPA: Corrective and Preventive Action
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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