GRLR

Investigation Report Advice

The primary purpose of a deviation investigation report in a GMP environment is to clearly and concisely demonstrate that the root cause of the deviation has been identified; corrective actions have been taken; preventative actions have been identified; and that safety, integrity, strength (potency), purity, and quality of the product has been ensured.

The investigation report should house the details of the investigation in a manner that provides an appropriate level of background information, and can serve as a stand-alone document such that the reviewer can ensure that the level of investigation is thorough and commensurate with level of risk. To achieve these objectives, the investigation report must contain the following sections:

Top Line/Executive Summary

Brief summary of the quality management system (QMS) failure, including: 1) investigation number assigned, 2) Executive Summary – description of failure, 3) Product name, 4) batch/lot number, 5) date of occurrence, 6) date discovered, 7) date of report, 8) name of person who completed the report, 9) other lots impacted, and 8) initial risk categorization (incident, minor, major, critical).

Detailed Description of the Event

Provide details regarding the known series of events that led to the failure, including equipment involved, procedures, aspects about the product, batch records, relevant training, relevant test results, known trends, etc. It can be useful to provide clarifying drawings, pictures, and process flow diagrams, as appropriate.

Probable Root Cause State root cause(s) or most probable root cause(s). Root cause: Subsection begins with “The most probable root cause of deviation # is ….” followed by the concluding statement taken directly from Root Cause Investigation section (described below). It must be made clear to the reader that a formal investigation tool was used to arrive at the most probable root cause.

Root Cause Investigation

Attach any problem-solving tools/templates used (i.e., 5 M , Why-Why, Fishbone, UPS Tools, etc.). Also discuss potential root causes that were ruled out based upon evidence/rationale. State if there is or is not direct or potential impact to product equipment/systems/materials in scope. Provide a thorough risk assessment for all products, materials, equipment, systems, etc. within the scope. Provide evidence that the quality systems (GMPs) are in control, if possible.

Items to Include:

Individuals Involved

List of key operational roles involved in the initial deviation and subsequent investigation (i.e., manufacturing operator, manufacturing supervisor, packaging operator, laboratory analyst, etc.).

Sequence of Events

Describe what actually happened. (List the meaningful and factual sequence of events, typically in chronological order using a timeline format).

Extent/Scope Assessment

Identify all Products, directly or potentially impacted by the failure. This can be summarized in general terms by date range, operation, etc. What data/evidence demonstrates the failure is limited to a timeframe, product, operation, shift, etc.?

Key Learnings - Corrective/Preventive Actions

Corrective and Preventative Actions eliminate the cause of an existing non-conformity and prevent recurrence. Preventive Actions identify and eliminate the cause of potential non-conformances from occurring.

A trend analysis related to the failure must be conducted in order to determine if there is a large impact. For example, if there is an issue with equipment, then an assessment of all like-equipment should be conducted to see if the same failure has occurred, which would impact more lots and/or products. An assessment of impact to lots already released to the market needs to be completed as quickly as possible, in order to determine if a recall is needed.

Disposition Recommendation

Based on the investigation and the data you have as a Quality Assurance assessor. Does the company release the lot to the market or reject the lot? You must be able to assure that the root cause of the deviation has been identified; corrective actions have been taken; and that safety, integrity, strength (potency), purity, and quality of the product has been ensured.

Alternative??