| What is a Deviation: | | | | Deviation from Company Standards and/or |
| A Deviation is a departure from standard | | | | current regulatory expectations that provide a |
| procedures or specifications resulting in | | | | potentially significant risk to product quality, patient |
| non-conforming material and/or processes or | | | | safety or data integrity or could potentially result |
| where there have been unusual or unexplained | | | | in significant observations from a regulatory |
| events which have the potential to impact on | | | | agency or a combination/repetition of "other" |
| product quality, system integrity or personal | | | | deficiencies that indicate a failure of system(s). |
| safety. For compliance to GMP and the sake of | | | | Level 3: Standard Deviation |
| continuous improvement, these deviations are | | | | Observations of a less serious or isolated nature |
| recorded in the form of Deviation Report (DR). | | | | that are not deemed Critical or Major, but require |
| Types of Deviations: | | | | correction or suggestions given on how to |
| 1. Following are some examples of deviations | | | | improve systems or procedures that may be |
| raised from different functional areas of business: | | | | compliant but would benefit from improvement |
| 2. Production Deviation - usually raised during the | | | | (e.g. incorrect data entry). |
| manufacture of a batch production. | | | | How to Manage Reported Deviation: |
| 3. EHS Deviation - raised due to an environmental, | | | | The department Manager or delegate should |
| health and safety hazards. | | | | initiate the deviation report by using a standard |
| 4. Quality Improvement Deviation - may be raised | | | | deviation form as soon as a deviation is found. |
| if a potential weakness has been identified and the | | | | Write a short description of the fact with a title in |
| implementation will require project approval. | | | | the table on the form and notify the Quality |
| 5. Audit Deviation - raised to flag | | | | Assurance department within one business day to |
| non-conformance identified during internal, | | | | identify the investigation. |
| external, supplier or corporate audits. | | | | QA has to evaluate the deviation and assess the |
| 6. Customer Service Deviation - raised to track | | | | potential impact to the product quality, validation |
| implementation measures related to customer | | | | and regulatory requirement. All completed |
| complaints. | | | | deviation investigations are to be approved by |
| 7. Technical Deviation - can be raised for validation | | | | QA Manager or delegate. QA Manger has to |
| discrepancies. For example: changes in | | | | justify wither the deviation is a Critical, Serious or |
| Manufacturing Instruction. | | | | Standard in nature. For a deviation of either critical |
| 8. Material Complaint - raised to document any | | | | or serious nature QA delegate has to arrange a |
| issues with regards to non-conforming, | | | | Cross Functional Investigation. |
| superseded or obsolete raw materials | | | | For a standard type deviation a Cross functional |
| components, packaging or imported finished | | | | Investigation (CFI) is not necessary. Immediate |
| goods. | | | | corrective actions have to be completed before |
| 9. System Routing Deviation - raised to track | | | | the final disposition of a batch. Final batch |
| changes made to Bill of materials as a result of an | | | | disposition is the responsibility of Quality |
| Artwork change. | | | | Assurance Department. |
| When to Report Deviation: | | | | If a critical or serious deviation leads to a CFI, |
| A Deviation should be raised when there is a | | | | corrective and preventive actions should be |
| deviation from methods or controls specified in | | | | determined and follow up tasks should be |
| manufacturing documents, material control | | | | assigned to area representatives. Follow up tasks |
| documents, standard operating procedure for | | | | should be completed within 30 business days of |
| products and confirmed out of specification results | | | | the observation of deviation. If a deviation with |
| and from the occurrence of an event and | | | | CFI can not be completed within 30 business |
| observation suggesting the existence of a real or | | | | days, an interim report should be generated |
| potential quality related problems. | | | | detailing the reason for the delay and the |
| A deviation should be reported if a trend is | | | | progress so far. |
| noticed that requires further investigation. | | | | After successful completion of the Follow up |
| All batch production deviations (planned or | | | | tasks Deviation should be completed and attached |
| unintended) covering all manufacturing facilities, | | | | with the Batch Report /Audit report/ Product |
| equipments, operations, distribution, procedures, | | | | complaint report /Safety investigation report as |
| systems and record keeping must be reported | | | | appropriate. |
| and investigated for corrective and preventative | | | | What To Check During The Deviation |
| action. | | | | Assessment: |
| Reporting deviation is required regardless of final | | | | QA delegate has to conduct a primary |
| batch disposition. If a batch is rejected a deviation | | | | Investigation on the deviation reported and |
| reporting is still required. | | | | evaluate the following information |
| Different Levels of Deviation Risks: | | | | 1. Scope of the deviation - batch affected (both |
| For the ease of assessing risk any deviation can | | | | in-process and previously released) |
| be classified into one of the three levels 1, 2 | | | | 2. Trends relating to (but limited to) similar |
| & 3 based on the magnitude and seriousness | | | | products, materials, equipment and testing |
| of a deviation. | | | | processes, product complaints, previous |
| Level 1: Critical Deviation | | | | deviations, annual product reviews, and /or |
| Deviation from Company Standards and/or | | | | returned goods etc where appropriate. |
| current regulatory expectations that provide | | | | 3. A review of similar causes. |
| immediate and significant risk to product quality, | | | | 4. Potential quality impact. |
| patient safety or data integrity or a combination | | | | 5. Regulatory commitment impact. |
| repetition of major deficiencies that indicate a | | | | 6. Other batches potentially affected. |
| critical failure of systems | | | | 7. Market actions (i.e. |
| Level 2: Serious Deviation | | | | |