Deviation is an unexpected event that occurs during the on-going operation/Activity/ Documentation / Entries at any stage of Receipt, Storage and Manufacturing, Analysis and Distribution of Drug Products/Intermediates/Raw Materials/Packing materials. Deviations are to be reported as and when they occur and to be investigated for impact Assessment.

 Critical Deviation: Deviation that could have significant impact on the product quality or GMP system. Examples of critical deviations are given below but not limited to:

 ·   Cross contamination or product mix up in a product.

·    Failure to process step during manufacturing.

·    Use of obsolete batch document / test method.

·    Filter integrity failure.

Major Deviations: Deviation that could have a moderate to considerable impact on the product quality or GMP system. Examples of major deviations are given below but not limited to:

 ·   Machine breakdown during processing

·    Mix ups of cartons of same product with different strength.

Minor Deviations:

Deviation unlikely to have a detectable impact on product quality or GMP system.

Examples of minor deviations are given below but not limited to:

· Minor errors in batch records or document that not affecting the integrity  of data.

· Spillage of material during dispensing.

· Failure to meet environmental condition during batch processing.

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PROCEDURE:

 All deviation shall be documented, investigated, tracked and trended. All deviation shall be reported as when they occur.

The person who observes the deviation shall inform the immediate supervisor or concern department head/designee and to Quality Assurance.

As per the severity of deviation and stage of process, the process may be stopped for initial assessment.

QA shall issue the “Deviation Control Form “on the request of initiator (Concerned department) by assigning deviation number

The initiator shall fill the details (like Product / Material / Equipment / Document / Other If any and Batch No. / A.R.No. If applicable) in deviation control form.

Initiator shall do the initial assessment and shall take suitable immediate action according to the nature  of deviation and inform to department head and concern QA person.

Initial impact assessment shall be done by the observing department head / designee and designated person QA. Recommendation for continuation of process / discontinue the process shall be given by  head of department and Head QA or designee.

Based on nature of deviation, initial assessment and immediate action taken, Head of initiating department shall approve the deviation for further evaluation of QA.

After approval of deviation from head of initiating department deviation form shall be forwarded to QA for evaluation.

During evaluation, designated QA person shall verify whether the deviation is quality relevance or not and whether deviation is a repeat occurrence or not.

If it is quality relevance, impact shall be assessed on other areas/departments.

And if it is a repeat occurrence, impact assessment shall extend to verify the effectiveness of previous CAPA taken.

After evaluation categorizes deviation into critical, major or minor based on the evaluation of impacted areas and product quality impact.

If deviation is categorized as Critical or Major, Cross Functional Team comprising of technical experts from different department (as per the nature of deviation) shall be form to investigate the root cause of deviation.

If deviation is minor, investigation shall be carried out jointly by designated QA person along with a person from department where deviation happened.

Failure Investigation and Root Cause identifications shall be carried out by the investigation team using investigational methodologies.

Upon identification of root cause of failure, the probable root cause of failure shall be documented.

Corrective actions and preventive actions shall be recommended to prevent the reoccurrence of the same.

The deviation including investigation report (wherever applicable) shall be closed within 30 working days of the initiation date. The initiation date is the date of observation of deviation.

If deviation is not closed within specified timeline, initiator shall raise “Period Extension Request” as  per SOP. Initiating department Head shall review the extension request and write justification for delay with impact assessment. QA shall assess the impact of delay in action completion and approve / reject the Period extension request.

Deviations shall be closed only when all relevant actions in the CAPA log are completed.

Continuous trending of deviations shall be carried out on Quarterly basis

QA shall carry out trend analysis for all the deviation in the whole year at the beginning of the next year by using monthly trend data. A copy of trend analysis shall be forwarded to Head CQA.

The record retention for all closed deviation and investigation reports shall be not less than 7 years or as otherwise agreed with concerned regulatory body.

All deviation and investigation reports shall be kept in custody of QA and QA shall maintain the Deviation register.

Product Identification Discrepancy

2)  Case/carton/Label/Product/Lot not identified, Status is incomplete or incorrect.

3)  A lot number discrepancy either physical or systemic between what is expected and what is received.

Potential Product Defect

2) Temperature Deviation – Temperature goes outside the specified range

Third Party / Vendor or Supplier issues

2)  Third Party Vendor Error – An error by third party vendor that effects product identity, safety, stability

3)  Transportation error – An error made by a carrier of our products.

Lot Status Issues

2) Improperly Placard – Placards do not reflect actual product status