DEVIATION

DEVIATION:- 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.

Deviations may be classified into following two categories:

Planned Deviation
Un-planned Deviation

Unplanned Deviation:- An accidental or unanticipated non-conformance or deviation observed or noticed during or after the execution of an activity. An unplanned deviation can be a critical or major or minor in nature. For example: deviation in failure of procedure, utility, material, equipment or any system is occurred. We can consider it as any change from the previous or our written procedure.
Planned Deviation:– Any deliberate or intentional non-conformance or deviation Planned prior to the execution of an activity, which is to be undertaken following documented, justifiable and approved rationale. No critical or major deviation, which has potential to alter the quality of the product, shall be planned. For example: – Calibration or validation is not carried out as per schedule due to delay for various reasons.
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”. 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 monthly 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.

Frequently Asked Questions on Deviations

Published on: April 2, 2021

Susan J. Schniepp, Steven J. Lynn

Pharmaceutical Technology, Pharmaceutical Technology-04-02-2021, Volume 45, Issue 4

Pages: 66, 65

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.

Q. What is a deviation and do all deviations need to be investigated?

A. A deviation is when there is a failure to follow the instructions guiding the performance of how an activity should be executed for optimal results. Simply put, deviations result from people not following their standard operating procedures (SOP), work instructions, batch record instructions, or other documents that explain what needs to be done in performing certain functions or tasks. Deviations relate to non-compliance and are a serious issue. While not all deviations are equal in their impact on product and quality, all should be investigated.

Q. What is a planned deviation?

A. In our opinion, there is no such thing as a planned deviation. Planned deviations were supposed to justify changes from SOPs that would be utilized to carry out the operation over a certain period of time. The current thinking by regulatory authorities is there is no such thing as a planned deviation. During a breakfast session at the 2018 PDA/FDA Joint Regulatory Conference, a representative from the FDA stated, “it’s a very strange term, and it kind of makes your skin crawl a little bit” (1). If you need to make a change to a procedure for a short period of time, we suggest you use the change control system to document the change. This may seem like a picky point, but until the change is evaluated for its impact on the process validation requirements and formally documented in a change control, encouraging the deviation’s continued use is supporting a posture of non-compliance.

Q. What’s the best process for investigating deviations?

A. There is no single best process for investigating deviations. The ultimate goal of deviation investigations is to determine why something went wrong, what caused it to go wrong, and how to address the issue and prevent its recurrence. To achieve successful resolution of deviations, keep the following general considerations in mind:

A one-size investigation doesn’t fit all situations. Simple errors require simple documentation while more serious deviations require broader investigations.
The best tool to have is inquisitiveness. Ask yourself how far this deviation could extend.
Widen your perspective. Look for ways to relate, not separate, similar issues.

Human error is rarely a sufficient root cause.
Always verify information or your instincts and never assume you are correct without proper data to support your instincts.

Q. Why is human error not an acceptable finding for deviations?

A. The overuse of human error as a root cause to a deviation represents lost opportunities to reduce future issues by masking the identity of the true root cause. Herein is the human error in Human Error. The question that needs to be asked during the initial investigation into a deviation is what caused the employee to make the human error? Asking this question early in the investigation leads to better root cause identification and opportunities for continued improvement.

Let’s look at an example that might help clarify why human error can mask the real root cause of a deviation. Suppose, for example, you have a second shift manufacturing operator who continually forgets to sign a step in the batch record for a specific product. This operator is the only one who seems to have this issue. Your initial investigation into the first occurrence of the issue determines a root cause of human error. Because the operator works on the second shift, it is inconvenient to interview him directly, so you rely on the word of his supervisor that this was just a case of human error. You decide to retrain the operator on the proper use of filling out the form and skip the operator interview in order to complete the investigation and perform the retraining in the allotted 30-day time frame. This scenario repeats itself 10 times over the course of four months. You finally decide to interview the operator directly. When you talk to the operator, he informs you that in order to sign the batch record when it needs to be signed, he needs to exit the aseptic core, degown, sign the batch record, and regown, leaving the product unattended during that time. The operator tells you he chose to stay with the product and sign the batch record later but sometimes forgot after the manufacturing run. In this simple exchange with the operator, you realize that the root cause of the repeat deviation is not a result of human error but a result of poor process flow.

Q. How much time should I allow for a deviation to be investigated?

A. The length of time it takes to complete an investigation depends on the complexity of the investigation. Simple deviations can be completed in a short time frame, but more involved deviations will take longer to complete. We recommend you set a time frame that is reasonable for your organization. For example, you might indicate that deviations will be investigated and completed between 30–60 days after the deviation was documented. This gives you some flexibility.

Q. Are out-of-specification (OOS) results considered deviations?

A. No. OOS results need to be investigated separately and quickly due to the potential impact to the product. If the root cause of the OOS cannot be attributed to laboratory error, you should initiate a deviation/investigation to determine what happened during product manufacturing that attributed to the erroneous laboratory result.

Download Issue: Pharmaceutical Technology-04-02-2021

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Frequently Asked Questions on Deviations

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