A Brief Overview on Pharmaceutical Deviation Cover topic -Definition -Types -Category -Basic Process for Handling Deviation -Process how to file deviation -Requirements for it during filing and many more

 

Content:-

-Definition

-Types

-Category

-Basic Process for Handling Deviation

-Process how to file deviation

-Requirements for it during filing

Definition: Deviation is a departure from approved procedure or specification. A deviation is an activity performed differently and/or modified than that specified in an approved document.

OR

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.

There are two types of deviations

1) Planned Deviation             

2) Unplanned Deviation.

1.Planned Deviation:  Planned deviations, which are described, and pre-approved deviation from the current operational document/system, covering a specified period of time or number of batches. Planned deviation shall be approved before execution

The term “planned deviation” is frequently used to describe a decision to carry out a process in a different way from which it is established in a SOP, Method or Manufacturing Batch Record due to an unforeseen event. Planned deviations need to be fully documented and justified. Usually, planned deviations associated to onetime events, and change control to permanent changes.

2.Unplanned Deviation:    Unplanned deviations also called as incident.

Incident can be defined as unplanned or un-controlled event in the form of non-compliance from the designed systems or procedures at any stage of manufacturing, packaging, sampling, testing, holding and storage of drug product due to system failure or equipment breakdown or manual error.

Incidents are again of two type

1. Quality Impacting Incident

2. Quality Non-impacting Incident

1.    Quality Impacting Incident

Quality impacting incidents are errors or occurrences during execution of an activity which will affect the Quality, Purity, and Strength of the drug product.

2.    Quality Non-impacting Incident

Quality Non-impacting incidents are errors or occurrences during execution of an activity which may have no impact on the quality, purity and strength of a drug product

Category of Deviation:  Deviations should require a higher level of analysis and documentation, and are usually covered by a deviation handling procedure as per SOP made for it. At this point, a decision needs to be made to categorize the deviation as Minor, Major or Critical. This decision process should be based as applicable and as possible on the impact (or hazard) and risk on the process and product quality by the use of any QRM tool.

-Minor Deviations

When the deviation does not affect any quality attribute, a critical process parameter, or an equipment or instrument critical for process or control, it would be categorized as Minor, and treated as such by the applicable procedure. Possible examples of minor deviations are given below:

Example of Minor deviation

-Skip of FEFO principle (first expired-first out) in raw material handling.

-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.

-Balance out of tolerance used to determine gross weight of raw materials upon reception.

-Pressure differential out of established limits in class D washing area.

-Inadequately trained personnel to perform warehouse cleaning activities.

-Major Deviations

When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel/environment) is unlikely, the deviation is categorized as Major requiring immediate action, investigation, and documented as such by the appropriate SOP. Possible examples of major deviations are given below.

Example of Major deviation

- Use of unapproved reference standard to test an API or drug product.

- Inadequately trained personnel to perform sterility tests.

- Production started without line clearance.

-Machine breakdown during processing

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

-Filter integrity test has been carried out using equipment with no documented installation qualification completed.

- Gross misbehavior of staff in a critical aseptic process.

- Pressure differential out of established limits in aseptic fill areas.

- Operational parameter out of range for a parameter defined as non-critical.

- Untrained personnel responsible for segregating the approved and rejected raw-material in the warehouse

Critical Deviations

When the deviation affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation, the deviation is categorized as Critical requiring immediate action, investigated, and documented as such by the appropriate SOP.

Possible examples of critical deviations are given below:

Example of Critical deviation

- Expired or rejected API component used.

- Mix up of same product with different strength.

- Forgot to add any material at respective stage.

- Incomplete inactivation stage of fermentation.

Notice: Deviations need to be analyzed based on objective and justified criteria avoiding the natural bias from different people or groups. Therefore, the examples of minor, major and critical deviations given above should be considered as that only, and they could be categorized differently with proper justification.

Basic Process  for Handling Deviation

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. All deviation and investigation reports shall be kept in custody of QA and QA shall maintain the Deviation register. 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 Details / Material / Equipment / Document / Other If any/Concerned person involve during deviation took place  and Batch No. / A.R.No. If applicable) in deviation control form.

1. Planned deviation

Who will raise the deviation?

Concerned department officer/executive or above can raise the deviation by all details which are mentioned in deviation form as per SOP of respective industry according to SOP made and effective by them for every process.

Some points covered here which are commonly added during planned deviation

1) Document/Material/Product description

2) Item code /Document No./ A.R No./ Batch No.

3) Current procedure

4) Proposed Deviation

5) Reason for Deviation and Justification for deviation

6) Initiator by/prepared by/ Approved by

Who will review and authorize the deviation?

Concerned department head shall review deviation.

In case of any additional information required on the deviation, department head send back the form to the initiator.

If the deviation is found acceptable, Department Head shall make the comments on the deviation and send to QA for further evaluation.

Who will approve the deviation?

QA Manager is responsible for approve or reject it. On receipt of the deviation, QA Manager shall allocate a number to the deviation report. QA Manager shall evaluate the deviation and send the deviation format to other departments (QC/Engineering /SCM/RA), if require for their opinion. Respective Department Heads shall write their comments on the deviation report by evaluating the impact of deviation. QA manager shall evaluate the deviation report along with the opinion of the other Department Heads for the impact of deviation

On complete evaluation of the content of the deviation, QA Manager shall either approve or reject with comments.

On receipt of the deviation, shall allocate a number to the deviation report.

While indicating the corrective and preventive actions it shall be ensured that the actions committed are with timelines.

On confirmation of the corrective action as mentioned in the deviation report by QA Executive, QA Manager shall close the deviation and the same shall be recorded in the Deviation Log.

2. Unplanned deviation/Incident Report

Whenever any incident occurs, the identifier together with the department head shall evaluate the impact of the incident on the Quality, Purity and Strength of the Product.

Based on the evaluation, the incident shall be classified as Quality impacting or Quality non-impacting.

For the Quality impacting Incident,

For the Quality impacting Incident, the identifier shall immediately notify the QA, and shall raise the incident report by filling the relevant information in the incident format.

QA officer/ Executive shall register the incident in the Incident Log.

Concerned Department Head shall carry out detailed investigation immediately after the occurrence of the incident.

All documents or operations which give an information about the cause of the incident shall be investigated.

To identify the root cause five generic causes shall be considered and investigated according to that

a) Material

b) Method

c) Personal

d) Equipment

e) Environment

Identify the probable causes, which may be the reason of incident. Evaluate the probable causes and summarize to conclude and identify the root cause.

Details of investigation, conclusion shall be recorded by concerned department head

Based on the investigation, evaluation and conclusion, concerned department head shall take the immediate actions.

CAPA shall be mention to avoid the recurrence of the incident.

Concerned department head shall submit the incident report to QA Manager for evaluation and disposal.

QA manager or designee shall monitor the CAPA and on ensuring the compliance, incident shall be disposed.

Once the planned CAPA have been executed, QA officer/Executive shall close the Incident report.

If preventive action is planned in phased manner, the incident report shall remain open till the preventive action(s) is completed.

For Quality Non impacting incident,

For Quality Non impacting incident, the identifier shall register the incident by filling the relevant information in format.

The identifier and the concerned department head shall carry out the detailed investigation

All operations /analysis/ documents which give an information about the cause of the incident shall be investigated.

The details of investigation, conclusion shall be recorded by initiator/concerned head.

Based on the investigation, concerned HOD shall mention the CAPA to avoid the recurrence of the incident and the same shall be recorded

After taking corrective and Preventive actions, the Incident Report shall be disposed by concerned department head.

What are the contents in Deviation format?

Deviation no

Department

Document /Material /Equipment/ Product

Document No. / AR No. / Item Code No. /Equipment No./ Batch No

Current Procedures & Proposed procedures

Reasons & Justifications

Corrective and Preventive Action

Initiator Name, signature and date

Comments with Signature and Date of initiator department head, RA head and other department head (if applicable)

QA Manager opinion : Approve/Reject

Verification of CAPA by QA team

Incident no

Department

Date of Occurrence & date of report

Document /Material /Equipment/ Product

Document No. / AR No. / Item Code No. /Equipment No./ Batch No.

Brief description of incident -description and Observer and QA officer sign and date

Investigation & Conclusion.-description and concerned officer and concern department head sign and date

Immediate correction done & CAPA. –description and concern department head sign and date

Evaluation and Disposition by QA Manager

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