- 1. What is Deviation:
Any unwanted event that represents a departure from approved processes or procedures or instruction or specification or established standard or from what is required. Deviations can occur during manufacturing, packing, sampling and testing of drug products. Deviations are of three types Minor, Major and critical
- 2. When to take Deviation:
Deviation has to raise for the following criteria mentioned below (But not limited to)
- Temperature and RH of area goes out of limit during manufacturing
- Typographical error observed in approved documents
- Standard operating procedure (SOP) not followed
- Breakdown of equipment & Spillage of material during unloading, loading etc.
- Instrument calibration results goes out of limit
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- 3. What is Minor, Major and Critical deviation :
Critical deviation: A Critical Deviation is an unplanned event that affects a quality attributes a critical process parameter, an equipment or instrument critical for process control and has an immediate patient safety risk, life threatening situations.
Major deviation: A Major Deviation is an unplanned event that potentially affects a product’s quality, safety or efficacy or its ability to meet specification, or regulatory or documentation requirements which may not have direct impact on patient.
Minor deviation: A Minor deviation is an unplanned event that potentially has GMP impact (e.g. an event affecting a utility, equipment, materials, components environment or documentation) but does not affect product quality and / or the physical state of the product, intermediate or component, or it’s labeling.
- 4. Who is Observer and Initiator in deviation :
The person identifying the occurrence of deviation shall be termed as observer and the person initiating the documentation of deviation in deviation form shall be termed as Initiator.
- 5. When deviation shall be raised :
Deviation shall be notified to the concern department and QA for review, evaluation and logging within one working day (24 hours) after occurrence.
- 6. For which type of deviation Risk Assessment is required :
Quality risk assessment shall be performed for suspected product defects, potential impact on other batches or on other products etc. Wherever applicable
- 7. For deviation investigation report which type of tools shall be used :
The tools like Ishikawa diagram analysis (fish bone diagram), 5 why’s, fault tree analysis (FTA) failure mode and effects analysis (FMEA), Flow charts, Process flow etc. shall also be used for detection of the root cause, if necessary.
- 8. What to do if actual root cause is not identified during investigation :
If actual root cause is not identified, potential root cause shall be identified based on history of repetitive deviation, deviation trends, vendor assessment, scientific knowledge and actions shall be taken to prevent the potential from occurring.
- 9. What is the frequency of trending of deviation :
Periodic review of deviation system or Trending of deviation shall be conducted quarterly to check the effectiveness of deviation system and shall be documented.
- 10. What will be the contains of periodic review or trending of deviation :
Periodic review shall include (but not limited to) total no. of deviations during review period as per category (e.g. Critical, Major and minor), as per department, as per nature of deviation (e.g. Product related, Process related, equipment related, calibration validation failure, testing related etc.), no of repeat deviations (e.g. as per nature and as per root cause etc), department wise classification of deviation, Category wise, Type wise, Review of similar root cause, Review of previous open, Summary and conclusion.
- 11. When CAPA to be initiated from deviation :
Depending on the impact assessment / risk assessment, identified root cause, and comment received from various sources, Corrective action and preventive action (CAPAs) shall be defined by responsible department head in consultation with QA.
Appropriate CAPA’s shall be identified and subsequently logged into CAPA log book and the deviation report shall be closed.
QA shall check the implementation and completion of the corrective and preventive action and update the Log book.
- 12. Are all the deviations shall be forwarded to customer or Qualified person and CQA for Approval:
Yes All products related deviations (critical, major, and minor) having impact on product quality, safety, and efficacy, validated status of process & equipment shall be circulated to the customer/Qualified Person/Marketing Authorization Holder for notification and approval.
All the deviations shall be sent to CQA for approval
- 13. What is the timeline for closing of deviation :
All deviations shall be timely reviewed to close within 30 calendar days of occurrence of deviation & Justification for delay in closure shall be filled by the responsible department in case deviation is not closed in 30 days.
Only two extensions, of 30 days each, shall be allowed for Investigation & deviation closure, if failed to complete the activities after two extensions, then Quality Risk Assessment shall be prepared by responsible department.
- 14. Who shall be included in investigation team of deviation:
The cross functional investigation team shall be formed for the investigation of deviations and shall consist of Head of the department or designee where deviation has occurred and members with sufficient knowledge on current matter for investigation.
The team shall include members (depend upon nature and Applicability) from QA, QC, Manufacturing, Packaging, Regulatory, Engineering, Safety and Warehouse etc.
- 15. Who will perform investigation for deviation :
The responsible department head/designee shall initiate the investigation as per the SOP for Investigations as applicable, considering history & trending, root cause evaluation, risk and impact assessment and comments from other departments within the site along with QA department.
- 16. Is deviation required to be closed before release of batch to market :
Yes At the time of batch release, QA person shall ensure that the investigation for the deviations is carried out and closed.
17. What is the Responsibility of QA Change control coordinator in deviation :
QA shall evaluate the deviation and allot unique serial number to the deviation form.QA shall be responsible to review & approve the investigation.QA shall be responsible for approval & closure of the deviation reports.QA shall be responsible for disposition of all affected products and materials (wherever applicable).QA shall be responsible for the follow up and tracking of deviation and Corrective and Preventive Actions. |
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