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Deviation Management - Pharmaceutical Industry

Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure. A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing.

How many types of deviation are there in pharma?
  • Two types
A deviation is an activity performed differently and/or modified than that specified in an approved document. 
There are two types of deviations 
  1. Planned Deviation. 
  2. Unplanned Deviation

  • Deviation can be defined as departure from an approved instruction or established standard.
  • Such deviation may adversely affect the desired quality of the pharmaceutical product. Such deviation must be avoided, but if required than must be justified and explained if there is any quality impact on the pharmaceutical product. The noted deviation must be properly authorised and recorded. The deviation are defined in ICH Q7 as well as M schedule.

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ICH Q7 states that
  1. Any deviation from the established procedure should be documented and explained. Critical deviation should be investigated and the investigation and its conclusion should be documented.
  2. It is the responsibility of the quality units to ensure that critical deviations are reported, evaluated, completed and signed.
  3. In product quality review, a review of all critical deviation or non conformance and related investigation must be recorded.
  4. Deviation from the approved standards of calibration on critical instruments should be investigated if stored separately.
  5. Written procedure should be established and followed for investigating critical deviations or the failure of a batch of intermediate or API to meet the specification. the investigation should extend to other batches that may have been associated with the specific failure or deviation.
  6. All deviation reports should be reviewed as part of the batch record review before the batch is released.
  7. Deviation in yield associated with critical process steps should be investigated to determine their impact or potential impact on the resulting quality of affected batches.
  8. A validation report that cross reference the validation protocol should be prepared, summarising the result obtained, commenting on any deviation observed and drawing the appropriate conclusion including recommending changes to correct deficiency.


M schedule also talks about deviation but not in so much of details. As per M schedule:
  1. Comments or explanation for significant yield limit shall be given.
  2. There shall be notes on special problems including details with signed authorisation for any deviation from the master formula.

Deviation Management deals with different types of deviations such as standard (common) deviations and laboratory out-of-spec deviations. The system provides pre-defined reports for initiating any possible deviation investigation. The entire deviation process is supported by the system, from initiation and investigation, to review, approval and closure in compliance with CFR 21 Part 11.

Deviations are measured differences between observed value and expected or normal value for a process or product condition, or a departure from a documented standard or procedure.

A deviation may occur during sampling and testing, raw materials- and finished product acceptance and manufacturing. Deviations may also be triggered by customer complaints or comments when the customer company’s standards do not meet critical attributes as delivered per certificate.

For compliance to GMP and the sake of continuous improvement, any deviation from established procedures needs to be documented. FDA § 211.192 requires a thorough investigation of any deviation, including documentation of conclusions and follow-up. The Quality Management System should ensure that deviations from established procedures are identified and recorded. Incidents that could affect the quality or the reliability of records or tests should be investigated and resolved.

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