SOP of Deviation control in pharmaceutical

SOP of Deviation management or control

1.0 Objective :

To lay down a procedure for reporting and approval of deviations from the established procedure.

2.0 Scope :

This procedure is applicable to control deviations in various departments (Example: Production, Quality Control, Quality Assurance, Engineering, Personnel & Administration, Store, IT).
SOP for Deviation management

3.0  Responsibility:

Any employees of the Originating DepartmentInitiation of the Deviation process

Originating Department Head/Designee Find out root cause, Justification and suggesting corrective and preventive action for the deviation

QA Head/DesigneeReview and approval/rejection of deviation.
Implementation of corrective action & preventive action. Compliance of impact analysis & closure of deviation.

4.0 Procedure:

4.1 In cases when it is not possible to follow the approved procedure, or an error has occurred (Incident), deviation shall raise and notify to Department Head/Designee and QA also as per approved format.

4.2 QA Chemist/ Designee shall issue the Deviation format to the user initiating department. 

4.3 If there is any deviation observed then it should be categorized as minor, major or critical.

4.3.1 Minor Deviation: Any deviation having  no significant effect on product quality, safety, purity or efficacy of the product.

4.3.2 Major Deviation: Any deviation that may affect the quality, safety, purity or efficacy of the product. If minor deviations are repetitive in nature such deviations then shall be considered as major deviations.

4.3.3 Critical deviation: Any deviation that has affected the quality or has been shown to have detrimental effect on the quality, safety, purity or efficacy of the product.

4.4 Root cause of deviation is to be identified and mentioned which gives main reason of deviation occurrence.

4.5 QA shall assign control number as DX / YY / ZZZ.

The first character shall be an alphabet: “D” representing Deviations.

The second character ‘X’ is code for originating department like “P” representing the deviation in Production, “E” for Engineering, and “S” for Store, “Q” for QA, “C” for QC and “O” for others which include any other department along with IT and Human resources Department.

The third characters shall be ‘/’. The fourth and fifth character “YY” shall represent the year like ‘18’ for year 2018.

The sixth character shall be ‘/’.

Finally seventh, eighth and ninth character “ZZZ” shall be serial number of deviation starting from 001 to 999 for each department.

Example: DP / 11 / 001 is first deviation for year 2011 in Production department.

4.6 QA shall enter the detail of the deviations in the deviation logbook.

4.7 A deviation investigation may be initiated upon review of information obtained from processes, annual reviews, quality audit reports, Quality Control results, Equipment usage logs, return products and other sources of quality data.

4.8 Provide all information related to the affected Facility/ System/ Equipment/ Product /Component/ Procedures. The nature of deviation may be related to but not limited to:

4.8.1 Change in process parameter / equipment.

4.8.2 Less Yield / More yield.

4.8.3 Change in quality attribute of Raw Material / Packaging Material / Finished Product.

4.8.4 Change in manufacturing environment / storage conditions.

4.8.5 Any incidence recorded during manufacturing and packing operation or any other system.

4.8.6 Malfunctioning of equipment / utilities / out of calibration / planned preventive maintenance.

4.9 Initiator department shall provide Reason / Justification for deviation.

4.10 Initiating department Head/Designee along with QA designee, Engineering and QC (Wherever applicable) shall jointly investigate the root cause of deviation. QA Head/Designee shall take inputs during investigation from other department based on the need.

4.11  Department Head/Designee of respective department shall suggest corrective and preventive methodology for current stage.

4.12  QA shall review of proposed steps to resolve the deviation (correction) and suggested corrective action for current stage.

4.13  QA Head/Designee after review will evaluates the deviation and decides the Approval / Rejection.

4.14  Head QA shall decide initiation of CAPA review based on nature of deviation. All such deviations, which deems to be critical for quality of product, system or may pose a compliance risk, shall be considered for initiation of CAPA system.

4.15  After approval of the deviation QA Head/Designee shall ensure implementation of the corrective and preventive actions.  

4.16  QA shall ensure that all corrective actions recommended in the deviation form have been complied, all affected documents updated and affected batch or activity has been completed in compliance before closing the deviation.

4.17  All deviation shall be closed within 30 working days from the date of corrective action plan was approved. Proper justification by the initiating department and authorization from Head/Designee QA is required for further extension of implementation period.

4.18  The type of review based on initial deviation reporting that requires CAPA review shall also be closed within 30 days of the reporting of the deviations unless otherwise justified.

4.19  On completion of activity, deviation shall be closed by QA Head/Designee.

4.20  Maintain all Deviation records in a separate register for tracking of Deviations.

4.21 If the process cannot be stopped in between, QA Head/Designee and Production Head/Designee can take a decision on continuing the process till next stage, after assessing the impact of deviation on product quality and taking immediate corrective action(s). However, Head/Designee QA shall take final decision on batch disposition after reviewing the deviation and other related documents.

4.22  No deviation is permitted from Pharmacopoeia and other Regulatory specifications. However additional steps for betterment to Pharmacopoeial standard will not be treated as deviation.