| Handling of Deviation |
1.0 OBJECTIVE To lay down the procedure for handling of deviation In Quality assurance department. 2.0 SCOPE 2.1 This procedure is applicable for handling(i.e. initiation, justification, investigation, impact assessment, corrective and preventative actions, approval / rejection, implementation and closing) of deviations. 2.2 Some of the requirement of this SOP may be waived up in case of products manufactured for PL (Product License) Holders. In this case the procedure shall be followed as per technical agreement (TA). 3.0 RESPONSIBILITY • Officer or above of the User department shall be responsible for initiation of deviation. • Head of User Department shall be responsible for investigation and identifying & implementation of CAPA. • Quality control department shall be responsible for assessment of deviation and perform additional testing, if required. • Quality assurance department shall be responsible for recording, evaluation, impact assessment of deviation, review of CAPA, communication with MAHs and closure and trending of deviation. QA shall also communicate with other departments for review and impact assessment of deviation. 4.0 ACCOUNTABILITY Head Quality / QA To Read this SOP Click Here SOP for Handling of Technology Transfer. 5.0 PROCEDURE 5.1 Definition: Deviation is the departure from the approved procedure which may or may not have the direct or indirect impact on the product quality. 5.1.1 The deviation may be related to but not limited to established procedures, such as standard operating procedures, manufacturing, analytical, personnel, equipment, schedules, facility, specification and utility services. 5.2 Identification of Deviation: During routine operation, if deviation is observed or it is expected during execution of approved procedure, deviation shall be initiated. 5.3 Initiation of Deviation: To report the deviation concerned person from initiating department shall approach to QA department and shall take deviation form. Officer or above of QA Department shall issue the controlled copy of deviation form (Format No: XXX) and allot the deviation number. QA person shall mention department and date at the time of issuance of deviation format. The details of the deviation shall be recorded in the deviation log (Format No. XXX) before hand over the deviation form to initiating department. 5.3.1 Deviation Numbering System: Deviations numbers shall be assigned as per prototype DR/YY/NNN Where, DR: stands for deviation report Y Y: stands for last two digit of current year (e.g. 23 for 2023, 24 for 2024…….) Example: First deviation in year 2023 shall be numbered as DR/23/001. 5.3.2 Initiating person shall take the deviation from QA person and mention the details in the format as mentioned in below section. 5.3.3 Nature of deviation: Deviation is of two types; (a). Planned deviation and (b). Unplanned deviation 5.3.3.1 Planned deviation: a. It is proposed deliberate and temporary change to any approved procedure / process / standard / system / specification prior to execution. These deviations are carried out without intending to affect the strength, identity, purity and safety of the drug product / substances and with prior approval of quality assurance and MAH (marketing authorization holder). b. Planned deviation shallbe required to be planned for fix number of batches or fixed duration at the end of which outcome needs to be evaluated / validated. Wherever applicable, SOP on change control shall be followed to make changes permanent. c. Planned deviation shall be initiated in following cases but not limited to; I. Quality improvement (batch records, SOPs, test procedures) II. Market requirement III. Yield improvement IV. Better GMP / regulatory compliance V. Safety reasons VI. Any alternate proposal for approval and usage of material, not impacting on safety, efficacy and purity of product. VII. Any other temporary changes, not impacting of safety, efficacy and purity of product. 5.3.3.2 Unplanned deviation: a. Unplanned deviation is defined as any variance from established specification or requirements stated in SOPs or batch records or testing procedure or specification which may affect the safety, identity, strength, purity or quality of a product. b. Unplanned deviation is observed during and / or after the procedure has been carried out. Whenever an unplanned deviation occurs; it shall be immediately notified by originating department. c. Unplanned deviation shall be recorded within 72 hours after notification. d. Unplanned deviation can be initiated in following cases but not limited to; I. Utility or service failure / breakdown, II. Human error III. Temperature / relative humidity / differential pressure of the area is recorded out of limit IV. Malfunctioning of equipment / instrument V. Equipment / instrument breakdown VI. Final yield outside the acceptable limit VII. Any other parameters outside the limit mentioned in batch record VIII. Non-compliance of approved SOP IX. Calibration failure 5.3.4 Deviation related to: Deviation may be related but not limited to documents, procedure, specification and facility. 5.3.5 Brief description of deviation: Complete details shall be filled in the description. Description of the deviation shall contain the information as what is the deviation, where is the deviation occur, who observed the deviation, when did the deviation occur and what object is involve. Any relevant documents related to the deviation description shall be attached. Details of existing procedure shall be also mentioned. It should state what is expected as per approved procedure / documents and what is deviated related to it. 5.3.6 Immediate action performed in case of unplanned deviation or proposed action in case of planned deviation: In case of planned deviation, complete details shall be filled of proposed action for control strategy of proposed deviation to avoid any adverse impact on the system. In case of unplanned deviation, complete details shall be mentioned regarding immediate actions which are taken to stop the non compliance. After filling the details, initiating person shall sign at the space provided and forward to his HOD (head of department). 5.4 Investigation details: 5.4.1 QA manager / Head shall identify whether root cause analysis is required or not during investigation. If it is required, it shall be mentioned as which tools to be used for root cause analysis; Ishikawa diagram (6M) or WHY-WHY technique. 5.4.2 Root cause analysis: The concerned department along with QA does the investigation (if required). Investigation shall be done to identify the root cause of deviation. An appropriate level of root cause analysis shall be applied during the investigation of deviation, suspected product defects and other problems. 5.4.3 Root cause analysis of deviation shall be done as per format number QA01-011/F04. It shall be performed with intention to identify primary reason for the problem which if corrected prevents recurrence. 5.4.4 During root cause analysis primary focus shall be done on man, material, machine, method &Mother Nature (environment). 5.4.5 Impact assessment: 5.4.5.1 The investigation shall include the potential issues which shall have impact on patient safety, registration impact, stability, if any prior occurrences in previous or subsequent batches of the same product and also the other products or system that may have been affected by the anomaly. If any prior occurrences had happened then, Executive or above of QA shall review the CAPA and root cause identified at that time. 5.4.5.2 Executive or above of QA shall perform the impact assessment. |
