14-SOP FOR HANDLING OF DEVIATION

I.                  PURPOSE

To describe the investigation and control procedure for any type of deviation, which can affect the quality of the product, to enable a suitable and prompt corrective action.

II.               SCOPE

This procedure is applicable to planned and preplanned deviations in written procedures carried out at , Unit – V.

III.            RESPONSIBILITY

Executive, Head - User department

IV.            ACCOUNTABILITY

Head QA

V.               PROCEDURE

1.0            The user department should ensure that there are no deviations to the approved,  

            established procedure under normal conditions.

            2.0       Deviations are classified as:

      Planned Deviation

      Unplanned Deviation

            3.0       Planned deviation is carried out only for

3.1              Quality improvement

3.2              Yield improvement

3.3              Safety reasons

3.4              Break downs

3.5               Better GMPs

3.6               Market requirement

3.7               Insufficient inputs

4.0               Unplanned deviations can arise due to

4.1               Human error

4.2                

        4.2      Malfunctioning of any equipment or instrument.

        4.3      Equipment or instrument breakdown

        4.4      Utility or service failure/breakdown

        4.5      Yield deviation

5.0       Definition of Planned Deviation:

 Any deviation from documented procedure required for a temporary period to manage       unavoidable situation without affecting the quality and safety of intermediates / APIs is      to be termed as Planned deviation.

6.0       Procedure to handle Planned Deviations

6.1       Respective department Head/Executive raises the ‘Planned Deviation Report’ (P.D.R) in advance as per the Format No.: F02/SOPQA014-00, with deviation details and reason for deviation.

6.2       Quality Assurance enters the details of deviation in ‘Planned / Unplanned Deviation Log’ Format No.: F01/SOPQA014-00.

6.3        QA reviews the reason for deviation and its effect on quality, safety of      Intermediate and API. Based on the nature of deviation, QA comments on the     deviation and identifies the department heads from whom approval is required.

6.4        Based on the comments made by QA the initiating department responds to the      QA recommendations.

6.5       After getting approval from the identified department heads, QA decides whether to approve or reject the deviation and writes the final recommendations.

6.6       Finally the deviation report must be approved by the concerned department           heads and QA.

6.7       Quality Assurance ensures that proper action has been taken to prevent the

recurrence of the need for deviation.

7.0       Unplanned Deviation:

 Any deviation occurred in unplanned or uncontrolled manner due to system failure or       

                        equipment break down or manual error is to be termed as Unplanned deviation.

8.0       Procedure to handle Unplanned Deviation

 8.1       Deviation observer raises the ‘Unplanned Deviation Report’ (U.D.R)

             Format No.: F03/SOPQA014-00, with the description of deviation, reason for       deviation, immediate action taken, with present status details and forward to                     QA.

8.2         Quality Assurance enters the details of deviation in ‘Planned/Unplanned    Deviation Log’ Format No.: F01/SOPQA014-00.

8.3        Quality Assurance reviews the reason for deviation, present status. Based on the    nature of deviation QA recommends the investigation and proposes the                  investigation team.

8.4         The investigation team investigates the reason for deviation and prepares a        investigation report and proposes the corrective and preventive action.

8.5         Release/rejection of batch must be decided based on the out come of          investigation.

8.6         Finally QA reviews the results after implementing the proposed corrective actions and closes the deviation report.

9.0        Numbering of Deviation Report is done as follows

                        9.1       For Planned Deviation Report

PDR   XX   YY    XXX

                                                          Sequential number

                                                                                              Last 2 digits of the calendar year

                                                                                                          Product code

                                                                                                          Controlled Deviation Report

               Typical example: PDRAX04001 indicates First Planned Deviation Report

                                      of Amoxicillin Trihydrate obtained  in the year 2004.

            9.2       For Unplanned Deviation Report

UDR   XX   YY    XXX

                                                          Sequential number

                                                                                              Last 2 digits of the calendar year

                                                                                                          Product code

                                                                                                          Uncontrolled Deviation Report

                  Typical example: UDRAX05001 indicates First Unplanned Deviation Report

                                      of Amoxicillin Trihydrate obtained  in the year 2005.

                                      Finished product codes are given as per QA007.

10.0        Deviation log should be maintained product wise.

11.0    List of Formats

Format No.	Title
F01/SOPQA014-00	Planned/ Unplanned Deviation log
F02/SOPQA014-00	Planned Deviation Report
F03/SOPQA014-00	Unplanned Deviation Report

            VI.    REVISION SUMMARY

Version No.	Revised on	Reason for Revision
00	NA	NA

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