1.0 PURPOSE
To lay down the procedure for handling of deviation.
2.0 SCOPE
2.1 This SOP is applicable to all controlled & uncontrolled deviation occurred in Production, Quality Control, Quality Assurance, Warehouse, Safety and Environment, Engineering, Purchase and Electronic Data Processing (EDP) departments
2.2 Any planned deviation from validated system, which is directly related to the quality, and safety of the drug substances or drug product shall not be under the scope of this SOP. These deviations shall be handled as per the SOP of change control system.
3.0 RESPONSIBILITY
3.1 Concerned Department
4.0 ACCOUNTABILITY
4.1 Manager - Quality Assurance
5.0 PROCEDURE
5.1 Controlled Deviation: Any deviation from documented procedure opted deliberately for temporary period to manage unavoidable situation without affecting the quality and safety of drug substances or drug product shall be termed as controlled deviation.
5.2 Uncontrolled Deviation: Any deviation occurred in unplanned or uncontrolled manner due to system failure or equipment breakdown or manual error shall be termed as uncontrolled deviation.
5.3 Controlled deviation.
5.3.1 Initiator department shall raise deviation form as given in Annexure -I in advance.
5.3.2 Head of the concerned department shall review the deviation and shall record the corrective action to prevent the recurrence for the need of the deviation.
5.3.3 Head of Quality Assurance shall review the type and reason of deviation for its effect on the
quality and safety of the drug substance or drug product to approve or reject the deviation request.
5.3.4 Head of Quality Assurance shall ensure that proper action has been taken to prevent the
recurrence of the need for deviation.
5.4 Uncontrolled deviation.
5.4.1 If the uncontrolled deviation is taken place during manufacturing of batch, shift in-charge shall mention the type of deviation and reason of the deviation in Batch Production and Control Record (BPCR).
5.4.2 Uncontrolled deviation from the standard of non-critical parameter of manufacturing process written in BPCR need not to be documented in deviation form as given in Annexure-I. It shall be listed in the prescribed format of the BPCR.
5.4.3 Uncontrolled deviation of critical parameter of manufacturing process, need to be documented in Deviation form as given in Annexure -I. Actions required for handling this type of deviation shall be as follows.
5.4.3.1 Investigation shall be carried out to find out the cause of deviation.
5.4.3.2 Investigation report shall be attached with the deviation report.
5.4.3.3 The effect of the deviation on the quality and safety of the drug substance or drug product shall be reviewed based on the nature of deviation.
5.4.3.4 Release of the batch shall be decided on the basis of the outcome of investigation and effect of deviation on the drug substance or drug product.
5.4.3.5 Proper action shall be taken to prevent the recurrence of the deviation.
5.4.4 Uncontrolled deviation from the standard parameters of system or procedures other than manufacturing processing shall be documented in the deviation form.
5.4.5 Actions required for handling these types of deviation shall be as per the procedure described in point number 5.4.3.1, 5.4.3.2 and 5.4.3.3 & 5.4.3.5.
5.5 Deviation control numbering system is given below;
Initiator Department Code (Refer SOP Preparation, Review, Approval, Distribution And Revision Of Standard Operating Procedure)
Format title prefix
5.6 Deviation of manufacturing processes shall be recorded product-wise in the format as given in Annexure-II.
5.7 Deviation other than manufacturing process shall be recorded separately in format as given in Annexure-II.
5.8 Deviation log shall be reviewed on monthly basis to review adequacy of corrective action.
END OF DOCUMENT
Handling of deviation, quality assurance, drug product
