SOP on Handling of Non-Conformances

Recorded by                                                                                                              HOD/ Designee

(Sign/date)                                                                                                                  (Sign/date)

CAPA required/ not required :……….

CAPA number (If applicable) :……………..

Signatures with date of Technical Committee Members:

Disposition by Quality Assurance:

Head Quality Assurance/ Designee

                                                                                                                                                      (Sign./date)

Re-evaluation of Non conformance required/ not required

Remarks

                                 Head-Quality Assurance/ Designee

(Sign./ Date)

Re-evaluation of Non conformance required/ not required         

Re-evaluation of Non conformance:

Dated …………………..  by ………………………………………Department:……………………….

Remarks:

Sign./ Date

Dated …………………..  by ………………………………………Department:……………………….

Remarks:

Sign./ Date

a.       Does Store has a current list of Approved Vendors

Has the API(S) been received from more than one approved vendor

(especially supplier) ? If yes, compare the consignments received w.r.t.:

-Transportation chosen (measures taken by the transporters to prevent exposure of material to heat, humidity, light, etc.)

material(s)

i.       Proper labelling

ii.     Proper Storage

Adherence to the Standard Operating Procedures for storage and withdrawal of control samples

i.      As on date of investigation

ii.    During period of manufacture of product under investigation

i.       Stored properly (isolated from floor and detached from the walls)

ii.    Properly Labelled

iii.  Stored as per recommended Storage conditions

iv.  Stored in the relevant areas

v.    Retested, where applicable, as per requirement and labelled accordingly

i.      Proper labelling of the sampled containers

ii.    Proper Resealing of the sampled container

iii.  Inquire the QC Chemist for procedure followed for sampling

–                    Cleaning procedure of sampling aids

–                    Handling of material during sampling

–    Date of receipt of sample in QC

–    Conditions during storage of material in QC

–    Date of release of:

a. Has the calculation been checked by production personnel and verified by QC personnel?

i.        Quantities of materials dispensed

ii.      AR. No. of materials dispensed

iii.    Conformance of issuance of materials to FEFO

COA of materials dispensed and retest date (cross check AR. No. recorded in the issuance records, value of assay, water/ LOD, etc.)

i.        Area purging records

ii.      Line purging

iii.   Cleaning records(of both OFCF, dispensing aids and vessels/ containers in which the materials have been dispensed

iv.    Machine Log sheet

Preventive Maintenance

i.          Calibration Status

ii.     Cleaning Status

i.       Reason of deviation

ii.     Deviation authorised by

i.       Labelling on the containers

ii.     Retest date, if applicable on the label

iii.   Proper storage

i.        Balances used for dispensing

ii.      Hygrometer

iii.    Pressure gauges of the Open Fronted Containment Facility

i.      As on date of investigation

ii.     During the period of manufacture of the product

i.           Check area cleaning records

ii.         Has the frequency of cleaning as per SOP

iii.       Has rotation of disinfectants implemented

iv.        Has the checking of area undertaken by QA as per frequency mentioned in the SOP

i.         Material dispensed on:

ii.         Batch manufacturing started on : (date)                 (time)

iii.         Storage conditions of materials during the period dispensed material was stored prior to the start of batch manufacturing:

i.      Line purging record (cross check with the Batch Manufacturing Record of the previous product mentioned)

ii.     Preventive maintenance label and verify

iii.    Calibration records of instruments, where applicable

iv.   Qualification data

i.          For overwriting, cutting or any other indications suggestive of intentional change in data.

a.       Description/ capacity of equipment  as per BMR

b.      Line purging

c.       Calibration status of critical instruments, if applicable

d.      Preventive Maintenance Status

e.       Training records of the personnel who operated the machines at the time of manufacture of      the product (Select any three machines e.g. Compression/ Capsule filling/ Bottle filling, blender, FBD, etc.)

_________________           ____________               ____________     ___________  _______________           ___________         ___________        __________

_______________          ____________        ___________       __________

a.    Check if the parameters tested is an per specification or as mentioned in BMR

b.    Check if the in-process request is signed and dated both by production and QA, as appropriate

c.    Check the raw data

d.   Is the analysis records signed by both person who executes them and an authorised person from QC

e.    Verify if the testing has been done as per Standard Testing Procedure

Stage                                       Process Completed on Next step started on   ______________        _____________________     ______________________ ______________                   _____________________      ______________________

Does the period suggest any detrimental effect on the quality of intermediate e.g. de-blending?

i.              Sampling procedures followed

ii.          Testing records

iii.        Release reports

i.         i.  Storage Area environmental records for the period when the intermediate was stored

ii.  Period for which the intermediate was stored

iii.   Is the entry to the Intermediate storage area restricted

iv.   Is list of person(s) authorised for entry into restricted areas available

i.       Quantities issued

ii.      Stock register of stores for compliance to FIFO

iii.     Verification of Quantities by production after receipt of material in production

Check the line purging records of the packaging machine.

Time of issue of Packaging Material:

Time of Start of Packaging Operation:

i.       Quantity of samples withdrawn

ii.      Physical condition of Control Samples

iii.     Condition of Control Sample storage area.

iv.    Is the access to Control Sample storage area restricted

i.    If within the limit, compare the yield with at least preceding two batches and succeeding batch.

ii.   If out of limit, has deviation been raised and investigated?

iii.  Are any corrective and preventive actions taken?

i.    Deviation Report No.:

ii.  Has investigation been completed

iii.If investigation is pending, reason:

ii.     Date of release of batch by Production:

iii.                                        Date of release of batch by QA:

iv.                                        Does the product has any microbiological testing? If yes, date of release of batch

after microbiological analysis:

v.                       Date of dispatch of first consignment and quantity:

iv.     Storage condition

v.       Environmental conditions

vi.     Labelling

vii.   Segregation

–          If no, reasons thereof

–          If yes, are the conditions appropriate with the labelled storage conditions

–           Collect data of a period spreading across different season to obtain information regarding environmental conditions during transportation.

NCR No.

Conformance product