Purpose:
The purpose of this procedure is to describe the process for retesting of raw material and packaging materials (before retest date).
Scope:
This procedure is applicable for all raw materials (APIs and excipients) and some packaging materials received in XX Pharmaceuticals Limited.
Definitions/Abbreviation:
[][]SOP: Standard Operating Procedure.
[][]QC: Quality Control.
[][]API: Active Pharmaceuticals Ingredients
Responsibilities:
The roles and responsibility is as follows:
Officer/Executive/Sr. Executive, QC & Microbiology
[][]To ensure that the instructions of this procedure are correctly followed.
[][]To maintain the records properly as per SOP.
Executive, Warehouse
[][]To send retest request to QC in time.
[][]To ensure availability of containers to be sampled from quarantine area to the sampling booth and their replacement after sampling.
[][]To ensure cleanliness of Sampling booth and containers to be sampled.
Manager, Quality Control
[][]To ensure that this procedure is kept up to date.
[][]To confirm that the SOP reflects the required working practices.
[][]To arrange training on the SOP to all concerned personnel and to ensure implementation of the SOP after training.
Head of Quality Assurance
[][]Approval of the SOP.
[][]To ensure the overall implementation of the SOP.
Procedure:
[][]Mention the retest date on passed label at the time of first release.
[][]Frequency of re-testing will be one year from test date.
[][]If the next retest date exceeds the expiry date, assign the retest date same as expiry date.
[][]The expiry date provided by the manufacturer will not be extended in any circumstances for active raw material.
[][]In case of excipients and packaging material, the expiry date may be extended on the basis of retest result if the expiry date is mentioned as best before/use before/retest date in manufacturer’s COA.
[][]In such cases, recommended expiry will be assigned instead of expiry and the next retest frequency will be every six months.
[][]The expiry date may be extended as per manufacturer’s recommendation.
[][]If there is no manufacturer’s recommendation, the expiry date may be extended twice for every six month up to one year from expiry date on the basis of retest result.
[][]Executive, warehouse will raise ‘Retesting Advice Form’ (as per Annexure-I) by ERP for the identified raw/packaging materials subject to retest or expiry.
[][]In case of material to be retested, warehouse will send the retest advice form at least 7 days before the retest date and QC will test and release/reject retested material within the retest date.
[][]In case of material to be expired, warehouse will send the retest advice form on the expiry date and QC will reject the expired material after necessary entries in retest advice form.
[][]QC will receive retesting advice form from warehouse and enter necessary information in Raw Material Register and assign the new Lab. Control No. for retest as below:
e.g. Lab. Control No./R1
Where, Lab. Control No. is of the identified material subject to retest.
/ is separator
R1 is retest for first time (e.g. R1, R2…..)
[][]Take sample from last used container for active and excipients sufficient for necessary retest parameters to relevant test specification.
[][]Collect sample following SOP for Raw material sampling and release procedure SOP for Packaging material sampling and release procedure and affix ‘UNDER RETEST’ label on the previous ‘PASSED’ label in cascading manner.
Carryout the following tests for each raw material
[][]Description/Appearance
[][]LOD/Water Content/Moisture Content
[][]Chromatographic Purity/Related Substance
[][]Assay
[][]pH/Acidity/Alkalinity test
[][]Microbial limit test
[][]Bacterial Endotoxin test
[][]Other relevant test (If necessary)
[][]Carry out required tests as described in the respective test method.
[][]Record analytical raw data in analytical worksheet and analyst logbook. Entry all results in certificate of analysis in ERP.
[][]Verify the test report against specification in ERP.
[][]Follow SOP for handling of out of specification if the test result does not comply with the specification.
[][]After approval/rejection, take print out the COA and two copies of approved ‘Retesting Advice Form’.
[][]Attach the retest report and related documents with the previous test reports.
[][]Prepare the required number of status labels (PASSED/REJECTED) for retested material.
[][]QC will send a copy of approved ‘Retesting Advice Form’ to warehouse.