Rework, Purpose :
Rework, To establish general guidelines for reprocessing, reworking of a full batch or part of a batch of product of an unacceptable quality from defined stage of production so that its quality may be rendered acceptable by one or more additional operation and to set forth method for repackaging of product with proper approval & proper documentation
Rework, Scope :
This procedure is applicable for concern department at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]Reprocessing: Reprocessing means the reworking of all or part of a batch of product of an unacceptable quality from a refined stage of production so that its quality may be rendered acceptable by one or more additional operation.
[][]Reworking: Reworking is taking an out of spec. of product and running it through a non–standard process to bring it back in to spec.
[][]Repackaging: Repackaging requires that the final bulk product/ final product be repacked into a specific size or configuration for a special customer order.
[][]SAF: Sample Advice Form
[][]QA: Quality Assurance
Responsibilities:
[][]The roles and responsibility is as follows:
Production
[][]To ensure that Reprocessing/Reworking and Repackaging is done following this SOP.
Concern Department Head
[][]Responsible to perform the job accordingly
Quality Assurance
[][]To monitor and implementation of the procedure
General Manager, Plant
[][]To ensure that the implementation of the procedure as per SOP.
Manager, Quality Assurance
[][]Approval of the SOP.
[][]To ensure that the implementation of the procedure as per SOP.
Procedure:
[][]Acceptable Reasons for Reprocessing
[][]Granules or Powder: Granules or Powder shall be reprocessed / reworked to correct uniformity of mixing, uniformity of fill wt. and potency to achieve required quality of granules.
[][]Plain and core tablets: Plain and core tablets shall be reprocessed to correct poor appearance, thickness, weight, hardness to improve content uniformity, disintegration or dissolution rate.
[][]Coated tablets: Coated tablets may be reprocessed to correct poor appearance, disintegration or dissolution.
[][]Capsules: Capsules may be reprocessed to correct weight variation, potency, dissolution rate etc.
Reprocessing/Reworking procedure:
Initiation & Approval of Reprocess/Rework Request form:
[][]If any reprocessing or reworking seems necessary, concerned Department shall raise Reprocess/Rework Request Form (Annexure-I) upon agreement of Product Development Department and Quality Assurance Department.
[][]Each Reprocess/Rework Request Form shall contain a full explanation of the reason for reprocessing and the proposed reprocessing steps.
[][]An investigation shall be carried out by QA with the help of PD and concerned department (if required) to identify the reason and process for reprocessing.
[][]After that the concerned Department Head, Head of PD and General Manager, Plant shall give their comments.
[][]The Reprocessing work shall start only after getting approval of the proposed reprocessing steps from Head of Quality Assurance.
[][]After completion of reprocess, concerned department shall advice Quality Control for analysis through SAF.
[][]When the test result is received from QC, QA shall then give decision about release of the product.
[][]The appropriately filled Reprocess/Rework Request Form (Annexure-I) along with other necessary documents shall become the part of the batch document.
[][]Assignment of Batch No., Manufacturing Date, Expiration Date and Reference No. for Reprocessing/Reworking batch.
[][]In case of reprocessing a part of a batch or full batch, the Batch No. of part shall be the original Batch No.
[][]In case of reprocessing of a product from different batches tails, the batch no. shall be the first batch of among those batches which are to be reprocessed and “R” shall be suffixed for identification of reprocessed batch.
[][]Manufacturing Date of different batches tails that composed/reformed a batch should be within two months.
[][]Reference No. for Reprocessing/Reworking shall be as
RW-001/07/XX
where-
=>RW represents Reprocess/Rework
=>001 represents monthly sequential number
07 represents Month of July. It will be changed in next month
=>XX represents year of 20XX. It will be changed in next year.
Repackaging Procedure (Primary & Secondary):
[][]When any repackaging of product seems necessary, concerned department shall raise proposal through Repackaging Request Form (Annexure-II)
[][]When any finished product (local/export) returned from central store and are required to convert into physician/local/export pack, it shall be processed through Repackaging Request Form (Annexure-II)
[][]An investigation shall be carried out by QA with the help of PD and concerned department (if required) to identify the reason for repackaging and product quality of the part of the batch which shall be repackaged. Necessary analytical work shall be done for repackaging part of the batch by QC (if required).
[][]Concerned Department shall forward sample through SAF (Sample Advice Form ) to QC for analytical work of repackaging part of the batch.
[][]After completion of analytical work, QC shall forward the analytical test result to concerned department.
[][]Concerned Department Head shall forward Repackaging Request Form to PD and subsequently to General Manager, Plant for their comments.
[][]After that, the Concerned Department forwards the Repackaging Request Form along with test result (SAF) to Head of QA for approval.
[][]Reference No. for Repackaging shall be as
RP-001/07/YY where-
=>RP represents Repackaging
=>001 represents monthly sequential number
=>07 represents Month of July. It will be changed in next month
=> YY represents year of 20YY. It will be changed in next year.
=>Finally Repackaging Request Form and related QC test results shall be the part of the batch document.
Annexure:
Annexure-I: Reprocess/Rework Request Form
Annexure-II: Repackaging Request Form