Batch Tailing, Purpose:
Batch Tailing, To establish general guidelines for batch tailing of products. It is the process whereby residual defective product (e.g. Granules, broken tablets, capsules etc.) which is satisfactory on quality, is to be added to the subsequent batches as a relatively small portion of the final batch quantity (where to be added) without affecting the quality of finished product.
Batch Tailing, Scope:
This procedure is applicable for oral solid dosages form that manufactured at XX Pharmaceuticals Limited (both General and Sterile Block).
Definition / Abbreviation:
[][]N/A
Responsibilities:
[][]The roles and responsibility are as follows:
Production Personnel
[][]To ensure that the residual product to be added is physically and chemically okay and the entire process is done following SOP.
Concerned department head
[][]To ensure that above procedure is followed properly.
Quality Assurance personnel
[][]To monitor the entire process done according to SOP.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
Storage and Selection Criteria of Batch Tail:
[][]The product/material to be added shall be kept in a double lined poly bag in a container with lid closed by mask tape.
[][]The container and the polybag shall be labeled properly mentioning Product Name, Batch No., quantity and date of manufacturing and to be stored in cool & dry place of well-defined areas of production.
[][]Only Product from approved batches can be added.
[][]If any batch is reprocessed once, leftover material of that batch must be disposed immediately.
[][]Addition of any leftover material/product shall be completed within the same manufacturing month or subsequent month. In case of slow moving product, it shall be completed with next manufacturing batch but the difference between two batches shall not exceed more than 3 months.
[][]Products/materials must not be added from a batch which is kept for more than three months (i.e. 90 days) in bulk condition (e.g. bulk tablets, bulk powder of capsules, blended pellets etc.).
[][]Within above time limits, if there is any sign of deterioration of the product is seen visually, they must be discarded.
[][]The weight of the material/product to be added should be equal to or less than 5% of the original batch size (weight) of the product. Maximum 10% can be allowed with justification.
[][]If the quantity is huge, a reprocessed batch can be manufactured using all tailed quantity. In that case, Batch No., Mfg. & Exp. Date shall be according to the oldest batch of accumulated batches.
[][]Powder for Suspension cannot be added to any other batch(s). This is to be discarded with proper reconciliation in the batch document.
Steps for prior Approval of Batch Tailing
[][]Concerned department Executive shall raise Batch Tailing Form (Annexure-I) and fill up the relevant information in section A & B. There must be clear statement regarding the reason for Batch tailing.
[][]In section C of Batch Tailing Form, Manager of concerned department shall provide his comments ensuring the statement provided by his officer and suitability of reprocessing/reworking of the product.
[][]Before taking decision of addition of batch tailings to subsequent batch, physical verification of batch tails must be carried out by Quality Assurance Executive and shall record observation in section D of Batch Tailing Form.
[][]In section E of Form, Manager, Quality Assurance shall give comments to ensure its suitability of re-use.
[][]In section F of Batch Tailing Form, comments shall be given by General Manager, Plant.
[][]In section G of Form, Head of Quality Assurance shall provide comments regarding approval.
[][]The approved Batch Tailing Form shall be the part of batch records
Annexure:
Annexure – I: Batch Tailing From