To lay down the procedure for Blending procedure of Active Pharmaceutical Ingredients/Intermediates.
1.0 PURPOSE
To lay down the procedure for Blending procedure of Active Pharmaceutical Ingredients/Intermediates.
2.0 SCOPE
2.1 This procedure is applicable in Quality Assurance, Quality Control and Production departments.
3.0 RESPONSIBILITY
3.1 Manager – Production
3.2 Manager - QC
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 Only approved batches shall be taken for the Blending.
5.2 Blending shall be performed
5.2.1 To increase the batch size of small batches.
5.2.2 To blend the tailings (i.e., small quantities) from batches of the same product to form a single batch.
5.2.3 To make the homogeneous Intermediate or API
5.3 Blending shall be performed as per the Delivery order or as per the production process requirement.
5.4 Production department shall send the Requisition for Blending to QC department for “Blending Advise Request” as per Annexure-I.
5.5 As per the customer requirement QC shall prepare the “Blending advise note” as per Annexure-II.
5.6 QC shall a “Blending advise note” to the production department.
5.7 Production department shall send a requisition to QA for issuance for Blend BPCR as per Annexure-III.
5.8 QA shall issue the BPCR
5.9 The expiry or retest date of the blended batch shall be based on the manufacturing date of the oldest batch in the blend.
END OF DOCUMENT
Quality assurance, packing materials, raw materials
