1.0 PURPOSE
To lay down the procedure for Reprocessing of Intermediate / API.
2.0 SCOPE
2.1 This procedure is applicable in Production Department.
3.0 RESPONSIBILITY
3.1 Plant Manager
4.0 ACCOUNTABILITY
4.1 Manager – QA & RA
5.0 PROCEDURE
5.1 Quality Improvement of a batch undertaken for any parameter by following the same original process in full or in part as outlined in Master Production and Record.
5.2 Depending upon the nature of quality failure, a joint discussion is held between Production, QC and PD Lab to determine:
5.2.1 Reasons for failure and investigation there off.
5.2.2 Whether the batch is to be reprocessed or reworked to improve quality.
5.2.3 Whether stability studies will be required.
5.2.4 Whether any specific controls to be excised during reprocessing/rework.
5.3 Based on the out come of this discussion if reprocessing is recommended then reprocessing procedure shall be followed.
5.4 Any unusual observations made by production personnel during the manufacturing process is to be brought to the attention of plant manager. These observations may include.
• Colour
• pH
• Odour
• Any relevant observations.
5.5 Any observation made by QC is brought to the attention of the Plant Manager. These observation may include:
The condition listed in point 5.1 as well as in the following tests
(As applicable):
• Description
• Assay
• Solubility
• Identification
• Clarity and colour of solution
• Acidity
• Heavy metals
• Light absorption
• Sulphated ash
• Loss on Drying (LOD)
Before conducting reprocessing of a batch, a detailed investigation of failure is carried out (OOS investigation) to assist in taking suitable remedial actions for future lots.
5.6 Based on the area of non-compliance, plant manager initiates reprocessing of failing batch under advice from Process Development Laboratory/R&D as per the Master Production and control Record.
5.7 Separate Batch production and control record shall be prepared (if required) and issued for undertaking the reprocessing of the batch. The Batch production and control record is issued to production.
5.8 Batch Number for Reprocessing batch shall be given as per SOP Assigning Batch Number, Manufacturing and Re-Test / Expiry Dates For Active Pharmaceutical Ingredients And Intermediates
5.9 During reprocessing in process samples are tested in QC lab.
5.10 After reprocessing fresh samples are withdrawn and tested.
5.11 Batch number is assigned in continuation in the series.
5.12 Final test report is issued for release of batch after verification of compliance as per product specification.
5.13 Adequate documents are prepared to describe the reason, steps taken and final result. These document are the part of original Batch Production and Control Record (BPCR).
5.14 Stability studies of the reprocessed batches will be undertaken based on the assessment of QC, QA and PD Lab. The batches may be released for commercial purpose, if provided quality of such batches is similar to normal production batches.
END OF DOCUMENT
Reprocessing, intermediate api, quality assurance
