sop Holding time of in-process stage material.
1. OBJECTIVE 1.1. To provide the procedure for in-process stage materials which has crossed hold time. at such as blend, compressed tablets, coated tablets filled capsules.
2. SCOPE 2.1. To all the in-process stage material such as but not limited to dried granules, blend, compressed tablets, coated tablets, coated pellets, filled capsules at the site.
3. RESPONSIBILITY 3.1. Production Officer: To check the validity of material during storage and initiate request for testing. 3.2. In-process Quality Assurance Officer (IPQA): Verify the holding time of in-process material, to send the sample of material which has crossed the holding period & to evaluate the results received from Quality Control department. 3.3. Quality Control Chemist: To analyze and report the results of samples submitted by IPQA.
4. PROCEDURE 4.1. After completion of various steps of processing of a product, in-process stage material to be stored at designated “semi finished” product storage area. 4.2. While storing the material appropriate label to be affixed on the container to indicate the product name, batch number, date of processing and hold time period. 4.3. Based on the nature of the product the hold time shall vary. In general following are the hold time period assigned for various types of products unless until specified in the batch manufacturing record; 4.3.1. Multi vitamins: 15 days for each processing stage. 4.3.2. Dried granules: 7 days. 4.3.3. Other materials but not limited to: Blend, compressed tablets, coated tablets, coated pellets, filled capsules: 30 days. 4.4. The material under hold should be stored at the environmental (temperature and humidity) conditions as required by the product. 4.5. Responsible personnel from production to identify the product crossing its validity. If any product exceeds the holding period as per point 4.3, he/she should initiate testing of the material before proceeding for further processing. 4.6. Production personnel to inform IPQA about the material to be tested by sending duly filled “Holding Time Record” (format PRP/F/037.). “Holding Time Record” should be in duplicate form i.e. Production copy and Quality control copy. 4.7. IPQA to verify the status of the material and arrange to draw the sample and submit to QC for testing along with format (PRP/F/037). 4.8. IPQA to log the details of sample in their sample entry register & respective batch manufacturing record for traceability. 4.9. QC to test the sample for the specified tests mentioned in format and fill the results in “Holding Time Record” & forward to IPQA. 4.10. IPQA to evaluate the results against the specification requirement and decide the suitability of the material for further processing. 4.11. If the material does not meet the specification requirement (out-of-specification), QA to decide the disposal of the material after discussion with production. 4.12. The next process can be started up to last date (inclusive) of period irrespective of completion time required. 5. FREQUENCY 5.1. As and when required. 6. ACCEPTANCE CRITERIA 6.1. The material crossed the holding period should meet the specification requirement after testing. 7. RELATED DOCUMENTS 7.1. Batch Manufacturing Record (BMR). 7.2. Sampling of Inprocess Material (IM) and Finished Product (FP): SOP No.: SOP/PTN/QA/040. 8. REFERENCES 8.1. Nil