To lay down the procedure for Testing and Release of Raw materials, Intermediates and Active Pharmaceutical Ingredients (API).
1.0 PURPOSE:
1.1 To lay down the procedure for Testing and Release of Raw materials, Intermediates and Active Pharmaceutical Ingredients (API).
2.0 SCOPE:
2.1 This procedure is applicable for all Raw materials, Intermediates and API.
3.0 RESPONSIBILITY:
3.1 Chemist – Quality Control.
3.2 Section Head - Quality Control.
3.3 Chemist - IPQA
4.0 ACCOUNTABILITY:
4.1 Head - Quality Control.
5.0 PROCEDURE:
5.1 Raw materials:
5.1.1 Upon receipt of sample from QC distribution, executive – QC shall assign the analysis work to analyst at various sections.
5.1.2 Analyst shall take the concerned sample from respective tray.
5.1.3 Analyst shall analyze the sample as per respective Standard Testing Procedure (STP) and enter the data concurrently in the ADS.
5.1.4 Analyst shall fill the ADS and sign in the analysed by column with date, then shall enter the results in the Analytical report.
5.1.5 Raw data generated during analysis shall be signed & dated by the analyst and attached to the ADS.
5.1.6 Filled ADS and the raw data shall be forwarded to executive – QC for review along with filled ATR
5.1.7 Executive shall review ADS, and raw data, and then shall sign with date in all the pages.
5.1.8 Executive shall check all the observations against the respective specification and write the remarks in the ATR and attached MRR
5.1.9 Executive shall enter the data in ERP and save.
5.1.10 Reviewed ATR along with ADS with all the supporting documents including MRR shall be forwarded to head – QC for approval signature
5.1.11 Head – QC shall check the ADS, the raw data and MRR, and then shall sign with date in the approved by column.
5.1.12 Executive-QC shall forward the document to IPQA
5.1.13 Executive QA shall review the Completed ATR and ADS with all the supporting documents and check the contents in ERP and approve the status in ERP and release the status labels and take the Xerox copy of MRR . The same shall be attached to document
5.1.14 Documents shall be sent to document controller to preserve in designated area
5.1.15 Approved labels shall be pasted on all the containers over above the yellow color quarantine label.
5.1.16 Original copies of MRR shall be issued to Warehouse.
5.2 Intermediate and API:
5.2.1 Upon receipt of sample from QC distribution, executive – QC shall assign the analysis work to analyst at various sections.
5.2.2 Analyst shall take the concerned sample from respective tray.
5.2.3 Analyst shall analyse the sample as per respective Standard Testing Procedure (STP) and enter the data concurrently in the ADS.
5.2.4 Analyst shall fill the ADS and sign in the analysed by column with date, then shall enter the results in the Analytical report.
5.2.5 Raw data generated during analysis shall be signed & dated by the analyst and attached to the ADS.
5.2.6 Filled ADS and the raw data shall be forwarded to executive – QC for review along with filled ATR
5.2.7 Executive shall review ADS, and raw data, and then shall sign with date in all the pages.
5.2.8 Executive shall check all the observations against the respective specification and write the remarks in the ATR and attached sampling request and transfer slip
5.2.9 Executive shall enter the data in ERP and save.
5.2.10 Reviewed ATR along with ADS with all the supporting documents including sample request and transfer slip shall be forwarded to head – QC for approval signature.
5.2.11 Head – QC shall check the ADS, the raw data and including sample request and transfer slip, and then shall sign with date in the approved by column.
5.2.12 Executive-QC shall forward the document to IPQA.
5.2.13 Executive QA shall review the Completed ATR and ADS with all the supporting documents and check the contents in ERP and approve the status in ERP and release the status labels. Duplicate copy of sample request and transfer slip attached to document
5.2.14 Documents shall be sent to document controller to preserve in designated area.
5.2.15 Approved labels shall be pasted on all the containers over above the yellow color quarantine label.
5.2.16 Investigation of any Out of Specification (OOS) shall be followed as the rejected intermediates and API’s.
Testing, release, raw materials, intermediates, pharmaceutical, ingredients
