- OBJECTIVE:
- To lay down a procedure for testing and release of raw materials.
- SCOPE:
This SOP is applicable to the procedure for testing and release of raw materials at {Company Name} {Location}.
- RESPONSIBILITY:
- Chemist/Executive/Designee QC: Responsible for Analysis of Raw Materials
- Head QC or his designee: Responsible for Work Allocation and approval of Analytical data and Responsible for release of Raw materials.
- ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
- PROCEDURE:
- Testing:
- QC Chemist shall sample and register the Raw materials sample and submit it to Quality Control Department.
- Executive/Designee shall allot/delegate the sample to concerned chemists.
- The chemist shall prepare relevant work sheets as per SOP.
- Analyst shall perform the tests as per Standard Testing Procedure of respective Product.
- All “Sample for Analysis” containers of active ingredient shall be tested for identification test.
- In case of In Active ingredients all “Sample for Analysis” containers shall be carried Out for identification test.
- “Pooled Sample for Complete Analysis” container shall be tested as per Standard Testing Procedure for complete analysis.
- Testing:
Note: One identification shall be carried out preferably IR Method/HPLC Method wherever applicable if both methods are not applicable, in such case chemical identification method shall be done.
- After testing is completed, the chemist shall enter the data in work sheets and completed Worksheet and chromatograms shall be handed over to Sr. Executive-QC.
- On entry of the results, in case of an OOS result observation, the chemist shall report the same to the immediate supervisor; the supervisor shall initiate the investigation along with the Head-QC as per SOP.
- Sr. Executive-QC shall review the work sheet as per SOP and Section In charge or his designee shall ensure that all the tests are performed as per the standard test procedure and results are reported as per the specification and then only, he shall enter the Status column with sign in the Raw Material Sample Inward Register.
- Sr. Executive-QC shall take two copies of COA’s as per SOP, following the rounding off the digits as per SOP. (1 st copy for QC compilation and 2 nd copy for Stores)
- QC- Manager or his designee shall ensure that all the tests are performed as Per standard test procedure and results are reported as per the specification and then only, he shall sign and date in the “Approved by” column in the COA.
- The section in charge shall compare the results observed between the vendor’s COA and the In-house COA and record the observation in the worksheet. Any significant differences observed shall be intimated to the vendor through Head –QC.
- In case of any Non-Conformance in test results follow SOP for proper Investigation.
- Release:
- The completed Analytical report shall be submitted to Documentation cell for archival.
- QC in-charge shall approve and sends dually filled Approved/Rejected Labels to stores and same shall be affixed over the under-test labels in such a way that the “UNDER TEST” portion is hidden.
- Retesting criteria for Active/In Active Raw materials and flavors as per SOP.
- QC chemist shall ensure that the materials are transferred to appropriate storage area.
- REFERENCES:
Not Applicable
- ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
- DISTRIBUTION:
- Controlled Copy No. 01 : Head Quality Assurance
- Controlled Copy No. 02 : Head Quality Control
- Master Copy : Quality Assurance Department
- ABBREVIATIONS:
| No. | : | Number |
| OOS | : | Out of specification |
| SOP | : | Standard Operating Procedure |
| COA | : | Certificate of Analysis |
| QC | : | Quality Control |
- REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Frequently Asked Question ?
Q: What is the process for sampling and registering raw materials?
A: The QC Chemist samples and registers the raw materials sample and submits it to the Quality Control Department.
Q: Who allocates/delegates the sample to concerned chemists?
A: The Executive/Designee allocates/delegates the sample to concerned chemists.
Q: What are the steps involved in testing raw materials?
A:
- The chemist prepares relevant work sheets as per SOP.
- Analyst performs the tests as per Standard Testing Procedure of respective Product.
- All “Sample for Analysis” containers of active ingredient shall be tested for identification test.
- In case of In Active ingredients all “Sample for Analysis” containers shall be carried Out for identification test.
- “Pooled Sample for Complete Analysis” container shall be tested as per Standard Testing Procedure for complete analysis.
- After testing is completed, the chemist shall enter the data in work sheets and completed Worksheet and chromatograms shall be handed over to Sr. Executive-QC.
Q: What happens if the test results are out of specification (OOS)?
A: On entry of the results, in case of an OOS result observation, the chemist shall report the same to the immediate supervisor; the supervisor shall initiate the investigation along with the Head-QC as per SOP.
Q: Who reviews the work sheet and ensures that all the tests are performed as per the standard test procedure?
A: Sr. Executive-QC shall review the work sheet as per SOP and Section In charge or his designee shall ensure that all the tests are performed as per the standard test procedure and results are reported as per the specification and then only, he shall enter the Status column with sign in the Raw Material Sample Inward
Q: How many copies of COA’s are taken and who are they for?
A: Sr. Executive-QC shall take two copies of COA’s as per SOP, following the rounding off the digits as per SOP. (1st copy for QC compilation and 2nd copy for Stores)
Q: Who signs and dates the “Approved by” column in the COA?
A: QC- Manager or his designee shall ensure that all the tests are performed as per standard test procedure and results are reported as per the specification and then only, he shall sign and date in the “Approved by” column in the COA.
Q: How are the results of the raw material testing compared to the vendor’s COA?
A: The section in charge shall compare the results observed between the vendor’s COA and the In-house COA and record the observation in the worksheet. Any significant differences observed shall be intimated to the vendor through Head –QC.
Q: What happens to the completed Analytical report?
A: The completed Analytical report shall be submitted to Documentation cell for archival.
Q: How are the raw materials released?
A: QC in-charge approves and sends dually filled Approved/Rejected Labels to stores and the same are affixed over the under-test labels in such a way that the “UNDER TEST” portion is hidden.
Q: Who ensures that the materials are transferred to the appropriate storage area?
A: QC chemist shall ensure that the materials are transferred to the appropriate storage area.