To lay down a standard procedure for receiving, distribution, testing and reporting of Bulk, Intermediate and Finished Products.
This procedure is applicable for receiving, distribution, testing and reporting of Bulk, Intermediate and Finished Products in Quality Control Laboratory
Officers / Executive – Quality Control shall be responsible for follow the procedure mentioned in this SOP’s.
Head QC and Head QA shall be accountable for compliance of this SOP.
Bulk Product Inward Register Attachment-I
Intermediate Product Inward Register (Uncoated) Attachment-II
Intermediate Product Inward Register Attachment-III
(Coated, Capsules, Syrup and Sachet)
Finished Product Inward Register Attachment-IV
- Officer Quality Control shall receive the Intimation slip along with sample from Quality Assurance Department.
- Officer Quality Control shall make entry of samples detail and allocated the A.R. No. in the Bulk, Intermediate (uncoated), Intermediate (Coated, Capsules, Syrup and Sachet) and Finished Product inward register as per Attachment-I, II, III and IV.
- After entry of sample detail forward to Executive-Quality Control for distribution.
- Executive Quality Control shall distribute the sample with working sheet (issuance record shall be maintained as per SOP/QC/033) to analyst for analysis on the basis of priority.
- After distribution of work, analyst shall analyze the samples as per approved specifications and Standard Testing Procedure.
- All the Raw data of Analysis shall be recorded in working sheet as per SOP/QC/033.
- Attach all the chromatograms, weighing slips & other supportive documents with obtained analytical
results with working sheet.
- After completion of testing, the analyst must complete and sign the analytical record and all the
Supportive documents and analyst will hand over the analytical record and other documents to
Executive Quality Control for reviewing.
After reviewing, Officer Quality Control shall generate COA as per SOP/QC/076.
The COA shall be checked and signed by the analyst after comparing it with the analytical record.
Executive-Quality Control shall review the Certificate of Analysis, forward to Head Quality
Control for final approval.
After reviewing and signing of COA, Head Quality Control will approve the same.
Approved COA shall be forwarded to Quality Assurance Department.
Quality Assurance personnel shall approved/reject the Products on the basis of QC COA.
Note: In case of any discrepancy during analysis analyst shall inform to Head Quality Control.
SOP: Standard Operating Procedure
QC: Quality Control.
COA: Certificate of Analysis
RSD: Relative Standard Deviation
QA: Quality Assurance
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