SOP for Raw Material Release : Pharmaceutical Guidelines

SOP for Raw Material Release

Standard operating procedure to release the approved raw material.

1.0 OBJECTIVE

To clearly lay down the procedure for release of raw materials.

2.0 SCOPE

This procedure is applicable for all raw materials.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant /Executive
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 On receipt of the raw material sample from store to Q.C, put into "Under Test Sample" tray kept at a designated place.
5.2 Enter the details in the raw material register.
5.3 Distribute the sample for Chemical, Instrument and Microbiology test as per specification.
5.4 Issue the photocopy of protocol and COA format for analysis from the controlled computer system and put the date and signature on it.
5.5 Carry out the identification test separately for active raw material for each container.
5.6 For active raw materials perform rest of the test as per the specification from the composite sample prepared from all containers.
5.5 For active raw materials, perform the assay test from the composite samples prepared from every 10 containers & report the average value in the certificate of analysis.
5.6 For inactive raw materials perform the complete testing as per specification from the composite sample prepared from the sampled containers.
5.7 Write the identification no. of the instrument which is used for analysis on protocol.
5.10 Enter all results in protocol and accordingly in COA and complete the testing.
5.11 On completion of testing enter the detail in the raw material receiving a report under the heading of:
1. Approved/Rejected quantity
2. In case of Active raw material as such assay
3. Date of Release /Rejected
4. Approved/Rejected status
5.12 Submit material receiving report and testing report to Q.C Incharge for checking and signing it.
5.13 Attach Q.C copy of MRR with sampling report and file it .
5.14 Check the test report, enter the detail in the register and file it.
5.15 Send remaining two copies of MRR to R.M. store.
5.16 Enter the details in the computer for the assay (for active) and change the status to Approved/Rejected status of respective A.R.No. by the authorized person to whom passwords are allotted.
5.17 Take out the print out of assay status list daily. Verify by the concern Executive / Asst manager & submit one copy to production incharge & other copy to R.M store.
5.18 Print out the required no. of the status label from the computer.
5.19 Enter following details for green "APPROVED " label.
A.R. No.
:
Approved By
:                            Date :
Retest Due Date
:
5.20 In case of Rejection, write following details on red "REJECTED" label.
A.R. No.
:
Rejected By
:                            Date :
Reason
:
5.21 Paste APPROVED / REJECTED label over the word "UNDER TEST" on the yellow label.

6.0 ABBREVIATIONS

6.1 Q.C= Quality control
6.2 A.R.No. = Analytical report number
6.3 No.= Number
6.5 R.M.= Raw material
6.6 M.R.R = Material Receiving Report
6.7 Ref.no.= Reference number
6.8 C.O.A = Certificate of Analysis





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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