Release Of Finished Product SOPs
1.0 OBJECTIVE:
To
clearly lay down a procedure for release of finished product.
2.0 SCOPE:
This
is applicable to release finished product of all formulation.
3.0 RESPONSIBILITY:
3.1
Doing: Tech. Asst. /Executive/ Manager.
3.2
Checking: Executive/ Asst. Manager/
Manager.
4.0 ACCOUNTABILITY:
Head
of the Department.
5.0 PROCEDURE:
5.1
On receipt of finished product sample
along with intimation slip from Q.A dept, QC will give QC Report No. as per
following logic.
5.1.1
Product
Manufacture at Plant.
XZWYYYYA
Where,
X indicates type of
formulation.
e.g.
= T for tablet.
C for capsule.
P for parenteral
product.
Z= indicates Sr.
No. of analysis carried out for different specification of same batch no.
starting with 1.
W= indicates
location code.
Y= indicates B.No.
of the respective product.
A= indicates lot
no. of batch if it is given.
5.2
Enter the details respectively in register
maintained for Tablet, Capsule, Parenteral and Contract Mfg.
5.3
After completion of entry, put the sample
in to “UNDER TEST SAMPLE” tray.
5.4
Q.C Section In-charge/ Executive shall
distribute the sample along with intimation slip controlled testing data sheet
and prior to the chemical section, instrument section µbiology section
for respective analysis. The details of the protocol distribution to each
section are to be maintained in protocol distribution list as per SOP.
5.5
Chemist shall analyze the sample after
referring respective specification and method of analysis; record the results
in data sheet and record result in SAP system.
5.6
If any result is found out of
specification, follow SOP for OOS.
5.7
On completion of testing, give report to
QC section In-charge/ Executive for checking.
5.8
Q.C section In-charge/Executive shall
check the results of chemical, instrument and microbiological testing. Sign the
report on finding it satisfactory and Section In-charge/ Executive gives user
decision.
5.9
Sign the report on finding it
satisfactory. QC Section In-charge/ Executive shall give User Decision after
checking all results.
5.10 Q.C
Section In-charge/ Executive enter the result into respective entry register as
per annexure.
5.11 After
completion of entry, Q.C Section In-charge/ Executive will fill the details in
the prior to packing release slip in triplicate and release the product for
packing.
5.12 Q.C
Section In-charge/ Executive will send yellow and green copy to production
dept. and attach the third white copy with testing report.
5.13 In
absence of responsible person, Technical Assistant shall convey the results to
production dept. and send “Prior to packaging release slip” to production dept.
duly signed by analyst.
5.14 After
completion of testing destroy the sample as per SOP.
5.15 Put
report in to tray ‘report for computer entry’. Q.C Section In-charge/ Executive
will check & sign the computer generated COA and send total QC testing
report along with COA to QA dept.
5.16 For
export product follow instruction from the respective section or PPC section
attach respective specification in SAP system, allot the Q.C A.R. No. to sample
and attach the intimation which is received from packing section make entry in
Export register Annexure & keep the sample in to “UNDER TEST SAMPLE” tray.
5.17 Q.C
Section In-charge/ Executive distributes the sample along with “Export Plan
Slip” if received and controlled testing data sheet (for Export).
5.18 Review
the export data sheet on any country specification for its specification &
MOA. If it is found similar as like in domestic then on basis of analysis
carried out earlier, mention the same Q.C A.R. No. against each test export
data sheet as reference and no need to perform analysis.
5.19 In
Export data sheet if test method is different, then analyst shall carry out
analysis of that test as per respective method and report it in the data sheet.
5.20 Follow
step No. 5.5 to 5.9.
5.21 After
completion of testing Q.C Section In-charge/ Executive will send white copy of
“Export Plan Slip” with status of complies or does not comply to Pkg.
department and attached another pink copy with report & follow step No.
5.16.
5.22 After
completion of testing destroy the sample as per SOP.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
01/07/2020 |
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
S
|
Standard
operating procedure |
|
& |
And
|
|
% |
percentage |