sop for Preparation and Issuance of Analysis protocol standard

1.0 OBJECTIVE:
To lay down a procedure for the “Preparation and Issuance of Analysis protocol” for Raw material, Packing material, In-process sample, Stability Product and Finished Product.

2.0 SCOPE:
This SOP is applicable for “Preparation and Issuance of Analysis protocol” for Raw material, Packing material, In-process sample, Stability and Finish products in Quality Control department

3.0 RESPONSIBILITY :
Executive / Officer – Quality Control

4.0 ACCOUNTABILITY :
Head – QC

5.0 PROCEDURE:
5.1 The Analysis Protocol shall be prepared on test basis for RM, PM, In- Process, Finished Product and Stability as per respective Standard test procedure
5.2 After receiving the samples and Testing Requisition Slip in quality control department, entry shall be done in respective material inward register.

5.3 Section in-charge or designee of Quality Control shall receive the sample and check the sample details mentioned on the label against the testing requisition slip.
5.4 A typical format for all Analysis Protocol of Raw material, packing material, finished product and In- process sample and stability samples shall be followed as per respective Annexure of this SOP
5.5 QC department shall prepare the Analysis Protocol of individual Product / Item as per respective STP / Monograph.
5.6 Analysis Protocol No. shall be mention on Protocol header as follows:

The number shall be QCP/XX/ Code-YY,
QCP – denotes for Quality Control Protocol
/ – denotes Slash
XX – denotes code i.e. for FG for finished, RM for Raw material, IP for In-process samples and SB for Stability
/ – denotes Slash
Code – denotes Product code/Material code/Item Code
– – denotes Hyphen
YY – Revision No. of Protocol i.e. 00, 01, 02, etc.
5.7 Analysis Protocol No. (for Packing material) shall be mention on Protocol header as follows: The number shall be QCP/PM/XXX-YYY-ZZ, Where
QCP – denotes for Quality Control Protocol
/ – denotes Slash PM – Packing Material
/ – Slash
XXX – denotes three letters of packing material name For example CTN for Carton, LBL for Label etc
– – denotes Hyphen
YYY – Serial Number for example 001, 002, 003 and so on
– – Hyphen
ZZ – Revision Number For example 00, 01, 02, etc

5.8 Analysis Protocol shall be master by QA department.

5.9 A master Analysis Protocol shall be controlled by QA department as per proper issuance of document to QC dept
5.10 Control and Issuance of Analysis Protocol

5.10.1 Controlled protocol of RM / PM / Stability / Finished product / In-process shall be issued by QA Department.
5.10.2 QC department shall provide the “Request Form For Issuance of Documents” to QA dept. for issuance of Analysis Protocol.
5.10.3 Executive/Officer/designee of QA department shall check i.e. Product / Material / Item Name in the “Request Form For Issuance of Documents” for issuance of Analysis Protocol.
5.10.4 After checking the “Request Form For Issuance of Documents” Executive / Officer / designee of QA dept shall issue controlled Analysis Protocol from Master Analysis Protocol.
5.10.5 Analysis Protocol shall be issued by QA dept in the format as given in Annexure – I.
5.10.6 For Vendor sample & Miscellaneous sample analyst shall use Common raw data sheet.

5.10.7 Analysis Protocol shall be duly signed with date and Control stamp by QA dept on individual page of protocol.
5.10.8 Analysis Protocol issuance number shall be given by QA dept on each page of Analysis Protocol.

5.10.9 Analysis protocol issuance number shall contain ten characters which is as below:

(i) For RM/YY/XXXX
RM – denotes code for Raw Material
/ – denotes Slash
YY – denotes Last two digits of the Calendar Year i.e. 18 for 2018 and 19 for 2019
/ – denotes Slash
XXXX – denotes Serial number to be given for Raw material worksheet i.e. 0001,0002, 0003 and so on.
(ii) For PM/YY/XXXX
PM – denotes code for Packing Material.
/ – denotes Slash
YY – denotes Last two digits of the Calendar Year i.e. 19 for 2019 and 20 for 2020
/ – denotes Slash
XXXX – denotes Serial number to be given for packing material worksheet i.e. 0001, 0002, 03 so on
(iii) For FP/YY/XXXX
FP – denotes code for Finished Product.

/ – denotes Slash
YY – denotes Last two digits of the Calendar Year i.e. 19 for 2019 and 20 for 2020
/ – denotes Slash
XXXX – denotes Serial number to be given for finished product worksheet i.e. 0001, 0002, 0003 and so on
(iv) For SB/YY/XXXX
SB – denotes code for Stability.
/ – denotes Slash
YY – deontes Last two digits of the Calendar Year i.e. 19 for 2019 and 20 for 2020
/ – denotes Slash
XXXX – denotes Serial number to be given for finished product worksheet i.e. 0001, 0002, 0003 and so on
(v) For IP/YY/XXXX
IP – denotes code for In-process.
/ – denotes Slash
YY – deontes Last two digits of the Calendar Year i.e. 19 for 2019 and 20 for 2020
/ – denotes Slash

XXXX – denotes Serial number to be given for finished product worksheet i.e. 0001, 0002, 0003 and so on

5.10.10 The common raw data sheet shall be controlled by QA dept.

5.10.11 If Protocol of any item/Product/Material does not exist or any existing protocol is not prepared then common raw data sheet shall be used.

5.10.12 Do not leave any column in the record/ document unfilled. If any column is not applicable, write ‘NA’.
5.10.13 If any page left blank, draw a line across from left top to right bottom of the page.
5.10.14 Every step of analysis shall be documented.
5.10.15 Analysis Protocol shall be legible and on line filled during analysis.
5.10.16 For Validation sample (Process validation/Hold time validation) Analysis protocol for In-Process sample shall be used.
5.10.17 After Issuance of Analysis Protocol by QA department, Section head or designee of QC dept.

shall issue the Analysis protocol to the Analyst with testing requisition slip, Specification
/ Standard test procedure for analysis of sample
6.10.18 Re- issuance of new protocol with new number shall be applicable in case of any unforeseen reason (e.g. Spillage of chemicals/Tearing off) after incident login , submission of previous protocol
and approval of QA Head and record shall be maintained as per Annexure-II (same shall be indicated in Remark column with reissued copy)

sop for Preparation and Issuance of Analysis protocol standard

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