1.0 Purpose
1.1 To describe the procedure for issuance and control of Logbook and Register.
2.0 Scope
2.1 This Sop is applicable for issuance and control of Logbook and Register in all department of “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1 Manager / Head of user Department or his / her designee shall be responsible for giving the request for insurance of new Logbook or Register.
3.2 Officer / Sr. Officer QA shall be responsible for issuance, archiving and control of Logbook or Register Book.
3.3 Head of Quality Assurance are responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
4.1 QA : Quality Assurance
5.0 Materials and Equipment
5.1 Logbook
5.2 Register
6.0 Precaution / Health and Safety Considerations
6.1 Not Appreciable
7.0 Procedure
7.1 Officer / Senior Officer- Initiator department shall send the request for issuance of Log Books / Register
Books of two working days prior to implementation date. Request shall be authorized by department head.
7.2 Officer / Sr. Officer QA shall review the request and take the approval from Head of QA / his Designee for
issuance of the documents.
7.3 Officer / Sr. Officer QA checked the page number of Logbook / Register and give the serial no of Logbook /
Register as following procedure:
7.3.1 Each Logbook or Register shall have an identical serial number like LB/XX/000/YY or RB/XX/000/YY respectively.
LB - Logbook
RB - Register Book
XX - Two letter indicate Initiator Department
Such as:
General Production : PR
Quality Assurance : QA
Product Development : PD
Quality Control : QC
Engineering : EN
Warehouse : WH
Administration : AD
7.3.2 Then place “/” and three (000) numerical digits that indicate serial number.
7.3.3 Then place “/” and two (YY) numerical digits that indicate the year (i.e. 24 for 2024, 25 for 2025…. etc.) which the logbook or Register is issued.
7.4 Cover page of all the Logbooks or Register shall have the title respective to their utilization.
7.5 Officer/ Sr. Officer, QA shall issue the Logbook / Register as per request and put the issued date, page no. and his / her initials with date and maintain the record in Logbook Issuance Register or Register Issuance Register.
7.6 Logbook / Register issuance format and record shall be maintained and archived after two years from the issued date or as required.
7.7 Officer / Sr. Officer of the concern department shall check the number of Logbook / Register and receive sign and date in the Issuance Register.
7.8 After complete the Logbook / Register Book, the concern department put this QA Department duly filled the completion date and sign of Department Head for issuance of new Logbook / Register.
7.9 All the Logbooks / Register shall be archived in QA Department by Officer/ Sr. Officer, QA in documentation room.
8.0 Reference Document
8.1 WHO GMP Guideline; TRS-986, Annex-2 ;
8.2 In house
9.0 Annexure
9.1 Annexure-I : Request for Logbook / Register
9.2 Annexure-II : Format of Logbook Issuance Register
9.3 Annexure-II : Format of Register Issuance Register
10.0 Revision History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0 Training
11.1 Head of Quality Assurance or his nominee give the training of all Officer and Manager of all Department.
