Logbook , Purpose :
Logbook , The purpose of this SOP is to describe the procedure for issuance and control of logbooks authorized to use GMP related activities.
Logbook , Scope :
This procedure is applicable for all departments at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]Logbook: A bound book, which contains preprinted serially page no. and preprinted pages as per the respective SOP’s requirement.
Responsibilities:
[][]The roles and responsibility is as follows:
Quality Assurance Personnel
[][]To issue as per SOP.
[][]To close the completed one.
Concerned Department
[][]To write raw data in it as per defined procedure
[][]To maintain it properly
[][]To submit the completed book.
Manager, Quality Assurance
[][]Approval of the SOP.
[][]To ensure that the implementation of the system as per SOP.
Procedure:
Concerned department shall prepare it for equipment/instrument used in their department. It will be issued by Quality Assurance.
Issue of Log book:
[][]Concerned department shall raise logbook issuance request (Annexure–I) for authorization of it to Quality Assurance.
[][]Quality Assurance shall assign Reference number to new logbook as given below.
e.g. PRO/1
Where
=>PRO is the department code of Production (General)
=>/ is the separator
=>1 is the sequential number of log book
=>Next logbook number shall be 2, 3, 4………and so on.
=>The code of each department is given below.
Department /Code
[][]Production (General)/PRO
[][]Production (Sterile)/C-PRO
[][]Packaging (General)/PKG
[][]Packaging (Sterile)/C-PKG
[][]Warehouse (General)/WH
[][]Warehouse (Sterile)/C-WH
[][]Quality Assurance (General)/QCOM
[][]Quality Assurance (Sterile)/C-QCOM
[][]Quality Control (General)/QC
[][]Quality Control (Sterile)/C-QC
[][]Microbiology (General)/MICRO
Quality Assurance will prepare the front cover of log book (Annexure-III) with unique Reference number.
Review of the log books:
[][] It will be periodically reviewed by the departmental head make an initial.
[][]Concern personnel will ensure proper control and data record during day to day use of logbooks.
[][]After completion of any logbook, a new will be issued by Quality Assurance under same reference no. of the next serial no. of logbook.
Annexure:
Annexure-I: Log book Issuance Request
Annexure-II: Log book Issuance Record
Annexure-III: Log book Front Cover