1.0 OBJECTIVE
1.1 To lay down a standard procedure to be followed for the preparation, control, issuance, writing, and closure of logbooks.
2.0 SCOPE
2.1 This SOP shall be applicable for the procedure to be followed for the preparation, control, issuance, writing, and closure of logbooks in the Quality assurance Department (QAD) and Animal House Facility (AHF).
3.0 RESPONSIBILITY
3.1 Head- QA
3.2 QA Personnel (QAP)
3.3 Head- AHF
4.0 DEFINITIONS
4.1 Logbook: Defined as a systemic, daily, or hourly record of activities, events, and/or occurrences.
5.0 PROCEDURE
5.1 Preparation of logbook
5.1.1 The logbooks shall be in bound form.
5.1.2 The first page of the logbook i.e. cover page of the logbook shall contain the name and logo of the organization, the name of the department, the title of the logbook, the logbook number, and instrument id no. as per the currently running version of format no. F…………….. and F………….. for QA and AHF departments respectively.
5.1.3The second page shall document issuance, closing/return, and other specific details as per the currently running version of format no. F………………….
5.1.4 Remaining pages of logbook shall have columns for data recording as per the respective SOP of the instrument and pages shall be serially numbered.
5.1.5 Format for data recording shall be as per requirements of the respective department for all logbooks. For QA data recording shall be done in format no. F…………….. entitled “Operation and Usage Record”.
5.2 Numbering and Title of logbook
5.2.1 All logbooks shall be numbered as per a unique numbering system of 13 characters as below:
LB/XXX/YY/001
Where 1st and 2nd characters are ‘LB’ which signify ‘Logbook’, 4th, 5th and 6th characters are ‘XXX’ which signify ‘Department Code’ to which logbook belongs i.e. QAD for Quality Assurance, AHF for Animal House Facility; Character no. 8th and 9th are ‘YY’ which signify the last two digits of the year in which the logbook is issued; The 11th, 12th and 13th characters ‘001’ signifies the Sr. No. of logbook; Character No. 3rd, 7th, and 10th are oblique marks ‘/’.
5.2.2 For example Numbering of logbooks of the AHF Department for the year 2015 shall be LB/AHF/15/001, LB/AHF/15/002…and so on. When the year changes to 2016 the numbering shall start again from ‘001’ i.e. LB/AHF/16/001, LB/AHF/16/002…
5.2.3 The title of all the logbooks shall be the “Name of an instrument”.
5.3 Control and Issuance of logbook
5.3.1 All the logbooks shall be controlled by the QA department. All original formats of logbooks shall contain a ‘MASTER COPY’ stamp in green colored ink on the bottom left-hand side of every page. Such documents shall be kept in lock and key under the custody of the QA Head / authorized QA personnel.
Note: The authorized format shall be sent for printing if required.
5.3.2 Department head / Designee shall give requisition to QA department in a format no. F/SOP/QAD/002/02-00 mentioning number of pages in multiple of 5 as per requirement.
5.3.3 QA personnel shall make a record of all the copies as per Format No.: F........................
5.3.4 QA personnel shall take a xerox of the master copy for issuance as per the requirement and the same shall be numbered.
5.3.5 Logbook shall be issued with ISSUANCE STAMP in blue colored ink on the center bottom of second page with details of Issued by and date. Specimen for issuance stamp has been attached as annexure no. A/SOP/QAD/002/01-00 entitled “Specimen Stamp for Logbook / Format book Issuance”.
5.3.6 Only QA person is authorized to take the xerox of the master copy of all the logbooks.
5.4 Writing of logbooks
5.4.1 All the activities in the logbook shall be recorded in chronological order.
5.4.2 Strike off the incorrect entry with a single horizontal line with a sign, such that the incorrect entry shall remain legible.
5.4.3 Overwriting or use of correction fluid/material shall not be used.
5.4.4 Any row and/or space should not be left blank. In case of any blank row and/or space, make a diagonal line from top left to bottom right.
5.4.5 Calibration entries shall be made by writing the instrument’s current calibration status where applicable.
5.5 Archiving / Returning of logbooks
5.5.1 All logbooks shall be returned after completion to QAD.
5.5.2 Logbook shall be returned by designated personnel with name, signature, and date of closing within 30 days of completion of document.
5.5.3 If the time period exceeds 30 days, a deviation shall be filed by the respective department head.
6.0 ENCLOSURES
|
Sr. No. |
Format Title |
Format No. |
No. of pages |
|
1. |
Cover Page for QAD Logbook |
F……………………… |
01 |
|
2. |
Logbook Requisition
form |
F……………………… |
01 |
|
3. |
Operation and Usage
record for QAD |
F……………………… |
01 |
|
4. |
Cover Page for AHF
Logbook |
F……………………… |
01 |
|
5. |
Logbook Issuance Details |
F……………………… |
01 |
|
6. |
Record for the Issuance
of Logbooks |
F……………………… |
01 |
6.2 Annexures
|
Sr. No. |
Annexure Title |
Annexure No. |
No. of pages |
|
1. |
Specimen Stamp for Logbook Issuance |
A…………………… |
01 |
7.0 ABBREVIATIONS
7.1 SOP- Standard Operating Procedure
7.2 LB- Logbook
7.3 QAD- Quality assurance Department
7.4 AHF- Animal House Facility
8.0 REFERENCES
8.1 In-house
9.0 REVISION HISTORY
9.1 Nil
END OF THE DOCUMENT
You may like to read these links:
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment