1.0 Objective
To lay down a procedure for issuance and control of Records/ Formats / Log Books.
2.0 Scope
This standard operating procedure is applicable for pharmaceutical Formulation Plant.
3.0 Responsibility
3.1 Manager User department or his / her designee shall be responsible for giving the request for issuance of new Records/ Formats / Log Books and verification of Records/ Formats / Log Books before archiving.
3.2 Executive / Officer QA shall be responsible for the issuance, archiving and control of Records/ Formats / Log Books.
3.3 Head-QA shall be responsible for verifying and approval of the request.
3.4 Head QA or his/ her designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
QA : Quality Assurance
SOP : Standard Operating Procedure
Documents : Records, Formats or Log books issued to user department with stamp having initials with date
Procedure
5.1 Issuance
5.1.1 Officer/ Executive-Initiator department shall send the request for issuance of Formats or Log Books on monthly basis. Request shall be authorized by department head. (Annexure-I)
5.1.2 Request shall reach in QA department in last week of previous month as per the requirement.
5.1.3 Officer/Executive QA shall review the request and take the approval from Head QA / Designee for issuance of the Documents.
5.1.4 Officer/Executive QA shall issue the total number of Records/Log books/ Formats duly QA stamped in blue colour as per the request and put his / her initials with date(DD-MM-YY) on each formats and record of the same shall be maintained in Records /log book issuance record (Annexure-II).
5.1.5 Records/ Log Books issuance format and record shall be maintained as per calendar year.
5.1.6 Issuance of format/logbook shall be done two working days prior to implementation date of same for particular month.
5.1.7 Date mentioned on the format, logbooks, records etc. is the date of implementation of format/logbook for that particular month.
5.1.8 Issuance date of records/logbook/format shall be recorded in Annexure-III.
5.1.9 Officer/Executive of the concerned department shall check the number of formats/log books and receive with sign and date in the issuance record.
5.1.10 All log books shall be retrieved at the end of every calendar year or whenever filled whereas formats shall retrieve after one month of usage by user department e.g. machine Log sheets of January month shall be submitted to QA by end of 5th of Feburary
- For QC: All the Records/log books shall be issued and archived as per respective SOP.
5.2 Archival
5.2.1 Archival shall be done Department wise e.g. archival from the user department shall be done single time.
5.2.2 All the formats related to a single area/equipment shall be maintained in a single file.
5.2.3 Archival of all the formats issued shall be done and the integrity of all the formats/log books shall be checked before receiving the records and same shall be recorded in Format/Log Book Issuance Register.
5.2.4 Number of formats retrieved/ shall be equal in number to that issued.
5.2.5 Cover page of all the Log Books shall have the title respective to their utilization.
5.2.6 All the Formats/Log Books shall be kept in QA by Officer/Executive QA in documentation cell.
6.0 Forms and Records
6.1 Records/Log Book Request form – Annexure-I
6.2 Records /Log Books Issuance Register – Annexure-II
6.3 Records /Log Books Issuance Record – Annexure-III
7.0 Distribution
Master Copy – Documentation Cell-QA
Controlled Copy – Quality Assurance, Quality Control, Administration and Housekeeping, Engineering, Stores, HRD
8.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Annexure-II
Annexure-III
