SOP for Document Numbering System
1.0 OBJECTIVE:
To define and provide identity to the documents used in various departments at pharmaceutical unit for the purpose of traceability.
2.0 SCOPE:
This system of document numbering is applicable for all the documents prepared in the pharmaceutical manufacturing unit at [Company name].
3.0 RESPONSIBILITY:
All department personnel – to follow the document numbering system for respective documents identified in the SOP
4.0 PROCEDURE:
4.1 Departments shall allocate the document identification number as per procedure explained in this SOP.
4.2 In case of any new types of document to be generated in the facility, the department needs to inform to QA and new document numbering system needs to be included in this procedure.
4.2.1 Standard Operating Procedure (SOP) numbering system
SOP numbering system: SOP/XXX/001/00
Where:
SOP: Standard Operating Procedure
XXX: Department Code
001: Serial Number of SOP
00: Revision No.
Department Codes:
QAD: Quality Assurance Department
QCD: Quality Control Department
MCD: Microbiology Department
PRD: Production Department
HRA: Human Resource and Administration
WHD: Warehouse Department
ENG: Engineering Department
4.2.2 Standard Cleaning Procedure (SCP) numbering system
Standard Cleaning Procedure numbering system: SCP/XXX/001/00
Where:
SCP: Standard Cleaning Procedure
XXX: Department Code
001: Serial Number of SCP
00: Revision No.
4.2.3 Protocol numbering system
Protocol numbering system:AAA/BBB/XXX/YY
Where,
AAA: Protocol abbreviation (e.g. PVP – Process validation protocol, CVV – Cleaning Validation Protocol. One can define own abbreviation for analytical method validation, technology transfer, IQ, OQ, PQ, etc.)
BBB: Department code
XXX: Sr. No.
YY: Revision No.
4.2.4 Logbooks or Registers numbering system
Logbook numbering system: LOG/XXX/YYY/AAA/BB
Where:
LOG: Logbook
XXX: Department Code
YYY: SOP No.
AAA: Serial Number of Register
BB: Addition of Register 00, 01,
4.2.5 Format numbering system
Format numbering system: FRM/XXX/YYY/AAA/BBB
Where:
FRM: Format
XXX: Department Code
YYY: SOP No.
AAA: Serial Number of Format
BBB: Revision No.
4.2.6 BMR and BPR numbering system
BMR or BPR/XXX/YYY/AA
Where:
BMR: Batch Manufacturing Record
XXX: Product code
YYY: BMR or BPR
AA: Revision No.
4.2.7 Site Master File numbering system
SMF/XXX/001/00
Where:
SMF: Site Master File
XXX: Plant code
001: Sr. No.
00: Revision number
4.2.8 Validation Master Plan numbering system
VMP/XXX/001/00
Where:
VMP: Validation Master Plan
XXX: Plant code
001: Sr. No.
4.2.9 Quality Manual numbering system
Where:
QM/XXX/001/00
Where:
QM: Quality Manual
XXX: Plant code
001: Sr. No.
4.2.10 Drawing or Layouts numbering system
DRG/XXX/YYY/001/00
Where:
DRG: Drawing or Layouts
XXX: Type of drawing (FLR – Floor plan, MMM – Man and material movement, GAD – General arrangement, etc.)
YYY: Floor
001: Drawing No.
00: Revision No.
4.2.11 Miscellaneous Validation numbering system
Any validation activity under taken which do not fall in above mentioned numbering system then for such validation activity below mentioned numbering system shall be used.
MSC/XXX/YYYY/ZZZ/AA
Where:
MSC: Miscellaneous Protocol
XXX: Department name
YYYY: Year
ZZZ: Serial No.
AA: Revision No.
4.2.12 Temperature Mapping Protocol numbering system
TMP/XXX/YYYY/ZZZ/AA
Where:
TMP: Temperature Mapping Protocol
XXX: Department name
YYYY: Year
ZZZ: Serial No.
AA: Revision No.
4.2.13 Placebo Batch numbering system:
PLB/AAA/BBBB/XX
Where:
PLB: Placebo
AAA: Product Code
BBBB: Year
YY: Sr. No.
4.2.14 Assessment/ Trail Batch numbering system:
ASBAAAABB
Where:
ASB: Assessment/ Trail Batch
AAAA: Year
BB: Sr. No.
4.2.15 Area qualification protocol numbering system
AREA/XXX/YYY/AA
Where:
AREA: Area
XXX: Department
YYY: Room No.
AA: Revision No.
5.0 ANNEXURE(S):
Not applicable