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Reviewed By
Quality Khaled Nurus Shafa In-charge, DRA &
Assurance Dept. Tech Transfer
Quality Control Md. Mokter Hossain In Charge Analytical
Dept. Lab & IPQC
Research & Md. Mukarim Head of R & D
Development Kamran
Engineering Ruh Parwaz Ashish Head of Engineering
Khan
Technical Ops. Md.Abul Kalam Technical Manager
Azad
7. Human Resources
1.0 PURPOSE
To provide guidelines for numbering systems to all documents related to Standard
Operating Procedure, Formats, User Requirement Specification, Specification, Standard
Test Procedure, General Test procedure, Qualification and Validation, Master Formula
Record, Batch Production Record, Master List etc.
2.0 SCOPE
This procedure is applicable for allocating sequential numbers to all above mentioned
documents prepared at Healthcare Pharmaceuticals Limited for identify and easy traceability.
The numbering other quality related documents which are not covered by this SOP will be
described in their respective SOPs.
3.0 RESPONSIBILITY
3.1 QA shall be responsible for assigning/allocating the number to the new documents.
3.2 Head of QA or her nominee shall be responsible for effective implementation and
training of procedure.
3.3 Concerned Departmental Head shall be responsible for implementation of procedure.
4.0 ACCOUNTABILITY
4.1 Head of Quality Assurance
Head of QA (Sign/Date) :
5.0 PRECAUTION
N/A
6.0 PROCEDURE
6.1 For preparation of new documents or revision of existing documents follow
document control SOP. (GEQA-002)
6.2 QA shall assign a document identification number and revision level to a new
document and record in the respective Master list.
6.3 Do not reissue assigned numbers to another document even if the request for a
document change is cancelled prior to final document approval.
6.4 Assign a revision level in sequential order (e.g. revision “01” shall be “02”).
6.5 QA shall update the Master list as per Master List SOP (QA-006) to show the addition
of new documents or the revision of existing documents.
6.6 The following two character for facility code where the SOP or format to be
implemented is given bellow:
Code Facility for implementation
GE Common SOP/format implemented for all facility
GS SOP/format implemented only for General oral solid facility
CP SOP/format implemented only for Cephalosporin facility
ST SOP/format implemented only for sterile facility
MD SOP/format implemented only for MDI facility
SS SOP/format implemented only for semi-solid
6.7 The following two or three character for each department is given below:
Department Code
Production PR
Quality Assurance QA
Quality Control QC
Research & Development PD
Material Management MM
Human Resources HR
Engineering EG
Planning PL
Information services IT
Regulatory RG
Training TR
Head of QA (Sign/Date) :
Environment, Health & Safety ES
Product Promotional Materials Management PPM
6.8 Assign the document numbering as per following procedure
6.8.1 Standard Operating Procedure
The unique document identification number shall be consisting of 11 characters
broken down as follows -
(- - ) (- -) (-) (- - -) (.) (--)
Facility code Dept. Code Dash SOP No. Dot Revision No.
e.g.GEQA-001.00
Where
GE is the common for all facility
QA is the department code of Quality Assurance
- is the separator
001 is the sequential number of the SOP
. is the dot
00 is the revision level of the document. In case of a new SOP this number shall be
'00'. The next revision would be '01' and so on.
6.8.2 Formats
Formats in the form of appendixes or general documents shall be controlled by
issuing form no. (FORM No.: ) followed by unique identification number.
The unique document identification number shall be consisting of 10 characters
broken down as follows -
(-) (- -) (- -) (/) ( - - -) (.) (--)
Form Facility code Dept. Code Slash Sequential No. Dot Revision No.
e.g. FGEQA/001.00
Where
F is the format
GE is the common for all facility
QA is the department code of Quality Assurance
/ is separator
001 is the sequential number of the Format
. is the dot
00 is the revision level of the document. When new format is initiated the number
shall be '00'. The next revision would be '01' and so on.
6.8.3 User Requirement Specification
The unique document identification number shall be consisting of 10 characters
broken down as follows -
Head of QA (Sign/Date) :
(- - - ) (/) (- -) (/) (- - -)
URS Slash Dept. Code Slash Sequential No.
e.g. URS/EG/001
Where
URS is the code for User Requirement Specification
/ is separator
EG is the department code of Engineering
/ is separator
001 is the sequential number of the User Requirement Specification
The version number of the document shall be two characters of sequential numerical
number and started from 01. The next revision would be '02' and so on.
6.8.4 Specifications
The unique document identification number shall be consisting of 12 characters
broken down as follows -
(- -) (/) (- -) (/) (- - -) (-) (--)
Specification Slash Code Slash Sequential No. Dash Revision no.
Material/product identification codes (2 alphabetical characters) as defined below.
Specifications Document Identification Code
Raw Materials – Release RM
Raw Materials – Regulatory * RM
Packaging Materials PM
Finished product – Release FP
Finished product – Regulatory * FP
Intermediate / In-process product IP
e.g. SP/RM/001-00
Where
SP is the Specification
/ is separator
RM is the identification code of Raw material
/ is separator
001 is the sequential number starting from 001, 002 & so on.
- is separator
00 is the revision level of the document. When new format is initiated the number
shall be '00'. The next revision would be '01' and so on.
* Note: In case of Regulatory - Raw material and finished product specifications
numbering shall be given same, suffixed with “R” after sequential No.
(E.g. SP/RM/001R-00)
In case of specification developed based on a particular market/customer
requirement, the specification numbering shall be given same, suffixed with R1,
R2, R3 … etc. after sequential Number. (E.g. SP/RM/001R1-00)
6.8.5 Standard Test Procedures
Head of QA (Sign/Date) :
The unique document identification number shall be consisting of 13 characters
broken down as follows -
(- - - ) (/) (- -) (/) (- - -) (-) (--)
STP Slash Code Slash Sequential No. Dash Revision no.
Material/product identification codes (2 alphabetical characters) as defined below.
Specifications Document Identification Code
Raw Materials – Release RM
Raw Materials – Regulatory * RM
Packaging Materials PM
Finished product – Release FP
Finished product – Regulatory * FP
Intermediate / In-process product IP
e.g. STP/RM/001-00
Where
STP is the Standard Test Procedure
/ is separator
RM is the identification code of Raw material
/ is separator
001 is the sequential number starting from 001, 002 & so on.
- is separator
00 is the revision level of the document. When new format is initiated the number
shall be '00'. The next revision would be '01' and so on.
* Note: In case of Regulatory - Raw material and finished product standard test
procedure numbering shall be given same, suffixed with “R” after sequential No.
(E.g. STP/RM/001R-00)
In case of standard test procedure developed based on a particular market/customer
requirement, the standard test procedure numbering shall be given same, suffixed
with R1, R2, R3 … etc. after sequential Number. (E.g. STP/RM/001R1-00)
6.8.6 General Test Procedures
The unique document identification number shall be consisting of 10 characters
broken down as follows -
(- - - ) (/) (- -) (/) (- - -) (-) (- -)
GTP Slash Code Slash Sequential No. Dash Revision no.
Material/product identification codes (2 alphabetical characters) as defined below.
Specifications Document Identification Code
Raw Materials – Release & Regulatory RM
Packaging Materials PM
Finished product – Release & Regulatory FP
Head of QA (Sign/Date) :
Intermediate / In-process product IP
e.g. GTP/PM/001-00
Where
GTP is the General Test Procedure
/ is separator
PM is the identification code of packaging materials
001 is the sequential number starting from 001, 002 & so on.
- is separator
00 is the revision level of the document. When new format is initiated the number
shall be '00'. The next revision would be '01' and so on.
6.8.7 Qualification Protocols and Reports
The unique document identification number shall be consisting of 9 characters broken
down as follows -
(---) (/) (- -) (/ ) (--) (--) (---) ( _ ) (----) (/) (- -)
Document Slash Dept .Slash Perform Eqptmnt Month Under year Slash Seq.No.
Code Code System score
Document identification codes (2 alphabetical characters) as defined below.
Name of the documents Document Identification Code
Design Qualification DQ
Installation Qualification IQ
Operational Qualification OQ
Performance Qualification PQ
Facility Qualification FQ
e.g. PQP/EG/WS/Sep_2013/02
Where
PQP is the code of Performance Qualification Protocol
/ is separator
EG is the Department code of Engineering Department
/ is the separator
WS is the Water System
/ is the separator
Sep is the month of September
_ is the under score
2013 is the year of 2013
02 is the sequential number starting from 001, 002 & so on.
The version number of the document shall be two characters of sequential numerical
number and started from 01. The next revision would be '02' and so on.
6.8.8 Validation protocols and Reports
The unique document number for validation protocol shall be as follows -
(- - -) (/) (- - -) (/ ) (- - -) (-) (--)
Head of QA (Sign/Date) :
Document Code Slash Product code Slash Sequential No. Dash Revision no
Or Material code
Document identification codes for validation protocols (3/4 alphabetical characters) as
defined below:
Name of the document Document Identification Code
Process Validation Protocol PVP
Cleaning Validation Protocol CVP
Analytical Method Validation Protocol AMVP
Stability Study Protocol SSP
For Process Validation Protocol for Rozith Tablets 500 mg shall be
e.g. PVP/HCP 031/001-00
Where
PVP is the code of Process Validation Protocol
/ is separator
HCP031 is the product code of Rozith tablets 500 mg
/ is the separator
001 is the sequential number starting from 001, 002 & so on.
- is the separator
00 is the revision level of the document. When new validation is initiated the number
shall be '00'. The next revision would be '01' and so on.
The unique document number for validation reports shall be as follows -
(- - -) (/) (- - -) (/ ) (- - -) (-) (--)
Document Code Slash Product code Slash Sequential No. Dash Revision no
Or Material code
Document identification codes for validation reports (3 alphabetical characters) as
defined below.
Name of the document Document Identification Code
Process Validation Report PVR
Cleaning Validation Report CVR
Analytical Method Validation Report AMVR
Stability Study Report SSR
For Process Validation Report for Rozith Tablets 500 mg shall be
Head of QA (Sign/Date) :
e.g. PVR/HCP031/001-00
Where
PVR is the code of Process Validation Report
/ is separator
HCP031 is the product code of Rozith tablets 500 mg
/ is the separator
001 is the sequential number starting from 001, 002 & so on.
- is the separator
00 is the revision level of the document. When new validation is initiated the number
shall be '00'. The next revision would be '01' and so on.
6.8.9 Master Formula Record (MFR)
The unique document identification number shall be consisting as follows -
(- - -) (/) (- - -) (/ ) (- - -) (-) (- -)
MFR Slash Product code Slash Sequential No. Dash Revision No.
e.g. MFR/HCP 031/001-00
Where
MFR is the code of master formula record
/ is separator
HCP 031 is the product code of Rozith tablet 500 mg
/ is the separator
001 is the sequential number starting from 001, 002 & so on.
- is the separator
00 is the revision level of the document. When new MFR is initiated the number
shall be '00'. The next revision would be '01' and so on.
6.8.10 Batch Manufacturing Record (BMR) and Batch Packing Record (BPR)
The unique document identification number shall be consisting of 14 characters
broken down as follows -
(- - -) (-) (- - -) (/ ) (- - -)
BMR or BPR Das Dosage form Slash Product code
e.g. BMR-TAB/201
Where
BMR is the code of Batch Manufacturing Record
- is separator
TAB is the TABLET
/ is the separator
201 is the product code of Solivo Tablet 375 mg
6.8.11 Master Lists
The unique document identification number shall be consisting of 12 characters
broken down as follows -
(- -) (/) (- -) (/) (- - -) (-) (--)
Head of QA (Sign/Date) :
List code Slash Dept. code Slash Sequential No. Dash Revision no.
Master list identification codes (2 alphabetical characters) as defined below.
Name of the document Document Identification Code
Master list ML
For Department code refer point 6.7
e.g. ML/QC/001-00
Where
ML is the identification code for Master list
/ is separator
QC is the department code of Quality Control
/ is separator
001 is the sequential number starting from 001, 002 & so on.
- is separator
00 is the revision level of the document. When new master list is initiated the
number shall be '00'. The next revision would be '01' and so on.
6.8.12 Other Documents
The unique document identification number for documents shall consist of 9
characters, broken down as follows -
(---) (/) (- - -) (- ) (- -)
Document Code Slash Sequential No. Dash Revision No.
Document identification codes (2 or 3 alphabetical characters) as defined below:
Name of the document Document Identification Code
Validation Master Plan VMP
Site Master File SMF
GMP Risk Analysis RA
Quality Manual QM
Training Manual TM
Safety Manual SM
e.g. VMP/001-00
Where
VMP is the code of Validation Master Plan
/ is separator
001 is the sequential number
- is the separator
Head of QA (Sign/Date) :
00 is the revision level of the document. When new document is initiated the number
shall be '00'. The next revision would be '01' and so on.
The unique document identification number for other validation Protocols & Reports
shall consist of 10 characters, broken down as follows -
(---) (/) (- - -) (- ) (- -)
Document Code Slash Sequential No. Dash Revision No.
Document identification codes for other validation Protocols & Reports
(3 alphabetical characters) as defined below.
Name of the document Document Identification Code
Environmental Monitoring Protocol EMP
Disinfectant Validation Protocol DVP
Computer System Validation Protocol CSP
Environmental Monitoring Report EMR
Disinfectant Validation Report DVR
Computer System Validation Report CSR
e.g. EMP/001-00
Where
EMP is the code of Environmental Monitoring Protocol
/ is separator
001 is the sequential number
- is the separator
00 is the revision level of the document. When new document is initiated the number
shall be '00'. The next revision would be '01' and so on.
5.8.13 Factory Acceptance Test
The unique document identification number shall be consisting of 10 characters
broken down as follows -
(- - -) (/) (- - ) (/ ) (- - -)
Document Code Slash Dept. code Slash Sequential No.
Document identification codes (3 alphabetical characters) as defined below.
Name of the document Document Identification Code
Factory Acceptance Test FAT
For Department code refer point 6.7
e.g. FAT/EG/001
Where
FAT is the document code
/ is separator
Head of QA (Sign/Date) :
EG is the department code of Engineering
/ is the separator
001 is the sequential number starting from 001, 002 & so on.
5.8.14 Equipment/Instrument Qualification
Off the shelf equipment/instrument purchased and installed shall be qualified. The
qualification document shall be numbered as defined below.
The unique document identification number shall be consisting of 9 characters broken
down as follows -
(- -) (/) (- - ) (/ ) (- - -)
Document Code Slash Dept. code Slash Sequential No.
For Department code refer point 6.7
e.g. EQ/QC/001
Where EQ is the document code of Equipment /Instrument Qualification
/ is separator
QC is the department code of Quality Control
/ is the separator
001 is the sequential number starting from 001, 002 & so on.
Qualification
6.0 REFERENCES
6.1 Good Manufacturing Practices Guidelines.
7.0 REVISION HISTORY
Reason for revision of SOP shall be given as indicated below.
Sr. No. Revision Effective Date Details of Revision Remarks
Status
01 00 01/07/2010 ---------- First Issue
02 01 i. Routine updated as per Second
SOP current format Issue
8.0 LIST OF APPENDIX
N/A
Head of QA (Sign/Date) :
