1.0 Purpose
1.1 To lay down a procedure for assigning of number for all GMP documents & records.
2.0
Scope
2.1 The numbering system is applicable for
all documents and records of "NAME" Pharmaceuticals Ltd.
3.0
Responsibility
3.1
All concerned Departmental
Heads shall be responsible to follow this SOP for numbering system of all
documents & records.
3.2
Every department shall be
responsible to maintain a log book for departmental document number.
3.3
Head of QA shall be
responsible for implementation of this SOP.
4.0 Abbreviations and Definitions
4.1 DOCUMENT: A document is a written, drawn, presented or recorded representation of thoughts. It is an editable file. Documents can be stored as paper or digitally. It can be changed and revised as needed.
4.2 RECORD: Records are historical files that provide proof of existence. They are used to prove a state of existence of the business. Records are not editable and cannot be recreated.
5.0 Materials and Equipment
5.1 Not Appreciable
6.0 Precaution / Health and Safety Considerations
6.1 Ensure the number is identical for each items.
7.0 Procedure
7.1 Numbering Of Qualification Documents
7.1.1 Allot the following system for document protocol number for instrument qualification.
7.1.1.1
NAME/URS/DC/001 for User Requirement Specification
7.1.1.2
NAME/CS/DC/001 for Comparative Study
7.1.1.3
NAME/DQP/DC/001 for Design Qualification
Protocol
7.1.1.4
NAME/DQR/DC/001 for Design Qualification Report
7.1.1.5
NAME/IQP/DC/001 for Installation Qualification
Protocol
7.1.1.6
NAME/IQR/DC/001 for Installation Qualification
Report
7.1.1.7
NAME/OQP/DC/001 for Operational Qualification
Protocol
7.1.1.8
NAME/OQR/DC/001 for Operational Qualification
Report
7.1.1.9
NAME/PQP/DC/001 for Performance Qualification
Protocol
7.1.1.10 NAME/PQR/DC/001 for Performance Qualification
Report
7.1.1.11 For Requalification Protocol R1, R2, R3….will
be added after departmental code of respective documents, such as NAME/DQP/DC/R001
7.1.1.12 For Requalification Report R1, R2, R3….will be added after departmental code of respective documents, such as NAME/DQR/DC/R001
Where, "NAME": corresponds for Name of Pharmaceuticals Ltd.
DC: corresponds to two the alphabets denoting the code number of department. Departmental code is described
in the section of 7.23
001: corresponds to three numerical figure of the serial No. starting 001
7.2 Numbering System of Validation Documents
7.2.1
Allot the following system for
validation document protocol and report number for validation
7.2.1.1
PVP/XXX/YY/001 for Process Validation Protocol
7.2.1.2
PVR/XXX/YY/001 for Process Validation Report
7.2.1.3
AMVP/XXX/YY/001 for Assay Method Validation
Protocol
7.2.1.4
AMVR/XXX/YY/001 for Assay Method Validation
Report
7.2.1.5
DMVP/XXX/YY/001 for Dissolution Method
Validation Protocol
7.2.1.6
DMVR/XXX/YY/001 for Dissolution Method
Validation Report
7.2.1.7
IMVP/XXX/YY/001 for Identification Method
Validation Protocol
7.2.1.8
IMVR/XXX/YY/001 for Identification Method
Validation Report
7.2.1.9
CVP/XXX/YY/001 for Cleaning Validation Protocol
7.2.1.10 CVR/XXX/YY/001
for Cleaning Validation Report
7.2.1.11 For
Revalidation Protocol R1, R2, R3….will be added after departmental code of
respective documents, such as PVP/XXX/YY/R001
7.2.1.12 For Requalification Report R1, R2, R3….will be added after departmental code of respective documents, such as PVR/XXX/YY/R001
Where XXX: corresponds to three alphabets denoting the short form of the name of dosages form/other, such as TAB, CAP, PFS, etc. example: PVP/TAB/000/00
Where TAB, CAP, PFS, alpha characters are denoting Tablet, Capsule, Powder for Suspension, respectively.
YY: corresponds to two numerical digits indicating the year like 24.
001: corresponds to three numerical figure of the serial No. starting 001
7.3 Sop Numbering System
Standard Operating Procedure (SOPs) numbering system will be applicable as per respective SOP ‘Preparation,
Approval, Distribution, Control & Revision of SOP’ (Ref. No. SOP/QA/000/00).
7.4 STP Numbering System
Standard Testing Procedure (STPs) numbering system will be applicable as per SOP ‘Preparation, Approval,
Distribution, Control & Revision of Standard Testing Procedure of Raw Material and Finished Product’ (Ref. No.
SOP/QC/000/00).
7.5 BMR & BPR Numbering System
BMR & BPR numbering system will be applicable as per SOP ‘Preparation of Batch Manufacturing Record (BMR)
(Ref. No. SOP/PD/000/00) & Preparation of Batch Packaging Record (BPR)’ respectively (Ref. No.
SOP/PD/000/00).
7.6 Deviation Numbering System
Deviation numbering system will be applicable as per SOP ‘Deviation Management’ (Ref. No. SOP/QA/000/00).
7.7 Change Control Numbering System
Change Control numbering system will be applicable as per SOP ‘Change Control Procedure’ (Ref. No.
SOP/QA/000/00).
7.8 Customer Complaint Numbering System
Customer Complaint numbering system will be applicable as per SOP ‘Management of Customer Complaint’
(Ref. No. SOP/QA/000/00).
7.9 Out Of Specification Numbering System
Out of specification numbering system will be applicable as per SOP ‘Handling of Out Of Specification’
(Ref. No. SOP/QC/000/00).
7.10 Recall & Mock Recall Numbering System
Recall & Mock Recall numbering system will be applicable as per SOP ‘Product Recall’ (Ref. No.
SOP/QA/000/00).
7.11 Numbering System Of Miscellaneous Documents
7.11.1 For Organogram of the Plant is NAME/ORG/001
7.11.2 For Organogram of the Department is NAME/ORG/DC/001
7.11.3 For Site Master File is NAME/SMF/QA/001
7.11.4 For Quality Manual is NAME/QML/QA/002
7.11.5 For Validation Master Plan is NAME/VMP/QA/003
7.11.6 For Training Manual is NAME/TML/QA/004
7.11.7 The numbering system of the documents without mentioned above will be as per NAME/DC/XX/001.
7.11.7.1
1st four alpha characters indicate
the name of the company.
7.11.7.2
The fifth character will be “/” (slash) for
separator.
7.11.7.3
The next two 6th and 7th (DC)
alpha characters are denoting the departmental code. Departmental code is
described in the section of 7.23
7.11.7.4
The 8th number character will be “/”
(Slash) for separator.
7.11.7.5
The next two 9th and 10th
(XX) alpha characters denote the short form of the document name.
7.11.7.6
The 11th number character will be “/” (Slash)
for separator.
7.11.7.7 The last three (12th to 14th ) characters denote serial number of the document.
7.12 Numbering System For Form
7.12.1 SOP related form numbering system will be applicable as per SOP ‘Preparation, Approval, Distribution,
Control & Revision of SOP’ (Ref. No. SOP/QA/000/00).
7.12.2 Some form no. is given below:
7.12.2.1
For Job
Description is NAME/JOD/DC/F001
7.12.2.2
List of
SOP is NAME/LOS/DC/F002
7.12.2.3
List of
Form is NAME/LOF/DC/F003
7.12.2.4
Work
Flow Chart is NAME/WFC/DC/F004
7.12.2.5
Equipment List is NAME/EQL/DC/F005
7.12.2.6
List of
Qualified Person is NAME/LQP/QA/F006
7.12.2.7
Product
List (Dosages Form) is NAME/PLD/QA/ F007
7.12.2.8 Product List (Therapeutic Class wise) is NAME/PLT/QA/F008
Where, DC: corresponds to two the alphabets denoting the Code of department. Departmental code is described
in the section of 7.23.
7.12.3 The numbering system of the form without mentioned above will be as per DC-F-XXX.
7.12.3.1
DC: corresponds to two the alphabets denoting
the code number of department. Departmental code is described in the section of
7.23
7.12.3.2
Then character will be “-/” (hyphen) for
separator.
7.12.3.3
The next character “F” denotes the short form
of ‘FORM’.
7.12.3.4
Then character will be “-/” (hyphen) for
separator.
7.12.3.5 ‘XXX’ corresponds to three numerical figure of the serial number of the ‘Form’. starting 001.
7.12.4 The following parameters may be included for coding of different form:
7.12.4.1
Company
logo (Top Left Side Corner)
7.12.4.2
Name of the Company (Top Right Side Corner)
7.12.4.3
Form Number (Top/Bottom Left Side Corner)
7.12.4.4
Revision.
(Top/Bottom Middle) e.g.: 01
7.12.4.5
Issue
Date/ Effective Date/ Review Date: (Top/Bottom Right Side Corner)
7.12.4.6 Page Number (Top Right Side Corner) e.g.: X of Y
7.13 Material Code Numbering System
Material (Raw & Packing) numbering system will be applicable as per SOP ‘Code Numbering System for Raw
Materials (Ref. No. SOP/QC/000/00) & Code Numbering System of Packing Materials (Ref. No. SOP/QC/000/00)
7.14 Batch Numbering System
Batch numbering system will be applicable as per SOP ‘Batch numbering, manufacturing and expiry date
incorporating system of products (Ref. No. SOP/QA/000/00)’.
7.15 Internal Audit Numbering System
Internal audit numbering system will be applicable as per SOP ‘Self Inspection & Internal Audit (Ref. No.
SOP/QA/000/00).’
7.16 NCR Numbering System
Nonconformity report (NCR) numbering system will be applicable as per SOP ‘Self Inspection & Internal Audit'
(Ref. No. SOP/QA/000/00).’
7.17 Vendor List Numbering System
Approved vendor list of raw materials & packing materials numbering system will be applicable as per SOP
‘Vendor Selection, Approval and Re-Evaluation (Ref. No. SOP/QA/000/00).’
7.18 Annual Product Review Report Numbering System
Annual Product Review Report Numbering System will be applicable as per SOP ‘Annual Product Review (Ref.
No. SOP/QA/000/00).’
7.19 Show Cause Numbering System
7.19.1 Show Cause numbering system will be as per SC/DC/001/YY
7.19.1.1 1st
two (SC) alpha characters indicate the short form of Show Cause.
7.19.1.2 The
third character will be “/” (slash) for separator.
7.19.1.3 The 4th
and 5th (DC) alpha characters are denoting the departmental code. Departmental
code is described in the section of 7.23
7.19.1.4 The 6th
number character will be “/” (Slash) for separator.
7.19.1.5 The
next three (7th to 9th) characters denote serial number of the Show Case.
7.19.1.6 The 10th
number character will be “/” (Slash) for separator.
7.19.1.7 The last two (YY, 11th to 12th) numerical digits indicate the year like 22.
7.20 Incidence Numbering System
7.20.1 Incidence numbering system will be as per IN/DC/001/YY
7.20.1.1 1st
two (IN) alpha characters indicate the short form of Incidence.
7.20.1.2 The
third character will be “/” (slash) for separator.
7.20.1.3 The 4th
and 5th (DC) alpha characters are denoting the departmental code. Departmental
code is described in the section of 7.23
7.20.1.4 The 6th
number character will be “/” (Slash) for separator.
7.20.1.5 The
next three (7th to 9th) characters denote serial number of the Incidence.
7.20.1.6 The 10th
number character will be “/” (Slash) for separator.
7.20.1.7 The last two (YY, 11th to 12th) numerical digits indicate the year like 22.
7.21 Meeting Minutes Numbering System
7.21.1 Meeting
Minutes numbering system will be as per MM/DC/001/YY
7.21.1.1 1st
two (MM) alpha characters indicate the short form of Meeting Minutes.
7.21.1.2 The
third character will be “/” (slash) for separator.
7.21.1.3 The
4th and 5th (DC) alpha characters are denoting the departmental code.
Departmental code is described in the section of 7.23
7.21.1.4 The
6th number character will be “/” (Slash) for separator.
7.21.1.5 The
next three (7th to 9th) characters denote serial number of the Meeting.
7.21.1.6 The
10th number character will be “/” (Slash) for separator.
7.21.1.7 The last two (YY, 11th to 12th) numerical digits indicate the year like 24.
7.22 File Numbering System
File numbering system will be as per DC/DN/001
Where,
DC: corresponds to two the alphabets denoting the code number of department. Departmental code is described
in the section of 7.23
DN: corresponds the name of the document. Such as SOP, STP, DMF, Process Validation, BMR etc.
001: corresponds to three numerical figure of the serial No. starting 001, Example: QA/SOP/001
7.23 Departmental Code
Department wise code for documents
& records numbering system is follows:
|
Department |
Code |
|
Quality Assurance |
QA |
|
Production |
PR |
|
Quality Control |
QC |
|
Microbiology |
MB |
|
Product Development |
PD |
|
Warehouse |
WH |
|
Engineering |
EN |
|
Factory Admin |
FA |
|
Commercial & TSD |
CT |
|
Marketing & Sales |
MS |
|
Product Management |
PM |
|
Distribution |
DB |
|
Human Resources |
HR |
|
Regulatory |
RG |
Note: In case of an addition
in the list of department the concerned department Head, Head of Quality
Assurance and Head of Plant shall finalize the abbreviation.
8.0 Reference Document
8.1 WHO Good Manufacturing Practices Guideline
8.2 In House
8.3 ISO 9001:2015 Guideline
9.0 Annexure
9.1 Not Appreciable
10.0
Revision
History
|
Revision No. |
Brief
reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
11.0
Training
11.1 Head of Quality Assurance or his nominee is
responsible to conduct a training session on this SOP.
