Numbering System for Level One Master Document
1.0 Objective
To lay down a Procedure for numbering system of Level One Master Documents.
2.0 Scope
This Standard Operating Procedure is applicable for numbering system of Level
One Master Documents like Site Master File, Validation Master Plan, Training Manual,
Quality Manual for Domestic and Export to be followed at formulation plant of ABC Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for assigning the number to Level One Master Documents.
3.2 Head-Quality Assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
Level One
Master Documents : Master Documents means a specific document which gives an idea regarding
the Plant, Quality Parameter, and different Manufacturing and Functional parameter in Brief.
Number : Number means a unique combination of letters, numbers or symbols from which the
complete history of the Document can be determined.
5.0 Procedure
5.1 Numbering system
5.1.1 A unique number shall be given to all Level One Documents by the QA Officer / Executive.
5.1.2 Two number of same or different Level One Document shall not match with each other.
5.1.3 Document code shall be given by QA Officer / Executive as per Annexure-1.
5.1.4 Document number shall correlate with the Level One Master Documents.
5.1.5 Number for Documents shall be of 09 alphanumerical characters in following way XXX YY Where
XXX – stands for Abbreviation of Document. (Refer Annexure 1)
YY – stands for Revision No. of Documents.
5.1.6 For example number for Site Master File shall be given as SMF/01-00 where
SMF stands for Site Master File
01 stands for first time Issuance of the Document.
00 stands for no revision of the Document.
6.0 Forms and Records
6.1 Document Code List – Annexure- 1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR
Procedure for Sampling of Rinse water Swab
Cleaning Validation of Equipment
Measurement and Recording of Temperature and Relative Humid
Sampling of Product at Intermediate Stages
Approval of Overprinting on Packing Material
sop for Procedure for Reprocessing
Preparation and Control of Master Batch Production and Control record
Issuance and Retrieval of Control documents
Calibration Policy for equipment
procedure for batch numbering system for products
sop for Handling of Incident during operation
Procedure for Allocation of Numbers for Machine Equipment
Validation and Qualification Facility System and Equipment
In-process Checks During Packing Operation
Procedure for Issuance of Extra Raw Material Packing Material