procedure for preparation of general test procedures and standard test procedures
1.0 Purpose
1.1 To describe a procedure for preparation of general test procedures and standard testing procedure.
2.0 Scope
2.1 This procedure is applicable to Quality Control department and serves as guidelines for its preparation,
implementation and control of general test procedures and standard testing procedure used for analysis at ABC Pvt. Ltd.
3.0 Responsibility
Officer QC/ Executive QC Preparation of SOP, Preparation of GTP & STP
Assistant Manager Reviewing and Training of SOP, Review of STP and GTP
Manager QC Final review of documents & Implementation of SOP
4.0 Accountability
4.1 Manager Quality Control is accountable for implementation and compliance with SOP.
5.0 Procedure
5.1 Preparation of Standard Test Procedures and specification.
5.1.1 Each standard test procedures shall be prepared by the Quality Control personnel in the respective format.
5.1.2 Standard A4 size white paper shall be used.
5.1.2 The text of standard test procedures / specification shall be in “Arial” font in a clear, unambiguous,
- easy to understand and easy to follow language.
5.1.3 The standard test procedures / specification shall consist of the following sections.
Reference gives the reference of the standard test procedure.
Chemicals & Reagent which shall list all the reagents involved in the preparation and standardization procedures.
Procedures which shall include the detailed procedures of the standard test procedures along with calculation
Revision History Each general test procedure shall include the revision history giving the details and
reasons for revision which shall be retained with the master copy for reference and shall not be part of
the distributed copies. In case of new document, “nil” shall be indicated in the columns
5.1.4 The header for general test procedures shall include the following sections
The header of each document shall contain the Name of Company and site address along with
Logo on the top right hand corner
The next section is the GTP / STP and STS No. which is a 12 digit general/standard test
- test procedure number represented as :
| R | M | / | S | T | P | / | I | P | 0 | 0 | 1 |
Sequential Reference serial no.
Sequential Reference serial no.
5.1.5 The first two digits represent the section of the standard test procedure.
VS for standard test procedures for volumetric solutions
RM/FP for standard test procedures for raw materials and finished products
PM for standard test procedures for packaging materials
The next digit is a slash “/”
The fourth to sixth digits “STP / STS” represent the standard test procedures / Specification
The seventh digit is a slash “/”
The eight to nine digit is reference.
The ten to twelve represents the sequential number which shall start with “001” for the first
STP/STS and proceed sequentially irrespective of the section of the general test procedure.
5.2 Supersedes
5.2.2 Shall give the document number which precedes this document. In case of new
documents, it shall be printed as “Nil”.
5.3 Effective Date
5.3.2 Shall be written as the date, month & year (DD/MM/YYYY) when this document is scheduled to be effective.
5.4 Review Date
5.4.2 Shall be written as the date, month and year (DD/MM/YYYY) for review (Three years from the date of issue),
However any changes in the document before the review date may be done due to changes in
pharmacopeia or regulatory bodies. In that case, it shall be done through a change control procedure
and due change in the revision number.
5.5 Page No.
5.5.2 Shall be the sequential page no. indicate as the current page no. of total no. of pages.
5.6 The footer of the document shall include the signatures of the persons responsible for preparing,
checking and approving the documents.
5.7 The name, designation and department name of the respective persons shall be preprinted in the format.
Note: Each signatory shall sign in blue pen in full and put the date of signature.
5.8 Revision History
5.8.2 Revision of standard test procedures shall be done at any time within the three years of the issue
but must necessarily be reviewed at the end of three years. The revision shall be initiated through the change control procedure.
6.0 Reference
In house specification
7.0 Attachments
Annexure I : Specification Format
Annexure II : Standard Test Procedures Format
8.0 Distribution
Distribution of the controlled copy to concerned departments.
Additional copies may be issued for specific purpose.
9.0 Abbreviations
QA : Quality Assurance
QC : Quality Control
SOP : Standard Operating Procedure
10.0 Revision History
| Revision No. | Supersedes | Effective Date | Details of Revision |
| 01 | Nil | New SOP |