SOP for Standard Testing Procedure of Pharmaceutical Industry

This document details the procedure for the preparation, numbering, approval, distribution and revision control for the standard testing procedures (STPs). It is the policy of XYZ Limited that the written procedure shall be followed for preparation, numbering, approval, distribution and revision control for standard testing procedures in the pharmaceutical industry.

This procedure is to be applied at the time of preparation and numbering of new STPs; revision in STPs; distribution, control and retrieval of STPs and review of STPs.


The following persons are responsible for the preparation, operation and implementation of this procedure:

Executive  – Corporate Quality Assurance:- To prepare, document, distribute, retrieve and control.

Trainee analyst/Jr. Analyst/Analyst/ Sr. Analyst:- To follow the STP.

Manager  – Quality Assurance/Quality Control:- To ensure implementation of STP.

Vice President – Technical:- To ensure implementation of STP.


All STPs shall be prepared in M.S. Word in “Arial” and Font size “11”.

All STPs shall be printed only on A4 size sheets having the pre-printed company logo on the extreme right.

Except for the headings, all other text styles shall be Normal.

Header Information

Margins and alignments for Header and Footer are as follow:

Top – 1”, Bottom – 1”, Left – 1”, Right – 0.6”

Header – 0.5”, Footer – 0” Header bears the name of the company “Xx Pharmaceuticals Ltd.” In “Revue”, “Italic”, “Bold” and font size “16” with full address of Analytical Division in “Arial” and font size “11”. The right side of the header displays a table with the following information in “Arial” font-size “9”.

Code:     (STP code No.)    

Issue No.:    (Version No. of STP)

Effective Date:  (Effective date of STP)

Code: This cell of the table gives the unique code number of STP.

Issue No.: This cell of the table gives the existing version number of STP.

Effective Date: This cell of the table gives the details of the effective date of the STP.

Footer Information

The file name of STP shall be given on the left side and page no. is on the right side in the footer. In the centre following information shall be given:


Uncontrolled Copy if CQA Stamp is not Red

File name shall be written as XX_XXX _STP_001Issue01 where the three alphabets XX represent the company name e.g. A for Xx, P for Pharmaceuticals and L for Limited, the next two or three alphabets, XXX represent the concerned department code, here, STP is for Standard Testing Procedure and the three numerals 001 represent the serial number of the STP, where 001 is the first STP in the QA or concerned department series, next one is 002 and so on, and finally the two numerals 01 represent the issue number, here the 01 is the first issue, then 02 and so on. Page number shall be written as Page X of Y where X is page number 1, 2, 3, 4 and so on and Y is the total number of pages in the STP.

Matters typed between the header & footer shall be with the following margins and alignment –

Top – 1”, Bottom – 1, Left – 1”, Right – 0.6”

Alignment - justify

The top of the page shall be read as “STANDARD TESTING PROCEDURE” in “Arial”, “Italic”, “Bold”, and font size “11” in centre alignment.

TITLE: The title of the STP explains the name of the STP in Capital, “Arial”, “Bold” letter and font size “11”.

OWNER (S): The HOD of the concerned department in Capital, “Arial”, “Bold”, letter and font size “11”.

DOCUMENT APPROVAL: The following table displays the approval details of the STP:



Job Title








Process Owner(s)










Authority: For each STP there are three levels of Authority.

Author: Writer of STP. The author is the analyst/ junior analyst of the concerned department. There can be more than one author for the activity.

Process Owner(s): The process owner is the senior analyst/ Section in Charge of the concerned department responsible for the activity. There can be more than one owner for the activity.

Approver: The Approver shall be the Head of the concerned department. There can be more than one approver for the activity. Name: This cell of the table in the STP implies the name of the respective person or Author, Process owner and Approver. Job Title: This cell of the table in the STP implies for Job designation of respective persons or Author, Process owner and Approver. Signature: This cell of the table in the STP implies the signature of aforesaid authority and is the one pre-defined in the specimen signature document. Date: This cell of the table in the STP is used for a date by the aforesaid authority. DOCUMENT DISTRIBUTION: The copy number of this field indicates the number of copies of the STP and the copyholder indicates the details of departments/ sections where STP needs to be distributed. The original copy shall be treated as a Master Copy and shall be in the custody of the Manager – Quality Assurance. CROSS-REFERENCE: This field of STP shall give the code and title of the STP which has been referred to in the STP. SECOND and OTHER PAGES OF STP

The header information from the second page onwards shall be the same as the first page with STP title in lieu of the company address.

Footer information shall be identical to the first page.

CONTENT: This field of STP shall give the details of STP with the page number.

VERSION CONTROL HISTORY: This field of STP details version control, in the form of the following table with its serial number “0.0”.


Issue No.


Change description/reason/supersedes





 Date indicates the effective date of the version, Issue No. indicates the version number of STP, CCR indicates the Change Control Reference number and change description/ reason/ supersedes indicates mention change description its reason for the change and details of any other STP which has been superseded by the STP.

5.2.5    WHAT: This part of STP describes the details of the title of STP and the numbering of this title shall be “1.0”.

WHY: This part of STP describes the details of why the STP is required. The numbering of this title shall be “2.0”.

WHEN: This part of STP describes the details of when the STP is needed for reference. The numbering of this title shall be “3.0”.

5.2.8 RESPONSIBILITY AND ACCOUNTABILITY: This part of the STP defines the responsibility and accountability for the preparation and implementation of STP as shown below with its serial number “4.0”.

Sr. No.













This part of STP shall start with the numbering “5.0” in the STP. The operational part of STP shall start with this number. numbering for procedure shall be 5.1, 5.2 & so on and subpart for each numbering shall be 5.1.1, 5.1.2 etc. All the recording formats shall be appended as an Appendix at the end of STP & identified with a unique number as per step no. 5.4.

The appendix shall be numbered using Roman Numerals as I. II. III. And so on. Any part of the document, if it has to be included in the STP shall be annexed at the end of STP and shall be numbered as Annexure followed by Roman Numeral I, II, III and so on.


The code numbering shall be given to all STPS in the Analytical Division. The numbering system shall have 14 to 15 characters.

The first three characters shall be “XX” for each STP. The characters “XX” are the characters of the Company name “Xx Pharmaceuticals Limited”.

The fourth character shall be”/” for all STPs and the next two/three characters shall represent its department code as shown in Table I.

The eighth character shall be “/” for all STPs and the next three characters shall represent an STP.

After the department code, the twelfth character shall be “-“(dash).

The last three characters (13th to 15th) shall be the sequence number of the STP in a department.

A typical example of numbering in the QA department shall be as follows:

The Code number for “Standard Operating Procedure for STP” shall be XX/XXX/STP-001.


Department/ Area


Quality Assurance


Quality Control




Molecular Biology


Building Material




Chemical Section


Bio-Analytical Division



Code numbering of formats shall have twenty or twenty-one characters.

The First 14 or 15 characters shall be as per the numbering system of STPs. The 16th character shall be “/” and the next two characters (17th & 18th) shall be “FR” and the 19th character shall be “-“.

The last two characters (20th & 21st) shall be sequential numbers of the appendixes format.

A typical example

The numbering of recording format for STP number XX/XXX/STP-001 shall be XX/XXX/STP-001/FR-01 and if there is more than one format then a number of the second formats shall be XX/XXX/STP-001/FR-02 and so on.

The format number shall be positioned at the top of the page on the right, in bold.

All the formats used for recording purposes shall be “Appendices” with the STP and shall be controlled by the Quality Assurance Department.


All approved STPs shall bear the original signature in black ink on the first page with the date.

Each and every page of the STP shall be stamped with a MASTER COPY stamp in RED at the centre of the Header. The stamp shall have text as “MASTER COPY” in the centre of the first row and space for the initials of the Process Owner and Approver written as Owner and Approver respectively.

Owner: The owner shall be the senior analyst/ Section in charge of the department to which this STP belongs.

Approver: The Approver shall be the Head of the Concerned Department/ Head of Quality Assurance.

The facsimile of the Master Copy stamp is shown below.

SOP for Standard testing procedure in pharmaceutical industry

This system of Master Copy shall authenticate all the pages of STP.

Photocopy from the master copy of STP (after final distribution) shall be allowed only after written approval from the Manager- Quality Assurance/ Head of the concerned department. A written requisition shall be made for issuance through the department head mentioning the reason for photocopy and the record shall be maintained as per format number XX/CQA /SOP-005/FR-02, Requisition for Photocopying of STP (Appendix II)

5.5.3 Manager- Quality Assurance shall organize photocopying of STPs.

5.5.4 The round rubber stamp “CONTROLLED COPY, XX PHARMACEUTICALS LTD., STAMPED IN RED” shall be stamped at the CENTER of the footer on each page of photocopied STP for distribution to different departments. The stamp shall also have the text ‘Copy No. _____’ which shall be written as per the copy no. of the copyholder at the time of distribution. The facsimile of the stamp is shown below:

control copy stamp

Manager - The quality Assurance department shall control the issuance & retrieval of all STPs. The details of issuance & retrieval shall be maintained on XX/CQA/SOP-005/FR-02 STP Issuance and Retrieval Register (Appendix II). 

The Master Copy shall be retained with the Head of Quality Assurance department/ Corporate Quality Assurance. preparation, ISSUANCE, RETRIEVAL AND REVIEW OF STP.

The owner departments shall prepare all the new & revised STPs. All new or revised STPs shall be circulated for approval. All the concerned personnel shall mark their signature & date in the appropriate columns.    

After approval of STP, stamp the STP as ‘Master copy’ and shall be photocopied for distribution as per ‘Copy Holder’ and shall be stamped as ‘Controlled Copy’ in red and the ‘Copy No’ written in the document distribution on the first page of the concerned STP.

The controlled copy shall be issued on the effective date of the respective STPs and at the same time, a controlled copy (ie) of the superseded STP shall be retrieved and destroyed immediately by the concerned QA/ CQA personnel.

5.6.4 Issuance, retrieval and destruction record of STPs shall be maintained as per format no XX/CQA /SOP-005/FR-03 STP issuance, retrieval and destruction record (Appendix III).

5.6.5 The master copy of the superseded STP shall be stamped as “SUPERSEDED” in red at the middle of each page of the STP and preserved for a minimum of two years from the effective date of the next version.

If the existing STP will not be used further, the master copy shall be stamped as “OBSOLETE” in red at the middle of each page of the STP and shall be retained forever.

STP shall be reviewed every two years or whenever any change is required in the STP, whichever is earlier.

A change control shall be raised if there is any change, for a revision of STP.

A change control shall not be required if the revision is periodic (no major change in the previous version) and written “PERIODIC REVIEW” in the version control history.

5.6.8    A list of STPs shall be prepared as per XX/CQA/SOP-005/FR-01, a List of STPs (Appendix I) for each department.


XX: Xx Pharmaceuticals Limited

CQA: Corporate Quality Assurance

QA: Quality Assurance

SOP: Standard Operating Procedure

STP: Standard Testing Procedure

CCR: Change Control reference number

HOD: Head of Department

APPENDIX I             XX/CQA/SOP-005/FR-01




Code No.

Title of STP


Issuance Date

Effective Date

Revision Due On























































































































Department  ______________________________________________________________ 

STP Number  _____________________________________________________________ 

Title of STP  ______________________________________________________________

Photocopy Required for: (Full STP / Part of STP)

            Department                                                                 No. of copies  


If part of STP is required give details of pages: ……………………….. 

Reason for Photocopy



Prepared By: ___________________                                         Date _____________


            (HOD) Approved By:


Quality Assurance Manager _________________                   Date: _____________




STP No.:           ____________________________________

STP Title:           ____________________________________

Date of Issue

Copy No.

No. of Copies


Received By / Date

Retrieved By / Date

Destroyed By / Date







































































>Handling of External Analysis or Subcontracting of Sample 

>Environmental health and safety | EHS policy for company


Hi I'm Banti Singh, a Chemical Engineer! Welcome all of you to my blog. If you got the information right? Share the information. All of you Thank you

Thanks to visit this site.

Post a Comment (0)
Previous Post Next Post