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.
RESPONSIBILITY AND ACCOUNTABILITY
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.
PROCEDURE
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.
FIRST
PAGE
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”
5.1.1.2 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”.
5.1.1.3 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:
COMPANY CONFIDENTIAL
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:
|
Authority |
Name |
Job
Title |
Signature |
Date |
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Author |
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Process
Owner(s) |
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Approver(s) |
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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.
5.1.7.2
Name: This cell of the table in the STP implies the name of the respective person
or Author, Process owner and Approver.
5.1.7.3
Job Title: This cell of the table in the STP implies for Job designation of
respective persons or Author, Process
owner and Approver.
5.1.7.4
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.
5.1.7.5
Date: This cell of the table in the STP is used for a date by the aforesaid authority.
5.1.7.8
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.
5.1.7.9 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”.
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Date |
Issue
No. |
CCR |
Change
description/reason/supersedes |
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5.2.4.1 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”.
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Sr.
No. |
Designation |
Responsibility |
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1 |
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2 |
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3 |
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PROCEDURE
This part of STP shall start with the numbering “5.0” in the STP. The
operational part of STP shall start with this number.
5.2.9.1Further
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.
5.2.9.2 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.
5.2.9.4
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.
CODE NUMBERING FOR STPs
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.
Table-1
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Department/
Area |
Code |
|
Quality
Assurance |
QA |
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Quality
Control |
QC |
|
Microbiology |
MIB |
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Molecular
Biology |
MBI |
|
Building
Material |
BMT |
|
Calibration |
CAL |
|
Chemical
Section |
CHE |
|
Bio-Analytical
Division |
BAD |
CODE NUMBERING FOR RECORDING FORMATS
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.
CONTROL OF STP
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.
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:
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.
ABBREVIATIONS USED
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
LIST OF STPs
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Sr. No. |
Code No. |
Title of STP
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Issuance Date |
Effective Date |
Revision Due On |
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XXCQA/SOP-005/FR-02
APPENDIX II
REQUISITION FOR PHOTOCOPYING OF STP
DATE:
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:
_____________
XX/CQA/SOP-005/FR-03
APPENDIX III
STP ISSUANCE, RETRIEVAL and
DESTRUCTION RECORD
STP No.: ____________________________________
STP Title: ____________________________________
|
Date of Issue |
Copy No. |
No. of Copies |
Department |
Received By /
Date |
Retrieved By /
Date |
Destroyed By /
Date |
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