1.0 OBJECTIVE
1.1 To
lay down the procedure for Standard Operating Procedure.
2.0 SCOPE
2.1 This
procedure applies to the Quality Assurance and Quality Control Department of XYZ.
3.0 RESPONSIBILITIES
3.1 QC
chemists and QA executives to prepare and follow the SOP.
3.2 Head
– QA & QC for implementation of SOP.
4.0 PROCEDURE
4.1 All
SOPs shall be prepared in MicroSoft. Word in “Arial” and font size “11”.
4.2 All
SOPs shall be printed on A4 size sheets only.
4.3 First
Page
4.4 Header
Information
4.4.1 Margins
and alignments for Header and Footer are as follows:
Top
– 1”, Bottom – 1”, Left – 1” Right – 0.6”
Header
– 0.5”, Footer – 0”
4.4.2 Header
bears the name of the company “XYZ” in “Arial”, “Bold” and font size “14”
4.4.3 The right side of the header displays a table with the following information in “Arial” font size “11”.
4.5 Footer
Information
4.4.4 The
top of the page shall read as “STANDARD OPERATING PROCEDURE” in “Arial”,
“Bold” and font size “11” in Centre alignment.
4.4.5 TITLE: The
title of the SOP explains the name of the SOP in Capital, “Arial”, “Bold” and
font size “11”.
4.5.1 The Document
Number of SOP shall be given on the left side and page no. is on the right side
in the footer.
4.7 Document
Approval: The SOP should have the following details at the end of the first
and last page.
4.8 First
and Other Pages of SOP
4.8. INDEX
SOP
shall start with an index and it should contain all the steps written in that
SOP.
4.8.2 CONTROL HISTORY
Control history shall contain the details of change control and
the reason for that. This part shall be numbered as 0.0.
4.8.3 OBJECTIVE
This
part of the SOP describes the details of the title of the SOP and the numbering of this
title shall be “1.0”.
4.8.4 SCOPE
This
part of the SOP describes the details to which department the SOP shall be
applied. The numbering of this title shall be “2.0”.
4.8.5 RESPONSIBILITY
This
part of the SOP defines the responsibility for the preparation
and implementation of the SOP. The numbering of this title shall be “3.0”
4.8.6 PROCEDURE
This
part of the SOP shall start with the numbering “4.0” in the SOP. The
operational part of SOP shall start with this number.
4.8.6.1
Further numbering for procedure shall be 4.1, 4.2 & so on and subpart for each
numbering shall be 4.1.1, 4.1.2 etc.
4.8.6.2
All the recording formats shall be recorded in the Annexure or Appendix at the end
of the SOP.
4.8.6.3
Annexure shall be numbered using Roman Numerals as I. II. III and so on.
4.8.6.4 ABBREVIATIONS: This
part of SOP shall be at the end of the procedure or calibration. This part
shall define the short forms written in the SOP.
4.8.6.5 REFERENCE: At
the end of SOP reference shall be given.
4.9 SOP Numbering
For SOPs
4.9.3.1
The SOP numbering shall be given to all SOPs. The numbering system shall have
13 to 14 characters.
4.9.3.2 The first three characters shall be “ALL” for each SOP. The characters “ALL” are
the characters of the Company name
“xyz”.
4.9.3.3 The fourth character shall be “/“for all SOP’s and the next three characters are “SOP”
and it denotes that it is a Standard Operating Procedure.
4.9.3.4 The Eighth
character shall be “/“for all SOP and the next two or three characters shall
represent its department code which is shown in Table 1.
4.9.3.5 After the department code eleventh character shall be “-“.
4.9.3.6 The last two characters (12th to
13th) shall
be the sequence number of the SOP in a department.
4.9.3.7 A
typical example of numbering in the QA department shall be as follows The
SOP number for “Standard Operating Procedure on SOP” shall be ALL/SOP/QA-01
4.10 Code
Numbering For Document
4.10.1 The code numbering shall
be given to all SOPs in the plant. The numbering system shall have 16 characters.
4.10.2 The first 13 characters remain the same as SOP numbering for SOP.
4.10.3 The 14th character
shall be “/“for and the last two characters “00” shall be the revision number of
that SOP.
4.10.6 A
typical example The code of document
number for QA SOP shall be ALL/SOP/QA-01/00 and it shall be at
the left side of the footer.
4.11 Code
Numbering For Recording Format (ANNEXURE)
4.11.1 The
format numbering shall be 17 characters.
4.11.2 The first three characters shall be “ZYz” for each SOP. The characters “XYZ” are the
characters of the Company name “XYZ”.
4.11.3 The fourth character shall be “/“and the next two or three characters shall be department
code.
4.11.4 The seventh character shall be “/“and the next two characters shall be the SOP number to trace to which SOP this format belongs.
4.11.5 Tenth
character shall be “/” and the next character “FR” shall represent the “Format”.
4.11.6 Twelve
and thirteen characters represent the format number. The next character shall be
“-” and the last two characters shall be “00” to represent the revision number
of that SOP and Format.
4.11.7 The
format number shall be positioned at the top of the page on the right, in bold, and
shall be like XX/QA/01/FR01-00 in all formats of that SOP.
4.11.8 All
the formats used for recording purposes shall be “ANNEXURE” and “APPENDIX” with
the SOP and shall be controlled by the Quality Assurance Department. An appendix shall not be numbered, as it shall be a part of the SOP.
4.12 Preparation, Distribution, Retrieval and Destruction of Sop
4.12.1 The QA
/ QC department shall prepare all the new & revised SOPs of the QA, QC,
Microbiology, Production, and Store Departments. HR department shall prepare
SOP’s of Human Resources.
4.12.2 After
approval of SOP, it should be stamped as ‘Master copy’ in red and photocopied
for distribution and shall be stamped as ‘Controlled Copy’ in blue.
4.12.3 The
controlled copy shall be issued on the effective date of the respective SOPs
and at the same time controlled copy (ies) of the superseded SOP shall be
retrieved and destroyed immediately by the concerned QA personnel / QC
personnel.
4.12.4 Document Distribution
The document is to be distributed in the specific department/departments wherever the
need and the no. of copies, signature of the authorized person of that
particular department, and signature of the person who is distributing the
SOP, retrieving the previous SOP, and destroying the control copy of SOP
shall be recorded on the format of Annexure I i.e. ALL/QA/01/FR01-00. The
original copy shall be treated as a Master Copy and shall be in the
custody of the Quality Assurance Department.
4.12.5 The
master copy of the superseded SOP shall be stamped as “OBSELETE” in red at the middle
of each page of the SOP and preserved for a minimum of five years from the
effective date of the next version.
4.12.6 SOP
shall be reviewed after every two years or if any change is required in the SOP,
whichever is earlier.
4.12.7 A
change control shall be raised if there is any change, for a revision of SOP.
4.12.8 A
change control shall not be required if the revision is periodic.
5.0 ABBREVIATION
SOP: Standard
Operating Procedure
QA: Quality
Assurance
QC: Quality Control
HR: Human Resources
PR: Production
ST: Store
No.: Number
6.0 REFERENCE: NIL