1.0 OBJECTIVE
1.1 To
lay down the procedure for Standard Operating Procedure.
2.0 SCOPE
2.1 This
procedure applies to 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 Micro Soft. 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 follow:
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 following information in “Arial” font size “11”.
4.5 Footer
Information
4.4.4 The
top of 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 Document
Number of SOP shall be given in 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 on the end of first
and last page.
4.8 First
and Other Pages of SOP
4.8.1 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 SOP describes the details of title of SOP and numbering of this
title shall be “1.0”.
4.8.4 SCOPE: This
part of 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 SOP. The numbering of this title shall be “3.0”
4.8.6 PROCEDURE: This
part of SOP shall start with 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 on Annexure or Appendix at the end
of 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
First three characters shall be “ALL” for each SOP. The characters “ALL” are
the characters of Company name
“xyz”.
4.9.3.3
Fourth character shall be “/“for all SOP’s and next three characters are “SOP”
and it denotes that it is Standard Operating Procedure.
4.9.3.4 Eighth
character shall be “/“for all SOP’s and next two or three characters shall
represents its department code that is shown in Table 1.
4.9.3.5 After
department code eleventh character shall be “-“.
4.9.3.6 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 First
13 characters remain same as SOP numbering for SOP.
4.10.3 14th character
shall be “/“for and 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 of 17 characters.
4.11.2 First
three characters shall be “ZYz” for each SOP. The characters “XYZ” are the
characters of Company name “XYZ”.
4.11.3 Fourth
character shall be “/“and next two or three characters shall be department
code.
4.11.4 Seventh
character shall be “/“and next two characters shall be the SOP number to trace
that to which SOP this format belongs to.
4.11.5 Tenth
character shall be “/” and next character “FR” shall represent the “Format”.
4.11.6 Twelve
and thirteen character represents the format number. Next character shall be
“-” and 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 top of the page on 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 purpose shall be “ANNEXURE” and “APPENDIX” with
the SOP and shall be controlled by the Quality Assurance Department.
Appendix shall not be numbered, as it shall be a part of SOP.
4.12
Preparation, Distribution, Retrieval and Destruction of Sop
4.12.1 QA
/ QC department shall prepare all the new & revised SOPs of QA, QC,
Microbiology, Production and store Department. 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:
Document
is to be distributed in the specific department / departments where ever 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 Master Copy and shall be in the
custody of Quality Assurance Department.
4.12.5 The
master copy of superseded SOP shall be stamped as “OBSELETE” in red at middle
of each page of SOP and preserved for minimum 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 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
Operation and calibration of Bursting
Strength Tester.
