How to write a standard operating procedure in a Pharmaceutical Industry
1.0 OBJECTIVE:
To
describe the procedure for Preparation, Review and Approval of standard
operating procedure.
2.0 SCOPE:
This
describes the basic principles, defines the responsibilities and lays down the
procedure for preparing SOPs. This SOP shall be applicable to all the SOPs.
3.0 RESPONSIBILITY:
3.1
Executive/ Officer
Q.A/ Designee: Preparation and Revision/ Periodic review of SOPs.
3.2
Q.A Head/
Designee: Review and Training of SOP.
3.3
Site Quality Head/
G.M-works/ Designee: Approval of SOP.
4.0 ACCOUNTABILITY:
4.1
Head of the Q.A
Department.
5.0 PROCEDURE:
5.1
All SOPs shall be
as per the SOP Format, attached as Annexure-1.
5.2
Each page
including Annexure shall bear Company Logo.
5.3
Prepare front
cover page of each SOP.
5.4
All the SOPs shall
consist of Header, Cover page, Content and Footer part.
5.4.1
The Header Part of each SOP shall remain on
first page. The Header part of the SOP shall consist of the following:
5.4.1.1
Logo:
The
Logo on the left-hand corner of the header with 30mm (L) x 6mm (H).
5.4.1.2
Standard
Operating Procedure: STANDARD OPERATING PROCEDURE… shall
be printed in Font: Times New Roman letters, Font size: 14, Style: Bold,
Capital.
5.4.2
The Cover Page of each SOP shall consist of
the following:
5.4.2.1
Title:
The title of SOP shall be in Font: Times
New Roman letters, Font size: 12, Style: Normal, Bold sentence case. It should
be self-descriptive.
5.4.2.2
Copy
No.: The copy no. shall appear on the page of SOP except
Master Copy.
5.4.2.3
Location:
The name of location of the plant for which SOP is applicable. Font: Times New
Roman letters, Font size: 12, Style: Bold, Regular.
5.4.2.4
Department:
The
name of the department preparing the SOP shall be in Font: Times New Roman
letters, Font size: 12, Style: Bold, Regular.
5.4.2.5
Area: The
name of area/ sub-section of the Department shall be mentioned wherever
applicable. Font: Times New Roman letters, Font size: 12, Style: Bold, Regular.
5.4.2.6
SOP
No.:
5.4.2.6.1
Each SOP shall
have a unique numbering system. Once number is allocated to any SOP, the same
number shall not be repeated to other SOP.
5.4.2.6.2
SOP
Number shall consist of 16 characters.
5.4.2.6.2.1 First
two characters ‘XYZ’ denote “XYZ Limited”.
5.4.2.6.2.2 Third
character denotes site, e.g. XYZ for XYZ Plant.
5.4.2.6.2.3 Fourth
character denotes slash (/).
5.4.2.6.2.4 Fifth
and sixth character denotes Department or Section code, e.g. QA for Quality
Assurance, PR for Production.
5.4.2.6.2.5 Seventh
character denotes slash (/).
5.4.2.6.2.6 Eighth,
ninth and tenth characters denote “SOP”.
5.4.2.6.2.7 Eleventh,
twelfth & thirteen characters denote serial number of SOP, starting from
“001” onwards.
5.4.2.6.2.8 Fourteenth
character denotes dash (-).
5.4.2.6.2.9 Last
two characters denote Revision No. of SOP.
5.4.2.6.3
e.g. First new SOP
of QA shall have SOP number as XYZ/QA/SOP001-00.
5.4.2.7 Supersede: In case of a new SOP, Supersede No. will be nil. If
Revision of SOP is done than the previous SOP No. will be written against
supersede.
5.4.2.8 Effective date: The effective date is the date from which the SOP shall be
effective. Training shall be given to all concerned personnel before effective
date of the SOP.
5.4.2.10 Prepared/ initiated
by: Person
preparing the SOP from the initiating department, shall sign with the date, in
black ink. Designation shall be printed with department mentioned in
Annexure-2.
5.4.2.11 Approved by: Head
of the initiating department/ designee shall review the SOP and sign with date,
in black ink. Designation shall be printed with department mentioned in Annexure-2.
5.4.2.12 Authorized by: Site
Quality Head and his designee shall approve all SOPs of Quality Assurance and
Quality Control department. Site Quality Head and concerned Department Head
shall approve all SOPs of other departments. They will sign with date in blue
ink.
5.4.3
The Content Part of the SOP shall contain
the following sections:
5.4.3.1
Purpose/
Objective: This section shall describe the
justification for the preparation of the SOP and what is expected from it in
one sentence or maximum two sentences starting with a letter “To”.
5.4.3.2
Scope:
This
section shall indicate the applicability of the SOP and also specifies
departments, areas, or sections to which this SOP shall be applicable.
5.4.3.3
Responsibility:
Write
here the designation of the person/ persons who are directly responsible for
the operations mentioned in the ‘Objective’ of the SOP.
5.4.3.4
Accountability:
Write
here the Head of the Department who is accountable for compliance of the SOP.
5.4.3.5
Material
and equipment: Write here the material and equipment
used in the procedure, mostly in Production and Q.C SOPs preparation there is
need of material and equipment heading.
5.4.3.6
Procedure:
5.4.3.6.1
Write the
procedure/ method in short sentences. Do not write the instructions in long paragraphs.
5.4.3.6.2
This section shall
cover stepwise activities performed and conditions/ precautions required for
implementing the SOP.
5.4.3.6.3
Mention all the
checks to be carried out, records to be maintained, frequency of various
operations, checks and special precautions, if any.
5.4.3.6.4
SOP text shall be
written in simple and clear language in Font: Times New Roman letters, Font
size: 12 and space between the lines shall be 1.5 lines.
5.4.3.6.5
A-4 size white
paper shall be used for printing.
5.4.3.6.6
Bold letters shall
be used for heading or sub-heading.
5.4.3.6.7
All SOP shall be
written in English language.
5.4.3.7
Revision
Log: It has the following details:
5.4.3.7.1
Revision
No.: Revision No. consists of
two numerical characters which start from ‘00’ with increment in one digit
after each revision. ‘00’ indicates the first issuance of that particular SOP.
5.4.3.7.2
Effective
date: It shall be stamped by Q.A. after final authorization
before circulating the SOPs.
5.4.3.7.3
Reason:
If
there will be a change required in the SOP the reason should be given in this
column for change.
5.4.3.8
Reference:
Mention
a list of references or any other guidance documents based on which the SOP has
been prepared. If there is no reference for the SOP, mention ‘Not Applicable’
under this sub-heading.
5.4.3.9
Annexure:
5.4.3.9.1
Annexure shall be
formats, used for recording the data, related to the activity.
5.4.3.9.2
Mention a list of all
Annexure enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not
Applicable’ under this sub-heading.
5.4.3.9.3
Annexure shall
have a unique format number linked to the relevant SOP and shall be written at
the bottom, left of the page.
5.4.3.9.4
Copy of an
Additional Format taken from other SOPs shall be attached as Annexure, which
has a linkage or bearing on the said SOP. The same shall be indicated in the
list of Annexure.
5.4.3.10 Abbreviations: Mention
a list of all abbreviations & their full forms/ descriptions used in the
SOP. If there is no Abbreviation in the SOP, mention ‘Not Applicable’ under
this sub-heading.
5.4.4
The Footer Part of the SOP shall contain
the following sections:
5.4.4.1 Block for stamping
purpose:
This space shall be used for putting
stamp for controlled documents on the photocopies. This block shall be on the
right side of the footer.
5.4.4.2
Page
No.: The page no. shall appear on the right hand corner of
the footer. This specifies the page no., with respect
to the total number of pages of the SOP, may exclude the Annexure.
5.4.4.3
Format
No.:
5.4.4.3.1
The format number
used for preparing the SOP is mentioned in the footer block. Font: Times New
Roman letters, Font size: 10, Style: Regular.
5.4.4.3.2.1 First
two characters ‘XX’ denote Company name.
5.4.4.3.2.2 The
third character ‘B’ denotes the manufacturing site.
5.4.4.3.2.3 Fourth
character represent “Slash” (/).
5.4.4.3.2.4 Fifth
& sixth characters denote the name of the Department or Section.
5.4.4.3.2.5 Seventh,
eighth & ninth characters denote SOP no. of respective department to which
the format is linked.
5.4.4.3.2.6 Tenth
character is “Slash” (/).
5.4.4.3.2.7 Eleventh
Character is ‘F’, which stands for format.
5.4.4.3.2.9 Fourteenth
character denotes dash (-).
5.4.4.3.2.10 Fifteenth
& sixteenth characters represent Revision number of
the format. If a format is made for the first time it is indicated as “00” in
the Revision No. and subsequent revisions in the format shall be indicated by
“01”, “02”, and so on.
5.4.4.3.2.11 e.g.
XYZ/QA001/F01-00
Where,
“XYZ” represents XYZ plant, “QA” represents the Quality Assurance, “001” is the
SOP number to which the format is linked, “F” represents the format, “01”
represents the format no., followed by dash (-) and “00” indicates the revision
number i.e. new format.
5.5
User department
shall prepare the draft SOP as per the procedure described in 5.4. Draft copy
shall be identified by stamping or watermark on each page.
5.6
Draft copy shall
be circulated to responsible persons for its review.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: SOP
Format.
Annexure 2: List
of Codes for Site and Department.
Annexure:
1
SOP
Format
|
STANDARD
OPERATING PROCEDURE TITLE: (detailed title)
Page 1
of 2 STANDARD OPERATING PROCEDURE 1.0 OBJECTIVE: 2.0 SCOPE: 3.0 RESPONSIBILITY: 4.0 ACCOUNTABILITY: 5.0 MATERIAL AND
EQUIPMENT: 6.0 PROCEDURE: 7.0 REVISION LOG:
8.0 REFERENCES: 9.0 ANNEXURES: Annexure 1: Annexure 2: …………. So on. 10.0 ABBREVIATIONS:
|
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Annexure: 2
List of Codes for Site
and Department.
|
Site |
Code |
|
Company Name Pharma,
Ltd. |
COMPANY NAME FIRST
ALPHABET |
|
DEPARTMENT
FUNCTION |
DEPARTMENT
CODE |
|
Administration |
AD |
|
Accounts
|
AC |
|
Human
Resource and Management |
HR |
|
Information
Technology |
IT |
|
Stores/
warehouse |
S |
|
Store
(Raw material) |
SR |
|
Store
(Raw Material Quarantine Area) |
SRQ |
|
Store
(Raw Material Rejected Area) |
SRR |
|
Store (Raw Material
Sampling Area) |
SRS |
|
Store (Raw Material
Dispensing Area) |
SRD |
|
Store (Raw Material
Cold Room) |
SRC |
|
Store (Packing
Material) |
SP |
|
Store (Packing Material
Quarantine Area) |
SPQ |
|
Store
(Packing Material Rejected Area) |
SPR |
|
Store (Finished Goods) |
SFG |
|
Store (Finished Goods
Quarantine Area) |
SFGQ |
|
Quality
Control |
QC |
|
Quality
Control (Laboratory) |
QCL |
|
Quality
Control (Instrument Lab) |
QCI |
|
Quality
Control (Stability Chamber) |
QCS |
|
Quality
Control (Retaining Sample Area) |
QCRs |
|
Quality
Control (Active Ingredients) |
QCA |
|
Quality
Control (Reagents) |
QCR |
|
Quality
Control (Equipments) |
QCE |
|
Quality
Control (Equipment Cleaning) |
QCEC |
|
Quality
Control (Equipment Operations) |
QCEO |
|
Quality
Control (Equipment Calibrations) |
QCEB |
|
Quality
Control (Test) |
QCT |
|
Quality
Control (in-process test) |
QCi |
|
Quality
Control (finished product test) |
QCf |
|
Quality
Control (Finished goods) |
QCF |
|
Quality
Assurance |
QA |
|
Research
and Development |
R&D |
|
Production
|
PR |
|
Production
(Machinery) |
PM |
|
Production
(Machinery Cleaning) |
PMC |
|
Production
(Machinery Operations) |
PMO |
|
Production
(Machinery Calibrations) |
PMB |
|
Production
(Methods) |
PRM |
|
Production
(Tablet) |
PT |
|
Production
(Capsule) |
PC |
|
Production
(Sachet) |
PS |
|
Production (Syrups) |
PL |
|
Engineering
|
EN |
|
Marketing
|
MK |
|
Purchase
|
PU |
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
SOP |
Standard operating
procedure |
|
& |
And |
|
No. |
Number |
|
Ltd. |
Limited |
|
Q.A |
Quality assurance |
|
G.M |
General Manager |
|
L |
Length |
|
H |
Height |
|
Q.C |
Quality control |
|
PR |
Production |
|
F |
Format |
|
COMPANY NAME FIRST
ALPHABET |
Company Name |