Learn how to design and write a (Standard Operating Procedure) SOP of SOP in Pharmaceuticals.
Table of Contents
1.0 PURPOSE
To describe a standard procedure for the preparation, approval, authorization, control, and revision of Standard Operating Procedures in this company.
2.0 SCOPE
This SOP outlines the key concepts, specifies roles, and provides the process for creating SOPs. The specifications of this SOP shall apply to all SOPs.
3.0 RESPONSIBILITY
3.1 Initiation & Prepare: Executive/officer and above level
3.2 Review & checking: Senior Executive and above level
3.3 Training: All personnel who are involved in the preparation, reviewing, approval and distribution activities as defined by this
procedure require Level 2 (L2) training (i.e. with assessment) and all others require Level 1 (L1) training (i.e. read and understand).
3.4 Approval: Manager and above
4.0 ACCOUNTABILITY
Head of the Quality Assurance Department
5.0 REFERENCES/ASSOCIATED DOCUMENTS
Not applicable
6.0 PRECAUTIONS
Not Applicable
7.0 PROCEDURE
7.1 At first select the A-4 size paper format to prepare the SOP.
7.2 Design and Prepare the SOPs to describe the operating procedures and steps.
7.3 Write all the SOPs in apparent language which is easy to understand and follow.
7.4 Write the SOPs under the following sub-headings as contents:
7.4.1 PURPOSE
7.4.2 SCOPE
7.4.3 RESPONSIBILITY
7.4.4 ACCOUNTABILITY
7.4.5 REFERENCES/ASSOCIATED DOCUMENTS
7.4.6 PRECAUTIONS
7.4.7 PROCEDURE
7.4.8 ABBREVIATIONS
7.4.9 ANNEXURES
7.4.10 REVISION HISTORY
7.4.1 PURPOSE
Write here, in a maximum of two sentences, the justification for creating the SOP starting with the letter “To”
7.4.2 SCOPE
This Section specifies how the SOP is applicable and identifies the departments, areas, or departments to which it must be applied.
7.4.3 RESPONSIBILITY
Identify the individual or people who are directly in control of the operations listed in the SOP’s “Purpose” by writing their names here.
7.4.4 ACCOUNTABILITY
The department head responsible for SOP compliance should be listed here.
7.4.5 REFERENCES/ASSOCIATED DOCUMENTS
Write here the list of references and associated documents or related SOP numbers based on
which the SOP was developed. ‘Not Applicable’ should be mentioned under this subheading if there is no reference for the SOP.
7.4.6 PRECAUTIONS
Write down here the name and wearing procedure of the safety materials (safety googols,
hand gloves, knife, etc) and clothing (apron, clean room gown, mask, shoes, cap) are
essential for operating or following the SOP.
7.4.7 PROCEDURE
7.4.7.1 Please Write the procedure/method in short sentences and simple words. Do not write
the instructions in long paragraphs.
7.4.7.2 Mention all the checks to be carried out, records to be maintained, and frequency of
various operations, checks, and special precautions, if any.
7.4.7.3 Enclose all the Annexures and attachments with SOP if applicable.
7.4.8 ABBREVIATIONS
Mention an alphabetical list of all abbreviations and their full meanings or definitions that were used in the SOP. Mention “Not Applicable” under this subheading if there is no abbreviation in the SOP.
7.4.9 ANNEXURES
List all of the annexures that are included in the SOP. Mention ‘Not Applicable’ beneath this category if the SOP does not contain an annexure.
7.4.10 REVISION HISTORY
Write down here the SOP history. Revision number, changing or reviewing causes, and who is
prepared for the SOP.
7.5 Write the SOP in English (If required, some of the SOPs shall be written in the local language, i.e
Hindi, Urdhu, Bengali.
7.6 Font Format of SOPs:
| Content of SOP | Font Type | Font Size | ||
| Header | ||||
| (In the upper right corner) “COMPANY NAME” (First-row right column and middle position) | Arial Bold Upper Case | 16 | ||
| Company Address (Under the company name) (First-row right column and middle position) | Arial Bold Sentence Case | 10 | ||
| LOGO (On the top left corner) (First row left column and middle position) | JPEG format Picture | Height: 0.45-inch Width: 0.40 inch | ||
| “STANDARD OPERATING PROCEDURE” (Second row with single column and middle position) | Arial Bold Upper Case | 14 | ||
| TITLE (Third row with 2 columns and left position in column and page) | Arial Bold Upper Case | 10 | ||
| DEPARTMENT (Fourth row in 1st & 2nd column and left position in column and page) | Arial Bold Upper Case | 10 | ||
| Page No. (Fourth row in 3rd column and left position in column and right position in page) | Arial Bold Sentence Case (Page 0 of 0 Format) | 10 | ||
| Title of the “SOP No.”, ‘’Issue No.”, “Revision No.” “Issue Date”, “Effective Date”, “Review Date”, (Fifth row with six columns) | Arial Bold Sentence Case | 10 | ||
| Details of the “SOP No.”, ‘’Issue No.”, “Revision No.” (Sixth row with 1 to 3 columns) | Arial Sentence Case | 10 | ||
| Details of the “Issue Date”, “Effective Date”, and “Review Date”, (Sixth row with 4 to 6 columns) | Stamped | 10 | ||
| Body | ||||
| SUBHEADING and SUBHEADINGS NUMBER (Subheadings number start from 1.0) | Arial Bold Upper Case | 10 | ||
| Body content writing of SOP | Arial Sentence Case | 10 | ||
| Headings in the table of body content | Arial Bold Sentence Case | 10 | ||
| Footer | ||||
| Signatories Title (Function, Name, Designation, Signature, Date, Prepared by, Checked by, Approved by) | Arial Bold Sentence Case | 10 | ||
| Details of Signatories | Arial Sentence Case | 10 | ||
| Form No. | Arial Sentence Case | 8 | ||
| Version | Arial Sentence Case | 8 | ||
| CONFIDENTIAL | Arial Upper Case | 8 | ||
| Supersedes Form | Arial Sentence Case | 8 | ||
7.7 Numbering System of SOPs:
7.7.1 Each SOP shall have a unique numbering system. Every SOP has a different number. If a
If a number has been assigned to one SOP, it cannot be assigned to another SOP at the same time.
7.7.2 Each SOP number consists of four distinct parts. For example, the first SOP prepared
in the QA department shall be numbered X/Y/SOP/01.
7.7.2.1 The first alpha character part indicates the location code, where ‘X’ indicates a short
form of the company name.
7.7.2.2 The second alpha character, “Y” indicates the department code and the alpha character
indicates the code for the departments mentioned in point no. 7.7.3.
7.7.2.3 The third alpha character part “SOP” indicates a short form of Standard Operating
Procedure (SOP).
7.7.2.4 The fourth numerical character, 01,” indicates a serial number of the first SOP
prepared under a particular department.
7.7.3 By department SOP Numbering System Code for All Departments:
7.7.2.5 The fifth character is a dash; ’/‘ indicates a separator.
| SL No. | Department | Code for SOP No. |
| 1 | Quality Assurance | QA |
| 2 | Quality Control | QC |
| 3 | Microbiology | MB |
| 4 | Product Development | PD |
| 5 | Production | PRO |
| 6 | Warehouse | WH |
| 7 | Administration | AD |
| 8 | Product Management Department | PMD |
Article on the Same Topic: SOP in the Pharmaceutical Industry
7.8 Content of Header:
7.8.1 Title: This is the heading of the SOP.
7.8.2 Department: This is the name of the Department for which SOP is applicable.
7.8.3 SOP No.: This is the unique SOP number. The numbering procedures described in point
no. 7.7.
7.8.4 Issue No.: This is the random creation or issuance number of that particulate SOP. For the
first issuance number of that SOP shall start from 01.
7.8.5 Revision No. : The revision number is made up of two numerical characters that begin with ’00’ and increase by one digit each time a revision is made. The number “00” denotes the publication of that specific SOP for the first time.
7.8.6 Issue Date: The issue date shall be stamped by Q.A. after final creation when issued before
circulating the SOPs.
7.8.7 Effective Date: The effective date shall be stamped by Q.A. after final approval before
circulating the SOPs.
7.8.8 Review Date: The normal review period will be 2 (two) years from the effective date of the
SOP. For example, if any SOP has an effective date “of 10-01-2023”, its review date will be
“09-01-2025
7.8.8.1 All SOPs shall be revised on a need basis with proper justification. It is important that all
SOPs must be reviewed and revised once every two years.
7.8.8.2 In the first revision of an SOP, the details of changes shall be recorded on the
“Document History” of the respective SOP.
7.8.9 Page: The page number of all SOP shall be allocated in ‘xx of yy’ format on every page.
7.9 Content of Footer:
7.9.1 Signatories Table: The footer part has a table with specific columns and rows for signing.
7.9.1.1 The signatories table is designed and allocated with Function, Name, Designation,
Signature, Date at column alignment.
7.9.1.2 The signatories table is designed and allocated with Prepared by. Checked by and
Approved by a row alignment.
7.9.1.3 Prepared by: The author a designated person, who has prepared the SOP, must be
assigned the name and designation in the “Name” and “Designation” columns
of the “Prepared by” row. This person should signature & date in the “Signature” and
“Date” columns and “Prepared By” row in blue ink.
7.9.1.4 Checked by: After the SOP is created, one or more individuals must check it and sign their names along with the date in blue ink.
7.9.1.5 Approved by: The person who finally approved the SOP, shall sign here. Approval shall
be done by the Head of Quality Assurance. This person shall write his/her name clearly with
signature and date in blue ink.
7.9.2 Format No.: This is a unique number assigned to the format used for the preparation of all SOPs
Formats of QA shall have the format no. FRM/QA/001.
7.9.2.1 The format part contains Form No., Version, CONFIDENTIAL, and Supersedes Form.
7.10 General procedure for creation of new SOPs.
7.10.1 User department shall prepare the draft SOP as per the procedure described in point
no. 7.0
7.10.2 Draft copy shall be identified by stamping or watermark on each page.
7.10.3 A draft copy must be distributed to the accountable parties for evaluation. The responsible parties are permitted to suggest any changes to the content.
7.10.4 By the suggestion, the user department will edit the draft SOP and provide a final printout for approval along with a Change History Log.
7.10.5 Following approval, the user department must send the Original Copy (Master Copy) of the SOP to QA for review and issuance together with the “Change History Log” and must destroy the draft SOP.
8.0 ABBREVIATIONS
8.1 SOP – Standard Operating Procedure
8.2 QA – Quality Assurance
8.3 QC – Quality Control
8.4 No. – Number
8.5 FRM – Form
9.0 ANNEXURES
9.1 Annexure-1: SOP Template for First Page
9.2 Annexure-2: SOP Template for Second and Remaining Pages
FAQ
What is SOP?
Standard Operating Procedure
The standard operating procedure is referred to as SOP. SOPs are more than just a list of processes that are written down. An organization’s personnel are given step-by-step instructions in a standard operating procedure (SOP) document on how to carry out a complex, repeated task.
What should be included in an SOP?
An SOP typically includes a personal introduction, your academic and professional journey, your specific interests and goals related to the program or job, and how your background aligns with the opportunities the program or position offers. It’s also important to mention any relevant achievements, skills, and experiences.
How long should an SOP be?
The length of an SOP varies, but most universities or employers provide guidelines. Generally, SOPs are around 500 to 1000 words, but it’s crucial to be concise and focused while covering all the necessary points. Quality and relevance matter more than quantity.
What tone and style should an SOP have?
An SOP should be written in a formal, professional tone while still reflecting your personality and motivations. It’s important to avoid overly casual language or slang. Use clear and concise language, and make sure to proofread for grammar and spelling errors before submitting.
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the first Bangladeshi pharmaceutical blogger since 2019.
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