SOP for Standard Operating Procedure in Pharmaceutical

A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance while reducing miscommunication and failure to comply with industry regulations.

OBJECTIVE

To lay down a procedure for the preparation, approval, authorization, control and revision of Standard Operating Procedures.

SCOPE

This SOP describes the basic principles, defines the responsibilities, and lays down the procedure for preparing SOPs. This SOP shall be applicable to all the SOP's at PharmaInfo Ltd.

RESPONSIBILITY

Preparation & Execution: Executive and above

Approval: Asst. Manager and above

Authorization: Asst. General Manager and above

ACCOUNTABILITY

Head of the Concerned Department

PROCEDURE

• Prepare the SOP on the approved format on A-4 size paper.
• Prepare the SOPs to describe the operating procedures and steps.
• Write all the SOPs in clear, unambiguous language, easy to understand and easy to follow.
• Write the SOPs under the following sub-headings:

1. OBJECTIVE
2. SCOPE
3. RESPONSIBILITY
4. ACCOUNTABILITY
5. PROCEDURE
6. REFERENCES
7. ANNEXURES
8. ABBREVIATIONS

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Objective

Write here the reason for preparing the SOP in one sentence or a maximum of two sentences starting with the letter ‘To’.

Scope

This Section defines the applicability of the SOP and also specifies departments, areas or sections to which this SOP shall be applicable.

Responsibility

Write here the designation of the person/persons who are directly responsible for the operations mentioned in the ‘Objective’ of the SOP.

Accountability

Write here the Head of the Department who is accountable for compliance of the SOP.

Procedure

Write the procedure/method in short sentences. Do not write the instructions in long paragraphs.

Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.

Enclose all the Annexures with SOP if applicable.

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 subheading.

Annexures

Mention a list of all Annexures enclosed in the SOP. If there is no Annexure in the SOP, mention ‘Not Applicable’ under this subheading.

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 subheading.

• Write the SOP in English.

FORMAT REQUIREMENTS:

• Prepare all the SOPs as per the specimen format given as Annexure I to this SOP.
• The type of font for the contents in SOPs shall be ‘Times New Roman’. The font size to be used for the contents of SOPs shall be as follows:

Fonts

THE NUMBERING SYSTEM OF THE SOP

• Each SOP shall have a unique numbering system. Once a number is allocated to any SOP, the same number shall not be repeated to other SOP.
• Each SOP No. consists of seven alphanumeric characters. For example first SOP prepared in the QA department shall be numbered as BQA-001.
• 1st alpha character indicates the location code.
• 2nd alpha character indicates the department code and 3rd alpha character indicates the subsection/area code for the departments.
• 4th character is the dash’-‘ for separator.
• 5th,6th & 7th numerical characters indicate a serial number of that particular department code. ‘001’ indicates the first SOP prepared under a particular department code.
• Department-wise Code for SOP Numbering System for Manufacturing and Quality Control:

• Department-wise Code for SOP Numbering system for other departments:

Department	Code for SOP No.
Accounts	AC
Administration	AD
Human Resources & Development	HR
Information Technology	IT
Production Planning & Supply Chain	PP
Purchase	PU
Quality Assurance	QA

• For example, the first General SOP of the Tablet department shall be numbered as BTG-001.

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CONTENTS OF HEADER

• Location: The name of the plant's location for which SOP is applicable.
• Department: The name of the Department for which SOP is applicable.
• Area: The area / sub-section of the Department shall be mentioned wherever applicable.
• Title: Detailed heading of the SOP.
• SOP No.: Unique SOP No. as per procedures described shall be mentioned here.
• Revision No.: Revision No. consists of two numerical characters which start from ‘00’ with an increment in one digit after each revision. ‘00’ indicates the first issuance of that particular SOP.
• Effective Date: The effective date shall be stamped by Q.A. after final authorization before circulating the SOPs.
• Supersedes: For the first issuance, ‘New introduction’ shall be mentioned in this column, otherwise effective date of obsolete ( previous) SOP shall be mentioned.
• Review Date: The normal review period is 2 years from the effective date of the SOP. For example, if an SOP has an effective date of “07-10-2020,” its review date will be “07-10-2022.” SOPs shall be revised according to the procedure mentioned.
• Page: The page number shall be mentioned in ‘xx of yy’ format.
• Signatures: The Header comprises of three columns i.e. Initiated By, Approved By & Authorized by.
• Each of the three columns consists of 3 rows i.e. Name of the person who signs the SOP in full signature and the date on which the person signs the SOP.
• Initiated by: Designated person, who has initiated the SOP shall write their name clearly with their signature & date in blue ink in the column “Initiated By”. 
• Approved by: Two persons shall approve the SOP after review. One of them shall be the concerned Department Head and the other shall be Head of Quality Assurance. They shall write names clearly with signatures and dates in blue ink. In the case of QA SOPs, first approval shall be done by Asst. Manager and above an second approval shall be done by the Manager and above of the Quality Assurance Department.
• Authorized by: The person finally authorizing the SOP, shall sign here. The authorization shall be done by the Location Head, who shall write the name clearly with signature and date in blue ink. In the case of QA SOPs, the Location QA Head shall authorize all the SOPs except SOP No. BQA-001 (Preparation, Approval, Authorization, Control, and Revision of SOPs). This SOP shall be authorized by Vice President – Corporate QA.

CONTENTS OF FOOTER

Format No.: This is a unique number assigned to the format used for the preparation of all SOPs as described.

GENERATION OF NEW SOPs

• User dept. shall prepare the draft SOP as per the procedure described in the point. A draft copy shall be identified by stamping or watermarking on each page.
• A draft copy shall be circulated to the responsible persons for its review. The responsible persons may recommend any changes in the text.
• Based on the recommendation, the user dept. shall correct the draft SOP and take a final printout for approval and authorization along with the Change History Log.
• After approval and authorization, the user dept. shall submit the Original Copy (Master Copy) of the SOP along with the ‘Change History Log’ to QA for control and issuance and shall destroy the draft SOP.

ANNEXURE

Nil

REVISION HISTORY

Nil

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