SOP on SOP

SOP on SOP

 SOP of SOP

• How to write an SOP for Pharmaceuticals and what should be the content of an effective Pharmaceutical SOP including header, body, and footer and numbering system of SOP.

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 SOPs.

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 in 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 that is easy to understand and follow.
• Write the SOPs under the following sub-headings:
• OBJECTIVE
• SCOPE
• RESPONSIBILITY
• ACCOUNTABILITY
• PROCEDURE
• REFERENCES
• ANNEXURES
• ABBREVIATIONS

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 the compliance with 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.

REFERENCES

• 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, me
• ‘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 the subheading.
• Write the SOP in English (If required, some of the SOPs shall be written in the local language i.e Hindi in India, French in France, English in England,The USA).

 FORMAT REQUIREMENTS

• 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:
• Content of SOP Size of Font
• Header
• “STANDARD OPERATING PROCEDURE” & “TITLE” 12 Bold in Upper Case
•  Logo on the right-hand corner 30 mm (L) x 6 mm(H)
• “COMPANY NAME” ( on top left corner ) 14 Bold in Upper Case
• “Pharmaceutical Ltd.” “Restricted Circulation” “Location”, “Dept.”, “Area”, “Page”, “SOP No.”, “RevisionNo.” “Effective Date”, “Supersedes”, “Review Date”, “Initiated By”, “Approved By”, “Authorized By”, “Name”, “Signature & Date”
• 10 Bold in Title Case
• Actual Title ( detailed heading ) of SOP 12 Bold in Upper Case
• Body
• Subheadings 12 Bold in Upper Case
• Write up of SOP 12 in Sentence Case
• Footer
• “Format No.” 10 in Title Case
• Actual format number 10 in Upper Case

NUMBERING SYSTEM OF THE SOP

• Each SOP shall have a unique numbering system. 
• Once the 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 XQA-001st alpha character indicates the location code whereas ‘X’ indicates plant location. 2nd alpha character indicates the department code and 3rd alpha character indicates the subsection/area code for the departments mentioned in the. For departments other than point no.& 3rd alpha characters indicate department code as mentioned 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 part.

Department code

• Department-wise Code for an SOP Numbering System for Manufacturing and Quality Control:
• Department Code General Operational 
• Calibration
• Cleaning Code for SOP No
• Mfg. & Packing  
• API, Capsules, Liquid Orals, Packing, Tablets, Other Departments, Engineering,  Safety, Health & Environment, Ware House( RM, PM, FG Quarantine )
• Department-wise Code for an SOP Numbering system for other departments:
• Department  Code for  SOP No.
• Accounts, AC
• Administration, Admin
• 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 XTG-001.

CONTENTS OF HEADER

• Location: The name of the location of the plant 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
• Revision No. : Revision No. Consists of two numerical characters which start from ‘00’ with an increment of 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 the effective date of obsolete.
• Review Date: The normal review period will be 2 years from the effective date of the SOP. For example, if any SOP is having an effective date “00 2025”, its review date will be “01-12-2025”.
• SOPs shall be revised on a need basis with proper justification. All SOPs shall be mandatory reviewed and revised once in two years.
• Upon first revision of an SOP, the details of revision shall be recorded on the revision page of the respective SOP.
•  Page: The page number shall be mentioned in ‘xx of yy’ format.
• Signatures: The Header comprises three columns, 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 signature & date in blue ink in the column “In By”.
• Approved by: Two persons shall approve the SOP after review. One of them shall be the concerned Department Head.
• 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.
• above and second approval shall be done by the Manager and 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 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. XQA
• (Preparation, Approval, Authorization, Control and Revision of SOPs). This SOP shall be authorized by– 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 in point no. Example: Formats of QA shall have format no. FQA-001.

GENERATION OF NEW SOPs

• User dept. shall prepare the draft SOP as per the procedure draft copy shall be identified by stamp or watermark 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 the final printout for approval and authorization along with Change History Log.
• After approval and authorization, user dept. shall submit the Original Copy (Master Copy) of SOP along with ‘Change History Log’ to QA for issuance and shall destroy the draft SOP.