OBJECTIVE:

• To define the procedure for preparation, approval, distribution, control, revision, training, a destruction of Standard Operating Procedures (SOPs) in compliance with international standards (ICH Q7, WHO GMP, EU GMP, PIC/S).

 SCOPE:

• This SOP applies to all SOPs prepared and implemented in all departments of Company.

RESPONSIBILITIES:

Initiator / Section Head:

• Draft new SOPs or revisions.
• Circulate draft to concerned personnel for comments.
• Ensure training for departmental staff.
• Submit obsolete SOPs to QA after revision.

 Department Head:

• Review SOPs for technical content.
• Ensure cGMP/EU GMP principles during implementation.
• Confirm training completion before SOP effective date.

Quality Assurance (QA):

• Approve SOPs.
• Issue, control, and track distribution of Controlled Copies.
• Authorize and stamp Uncontrolled Copies where required.
• Withdraw and destroy obsolete SOPs.
• Maintain SOP master list and records.

DEFINATIONS:

• Master Copy: Original signed SOP maintained by QA.
•  Controlled Copy: Officially issued, numbered, and tracked SOP for routine operations. Stamped “CONTROLLED COPY.”
•  Uncontrolled Copy: Copy issued for training, external sharing, or non-routine use. Manually stamped in red “UNCONTROLLED COPY” and signed by QA designee.
• Obsolete Copy: Superseded SOP, stamped “OBSOLETE COPY” in red and withdrawn by QA.

PROCEDURE:

Document Format, Point Numbering & Page Setup (Main Body Rules):

• All SOPs shall be prepared in Microsoft Word using A4 paper in portrait orientation, although landscape may be used for drawings, layouts, flowcharts or photographs when appropriate.
• The page margins shall be maintained between 0.6 inch and 1.0 inch on each side and, for consistency, 0.7 inch is preferred.
• The header spacing shall be approximately 0.8 inch and the footer spacing shall be between 0.8 inch and 1.4 inch.
• The body text shall be set in Times New Roman 12-point font with full justification.
• Section headings such as OBJECTIVE, SCOPE, RESPONSIBILITIES, DEFINITIONS, PROCEDURE, REFERENCES, RECORDS and REVISION HISTORY shall appear in bold uppercase, while sub-headings shall appear in bold sentence case.
• Numbering shall follow a four-level scheme in which Level 1 is 1.0, 2.0, 3.0 and so on, Level 2 is 1.1, 1.2, 1.3 and so on, Level 3 is 1.1.1, 1.1.2 and so on and Level 4 is 1.1.1.1, 1.1.1.2 and so on.
• The language shall be clear, instructive, sequential and unambiguous; were helpful, the procedure may include flowcharts or pictorial elements for clarity.
• The Body Part Includes following information,
• Objective: Purpose is an outline the objective/intention of the SOP.
• Scope: Outline the equipment, area, department, facility, system and personnel etc. which the procedure covers and is applicable too.
• Responsibilities: All responsibilities of each department should be explained as per the designation and should be mentioned for departmental procedures.
• Definitions: Provide a definition of any term/ system that requires to be defined or else include as ‘Not Applicable’. Technical terms used in the SOP should be well defined.
• Procedures: Provide procedure, method, a process in short and easy language. For local employee, if the English language is difficult to understand them then prepare SOP in the local language where they are performing routine operations.
• References: Mention the SOP number and name of the SOP required to be referred to consider internal reference. Mention the name of the guidelines that have been referred to while preparing the SOP consider external references. All references should be arranged serially as reflected in the SOP. If there are no References, then mention them as ‘Not Applicable’
• Records: List of annexures to be provided such as formats, flowcharts, photographs etc. Mention the number and name of the annexure attached to the SOP along with their format number. If there are no annexures, then mention them as ‘Nil”
• Revision: Provide the history of SOP related to the revision. Mention the reason for the revision of SOP. Also provide the details of Change Control for better understanding (if applicable) and traceability in case of first version writes “New SOP”

Header content and Layout:

• Each page shall begin with a standardized header containing the company logo at the top left.
•  The legend “STANDARD OPERATING PROCEDURE” aligns to the right side of company logo in 18-point Times New Roman.
•  The Title aligns below Company logo in 12-point bold uppercase.
•  The SOP Number aligns to the left in 12-point.
•  The Version aligned to the right in 12-point,
• The Effective Date aligned to the left in 12-point.
• The Next Periodic Review Date aligned to the right in 12-point.
•  SOP shall be assigned serialized numbers following the format i.e. QAXXX where QA stands for Quality Assurance and XXX stands for serial numbers. Following shortforms shall use for the departments.
• QA: Quality Assurance
• PD: Production
• QC: Quality Control
• EG: Engineering
• WH: Warehouse
• RA: Regulatory Affairs
• PV: Pharmacovigilance
• HR: Human Resources
• IT: Information Technology
• EH: Environment, Health, and safety
• Version “01” shall use for any new SOP, then 02, 03 04,…for subsequent approved revisions.
• Supersede “00” shall use for any new SOP, then 01, 02, 03…. for subsequent revisions.
• The date format shall be DD/MM/YYYY (for example, 02/06/2025). When DD stands for the Date, MM stands for the Month and YYYY stands for the Year.

 Footer content and signatures:

• The footer of every page shall include a paging line showing “Page x of y.”
•  All pages shall contain a signatory block with the fields “Prepared by,” “Reviewed by” and “Approved by” each followed by the name, designation and signature with date.
• The footer and signatory block shall use Times New Roman in the range of 12 points for readability and consistency.

 Preparation, review, approval and effective status:

• The Initiator shall prepare the draft SOP using the SOP template and shall apply a “DRAFT COPY” watermark diagonally on each page of the draft.
•  The draft shall then be circulated to the concerned departments for comments and the Department Head shall perform the technical review and return consolidated feedback to the Initiator for incorporation.
• QA shall review the revised draft for regulatory alignment and, upon satisfactory resolution of comments, shall approve the SOP.
• After approval, all draft copies shall be withdrawn and destroyed.
• Training of all concerned personnel shall be completed before the SOP becomes effective. QA shall confirm the completion of training and shall stamp or handwrite the Effective Date in green ink and stamped “MASTER COPY” in green ink on the left side of all the pages.
•  In general, the SOP shall be made effective within fifteen working days of approval unless a written justification is provided by the user department and accepted by QA.

 Distribution, stamping and traceability of copies:

• Following approval, QA shall print or photocopy the master copy.
•  Issue controlled copies that are stamped “CONTROLLED COPY” in black ink on the top right side of all the pages.
• QA shall record each issuance in the SOP Distribution Register, Format No. F/QA001/002-00, including the SOP Number, Title, Version, Copy Number, Department or Holder, Issue Date, “Issued by” and “Received by.”
• The user department shall verify the entries, count the copies received and sign under “Received by,”
• The QA shall verify the issuance and sign under “Given by.”
• Uncontrolled copies intended for training, external sharing or other non-routine use shall be manually stamped “UNCONTROLLED COPY” in red ink on the top right side of all the pages and shall be signed and dated by QA.
• Controlled copies shall be printed single-sided on A4 paper to aid legibility and filing.

 Periodic review, change control and revision management:

• Every SOP shall be reviewed at least once every two years with a tolerance of ± 30 days.
• It may be reviewed earlier in response to changes in regulation, process, system, equipment, deviation or corrective and preventive actions, or audit commitments.
• All revisions shall proceed through the site Change Control process.
• If Multiple SOPs are due for periodic review, we shall proceed revision of all SOPs with single change control and it will be closed after effective of all the SOPs which comes under that change control.
• Once a change is approved, the SOP shall be assigned the next version number in accordance with the SOP. (for example, 02 to 03).
• The Revision History shall be updated to include the reason for change and the Change Control reference.
• Training on the revised SOP shall be completed before the new effective date is assigned.
• QA shall withdraw superseded controlled copies, ensure their destruction and update the distribution records accordingly.

 Obsolescence scenarios and handling:

• A SOP shall be declared obsolete when
  • • The governed procedure is discontinued,
    • The SOP is merged into another document,
    • The SOP is split into multiple new SOPs,
    • A new technology or system replaces the existing approach,
    • Regulatory or organizational changes render the content invalid.
• When an SOP becomes obsolete, QA shall stamp “OBSOLETE COPY” in red ink on center of all the pages of the master copy.
•  QA shall retrieve all distributed controlled copies from user areas, shall record the withdrawal and shall destroy the retrieved controlled copies in accordance with the document retention SOP.
• The Obsolete master copy shall retain for the period specified in documents retention SOP.
• When two SOPs are merged, the newly issued SOP supersedes both previous SOPs and a new SOP number is assigned.
• When an SOP is split, the newly issued SOPs supersede the previous document and new SOP numbers are assigned.
• In both cases, the previous SOP numbers shall be marked as obsolete in the index.
•  All destructions and withdrawals shall be recorded in the SOP Distribution and Destruction Register.

 REFERENCES:

• This procedure refers to EudraLex Volume 4, Chapter 4 (Documentation),
•  ICH Q7 (GMP for Active Pharmaceutical Ingredients),
• The WHO Guide to GMP requirements for SOPs,
• The PIC/S GMP Guide.

  RECORDS:

 REVISION HISTORY.