A Standard Operating Procedure on Sop in a Pharmaceutical Industry is a detailed, written instruction that outlines the steps required to perform a specific activity within a pharmaceutical industry. It provides a standard and consistent approach to processes, ensuring that they are performed accurately, consistently, and in compliance with regulatory requirements.
In the pharmaceutical industry, SOPs are critical to ensure the quality and safety of drug products, as well as to ensure compliance with regulatory requirements.
Each SOP should include a clear description of the steps involved, the personnel responsible for each step, and the equipment and materials required. It should also include clear instructions on how to perform each step, as well as on how to document and record the results. Standard Operating Procedure on Sop in a Pharmaceutical Industry is typically reviewed and updated on a regular basis to reflect changes in processes, regulations, or best practices.
The use of Standard Operating Procedure on Sop in a Pharmaceutical Industry helps to ensure that all processes within a pharmaceutical industry are performed consistently and in compliance with regulatory requirements, and provides a foundation for continuous improvement and quality management.
To describe the Standard Operating Procedure on Sop in a Pharmaceutical Industry for the Preparation, Review, and Approval of Standard Operating Procedure.
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.
- Technical Operation Director.
- Q.A. Manager.
- Q.A. Officer.
All SOPs shall be as per the SOP Format, attached as Annexure-1.
Standard Operating Procedure on Sop in a Pharmaceutical Industry
Prepare front cover page of each SOP.
All the SOPs shall consist of Header, Cover page, Document revision control page, table of Content, Content and Footer part.
Header Part:The Header Part of each SOP shall remain on first page. The Header part of the SOP shall consist of the rectangle box having following items:
Logo: The Logo on the left-hand corner of the header with 1.83cm (L) × 2.4cm (H).
Name of Company: shall be written in top besides logo and above department name Font: Times New Roman letters, Font size: 20, Style: Bold, Capital, Line spacing: 1.0.
Name of Department: shall be written below company name in Font: Times New Roman letters, Font size: 12, Style: Bold, Capital, Line spacing: 1.0 & add space before paragraph.
Document No., Supersede, Revision No., Date of Effectiveness, Date of Next Review, Page No.: shall be written on the right-hand corner of the header
Font: Times New Roman letters,
Font size: 8, Style: Bold, Capital,
Line spacing: 1.5.
Document No.: See Annexure-2 for Document No. in catalogue.
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.
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.
Date of Effectiveness: 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
Date of Next Review: This is the date, before which the SOP shall be reviewed. Every three years from the effective date, SOP shall be reviewed. In case any need arises, SOP shall be reviewed, before the defined review period through a change control procedure.
Page No.: This specifies the page no., with respect to the total number of pages of the SOP, may exclude the Annexures. It will be written e.g. (1 of 10).
Title: The title of SOP shall be in Font: Times New Roman letters, Font size: 18, Style: Normal, Bold Upper case. It should be self-descriptive
Cover Page: The Cover Page of each SOP shall consist of the following:
Below header is the heading of STANDARD OPERATING PROCEDURE shall be written in Font: Times New Roman letters, Font size: 22, Style: Bold, Capital, Line spacing: 1.5.
Below this, REFERENCE heading is shown shall be written in Font: Times New Roman letters, Font size: 16, Style: Bold, Capital, Line spacing: 1.5.
Below the reference, APPROVAL BLOCK shall be printed in Font: Times New Roman letters, Font size: 16, Style: Bold, Capital, Line spacing: 1.5.It consists of:
- Written by: Person preparing the SOP from the initiating department, shall sign with the date. Designation shall be printed with department.
- Reviewed by: Person reviewing the SOP from the initiating department, shall sign with the date. Designation shall be printed with department.
- Verified by: Head of the department verifying the SOP from the initiating department, shall sign with the date. Designation shall be printed with department.
- Approved by: Site Quality Head or Technical Operation director shall approve all SOPs of departments.
Below the Approval block is the distribution list to which departments copy will be issued. The column includes: distributed to, copy no., copy holder and signature of copy holder.
Document Revision Control Page: When there is a need of to do some amendments in the SOP, the revision no. will be allotted, date will be mentioned, nature of amendment will be mentioned with page no. and amendments should be initiated by their specific department head and amendments should be done by the Q.A department head.
Table of Content : The table of contents should include all the headings of the content part.
Content Part: The Content Part of the SOP shall contain the following sections:
Purpose: 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”.
Scope: This section shall indicate 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 and also the Head of the Department who is accountable for compliance of the SOP.
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.
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.
- Write the procedure/ method in short sentences. Do not write the instructions in long paragraphs.
- This section shall cover stepwise activities performed and conditions/ precautions required for implementing the SOP.
- Mention all the checks to be carried out, records to be maintained, frequency of various operations, checks and special precautions, if any.
- 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.
- A-4 size white paper shall be used for printing.
- Bold letters shall be used for heading or sub-heading.
- All SOP shall be written in English language.
- Annexure shall be formats, used for recording the data, related to the activity.
- 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.
- 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.
Footer Part: The Footer Part of each SOP shall consist of the rectangle box consist of the following items:
Format No.: shall be written on the left side of the footer in Font: Times New Roman letters, Font size: 8, Style: Regular, Line spacing: 1.0. The Format Number shall consist of total 12 characters and this shall appear on all the SOPs.
First two characters ‘XX’ denote Company name i.e. PE for Pharma Egg.
Third character represent “Slash” (/).
The Fourth character ‘B’ denotes the manufacturing site. i.e. QA for Quality Assurance, QC for Quality Control, etc.
Fifth character represent “Slash” (/).
Sixth character is ‘F’, which stands for format.
Seventh & eighth characters represent sequential number to format, starting with ‘00’ onwards.
Ninth character denotes dash (-).
Tenth character 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.
Block for stamping and sign: This space shall be used for putting stamp and sign of Technical Operation Director for controlled documents on the photocopies. This block shall be on the right side of the footer.