SOP on SOP
Objective : To lay down a procedure for the preparation, approval and control of Standard Operating Procedures.
Scope: This Standard Operating Procedure is applicable for the preparation and implementation of all Standard Operating Procedures to be followed at Pharmaceutical Company.
Staff of Initiator Department shall be responsible for:
Development or generation of draft of new SOP as per the procedure given in this SOP.
Updation / Revision of the existing SOP, whenever required.
Head / Section Incharge or his / her designee of Initiator Department shall be responsible for:
Review and verification of SOP
Training of the user staff.
Approval of SOP
QA Officer or above shall be responsible for:
Checking and developing, if applicable, word processing styles and formats for SOPs; printing out the finalized SOPs.
Issuance of a unique number for new SOP.
Head / Incharge, Quality Assurance or his/her designee shall be responsible for:
Review of SOP for its correctness and adequacy with respect to regulations/ guidelines or company standards related to written procedures, if applicable.
Final approval and subsequently compliance of the SOP.
Accountability : Department Head & QA Head shall be accountable for implementation of this SOP.
Abbreviations and Definitions
Initiator Department : Department who shall initiate the preparation or revision of SOP.
SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
QA : Quality Assurance
No. : Number
An SOP shall be written in short, clear sentences and preferably in a passive voice. SOP should be easy to understand / follow and shall depict the sequence of activities logically.
Competent technical staff shall prepare SOP as per Annexure-I (Format for Standard Operating Procedure).
A person directly supervising the operation shall initiate the SOP.
A SOP shall be written after thorough understanding of the operating procedures. The author of the SOP shall have adequate knowledge, training and experience in the related areas of operation. Wherever necessary, some illustrations, drawings, flow charts or exhibits may be incorporated in the SOP, to provide better clarity and understanding.
Wherever abbreviations are used, these shall be elaborated in point “Abbreviations & Definitions”.
Language of SOP
The language used in SOP shall be clear, instructive, sequential, unambiguous and English language shall be used.
Where required, for operational purpose, any SOP is to be translated in vernacular language, the same shall be done by the initiator department by preparing draft of SOP as per Annexure-I.
Once the concerned SOP is reviewed by QA then it shall be approved by Head-QA along with its main SOP in English language.
QA shall maintain the distribution and retrieval record of this SOP separately as per SOP “Document and Data Control”.
SOP number of this local translated SOP shall remain same as English language SOP.
If there is a revision and or change in the original SOP, the SOP in vernacular language shall also be revised for the desired changes.
Initiation of new SOP
For new SOP, Concerned Department personnel shall prepare the draft of SOP as per Annexure-I and “DRAFT” shall be written in diagonal using application watermark as shown below:
After completion of draft the user shall send it to the Department Head for review.
Department Head shall review the draft SOP, put the remarks or suggestion if any and forward it to QA Deptt.
QA personnel shall review the draft copy of SOP, write the comment if any and send it to QA Head for final approval.
QA Head or his/her designee shall review the draft copy of SOP and if suggested then necessary corrections shall be done by concerned department personnel.
After getting satisfactory correction and changes, QA Head or his/her designee shall approve the draft copy of SOP by making his initial.
After approval of draft, corrected soft copy of SOP along with Annexures and Formats (if any) shall be submitted by the concerned department to QA.
Soft copy of respective SOP shall be deleted by concerned department from their computer after handover it to QA.
QA personnel shall take the printouts of SOP in black ink on A4 size white paper (on one side of the paper only).
In case of the rejection of draft copy of SOP by Head-QA or his/her designee, the same shall be maintained in documentation cell by QA personnel.
SOP Numbering system
SOP number shall consist of 10 alphanumeric characters:
The first, second and third characters shall represent the words “Standard Operating Procedure” and shall be written as SOP.
The fourth character shall be ‘/, (Forward slash).
Fifth and sixth characters shall represent department code as per Annexure-II.
The seventh character shall be a ‘-’ (dash).
The eighth, ninth & tenth characters are numbers, which shall denote serial number of the SOP. The first SOP of any department shall be 001. The subsequent serial numbers shall be 002, 003, and so on.
Note: Numbering system shall be defined department wise.
Formatting of SOP
All SOPs shall have a standard common format for page layout as per Annexure-I.
An SOP shall be neatly typed using Microsoft Word application software.
Page set up of word file for SOP preparation shall be as follows:
Orientation of page shall be portrait. Landscape orientation shall also be used in annexures
Paper size shall be A-4 with width of 8.27 inch and height of 11.69 inch.
Margins setting on word file shall be as follows:
Top margin shall be 0.8 inch (0.8”)
Bottom margin shall be 0.6 inch (0.6”)
Left margins shall be 0.6 inch (0.6”)
Right margin shall be 0.6 inch (0.6”) as described below:
Page Layout from edge shall be header 1” and Footer 0.4”.
Page border’s line width shall be 1 point (1pt) as appears in this SOP.
Line spacing between the lines shall be as follows:
Before: 0 pt
After: 0 pt
Line Spacing: Single
Note: This tool is available in paragraph option.
All the points in the SOP shall be numbered sequentially. Similarly the sub-paragraphs of each point shall also be numbered sequentially, with an incremental number derived from the heading number.
A outline system of numbering shall be followed as follows: First level shall be 1.0, 2.0, and 3.0 …….so on, Second level shall be 1.1, 1.2, 1.3……..so on, this shall continue up to fifth level and fifth level shall be 126.96.36.199.1, and after this level sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on. This sequence shall be start from the heading of responsibility.
In case where numbering of sub-paragraphs are not necessary and listing is essential, bullets or other suitable identification marks may be used to illustrate the same.
Contents of SOP
All contents of SOP shall be written by using “Times New Roman” font.
SOP content shall be divided into three parts:
Contents of Header
Contents of SOP Body
Contents of Footer
Contents of Header: contents of header is as follows:
Header shall start from the top where name of SOP initiator department shall write at the top right side with regular & bold letter in font size 12. Below this a header table shall place.
First column of this table shall have company Logo and in second column name of the company in font 14 with caps and bold letter shall be mentioned.
Except company name in header the whole SOP shall be in 12 font size.
All the contents of header table shall remain same for all SOPs except the ‘Title’ and content for ‘SOP No.,’ ‘Revision No.’ ‘Supersedes’ & ‘Page no.’.
Description of heeder content is as follows:
Title: Subject of the SOP as per SOP no. shall be written.
SOP no.: SOP no. shall be written as described in point no. 6.8
Revision No.: Revision no. shall be denoted in two numeric characters. New SOP shall carry Revision No. ‘00’ and the subsequent revisions shall be denoted by 01, 02, 03 and so on.
Supersedes: Superseded number of the SOP shall be given in this column. For example, SOP/QA-001 (the first SOP of QA) when prepared for the first time (first version or edition), ‘Supersedes’ column shall be filled with the word ‘None’ and when the same is revised for the first time, ‘Supersedes’ shall be given as ‘SOP/QA-001, Rev.00’ and the ‘Revision No.’ for this SOP shall be filled as ‘01’.
Page No.’: Page no. shall be numbered as X of Y where X is the page number and Y is the total number of pages.
The sequence of signature in SOP header column shall be described as follows:
SOP initiator shall sign with date, write his/her name and designation by hand in ‘Prepared by’
QA personnel shall review the SOP and sign with date, write his/her name and designation by hand I n ‘Checked by’
Department Head/designee and Head or Incharge, QA or his / her designee shall also sign with date, write his/her name and designation by hand in ‘Approved by’ column hence approving the proposed SOP for implementation.
Effective Date: ‘Effective Date’ is the date when the content of SOP becomes operational for the user department(s). It shall be hand written by QA department after completion of training on the approved SOP, in DD/MM/YY format.
Next Review Date: The ‘Next Review Date’ shall be after two years from the Effective Date of the SOP. It shall also be hand written by QA department in DD/MM/YY format.
Every SOP shall be reviewed within one month of the Review Date or earlier (if any amendment is required) e.g. if effective date of document is 26/11/20 then next review date for it shall be 25/11/22.
Contents of SOP Body
The content of Standard Operating Procedure (prepared in the format Annexure-I) shall contain the following headings:
Objective: as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading. The ‘Objective’ shall always start with the word ‘To’.
Scope: as second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the Standard Operating Procedure is applicable.
Responsibility: as third point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the Standard Operating Procedure.
ACCOUNTABILITY: as fourth point; Deptt. Head and Head QA shall be accountable for implementation and compliance of the Standard Operating Procedure.
Abbreviations and Definitions: as fifth point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in the Standard Operating Procedure.
Procedure: as sixth point; describes the detailed procedure to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.
Forms and Records: as seventh point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.
Distribution: as eighth point; describes the distribution of the SOP to various concerned departments.
History:as ninth point; history shall contain a chronological record of significant changes / modifications in an SOP in brief, mentioned in three columns, namely: ‘Date’, ‘Revision Number’ and ‘Reason for Revision’.
Note: Under ‘Date’ put the effective date of previous version SOP. Under ‘Revision Number’ write previous revision number of the SOP shall be mentioned. Under ‘Reason for Revision’ give reasons why the SOP at previous revision number is modified or changes made in SOP.
In case of new SOP write ‘New SOP’ under ‘Reason for Revision’ and in case of periodic revision write ‘Periodic Revision’ under this column. (For more clarity refer ‘History’ at point no. 8.0 of this SOP)
Narrative text of each heading shall be aligned below the heading, not across the length of the heading.
Note: Method or procedure adopted for typing the text for this SOP shall be used as reference for the typing of SOPs.
Recordings, if required, as a result of implementation of an SOP shall be discussed in the relevant SOP by defining a format for the recording purpose which is termed as ‘Form’ of the SOP and shall be annexed to the SOP.
Contents of Footer
Only Form no. shall be written in footer at left side corner of the page and outside of page border
Form number shall be typed in footer as ‘Form No.: SOP/QA-001/F01-00’, in regular fonts in font size 10.
Once the concerned SOP is approved by Head or Incharge QA, Initiator department shall conduct training of the SOP and evaluation of training there upon, as per respective SOP on ‘Training of Personnel’.
Note: If a department prepares an SOP that involves other departments(s) in its execution, then the persons from this (these) department(s) shall also be trained.
Department Head shall ensure that training is imparted to all concerned.
After completion of training on concerned approved SOP, the initiator department shall forward the approved SOP along with training record to QA.
QA personnel shall retain the training record and put the effective date and review date in approved SOP.
Master Copies and Controlled Copies (for distribution) of the SOPs shall be prepared by QA as described in SOP on ‘Document and Data Control’.
Issuance and distribution shall be done as per SOP ‘Document and Data Control’.
Revision of SOP
Biennial review of an SOP shall be undertaken as per SOP on ‘Document and Data Control’ however change in any SOP shall be undertaken through SOP titled ‘Change Control’.
If there is change in SOP, but no change in format, version number of format shall remain same (hard copy of the existing format shall be in use) and if there is change in the text of format, format and SOP shall be revised through change control Procedure.
Storage, archival, Obsoletion of Superseded SOP
Storage, archival and Obsoletion of SOPs shall be done by QA as per SOP ‘Document and Data Control’.
Uncontrolled Copies of SOP
These are copies of SOPs made by photocopying the “MASTER COPY”, for information purposes only. They are provided, for example, to regulatory or certification authorities for their reference.
Such copies shall be made by the QA personnel (as per SOP ‘Document and Data Control’ ) with the knowledge and consent of the QA Head.
Master List of SOPs
QA shall maintain a master list of SOPs as per Annexure-III. It shall contain the list of SOP’s of all the departments.
Master list of SOPs shall be approved by Head QA / designee.
The list shall be revised as and when required.
A hard copy shall be printed and signed by Head QA / designee and kept in QA records as master copy.
All the pages of SOP excluding annexures shall be signed and dated only in blue ink, using ballpoint pen.
All headings of SOP shall be in regular & bold letter and single space equivalent to font size 12 shall remain between heading and previous line.
All designations and name of departments used in SOP shall start from capital letter.
If any coloured photograph is required for SOP then it can be incorporated in SOP.
A “flow chart”, detailing the steps involved, may be attached in the SOP.
Master copy and control copies of SOP shall not be stapled and punched.
Content of Form and Records (Annexures)
A suitable “Record format” shall be prepared for recording the control parameters and included as a part of the SOP itself.
A unique format number shall be assigned to theses format as described below:
The form of the SOP shall be numbered with seventeen alphanumeric characters its description is as follows:
The first ten characters of the form number shall be derived from the concerned SOP and the remaining seven characters shall be as follows
The eleventh character shall be a ‘/’ (forward slash).
The twelfth character shall always be ‘F’ which denotes ‘Form’.
The thirteenth & fourteenth character shall denote the Form’s Serial Number ranging from 01 to 99.
The fifteenth character shall be a ‘-’ (dash).
The sixteenth and seventeenth characters shall denote the Revision Number of the form. The first version of any form shall carry Revision Number ‘00’. The subsequent revisions shall have Revision Number 01, 02, so on. Example: Form number SOP/QA-001/F09-00 is the first version of the ninth form of first SOP of Quality Assurance.
All recording formats of SOP shall be attached with SOP as annexures.
A list of annexure(s), described in the SOP, shall be mentioned (along with annexure number) in section written as Forms and Records.
The annexure shall be written at the top of the page as “Annexure-I”. The numbering of the annexure should be given in roman numerals as I, II and so on.
Page no. shall be written at the bottom of page at right side in formats and annexures.
Annexures used for technical direction to perform any activity like picture, drawing, list, flow chart etc. related to SOP may be attached with SOP in form of annexure but form no. shall not be allotted to them.
Annexure shall also have the signature columns and stamping shall be made in all annexures.
Note: If there is any change in SOP but not in annexure, then revision number of Annexure shall not be changed.
Forms and Records (Annexures)
Format for Standard Operating Procedure – Annexure-I
List of Department Name with code – Annexure-II
Master List of SOPs – Annexure-III
Master copy – Quality Assurance
Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
Reason for Revision
Format for Standard Operating Procedure
Form No.: SOP/QA-001/F01-00
Form No.: SOP/QA-001/F02-01
Master List of SOPs
|Name of Department: ______________
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube