SOP ON SOP (Preparation, Approval and Control of Standard Operating Procedures)
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 Research and Development and all pharmaceutical formulation plants/ operations Company Name.
Responsibility :
Staff, Initiator Department shall be responsible for:
Development or generation of draft(s) of new SOP as per the procedure given in this SOP.
Updation of the existing SOP whenever required.
Head/ Section Incharge or his/ her designee, Initiator Department shall be responsible for:
Review and verification of SOP.
Approval of SOP and thereby training of the user staff.
Incharge, Documentation Cell -QA or his/ her designee 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.
Abbreviations and Definitions
Initiator Department :Department who shall initiate the preparation 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.
Site specific SOP: An SOP which shall be applicable for a particular site.
Corporate SOP : An SOP which shall be applicable for all formulation plants.
Procedure :
Generation of New SOP
All Standard Operating Procedures shall be written in clear and easy to understand language.
All the SOPs shall be generated on computer. The text of the SOP shall be typed preferably in font face ‘Times New Roman’ with font size ‘12’ or with other appropriate font size as per the requirement of the SOP.
An SOP shall be printed in black colour on standard A-4 size sheet of good quality having company’s corporate logo on the top left hand side of the sheet.
All SOPs shall be prepared using Microsoft Word application software
- Page setup and Page border settings.
- 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”)
- Page Layout from edge shall be header 1.0” and Footer 0.4”.
Page border’s line width shall be 1 point (1 pt) as appears in this SOP.
Form Number of the SOP (format) shall be put in the ‘footer’ and not surrounded by the page border, as appears in this SOP.
Upper portion (non text part) of the SOP (format) shall be put into the ‘Header’ as appears in this SOP.
Description of the format for SOP preparation.
Name of the initiator department e.g. Quality Assurance, Production, etc. shall be typed in bold on the top of right hand side of the page (font size 13).
‘STANDARD OPERATING PROCEDURE’ shall be typed in bold capital letters (font size 11).
‘Title’ of the SOP shall be brief and self descriptive in nature. It shall be typed in regular text keeping the first letter of the key words in capitals (i.e. title case, preferably font size 11).
‘SOP No.’ shall be denoted in nine characters as described below (to be typed in regular font with font size 11).
The First character shall denote the location of the formulation plant(s)/ operations e.g.
Alphabet A shall represent SOP common for ‘All’ plants/ operations at more than one location
Note: In case, the first letters of two locations are same, then any letter of the new location’s name that is not matching with the first letter of the existing locations’ name can be used while numbering the SOP for that location.
The second character shall be alphabet ‘F’ denoting ‘formulation / operations’.
The third character shall be a ‘-’ (dash).
The fourth and fifth characters shall depict the department code.
The sixth character shall be a ‘-’ (dash).
The seventh, eighth, and ninth 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. For example, the first SOP of Quality Assurance department common for all formulation plants shall have the number AF-QA-001. Similarly, first production SOP for Goa formulation plant shall be GF-PD-001.
Note: Numbering system can be defined with respect to number of sections or blocks serving a department e.g. If Production department of Formulation Plant located at Goa has different sections or blocks (e.g. tablet section, capsule section, etc.), the numbers for such blocks can be defined in such a way that the SOP applicable in a block or section can be identified by the allotted numbering system; for example, SOP Nos. GF-PD-001 to GF-PD-150 can be allotted for the SOPs applicable for one block or section, SOP Nos. GF-PD-151 to GF-PD-300 can be allotted for the SOPs applicable for another block or section and so on.
The SOPs carrying ‘IF’ in their numbering system shall be the Corporate SOPs (which shall reflect the system to be followed in all the plants or operations located at different locations) and the SOPs carrying ‘GF’ or ‘BF’, etc. shall be the Site specific SOPs.
‘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. (to be typed in regular font with font size 11).
‘Supersedes’: Superseded number of the SOP shall be given in this column. For example, GF-PD-001 (the first SOP of Production of Goa plant) 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 ‘GF-PD-001, Rev.00’ and the ‘Revision No.’ for this SOP shall be filled as ‘01’. ‘Supersedes’ column shall carry full SOP number in case of the revision of the SOP carrying SOP number in compliance with earlier numbering system (12 characters number) e.g. when SOP with SOP No. ‘IF-QA-001-03’ is revised as per this SOP, ‘Supersedes’ column shall be filled as ‘IF-QA-001-03’ and ‘Revision No.’ column shall be filled as ‘04’ and ‘SOP No.’ shall be filled as ‘IF-QA-001’. (To be typed in regular font with font size 11)
‘Page No.’ shall be numbered as specific page number of the total pages of the SOP e.g. first page of SOP of total 05 pages shall be 01 of 05. (to be typed in regular font with font size 11)
Standard Operating Procedure shall be prepared and checked by two individuals who shall be involved with implementation of the SOP and accordingly shall write their names and sign with date in columns ‘Prepared by’ and ‘Checked by’. ‘Prepared by’ and ‘checked by’ shall be typed in bold with font size 11.
Head of Department or his / her designee of concerned department shall sign with date in the column ‘Approved by’. ‘Approved by’ shall be typed in bold with font size 11.
Head or Incharge, QA or his / her designee shall also sign with date in the column ‘Approved by’ hence approving the proposed SOP for implementation.
‘Effective Date’ is the date when the content of SOP becomes operational for the user department(s). It shall be given by QA department after completion of training on the approved SOP, in DD-MM-YY format, by hand.
Once the concerned SOP is approved by Head or Incharge, QA, Initiator department shall conduct training of the SOP and evaluation of training thereupon, as per respective SOP on ‘Training of Personnel’ applicable for the respective location.
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 as per the effective SOP on training, as applicable at different locations, and the training records generated thereupon shall be compiled by the initiator department or by training manager as applicable and shall be transferred to Documentation Cell of QA.
After completion of training on SOP, the initiator department shall forward the SOP to QA with the date on which training was imparted, for assigning ‘Effective Date’ on it. ‘Effective Date’ shall be typed in bold in font size 11.
The ‘Next Review Date’ shall be after two years from the Effective Date of the SOP given by QA department in DD-MM-YY format, by hand. Every SOP shall be reviewed within two months of the Next Review Date, or earlier, if any amendment is required. ‘Next Review Date’ shall be typed in bold in font size 11.
Note: All the entries made in hand by the concerned personnel shall be in black ink, preferably using ballpoint pen. Ink of good quality shall be used for the purpose.
The content of Standard Operating Procedure 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.
Abbreviations and Definitions: as fourth 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 fifth 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 sixth point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.
Distribution: as seventh point; describes the distribution of the SOP to various concerned departments.
History:as eighth 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 date of preparation of the SOP. Under ‘Revision Number’ current revision number of the SOP shall be mentioned. Under ‘Reason for Revision’ give reasons why the SOP at previous revision number is modified. In case of new SOP write ‘New SOP’ under ‘Reason for Revision’ and in case of routine revision when the revision is not being addressed through change control procedure, write ‘Routine Revision’ under this column.
Narrative text of each heading shall be aligned below the heading, not across the length of the heading.
Main headings of the SOP as discussed shall be numbered 1.0, 2.0, 3.0,…….and so on. Each heading shall be typed in bold keeping first letter capital and rest in small for each word. The subsequent numbering for headings or steps shall be typed with outline numbering system through five levels. For instance, first level number for the heading at fifth position shall be ‘5.0’ and its second level shall be 5.1, 5.2……so on and the fifth level shall be ‘5.1.1.1.1’ against the first step of every subsequent level. After fifth level the sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on.
Note: Method or procedure adopted for typing the text for this SOP can 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.
The form, if any, of the SOP shall be numbered with fifteen characters or sixteen characters. and its number shall be mentioned at left hand side of the bottom of each page.
The first nine characters of the form number shall be derived from the concerned SOP and the remaining six characters shall be as follows
The tenth character shall be a ‘/’ (slash).
The eleventh character shall always be ‘F’ which denotes ‘Form’.
The twelfth character (and thirteenth, in case with sixteen characters) shall denote the Form’s Serial Number ranging from 1 to 99 (a single digit number from 1-9 and double digit number from 10-99). Example: If an SOP containing more than nine forms then that SOP shall bear forms from Form Number one (F1) to Form Number nine (F9) with fifteen characters and then from 10th Form (F10) onward the Forms shall be numbered with sixteen characters.
The thirteenth (or fourteenth, in case with sixteen characters) character shall be a ‘_’ (dash).
The fourteenth (or fifteenth, in case with sixteen characters) and fifteenth characters (or sixteenth, in case with sixteen 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 IF-QA-001/F9-00 is the first version of the ninth form of first SOP of Quality Assurance common for all formulation plants/ operations. Similarly, Form No. GF-PD-001/F11-00 is the first revision of the eleventh form of the first SOP of production for the Goa formulation plant.
e.g. For ninth form of SOP, Form number shall be typed as ‘Form No.: IF-QA-001/F9-00’, in regular fonts in font size 10.
If a form or a record of an SOP is also relevant to another SOP, the attached form or a record shall bear the Form No. as assigned for the initial SOP, e.g. if first form (GF-PD-002/F1-00) of second SOP (GF-PD-002) of production department for Goa formulation plant is required to be attached in SOP with number GF-PD-015, the form shall have the same form number as mentioned on the concerned form attached with its original SOP i.e. GF-PD-002/F1-00. Whenever this form is revised in future, this shall invite replacement in all other concerned SOPs where it has become a part of that SOP.
If a Form of an SOP needs some change(s) and these changes are not affecting the text of SOP then the form shall be revised as per SOP titled ‘Document and Data Control’.
SOP(s) prepared for the operation/calibration/cleaning/maintenance of equipment or instrument of one make and model number can be applied for the operation/calibration/cleaning/ maintenance of other equipment or instrument(s) of same make or model number.
Note: Any SOP that addresses the recording of an operation or an activity in logbooks, the format (when discussed in the concerned SOP) for recording shall carry the form number. All such bound forms (spirally bound or bound with some other type of binding) shall constitute a logbook. Requisition and Issuance of all these logbooks and/ or forms of the SOPs for recording purpose shall be regulated through SOP titled ‘Document and Data Control’.
The initiator department shall forward the draft(s) of SOP under preparation (putting “DRAFT’ word on every page of the SOP as water mark of appropriate size) to QA department for comments and necessary input, if any.
Once the Draft SOP is finalized, QA department shall forward the SOP to Documentation Cell of QA for final printing.
Documentation Cell of QA shall send the SOP to the initiator department for signatures on the relevant columns of the SOP and then initiator department shall forward the same to QA for final approval.
Note: The drafts reviewed by QA, if available with the concerned department, shall be sent to Documentation Cell of QA for the destruction.
After approval, Head, QA or his / her designee shall forward the SOP to Incharge, Documentation Cell or his/ her designee for putting dates by hand in ‘Effective Date’ and ‘Next Review Date’ columns of the SOP in DD-MM-YY format, once the training records are received at Documentation Cell of QA.
Distribution, Review and/ or Revision of SOPs :
Master Copies and Controlled Copies (for distribution) of the SOPs shall be prepared by Documentation Cell of QA as per SOP ‘Document and Data Control’.
Biennial review of an SOP shall be undertaken as per SOP ‘Document and Data Control’ however change in any SOP shall be undertaken through SOP titled ‘Change Control’.
Site QA shall circulate updated list of SOPs once in every four months.
For operational purpose, if any SOP is required to be translated in vernacular language, the same shall be done by the initiator department once the concerned SOP is finalized by QA using same format (Annexure-1) and shall be finally approved by QA along with its main SOP in English language. QA shall maintain the distribution and retrieval record of this SOP separately as per “Titled-Document and Data Control”.
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.