All activity in pharmaceuticals is based on Standard Operating Procedure (SOP). SOP on SOP will be helpful for how to write, what is the content required for effective SOP. Also, it gives details about the review, approval, distribution, implementation, and destruction of SOP. Hence, titled SOP on SOP / Procedure for Standard Operating Procedure (SOP).

SOP ON SOP / Procedure For Standard Operating Procedure (SOP)

1.0 PURPOSE:

This procedure for preparation, review, approval, distribution, implementation, and destruction of Standard Operating Procedures.

2.0 SCOPE : 

Applicable to all Standard Operating Procedures. 

3.0 RESPONSIBILITY : 

3.1 User department:

This includes all departments like production, QA, QC, HR and Personnel, Store (Warehouse), IT, EHS, engineering, etc (Refer Table No. 2)

1. Preparation of draft SOP and review it for quality standards and cGMP compliance. 

2. Circulate this draft copy for comment to the concerned department.

3. Identify the impacted documents and implementation of SOP. Provide training of SOPs.

4. Submit an obsolete copy of SOPs to QA department after revision of SOP.

3.1 Quality Assurance:

1) Maintenance of soft copy and a hard copy of Master SOP.

2) Review of SOPs. 

3) Impact evaluation and training to all concerned.

4) Ensure implementation of SOPs. 

5) Distribution and withdrawal of authorized usage copies. 

6) Approval of SOPs. 

7) Obsolete previous version of SOP.

8) Preparation and Updation of SOP index.

4.0  DEFINITION    

1. SOP/ Standard Operating Procedure:

SOP is sequential events in the form of instruction on how, when, where, and by whom the activity/process/operation is to be carried out.  It is beneficial to keep uniformity, efficiency, reduce the chance of miscommunication and quality at the workplace so, a person easily performs complex routine work. In simple language, SOP is a written procedure that gives direction to perform a particular operation inconsistent manner. It may also specify the frequency at which the activity is to be performed. SOP is prepared to maintain uniformity in performing the activity when it is performed by different persons at different sites or within the site.

As per WHO Standard Operating Procedure (SOP) is a document that mentions the regularly recurring operations to ensure that the operations are carried out quality and always in the same manner consistency.

2. Master copy: 

Master copy is any copy with the original sign should be considered as a master copy.

5.0 PROCEDURE :

5.1 SOP preparation: 

5.1.1    Preferably following font and sizes of letters should be used in the SOP Refer table No. 1.

5.1.2    Refer to a standard format. “Standard format of SOP“.

The SOP should be printed on A4 size paper.

Table No. 1

Name of items	Font	Size	Style
Logo (Top right-hand corner)	Times New Roman	20	Adjust to the size is given in the header, Bold
Heading as Standard Operating Procedure	Times New Roman	14	Capital (Upper Case) and Bold
Title	Times New Roman	12	Capital (Upper Case) and Bold
Header other than title (SOP No., Supersedes, Version, Issue date, Effective Date etc)	Times New Roman	11	Bold
Text Matter	Times New Roman	11	Bold for heading and subheading and normal for other text
Footer / Signatory page	Times New Roman	11	Bold

5.1.3   SOPs should be divided into 3 parts Header, Body, and Footer which contains the following information:

5.1.3.1. HEADER :

All pages of the SOP should start with the header. The Header includes the following information.

5.1.3.1.1 Logo should be on the top right corner.

5.1.3.1.2 Title of SOP: It indicates SOP topic/subject, address specific activity, system, process, products, equipment, and instrument description. All letters in the title should be in bold and capital (upper case) 

5.1.3.1.3 SOP Number: SOP should have a unique numbering system. Master list of SOP all department maintains by QA dept. SOP/ Format/ Exhibit   numbering should be as per below:

SOP No. A1/S/XYZ/001 , 

Format No. A1/F/XYZ/001.1  ,

Exhibit No. A1/E/XYZ/001.1

A1 – Indicates Organization plant code.

S – Indicates SOP ,   

F – Indicates Formats of SOP,   

E – Indicates Exhibit

XYZ – Indicates department codes (Refer to Table No. 2)

001 – serial number of SOP

1 – serial number of format and exhibit 

For Example, 

SOP No. – A1/S/QAD/001         

Format No. – A1/F/QAD/001.1    

Exhibit No. – A1/E/QAD/001.1

Table No. 2

Sr. No	Department	Department  Code
1	Quality Assurance	QAD
2	Quality Control	QCD
3	Microbiology	MCR
4	Store	STR
5	HR and personnel	HRD
6	Administration	ADM
7	Production	PRD
8	Engineering and Maintenance  / Technical	ENG / TEC
9	Information Technology	ITD
10	Bonded Store Room	BSR
11	Dispatch	DIS
12	House Keeping	HKD
13	Stability	STB
14	Formulation and Development	FAD
15	Analytical	ALT
16	Purchase	PUR
17	Marketing	MKT
18	Medical	MED

5.1.3.1.4 Version No.:  Indicates the number of revisions done in the SOP. SOP periodically revise after every 2 years ± 30 days. It is “00” for a first issued copy of the SOP. If SOP shall revise because of any Document Change request note, Change Control, Deviation, CAPA then numerically increases for every subsequent revision.

5.1.3.1.5  Supersedes : Supersedes date should be mentioned on the SOP in case of a change in version. It should be the effective date of the previous version of the SOP. It is “New” for the first issue of SOP. In case two or more SOPs are merged in one SOP then the SOP number is given as the number of any one of the merged SOP. In such a case, Supersedes date should be the effective date of the previous version of SOP whose number is continued.

5.1.3.1.6    Date of issue : Date of issue is the issue date of the current SOP, after approval of SOP by head QA. After approval of head QA, SOP training was conducted for concerned department person. This date should be stamped or handwritten in blue ink by Quality Assurance.

5.1.3.1.7  Effective Date: This date should be stamped or handwritten in blue ink by Quality Assurance. After completion of training to all concerned persons, SOP is effective and useful for routine operations. 

Date format : DD/MM/YY in both cases handwritten or stamped. 

DD – Current date , MM – month in numerical form, YY – last two digit of year. 

For  Example – 03/09/20 

5.1.3.1.8  Review Date : Review date is the date on which the SOP should be reviewed. The review date considers being validity or expiry date of the SOP. All SOPs should be periodically reviewed every 2 years ± 30 days from the effective date. If SOP is effective on 03/09/20 then it should be reviewed on 03/09/22.

5.1.3.1.9  Page: Indicates individual page number and the total number of pages of each SOP. 

5.1.3.2  BODY :  

The body part includes the following information. 

5.1.3.2.1 Purpose: Purpose is an outline the objective/intention of the SOP.

5.1.3.2.2 Scope: Outline the equipment, area, department, facility, system and personnel etc. which the procedure covers and is applicable too.

5.1.3.2.3 Responsibility: All responsibilities of each department should be explained as per the designation should be mentioned for departmental procedures.

5.1.3.2.4  Definition:  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. 

5.1.3.2.5. Procedure: 

1. 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.
2. All SOPs and their formats should be prepared in ‘Microsoft word’. wherever required, annexures can be prepared in excel, paint, or software if available like AutoCAD.
3. SOPs should be written in a concise, instructive, framed manner.
4. The SOP may be represented in the form of a narration, a flow chart, computer screen print outs or combination of all or any other suitable form like a pictorial diagram, illustrations should be provided for better understanding.
5. Annexures should be classified.

5.1.3.2.6 Abbreviations: State the full form of all abbreviations used in the SOP. All abbreviations should be arranged serially as reflected in the SOP. If there are no Abbreviations used, then mention as ‘Not Applicable’.

5.1.3.2.7 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 reference. All references should be arranged serially as reflected in the SOP. If there are no References, then mention as ‘Not Applicable’

5.1.3.2.8 History:  Provide the history/past of SOP related to the revision. Mention the reason for the revision of SOP. Also provide the details of change control, deviation, CAPA for better understanding (if applicable). It is ‘Not Applicable’ for the new SOP.

5.1.3.2.9 Annexure/Exhibit:   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 ‘Not Applicable’. 

5.1.3.3  FOOTER : 

The Footer includes the following information : 

5.1.3.3.1 Footer should include the name, designation of the person along with sign/ date as DD/MM/YY.

Prepared by: Person from the user department who is responsible for the preparation of SOP.

Reviewed by: SOP review by Head of the user dept. or authorized person from QA dept.

Approved by: After review, the person who authorize/ Head QA should responsible for approval of SOPs.

5.1.3.3.2 While preparing SOP, sufficient space on each page should be kept above the header and below the footer. 

5.2 Approval of SOPs :

5.2.1  The person responsible to prepare the SOP should first make a draft copy of the SOP in the format indicated above. Put watermark as “DRAFT COPY” diagonally on each page of SOP.

5.2.2  The draft should be circulated to the concerned departments for suggestions, if required.

5.2.3  Make, appropriate changes to the SOP based on feedback/suggestions from the departments.

5.2.4   Any updation in the SOP should be done by giving subsequent version no.

5.2.5  In case there is updation only in the SOP and no change in the annexure or format then only the version number of SOP should be changed. There will not be any change in the version number of the format or annexure. Update the history in the SOP.

5.2.6 In case there is updation only in the annexure or format and no change in the SOP,  then version no. of the SOP should be changed. Update the history in SOPNote: It is not applicable for an organization using software like TcU (Team center Unified). In that case SOP, annexure and format having their separate history. so, if any change occurred and format, annexure/exhibit, SOP not having an impact on each other in that case only specific format, annexure/exhibit should be changed with their revision number.

5.2.7 Final soft copy of SOP should submit by user dept to the Quality Assurance department. All soft copies of the SOPs should be under the control of Quality Assurance and the final printout of SOP should be taken by Quality Assurance. All soft copies of the SOP should be deleted by the initiating department after submitting it to QA.

5.2.8 The soft copies should be handled only by Quality Assurance.

5.2.9 Master copy of the SOP should be printed in black ink, except photographs, diagrams, and screenshots which can be in color.

5.2.10 Complete history of the changes should be maintained with the current version of the SOP.

5.2.11 After reviewing and verifying the correctness of the contents of the printed SOP, it should be approved by Head QA.

5.2.12 After approval of SOP, Quality Assurance a person should ensure that available draft copies are destroyed.

5.2.13  All person Prepared by, Reviewed by, and Approved by should sign and date in a blue ink ball pen.

5.3 Distribution of SOPs.  

5.3.1 Take a photocopy of master SOP. This photocopy of the SOP stamp with ” CONTROLLED COPY” in green ink should be distributed to the identified dept.

5.3.2 The stamp should be put on the top left-hand corner in the header on the first page with sign/date. 

5.3.3 QA should maintain a distribution record of a controlled copy of SOP in format. 

5.3.4  QA person should collect old/obsolete copy of SOP from the concerned department and handover revised SOP to concerned department and department person received the SOP with sign/date in format.

5.4 Implementation of SOPs :

5.4.1 Quality Assurance along with the concerned department should conduct training for persons identified to make them aware of the revised SOP and reason for revision.

5.4.2 Impact evaluation should also be done for SOPs which are merged with some other SOPs or withdrawn independently.

5.4.3  Based on the training session an effective date should be stamped or handwritten on SOP with a blue ball pen.

5.4.4    The training documentation should be filed and under the control of the QA department.

5.4.5  The SOP should be made effective within 30 days after the date of the issue. If SOP is not made effective within this period, raise deviation with proper justification for delay.  

5.5 Handling of obsolete copies of SOPs: 

5.5.1  Obsolete master copy of SOP should be maintained at QA for 5 years.

5.5.2  Obsolete master copy should be stamped on top with “OBSOLETE” in red ink on all pages in the center in the header.

5.5.3  Obsolete copy received from concern, department should be destroyed.

5.5.4  Destruction record for SOPs should be maintained by the QA dept.

5.5.5  If any format or annexure is obsolete then need to revise SOP. Because of updation of the list of Annexure/Format. 

5.6 Review of SOPs :

5.6.1 Based on the requirements (CAPA, change control, deviation, better Clarity purpose) or all SOPs should be reviewed every 2 years ± 30 days from the date of effect should be updated and the change control should be filled for the same.

5.6.2 QA should check SOP index in the first week of every month and intimate accordingly to the department head or concerned person to initiate the change control and review of SOP.

5.6.3  Updation and review of SOPs should be done by a trained person. 

6.0 ABBREVIATIONS :       

SOP – Standard operating procedure

QA – Quality Assurance

QC – Quality Control

HR – Human Resource

IT – Information Technology

EHS – Environment, Health and Safety

Dept. – Department

No. – Number

CAPA – Corrective and preventive action

Sign – Signature 

7.0 REFERENCES:

7.1 EudraLex  Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Part-I, Chapter 4: Documentation. Pg. No. 2 Procedures, Point no.4.4

7.2 ICH guideline Q7 Good manufacturing practice guide for active pharmaceutical     ingredient Point No. 6.10

7.3 USFDA office of regulatory Affairs ORA laboratory manual Volume III Section 5 Point no.3.2.1.7 and 3.2.1.8

7.4 WHO/VSQ/97.01 – A WHO Guide to GMP Requirements, Part 1: SOPs and Master Formulae

7.5 Schedule M, Part 12, Documentation and Record, subpart 12.1, 12.2 and 12.3

7.6 PIC/S, GUIDE TO Good Manufacturing Practice for Medicinal Products, Part I, Chapter 4, Subpart 4.3,4.4, 4.5

7.7 21 CFR Part § 211.180

8.0 HISTORY      

 Not Applicable

9.0 ANNEXURES          

9.1 Standard format for SOP

9.2 Distribution and destruction record