SOP for Preparation and management of Standard Operating Procedures in pharmaceuticals

Standard Operating Procedure for Preparation and management of Standard Operating Procedures OR SOP for preparation of SOP OR SOP for SOP

1. Purpose

To provide a standard operating procedure for the preparation, review, approval, issuance, revision, retrieval, archival, and destruction of Standard Operating Procedures (SOP).

2. Scope

The scope of this SOP is applicable for the preparation and management of Standard Operating Procedures at [company name].

3. Responsibility

User department person: The user department person is responsible for preparing and revising Standard Operating Procedures.

Head of the department: To check the Standard Operating Procedures that the department prepares.

Quality Assurance (QA) Person: To review all the departments’ Standard Operating Procedures. Preparation of SOPs applicable for the QA department. Quality system SOPs shall be prepared by the QA department person.

Quality Assurance Head: To approve the SOP.

4. Definitions, Abbreviation, and Acronyms

Prepared by: The person who is responsible for preparing the SOP.

Checked by: The person responsible for confirming or checking the SOP based on verifying the sequential steps and procedure for its practicability and applicability.

Reviewed by: The person responsible for evaluating the SOP based on the supporting data, documents, or references, and ensuring the compliance requirements are embedded in the SOP. The review means examining SOP to verify the accuracy of the data.

Approved by: The person who is responsible for approving SOP.

Standard Operating Procedure (SOP): SOP is a document used to perform the activities in a GMP environment to enable consistency in operations to ensure the quality and integrity of the product, activity, and actions. SOP is a written, approved and controlled document that describes a process, procedure, or practice required to perform operations consistently.

Annex: Annex is an attachment or supporting document part of SOP added in the respective section.

Format: Format is a standard template provided in the document that will be reproduced as per procedure to record the data. The format can be reproduced as controlled copies (issued by QA) or in the form of a logbook that QA will issue to the user department.

5. Procedure

5.1 General procedure

• SOP shall be prepared by authorized personnel from the user department having adequate knowledge, background, education, or training about the subject or directly involved in the process or activities.

• The prepared SOP shall be checked by the respective department head (HOD) and reviewed by QA.

• Head QA shall approve the reviewed SOP.

• While preparing the new SOP, initiating department shall obtain the SOP number from QA.

• QA will provide the new SOP number by referring to the Master List of SOP. The new SOP number will be the following number to the last SOP number available in the Master List of SOP.

• The entire SOP will be prepared using the format provided in the “Standard Operating Procedure for Preparation and Management Standard Operating Procedures”.

5.1.1 Header and footer of Standard Operating Procedure:

• Company name and LOGO will be available on each page’s top left corner and top right corner. Format number and its revision number shall be mentioned in the footer of the SOP.

• Header: Header shall consist of SOP title, SOP Number, Revision No., and Page No.

• The SOP title is to be drafted per the purpose of the SOP. SOP number will be as allocated by the QA person in sequential order given in the master list of SOP. Page number shall be written as Page: X of Y, where X is page number and Y is the total number of pages of the SOP.

• First page: SOP effective date, next review date, SOP distribution copy number, and signatories.

• Footer: Footer shall have format number of SOP for SOP, space to affix stamp of “Master Copy” and “Controlled Copy”. In case of SOP is prepared, reviewed, approved, and distribute electronically (21 CFR part 11 and EU Annex 11 Compliant Software), stamping requirements can be exempted.

5.1.2 Body of Standard Operating Procedure:

• Purpose: Describe the objective and purpose of the SOP

• Scope: Scope means an area of application. The scope shall cover the applicable areas and activities to be covered in the procedure.

• Responsibilities: This section will cover the clearly defined responsibility of personnel who shall perform the activity within the scope of the SOP.

• Definitions, Abbreviation, and Acronyms: This section will cover the definitions, abbreviations, and acronyms used in the SOP.

• Procedure: This section will cover procedural steps for the operation or activities to be performed under the scope of the SOP. Following are general considerations while drafting the SOP.

• SOP shall be written in the English language. Depending on the nature of operations, the SOP shall also be written in vernacular language. There is a possibility that operating staff does not understand the English language fully and appropriately.

• Procedure shall be described in sequential steps and chronological flow of operations. Bullet and numbering can be used to write the procedural steps.

• Procedure shall be written in simple language and using smaller statements for easy understanding. The sentences should be written in such as a way that they should not have subjectivity.

• Describe the procedure in instructive language.

• Wherever procedure requires format or template, reference format name and number shall be written for easy understanding.

• For easy understanding of process steps, diagram and flow charts can be used.

• Reference of guideline, regulation, or policy document shall be provided in the SOP. The reference document will be helpful to establish traceability of standards used, help the person who will prepare or revise SOP, or explain to external parties, auditors, regulators, or visitors what references were used to establish the SOP. [Note: Reference section can be provide under separate heading in the SOP]

• Frequency: This section will cover the instruction regarding the frequency of operation or activity to be carried out under the scope of the SOP.

• Formats: This section will cover the list of Formats under the scope of SOP, which is required to record the activities or other relevant information needed by the procedure. Format number shall be unique and have a revision number. When the format is discontinued that format number will not be allocated to another format while revising the SOP. In the list of format, it should be specified that the respective format is discontinued. Example format No. AAA-AAAA-YYY/BB. Where, AAA-AAAA is SOP No., YYY is sequential format No. and BB is revision number of format.

• Annex: This section shall be used to draw flow charts, diagrams, or relevant information that will be part of SOP for ready reference. Example format No. CCC-CCCC-DDD/EE. Where, CCC-CCCC is SOP No., DDD is sequential format No. and EE is revision number of format.

• Revision History: This section will cover the revision history of the procedure from the first version of SOP to the current version of SOP. This part will consist of the changes made during each revision, change control number, SOP approval date, and SOP effective date.

5.2 Instruction for the formatting of SOP: The formatting of SOP shall be varying depending on the organization’s policy. It includes Font type, size, paper types, paper size, indenting requirements, numbering and sub numbering requirements, format for writing dates, etc.

5.3 SOP Numbering system: The requirement of SOP number is decided by the organization. Organization to organization, it differs. Example numbering system: AAA-AAAA, First three characters are for Department Name and Last four characters are representing sequential number of SOP for respective department.

5.4 Master list numbering system: The organization decides the requirement of the SOP master list number. Organization to organization, it differs. Example numbering system: ZZZ-SML-NN, First three characters are for Department Name, SML is abbreviation of “SOP Master List”, and Last two characters are representing revision number of master list. Master list shall be prepared as per format for “Master List of SOP for [Department name]”..

5.5 Steps for Preparation, Checking, Review, and Approval of new SOP:

• User department head shall identify the need for a new SOP. The user department shall draft the SOP for the required operation or activity.

• Once the draft is ready, the user department shall initiate the format “Request for new SOP”.

• User department shall initiate the request and attach the draft SOP with the format. The draft SOP shall be prepared by department personnel and reviewed by HOD with a sign on the draft copy.

• User department person and HOD will sign the request. The request shall be circulated to other concerned departments that may have impact because of the new SOP. The concerned department will acknowledge and sign the format for the new SOP.

• Submit the “Request for new SOP” to QA for their review and request approval.

• QA will evaluate the impact of creating a new SOP and assess the need for initiating change control if the new SOP may have impact on the existing system and procedures.

• Once the evaluation is found satisfactory, QA will allocate the new SOP number for the SOP.

• Once the “Request for new SOP” is reviewed and approved by QA, the user shall print the SOP and initiate the approval process.

• Once the SOP is approved, the QA person will put the “Master copy” stamp on the SOP footer part on each page.

• SOP preparation, checking, review, and approval shall be done only by authorized persons. The QA department shall maintain the “department-wise authorized person list”. The list shall be updated as and when necessary.

• Process for the preparation of flow charts as part of SOP is as flows:

5.6 Procedure for preparation and approval of SOP master list.

• Separate SOP master list shall be prepared by respective department person, checked by HOD, and approved by QA Head.

• Master List of SOPs shall be prepared as per format for “Master List of SOP for [Department name]”.

• Master list shall contain the list of all SOPs, with SOP name, SOP No., revision No., effective date, SOP review date, and remark. The master list of SOP shall not exclude the name and number of SOPs that have been discontinued.

• Master list of SOP shall be updated as and when needed for reasons such as while revision of SOP to update revision number when new SOP number is allocated, or SOP gets discontinued.

• Master list of SOP shall be mandatorily revised on a yearly basis.

5.7 SOP Training and implementation for use:

• User department shall initiate SOP training for the applicable audience using approved and Master Copy of SOP.

• Approved copy of the SOP shall be submitted to Training Department to upload in the Learning Management System (LMS) software.

• The training shall be completed within 30 business days from the date of SOP approval.

• Once the training is completed, the training department shall provide confirmation through the LMS regarding training completion.

• On confirmation of training completion, the Quality Assurance department shall make SOP effective within seven business days.

• On the day of SOP implementation, the QA person will put the ‘Effective date of SOP’ and ‘Next review date of SOP’ in the respective columns provided on the first SOP page.

5.8 Distribution and retrieval of SOP control copies:

• QA person will make the required number of photocopies using master copy of SOP with the effective date on it.

• Put a stamp “Controlled Copy” with red color ink on each page of all SOP copies. After putting the stamps, specify the copy number on the first page of the control copy as per department code.

• Master copy of SOP shall not have any copy number, and QA will retain that.

• At the time of issuance of controlled copy, make entries in the “SOP issuance logbook”. Write the details of ‘SOP No.’, ‘Rev. No.’, ‘Copy No.’, ‘SOP issues to’, ‘SOP issued by’, ‘SOP received by’, ‘Obsolete copy of SOP returned by’, ‘Obsolete copy of SOP received by’, and ‘Obsolete copy of SOP destroyed by’.

• On the retrieved obsolete copies of SOP controlled copies, it will be destroyed by making destruction entry in the logbook.

• Master copy of the previous version of SOP shall be stamped with “Obsolete copy” stamp with red ink. QA shall maintain obsolete SOP for future reference purposes only.

• Photocopy of SOP that QA does not control is not allowed to use for any operation or activities.

5.9 Distribution of SOP uncontrolled copies for reference:

• Uncontrolled copies of the SOP can be made when the reference copy is required by any external agency such as regulatory bodies, customers, or other relevant parties.

• Uncontrolled copy shall be created by photocopying the Master Copy of SOP by the QA department. Each page of the photocopy will be stamped using the stamp “Uncontrolled Copy” with purple color ink.

• Uncontrolled copy of SOP shall not be used for any operation or to carry out any activity.

5.10 Revision or Change in Standard Operating Procedure:

• In case of any modification or required update in any SOP, the user department can do it with the help of the change control procedure. The SOP owner department shall initiate change control to revise the SOP.

• Owner department shall initiate the change control as per SOP for change control and attach the proposed draft SOP with the change control.

• Once the change control is approved, the SOP approval process shall be initiated as defined under section “Steps for Preparation, Checking, Review, and Approval of new SOP”.

• If no change is warranted in any SOP over three years, it shall undergo periodic revision as per the frequency of periodic revision of SOP at every three years interval.

• SOP periodic review dates shall be tracked using format for “SOP revision tracker”. The tracker shall be prepared every year in the month of January. The tracker will cover SOP to be revised from month of March of current year to Month of February next year.

• SOP owner department will use the “SOP review format” to review the SOP for necessary improvement. The Owner department will circulate the SOP review format to the applicable cross-functional department for review comments regarding the required change in the SOP.

• Once the SOP owner department with the cross-functional department completes the review, it shall be reviewed by the owner department HOD and QA.

• Owner department will initiate the change control to revise the SOP as per received suggestions. If there is no suggestion received and no change warrants in the SOP after review, change control shall be imitated to revise the SOP as part of the periodic review process and change the revision number of SOP.

• Once the change control is approved, the SOP approval process shall be initiated as defined under section “Steps for Preparation, Checking, Review, and Approval of new SOP”.

• Change control to revise the SOP during periodic revision shall be initiated at least 60 calendar days before the “Next review date”.

• In case of periodic revision of SOP, if no content of formats have been revised, the revision number of formats shall remain the same as the previous version of SOP.

Note: Some organization does not review SOP during periodic revision but just extend the periodic revision validity from 3 years to 6 years by putting stamp on master copy of SOP and controlled copies are re-issued by QA to user having extended validity period.

5.11 Revision of formats or Annex:

• In case procedure is not required to change but just format or Annex required any change, it can be revised using the “Format for revision of Format and Annex”. This independent revision of format or Annex can be done only when there is no impact on any of the content of the SOP.

• SOP owner department will revise the format using “Format for revision of Format and Annex.” Existing format copy and proposed draft format or Annex shall be attached with the format for revision. After the initiation of the format, HOD will review the proposal. QA will review the proposal and approve or reject it as per QA evaluation.

• Once the format is revised, the QA person will make the master copy of the format and issue the controlled copies of the format to users as per the SOP distribution list and make an entry in the SOP issuance logbook. In addition, the QA person shall retrieve obsolete copies of the format. The master copy of format or Annex will be made obsolete and retained with the SOP master copy for future reference purposes.

• SOP revision history will be updated along with the format revision to track the changes made.

5.12 Discontinuation of SOP:

• In case of any SOP is required to be discontinued for any reason, the SOP owner department will initiate the change control to discontinue the SOP as per SOP for change control.

• Once the change control is approved for SOP discontinuation, the QA department shall initiate the SOP discontinuation process.

• QA person will collect all the controlled copies from respective departments, make an entry in the logbook for SOP retrieval, and put the remark in the logbook as SOP discontinued.

• Master copy of SOP will be stamped as “Discontinued” with a red color ink stamp. QA will maintain the discontinued copy of SOP for future reference.

• Management of damaged or missing controlled SOP copy of the SOP.

• In case any controlled copy is observed as missing or damaged during the use, the user department can request the additional copy using “format for additional SOP control copy request”.

• User department person shall initiate the request for additional copy request. HOD will review the request and sign the format. After that QA head will approve the request. On approval of the request, the QA person will issue the additional copy by entering the SOP issuance register.

• In case the SOP copy is found missing, that shall be investigated as per the applicable QMS process.

6.0 Frequency

• Periodic review of SOP revision is 3 years.

• Periodic review of SOP master list is 1 year.

7.0 Formats

7.1 Format for Preparation of Standard Operating Procedure Procedures

Company Name [LOGO]

Standard Operating Procedure for [Topic] SOP No.: Revisio Number: Page No.: X of Y

Effective date: Next review date: Department Copy no.:

Prepared by: Reviewed by: Approved by:

1. Purpose

2. Scope

3. Responsibility

4. Definitions, Abbreviation, and Acronyms

5. Procedure

6.0 Frequency

7.0 Formats

8.0 Annex

9.0 Revision History

Format No.:

7.2 Format for Master List of SOP for [Department name]

Master List of SOP for [Department name]	Page No.: X of Y
Revision No.:	Effective Date:

Sr. No.	SOP Name	SOP No.	Rev. No. & Date

Prepared By	Checked By	Approved By

Format No.:

7.3 Format for Request for new SOP

Format for Request for new SOP

Department name:

Date:

Proposed name of SOP:

Reason for new SOP preparation:

Draft Copy attached [Yes]/[No]

User department sign and date:

Impacted department(s) sign and date:

User department sign and date:

QA evaluation: Sign and date:

Approved/ Rejected: QA Head sign and date:

SOP Number allocated by QA:

QA Sign and Date:

Format No.:

7.4 Format for Department-wise authorized person list

Department-wise authorized person list

Department:

Name	Employee Id.	Responsibility (Prepare by/ Checked by/ Review by/ Approved by)

Prepared By [User department]	Reviewed by [HOD]	Approved by [QA]

Format No.:

7.5 Format for SOP Issuance, Retrieval and Destruction logbook

SOP Title:

SOP Number:

Rev. No.

Department Copy No.

Department name

Issued by

SOP issues to

SOP received by

Obsolete copy of SOP returned by

Obsolete copy of SOP received by’

Obsolete copy of SOP destroyed by

Format No.:

7.6 Format for SOP review format

SOP review format

SOP No.

Suggestions for improvements:

Reviewed by (user department):

Reviewed by (user HOD):

Reviewed by QA:

Format No.:

7.7 Format for Revision of Format and Annex

Request for Revision of Format and Annex

Department name:

SOP No:

Format/ Annex Name:

Format/ Annex No.:

Proposed change: [Attach existing and proposed format/ Annex]

Reason for change:

Proposed by (sign/ date):

HOD (sign/ date):

QA Evaluation: Change control required [Yes/ No]

QA (Sign/ Date):

Approved/ Rejected

Head QA (Sign/ date)

Format No.:

7.8 Format for additional SOP control copy request

Additional SOP control copy request

Department name:

SOP Name:

SOP No:

Department Copy No.:

Reason for request: [Attach supporting documents if any]

Requested by:

Request approved by HOD:

Remark:

Request approved/ rejected by Head QA:

Format No.:

7.9 Format for SOP revision tracker

SOP revision tracker for Department [Name of department]

Month

SOP Nos.

SOP Name

Next revision due date

Change control initiated for revision on

Change control No.

Verified by [User department person]

Reviewed by [HOD]

Format No.:

8.0 Annex

8.1 Specimen stamp – Master Copy

8.2 Specimen stamp – Controlled Copy

8.3 Specimen stamp – Obsolete Copy

8.4 Specimen stamp – Uncontrolled Copy

8.5 Specimen stamp – Discontinued

8.6 Department-wise SOP copy No. list

9.0 Revision History

S. No.	Revision Number	Reason for Revision	Change control No. and Approval Date	SOP approval date and Effective Date