SOP Template: Operating Standard Procedure
SOPs describe how to do activities that are necessary to complete specific tasks. SOP Template help to preparation and drafting of SOPs, A written authorized procedure, which gives instructions for performing operations/activities ,Usually these standard procedures are created to comply with industry regulations, laws, and the company’s own standards for running a business. An effective standard operating procedure clearly explains the steps taken to complete a task and informs the employee of any risks associated with the process. The manual should be brief and easy to understand, with a focus on how things should be done rather than what needs to be done. Once written, the SOP should be analyzed and updated every 24 months to guarantee it remains relevant to the standards and requirements of the organization; any changes made should be recorded.
SILDENAFIL CITRATE TABLETS
Preparation of new SOP Template
The concern department person or head shall identify the need for creating of new SOP. Department person/user shall inform to the department head or his deputy for new SOP requirement.
Department head shall evaluate the requirement of creating new SOP. If department head thinks that SOP need is justified to address the activity or perform the task, he will assign task of new SOP creation to the concern department person or expert.
The Department person shall raise the for preparation of new SOP as per attachment-III & forward to QA department.
QA Head or designee shall verify the SOP requirement & evaluate the rationale/ justification for creation of new SOP. If it is justified the change control shall issued to the concern department.
In case any SOP exists in the system to address the activity same shall be issued to the department & new SOP request shall be rejected.
Use simple language & positive sentences during SOP writing.
All the SOP’s shall be written in MS-Word and shall be printed on one side of the page.
The SOP shall be translated to local language as per requirement.
Format of SOP
Title: Mention title of the SOP, which is expressive of the subject of the SOP. It shall describe the aspects covered by the procedure exactly and include as many key words as possible for easy retrieval.
SOP numbering system :The numbering system for allocation to any SOP shall be department/Section specific.
Change Control Number (CC No.):In case of new SOP, mention CC no allocated by QA department. in this column mention the CC No. allocated by QA department
Supersedes: In case of new SOP, mention “Nil” in this column. In case of revision mention SOP No. of the superseded SOP. SOP No. of old version of SOP shall be written in this column.
Effective Date: Mention the effective date from which the SOP shall be implemented. It shall be mentioned in DD/MM/YYYY format with blue ink pen. While deciding effective date consider training time required to provide training to all concerned. Five days is recommended after the approval & before implementation of SOP.
Next Review Date: Mention the next review date on which the SOP shall be reviewed. It shall be mentioned in DD/MM/YYYY format with blue ink pen. All the SOP’s shall be reviewed every two year.
Page No.: Mention page No. in this column. It shall be mentioned in “Page X of Y” format, X page no. of the particular page and Y stands for total no. of pages of that SOP. Example: Second page of SOP with total 10 pages shall be numbered as “Page No. 2 of 10”.
Written By/Date: Signature of a person with blue ink pen, who has written the SOP and date, shall appear in this column. Written by signature and date shall appear on each page of the SOP.
Checked By/Date: Signature of QA person and user department head or designee with blue ink pen, who has checked the SOP, and date shall appear in this column. QA person shall sign each page of the SOP.
Approved By/Date: Signature & date of Plant Head and QA Head with blue ink pen, who has approved the SOP, and date shall appear in this column. Plant Head & QA Head shall sign on first page only
How to write an effective Standard Operating Procedure (SOP)
There are some steps you can follow that will help you to organize your thoughts and plan the most effective path to standardizing your procedures.
1.Objective
Define the scope
2. Gather information
3. Choose the format
4. Complete the draft
5. Review with stakeholders
6. Publish
7. Promote
8. Review and Amend
9. Analyze usage metrics
Content of the SOP:
Purpose:
Mention the intended use of the SOP in this column. It is a statement, which justifies the need of the SOP.
Scope:
Mention the application of the SOP in this section. It shall describe the extent of areas covered by the SOP.
References and Attachments:
References:
Mention the details of any references used in order to design the SOP. The references can be an official publication, guidelines, instruction manuals, other SOP’s and in house procedure /system to accomplish an activity.
Attachments:
Mention Attachment(s) used in SOP if any, otherwise type NA. Page numbering of each attachment shall be running format of SOP. Format Number shall be footer in left hand of each page.
In case of revision of attachment(s) the SOP shall be revised & assigned next revision number to SOP as well as attachment. But in case of SOP revision & no change in attachment format, the attachment format remains unaffected (i.e. revision number shall remain same of attachment). In case revision of attachment format the SOP is also revised to accommodate the change & assign next version to SOP also along with format.
Annexure shall be revised independently without impact the SOP & shall be attached separately from the SOP (Not a part of SOP text), other provision shall remain applicable as defined for attachment. But in case of revision of annexure format the same procedure applicable as for attachment.
Responsibility:
Mention the responsibilities of individuals/departments along with the clear ownership in this column.
Distribution:
This section provides a guideline for distribution of the controlled copy of the SOP to the concerned departments.
Additional copies shall be issued for specific purpose & distribution record shall be maintained if it is controlled copy.
In case of no change in SOP & further extension of validity the distribution record of initial & as well as after validity extension shall be maintained along with original SOP.
Definitions of terms:
Write down definitions of terms in this column where require.
Procedure:
This section shall start with new page only.
Outline of the logical steps to be carried out to complete the purpose of the SOP.
When require, give example or attachment for more clarification. Each step of the activities / operations shall be explained.
Frequency pertaining to monitoring, calibration, validation, checking, cleaning and sampling shall be mentioned, whenever it is applicable.
The instructions for any in-process controls with their limits shall be mentioned in the SOP.
Where necessary, the requirements for storage conditions of materials / products shall be mentioned in the SOP.
Where require information about format, Label, Equipment, Instrument and Area identification shall be mentioned in the SOP.
If require, specific work environment shall be mentioned in which the operation has to be
Any safety precaution required to be taken while performing activity shall be mentioned in the SOP.
Flow chart shall be used for better explanation and clarity of the process where necessary.
Abbreviation shall be mentioned in the SOP by giving full form of the abbreviation first time. e.g. Standard Operation Procedure (SOP)
History:
A brief history of changes made in the SOP shall be written in this section.
