SOP Template: Operating Standard Procedure
SILDENAFIL CITRATE TABLETS
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.
