Advertisements

Standard Operating Procedures.

As we all know SOPs is the most Important part of Pharmaceutical manufacturing Companies. What it does mean by SOPs…? Why it is so important…?? What if we don’t you SOPs…???

Actually it is very Simple SOPs stands for Standard Operating Procedures of Pharmaceutical manufacturing activities,it is not limited to Quality assurance department or Quality Control department or Production department.it is important because without standard Operating procedure we can achieve desire results.if we don’t have SOPs we can’t control out come of our activities.

Definition of SOPs:

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Standard Operating Procedures (SOPs):- one e.g Of SOPs Format.

  • Format of SOP:
  • All SOP shall be prepared as per following format
  • First A4 page of SOP shall bear a sign off column as follows:
  • All pages of SOP shall carry the following Header:
  • Refer SOP of SOP on SOP for Header and Footer.

Header should contain all this details

  • Department:
  • SOP No.
  • Title:
  • Effective Date:
  • Next Revision Date:
  • Supersedes:
  • Page No. : .
  • For preparation, review and approval shall be printed text as follows:
  • Prepared By:
  • Reviewed By:
  • Approved By
  • Designation:
Prepared By Reviewed By Approved By
Name
Designation
Signature
Date
  • Format of SOP:
  • The body of the SOP shall include following sub heading as per the sequence only:
  • Objective
  • Scope
  • Responsibility
  • Abbreviations
  • Procedure
  • Training
  • Distribution
  • Annexure
  • Reference
  • Revision History
  • Objective: the purpose of the SOP.
  • Scope: where the SOP covers the applicability of the document.
  • Responsibility:.

Procedure: details that describe step wise procedure or activity is to be performed.

  • Training : This shall specify
  • Who will be trainer
  • To whom the training on particular SOP has to be given.
  • Distribution:
  • Annexure:
  • Header and Annexure No.

Annexure – ?*

*Indicates the Annexure Number.

  • Footer and Format No.
Prepared By Reviewed by Approved by
Signature
Date

Format No.: f/xxx/yy

  • References:
  • Revision History:.
  • For new SOP modifications column shall bear “—” and in reason for modification “New SOP” shall be mentioned

Leave a Reply

Your email address will not be published. Required fields are marked *