Standard Operating Procedures

· Updated

Standard Operating Procedures, or SOPs, are documented practices and procedures that define how an organization carries out its day-to-day activities, establishing a benchmark for the quality of its products and services.

sop

SOP being used as a training tool

SOPs or Standard Operating Procedures define the practices and procedures adopted by organizations in their day to day activities. SOPs help establish a benchmark on quality of products and services. Importance of SOPs in different types of establishments has already been highlighted.

Benefits of SOPs in Laboratories

SOPs drafted in compliance with universally accepted guidelines ensure consistency of testing procedures and reporting of results. Additionally they serve as useful reference material for training of new entrants.

Drafting of SOPs

Each SOP has 3 levels of authority:

Author - person who drafts the SOP

Process Owner - Head of the concerned department

Approver - Quality Assurance Manager

The SOP should be drafted in simple language that should be easily understood by all concerned. It is best if SOP is written by individuals familiar with the related activity. The draft should be reviewed by trained and experienced persons and finally by the Quality Assurance Manager.

No universal format exists and internal formatting can vary from organization to organization, however, a basic format should contain:

1. Title page

Title page should be on company logo sheet mentioning

  • Name of organization with address
  • Title of activity or procedure
  • SOP identification No, Issue No. and effective date
  • Document details such as copy holder and his location
  • Cross references

2. Table of Contents

Should provide a quick reference to activities covered

3. Text

Describes activities along with references to relevant regulatory standard(s).

4. Header Details

| Code | SOP code No. | | --- | --- | | Issue No. |  Version No. | | Effective Date |  Date of implementation |

5. Footer Information

  • Position File name on the left, Page No. on the right and Company confidential in center
  • Header and Footer information should be the same on each page except for page numbers
  • Version control history should be presented in the format given below:

| Date | Issue No. | Change Control Ref. No. | Change Description/ Reason / Superseeds | | --- | --- | --- | --- |

Control of SOP

  • Each and every page of SOP should be stamped with a MASTER COPY stamp in red at the center of the header
  • Both owner and approver should sign in black on each page within the stamp
  • Photocopies of master copies should be provided by CQA manager only against written request with justification
  • Controlled copy should be stamped in red stamp
  • Corporate quality assurance manager should control the issuance and retrieval records of all SOPs
  • Master copy records (both hard copies as well as soft copy backups) should be retained by Quality Assurance Manager

SOP Record Keeping by User Departments

  • User department should maintain records of new SOPs in circulation. All receivers should sign and put the date of receipt in the distribution register
  • The distribution process should be completed before the effective date of SOP. The Quality Assurance Manager should provide awareness training to users before the effective date and maintain the training record
  • Superseded SOPs should be stamped as “SUPERSEDED” in red at middle of each page and preserved for a minimum 5 years
  • SOPs should be reviewed every two years
  • In case of urgent need for SOP amendments, an SOP can be reviewed before and a record of the change maintained
  • In the case that there is periodic revision then “Periodic Revision” is written in version control history chart
  • Before implementation of changes, training on such changes should be given

SOPs are sacrosanct documents and no deviations or alterations should be permitted unless these are reviewed and revised by authorized persons.