What is SOP / Standard Operating procedure?

SOP (Standard Operating procedure) is a set of written instructions that documents a routine or repetitive activates followed by the organization. The development and use of SOPs are an integral part of a successful quality management system as it provides individuals with the information to perform a job properly and facilitates consistency in the quality and integrity of the product

Types of SOP’s (Standard Operating procedures_

Basically the SOPs are classified as three types

1. Functional SOP

Functional SOP defines the functions handled in the GMP environment (Eg. Handling of Change, Handling of Failures, and General house keeping). These kinds of SOPs are prepared based on common Industrial practices and reference to the guidelines.

2.      Technical SOP

The so called Batch manufacturing record, Standard testing procedures etc. will comes under this type this will directly deals with the product manufacturing and testing.

3.      Guidelines SOP: Guidelines SOPs will guide the personnel to handle the activity (Eg. Preparation of training module). This kind of SOPs is very limited and no need to be followed what exactly Guidelines SOP says. Pharmaceutical organization may not need to have these guidelines SOPs.

Functional and technical SOP need to be implemented and followed strictly.

Basic requirements of SOP

1. SOP should be prepared and reviewed by user department at two different levels, followed by reviewed and approved by Quality assurance department.
2. All the SOPs need to be trained, training evaluated and implemented
3. SOPs should facilitate the records (Work sheets/raw data sheets) for documentation to show the consistency in implementation and following the procedure.
4. SOP should have the distribution, reterval and archival system.
5. Organization should follow the uniform procedure/format for preparing SOP
6. Each SOP should have a unique identity (Numbering) and should have the revision status to show the number of revision happened and existing revision

Where SOPs required?

The activity that influence the quality of product directly or indirectly need to be controlled through an SOP and its records. 

Basic elements of SOP

This is the step by step guideline to define the effective SOP, here explained is common industrial practices in the pharmaceuticals.

SOP should have the following elements consistency.

1. HEADER: The company name, document type, department, pagination, title, SOP No., Supersedes, Issue date, Effective date and review date shall appear as header on every page of the document.

2. FOOTER: The ‘Prepared by’, ‘reviewed by’ and ‘Approved by’ shall appear as footer on every page of the document. Name and designation of the person preparing, reviewing and approving the SOP shall be printed

3. CONTENT OF THE SOP

a) Reason For Revision: In the first page of the SOP format (Annexure-2), mention in brief, the revision history of the current revision number and its preceding revision number. History of other previous revisions shall be referred to in the obsolete SOPs.

B) Purpose: Mention the intent of the SOP for which the SOP is being made.

C) Scope: Provide limits to the use of the described procedure, e.g. limit the use to certain equipments, departments, utilities, area.  Also the applicability of the SOP is mentioned here.

D) Responsibility: Specify the designations of the persons responsible for performing, monitoring, implementing and ensuring compliance of the described activity, if applicable.

E) Abbreviations (If Applicable): Expand the short terms used in the document. If there is no abbreviations mention “not applicable”

F) Definitions (If Applicable):  Define the terms, if any, used in the document. If there is no definitions mention “not applicable”

G) Procedure :

Describe the detailed procedure to be followed to fulfill the intent of the SOP including follow-up actions in case of failures where applicable.

Use active verbs and direct statements to describe the procedure. e.g. 'Weigh 150 kg raw material or 'add 100 L of purified water'.

Describe the procedure 'step-by-step' and in chronological order.

Effectively communicate the procedure.        

Where applicable, describe in the procedure, actions to be taken in case of failures, e.g. handling temperature excursions, handling out of calibration, etc.

H) Environmental Health And Safety (If Applicable) : If applicable, specify health, safety and environmental protection measurements / precautions required to be followed while executing the SOPs related to equipment, utility and handling of chemicals / reagents. If there is no health safety and environmental protection required mention “not applicable”

I) Document Distribution List: The distribution requirements shall be documented in the SOP. Any additional distribution shall be recorded in the document distribution record QA/F/044 and updated into the SOP during subsequent revisions.

J) References (If Applicable) : Wherever applicable, give references, cross reference to other SOPs, text books, pharmacopoeias, regulatory requirements, manuals, general information, flow diagrams, pictorial reference, photographs and any other authentic supporting references to be referred during execution of the described procedure. If there is no references mention “not applicable”

K) Enclosures (If Applicable) :

Give a list of attachments to the SOP as Annexure. This includes the flowchart approach to SOPs which facilitates training and explanation of SOP. Annexure include formats to record the data, observations, labels, checklists, etc. generated for demonstrating compliance to the SOP. If there is no enclosures mention “not applicable”

The final copy of  SOP shall be printed on a standard A4 size white (210mm x 297mm) paper using Times New Roman

Numbering Of SOPs:

The SOP No. is a unique alphanumerical code given to every SOP.  The alphabetical part in the SOP number indicates the department to which the SOP belongs.  The numerical part is a unique serial number given to the SOP and this is followed by the revision status of the SOP.  The following are the code numbers and number of characters in the SOP No., department wise.

The font sizes and style of each section eg Header, content etc. should be followed in each SOP as uniform.