STANDARD OPERATING

PROCEDURE (SOP)

Presented by
GOVIND
What is standard operating procedure
(SOP)

An authorized written procedure giving

instructions for performing operations
necessarily specific to a given process, product
or material (e.g. equipment operation,
maintenance and cleaning; validation;
cleaning of premises and environmental
control; sampling and inspection).
 Introduction to SOP:
 In order to ensure that the best possible
medicine be made available to the consumer
 There are three critical parameters for SOP

1. Right quality
2. Right quantity
3. Right price
 Major information contain in
any SOP is :
1. Objective of the SOP
2. Procedure to be followed
3. Person responsible for doing the activity
4. Person responsible for checking and
supervision
5. Frequency of the activity
 In addition to the various SOPs that are
required, the company has to make SOPs
that define,how the various SOPs are made
 i.e. what kind of information, structure and
numbering system will be included in various
SOPs. Include a time frame for revision of
the SOPs and identify the person authorized
for each activity (1.including creating 2.
checking 3. verifying and implementing )
 Why do you require a standard
operating procedure (SOP)

For some time now during last 10 year there has

been an overwhelming demand for ensuring
safety and efficacy of various drug product that are
available in the market.
Other reasons:
 Storage and handling of raw materials at the vendor
place and consuming factory warehouse , cross
contamination possibilities
 Manufacturing precaution( to ensure right quantity and
right quality)
 Quality control lab procedure for testing the drug
product and finally the storage and handling
procedures at the warehouse and
stockiest/distributor/retailer.
Benefits Of Sop:

1. To provide people with all the safety, health, environmental and operational
information necessary to perform a job properly.

2. To ensure that production operations are performed consistently to maintain

quality control of processes and products.

3. To ensure that processes continue uninterrupted and are completed on a

prescribed schedule.

4. To ensure that no failures occur in manufacturing and other processes that would
harm anyone in the surrounding community.

5. To ensure that approved procedures are followed in compliance with company and
government regulations.

6.To serve as a training document for teaching users about the process for which
the SOP was written.
7.To serve as a checklist for co-workers who observe job
performance to reinforce proper performance.

8.To serve as a checklist for auditors.

9.To serve as an historical record of the how, why and

when of steps in an existing process so there is a
factual basis for revising those steps when a process
or equipment are changed.

10.To serve as an explanation of steps in a process so

they can be reviewed in accident investigations.
 Format of an SOP
1. Company Name and Pagination : The company
name and pagination must appear on every page

2. Title : The title should be descriptive. The title

should use directive language to declare what is
being done to what.

3. Identification and control :Procedures must be

easily identified by giving unique number and version
number.  This identification number of the SOP
supports accountability of the document throughout
the facility and over time as it change
4. Review and Approval : All Sops shall have space for signature of initiator
(the person who has written the SOP) Reviewer (The persons who has
reviewed the SOP) and approver (Quality Assurance Head of the
organization).

5. Purpose : : Describes as to why this procedure is required.

6. Scope: : Describes as to the areas / activities encompassed.

7. Responsibility : Names a person who remains accountable for

implementation.

8. Procedure: Describe the procedure in a step by step, chronological manner. 

Use active verbs and direct statements (e.g. check the cleanliness of
machine and too.

9. Check : Many activities use checklists to ensure that steps are followed in
order.  Checklists are also used to document completed actions
Precautions for preparing SOP:
Instruction and procedure should be written in
a clear language.
Record are made in such a way that during
manufacturing process.
Necessary step required by defined
procedures and instruction have been taken
and that the quality and quantity of the product
is expected.
Any significant expected deviation are fully
recorded and investigated.
 Procedure

Document required are to be designed,

prepared reviewed and distributed with such a
care that it will be comply with relevant part of
the manufacturing and operating procedures
as well as facility available.

Document will be approved, signed and dated

by appropriate authorized persons and person
nominated by the management.
1. Document must not be changed, amended or
added without authorization
2.Document should be title, code number,
supersede number, date of issue, effective date
as well as the purpose should be clearly stated.
3.Document should be laid out in orderly fashion
and easy to check, critical step should be
highlighted
4.Reproduced document should be clear and
legible.
5.Document should be regularly reviewed and
kept up to date.
6. Any alteration made to a document will be
signed and dated by all the above person who
are authorized to do.
7. One original copy each of Master Formula
Cards, Standard Operating Procedure and
specifications should be stored in lock, one
copy should be retained with each member
who signed that document and one copy is
required to be kept at each concerned
department.
8. All the record should posses particular code
number to identify it and should be easily
accessible with respective department.
 Standard Operating Procedure
Company Name and Address:     Page No: X of Y
 

Title : SOP No:

Revision No:
Review Period:
Prepared By Reviewed By Approved By

Objective :

Scope :

Responsibility:

Procedure :
 What are the kinds of standard Operating
Procedure ?

 Procedure for control and assurance

 Procedures for preparing protocol
 SOP can be classified into following types :
 1) CORPORATE SOPs
 2) LOCAL SOPs
 3) MIXED LOCAL AND CORPORATE SOPs
 4) sponsor and CRO SOPs
 How is compliance of an SOP
verified ?
 Evaluation through questionnaire
 Internal auditing / Verification of Actual
Performance
 Verification of Documents prepared in
compliance
 Quality compliance of intermediate / finished
product and meeting yields forms
 On the job evaluation by front line supervisors
 Reduction trend in rejection of product
 What are the records to be
maintained for compliance with
procedure ?
 Filled formats
 Equipment Logs
 Maintenance Logs
 Calibration records
 Test reports
 List all materials or equipment needed to perform
the procedure wherever found to necessary
 If any formats have to be maintained during carrying
out the activity, the same has to be attached
Thank You
FREQUENT PROBLEMS CONCERNING SOPs :

 1) They do not cover all aspects of clinical

research. Statistics, IT etc. are examples of
functional groups that frequently
 2)