Standard operation procedure is most important role in the pharmaceutical industry

1. STANDARD OPERATION PROCEDURE
Set of written instructions that is followed routinely or repetitively
Back bone of pharmaceutical industries.
SOPs described both technical & fundamental programmatic operational element of an organization
that would be managed under a works plan or a QA project plan.
In simple terms SOPs is: -
✓ A written process
✓ A way for the clinical site to perform a task the same way each time is completed.
Reason for having SOPs: -
❖ To provide people with all the safety, health, environmental, & operational information.
❖ To ensure that no failures occur in any processes.
❖ To ensure that approved procedure are followed in compliance with campnayy& government
regulations.
❖ Provide training& guidance for new staff.
FDAs three golden rules on proper documentation: -
a. If it is not written down, if didn't happen.
b. If it isn't written down properly, if didn't happen either.
c. Don't forget rules 1 & 2.
Position of SOP in total documentation: -
▪ 3rd layer in documentation
▪ 1st GLP & 2nd company policies.
▪ GMP
OBJECTIVES: -
1) to describe the responsibility of the coordinating center for managing & monitoring the
participating sites.
2) To details the regularly recurring work processes that are to be conducted or followed within
an organization.
3) To facilitate consistent conformance to technical & quality system requirement & to support
data quality.
4) To maintain their Qc & QA processes.
5) To ensure compliance with government regulations.
6) To serve as a training document for teaching users about the process for which the sop was
written.
BENEFITS: -
a) Provide information to perform job properly.
b) To provide people with all safety, health, environmental operational information necessary to
perform job properly.
c) Also provides consistency
d) Minimizes variation & promotes quality, steps can be reviewed in accident investigation
e) Serves as a training document for users.
f) Sop's are useful tool for training new members of staff.
g) Sop's give clarity to the pharmacy personal to follow steps & uniformly.
h) Sop's helps to assure the quality & consistency of the services.

2. AREA OF SOP -
Safety & precaution
To deal with complaints
Fundamental
Analytical methods
Preparation of reagents
Methodic
Instrument/ equipments & apparatus
QA
SOPS WRITTEN STYLES :-
• SOPs shall be written in a concise, step by step, easy to read and follow format.
• Information should not be complicated. The active voice and present verb tense should be
used.
• Should be simple and short.
• Routine procedures that are short and require few decisions can be written using simple
steps format.
• Long procedures consisting of more than 10 steps, with few decisions should be written along
with graphical format or hierarchical steps.
• Procedure that enquiries many decisions should be written along with flow chart.
INSIDE THE SOP: -
1. Company name and pagination -The company name and pagination (e.g. page 4 of 7) 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-Procedures must be easily identified by giving unique number and version
number.
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-The purpose or objective of the procedure should restate and expand well written
title.
6. Responsibility -Who is responsible for performing the work described? Who is responsible for
implementing the procedure?
7. Procedure-Describe the procedure in a step by step, chronological manner. Use active verbs
and direct statements.
TYPES
Of
SOP’s

3. Master SOP:-In addition to the various SOPs that are required, the company has to first make an SOP
that defines how the various SOPs will be made, i.e. what kind of information, structure and
numbering system will be included in various SOPs.
It should also contain a time frame for revision of SOPs.
It should identify the persons authorized for each activity (creating, checking, verifying and
implementing).
SOPs PROCESS :-
1) Sop preparation- environmental personal, performs the job, equipment manufacturers, safety,
technical initiation, performs maintenance
2) SOP Review and Approval- SOPs should be reviewed by one or more individuals with
appropriate training and experience with the process especially help fulfil draft SOPs are
actually tested by individuals other than the original writer before the SOPs are finalized.
3) Frequency of Revisions and Reviews- SOPs need to remain current to be useful. Therefore,
whenever procedures are changed, SOPs should be updated and re-approved. If desired,
modify only the pertinent section of an SOP and indicate the change date/revision number
for that section in the Table of Contents and the document control notation.
4) Implementing SOP-The most important step for implementing the SOP is in working area,
train or retrain the user. Everyone should follow the procedure exactly with each and every
step in detail, it is very important to train the user otherwise individual may interpret
meaning indifferent ways
5) Management of SOP-Organization shall have SOP on Preparation, approval, revision and
control of standard Operating Procedure for better control and management of SOPs.
SOP General Format:-SOPs should be organized to ensure ease and efficiency inuse and to be specific
to the organization which develops it.
Where possible break the information into a series of logicalsteps to avoid a long list.SOP generally
consists of
1. Title Page-The first page or cover page of each SOP should contain the
following information:
a. A title that clearly identifies the activity or procedure
b. An SOP identification (ID) number
c. Date of issue and/or revision
d. The signatures and signature dates of those individuals who prepared and approved the sop
2. Table of Contents:-
• A Table of Contents may be needed for quick reference, especially if the SOP is long
• To locate the information
• To denote changes or revisions made only to certain sections of an SO
3. Text:-
a. The purpose of the work or process
b. The scope of the work or process
c. Responsibilities and applicability’s
d. Summary of the method/procedure
e. Definition of any specialized/unusual terms and explanation of abbreviations.
f. Health and safety cautions
g. Attach any appropriate information, e.g., an SOP may reference other SOPs

4. Exmples of SOP
SOP's for sterilization
Dry sterilization- exposing materials to dry heat in hot air ovens. 160c for one hours.