standard operating procedure pharmacy

A SEMINAR ON
INTRODUCTION OF
STANDARD OPERATING PROCEDURE
(LIQUID & SEMI SOLID DOSAGE FORMS
MANUFACTURING EQUIPMENTS)

Prepared By:
SAGAR SOMAIYA
M.PHARM(SEM-1) ROLL NO. 2
DEPARTMENT OF
PHARMACEUTICS
School of Pharmacy, RK University 1

Contents
WHAT IS STANDARD OPERATING PROCEDURE?
OBJECTIVES
WHY IT IS ESSENTIAL?
BENEFITS
TYPES OF SOP
SOP WRITING STYLE
POINTS TO BE KEPT IN MIND WHILE WRITING SOP
INSIDE THE SOP
STEPS OF SOP
COMMON EQUIPMENTS USED FOR LIQUID AND SEMI
SOLID PEPARATION
GENERAL SOPS

Set of written instructions that is followed routinely or repetitively.
Created culture where Quality objectives are Transparent, well
understood, and Undoubtedly these goals can be achieved by certain
sets of Procedures called as “Standard Operating Procedures”.
Back bone of Pharmaceutical Industries.
SOPs describe both technical and fundamental programmatic
operational elements of an organization that would be managed
under a work plan or a Quality Assurance (QA) Project Plan .


1. If it isn‟t written down, it didn‟t happen.

2. If it isn‟t written down properly, it didn‟t happen either.

3. Don‟t forget rules 1 and 2.

• 3rd layer in documentation

• 1st GLP and 2nd Company policies

Q.A.
Documentation
GMP

Q.C.

To describe the responsibilities of the coordinating center for
managing and monitoring the participating sites.
To provide guidelines for accurate and timely data collection,
resolution of data clarifications (queries).
 To detail the regularly recurring work processes that are to be
conducted or followed within an organization.
To facilitate consistent conformance to technical and quality system
requirements and to support data quality.


Continued….

To maintain their quality control and quality assurance
processes
To ensure compliance with governmental regulations.
To serve as a training document for teaching users about the
process for which the SOP was written.


Why it is Essential ?
An integral part of successful quality system.
Plant‟s effectiveness and efficacy.
Regulatory requirement.
To ensure that production operations are performed consistently to
maintain quality control of processes and products.
To ensure that processes continue uninterrupted and are completed
on a prescribed schedule.


Provides information to perform job properly.
To provide people with all safety, health, environmental and
operational information necessary to perform job properly.
Also provides, consistency (very imp. In any of the field)
Gives information in order to achieve pre-determined specification
and quality end-result.
Minimizes variation and promotes quality. Steps can be reviewed in
accident investigations.
Serves as a training document for users.


Continued….

SOPs assist to ensure that GMP is followed and achieved at all times.
SOPs assist the pharmacy personnel to know who does what, and
when, thus avoiding confusion, and function overlapping. This also
takes care of accountability and responsibility.
SOPs help to assure the quality and consistency of the service, and
thus minimize harm to the patient.
SOPs are useful tools for training new members of staff.
SOPs give clarity to the pharmacy personnel, to follow
steps/procedures, systematically, and uniformly.


Safety To Deal
& With Fundamental
Precaution Complaints

Analytical
method
Types Prep. Of
Reagents
of SOP
Instruments/
Q.A.
Methodic equipment &
apparatus


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.


Continued….

Procedures that require many decisions should be written along
with flow chart.
Requirement for document identification and control,
accountability and traceability responsibility must be included
with every SOP; this can be achieved by providing consistent
format.


DO

 Write in the presence tense. Don‟t write in the past, conditional or
future tense unless you have good reason to do so.
 Avoid ambiguity.
 Be concise.
 Keep the words short and get to point.
 Move from one step to another step in logical manner.
 Highlight exception. Use a symbol to flag that this is an exception and
how to handle it.


Continued….

 Highlight warning. Again warn users that caution must be used in
this scenario. Warning must stand out; use a larger font or a warning
icon.

 Reduce the word count where possible without altering the meaning
of the text.


DO
NOT DO

Introduce acronyms without explaining what it means.
Don‟t use the word “may”, “if possible” as it implies that the user
can do something under conditions. Instead be positive and tell
them what to do.


Company name and pagination.
The company name and pagination (e.g. page 4 of 7) must appear on
every page.
Title
The title should be descriptive. The title should use directive language
to declare what is being done to what.
Identification
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 changes.


Continued….

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).
Purpose
The purpose or objective of the procedure should restate and
expand well written title. Expand or qualify the directive language
used in the title (e.g. to describe the operation procedure of
compression machine)


Continued….
Scope
The scope should provide limits to the use of procedure. The scope shall
be written in such a way that it answers following questions….
 Are there certain samples that are appropriate to test by this method?
 Do these operations apply only to certain equipment or certain
departments?
 Is there a limit to the capacity, volume, or throughput of the procedure?
 State to what areas this procedure does apply and does not apply?
Responsibility
Who is responsible for performing the work described?
Who is responsible for implementing the procedure?
Procedure
Describe the procedure in a step by step, chronological manner. Use
active verbs and direct statements 19
School of Pharmacy, RK University

1. Sop
Preparation

2. SOP Review and
5. Management of Approval
SOP
SOP
PROCESS
3. Frequency of
Revisions and
4. Implementing Reviews
SOP


SOP Preparation

 The organization should have a procedure in place for determining
what procedures or processes need to be documented.
 SOPs should be written by an individual who performs the tasks
routinely or someone who is directly responsible for the performance
of the task.


Environmental Performs the job Equipment
personnel manufacturers

Who will/can write
SOP?

Performs maintenance
Safety personnel Technical initiation on equipment


SOP Review and Approval

SOPs should be reviewed by one or more individuals with
appropriate training and experience with the process especially helpful
if draft SOPs are actually tested by individuals other than the original
writer before the SOPs are finalized.


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.

SOPs should be also systematically reviewed on a periodic basis, e.g.
every 1-2 years, to ensure that the policies and procedures remain
current and appropriate, or to determine whether the SOPs are even
needed.


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 in
different ways.
 While training the user trainer should share the reason WHY, SOP
must performed correctly. People are much more to follow when
they understand importance of procedure.
 Trainer should explain and demonstrate how each step in the SOP
will be performed and should assure them this will increase Quality
of product by providing safety and accuracy which will ultimately
increase the confidence of the user.


Management of SOP

 Organization shall have SOP on Preparation, approval, revision
and control of standard Operating Procedure for better control and
management of SOPs.

 Generally, administrative aspects of the SOP system such as
distribution and filing are well managed. On the other hand,
overall system management, frequently characterized by the lack
of a system owner, is generally poor. If a system owner exists at
all, his or her responsibilities are limited.


Continued….

Ideally a system owner
Eliminates obsolete SOPs. (Which is not needed)
Ensures that SOPs meet their quality requirements and are user
friendly.
Manages SOP change controls.
Distributes SOPs.
Ensures that SOPs are current.
Ensures that new or changed SOPs are valid only after training has
occurred and provides training about the SOP system.
Measures system performance and periodically reports results to
management.
Continuously improves the system.

Name of facility_____________________________________ page .......... of....

SOP Number ________ Title _________________________________________________
Revision number ________
Written by ______________________________ Edited by __________________________
Authorization signature ________________________ Department _______ Date___________
Effective date __________________________________Replaces ____________________

Purpose:
WHY:
Why is this procedure written.
Why is it being performed.
Scope
WHEN:
Indicate when this procedure needs to be performed.
WHERE:
Indicate where this procedure applies.
Responsibility
WHO:
Who performs the procedure, who is responsible to see it is performed correctly.
Materials and equipment
WHAT: What is needed to perform the test. The list should be completely specific.

Semisolid
Vanishing
Cosmetics cream

Gel & Jellies Cream

Paste Tooth paste Cold cream

Plaster Nail lacquers

Suppository Lipstick

Face wash

Liquid
dosage form

Oral Parenteral

Monophasic Biphasic

Simple Solutions
Suspension Emulsion
Drops
(Solid in (Liquid in
Syrups Liquid) Liquid)
Elixirs


Jacketed Kettle Mixing &
storage
• Steam heated Filter press
tanks/Vessels
• Gas heated
• Electrically
heated

Pilfer proof cap
sealing machine
Liquid/Jar/Tube Common
filling equipment Equipment
As per
GMP Deionizer
Planetary
mixer

Colloid Clarity tester
Triple roller
mill/Emulsifier mill/Ointment
mill

Pilfer Proof Cap Sealing Machine


SOP for Cleaning of Vessels
Fill the tank with hot tap water (50 -60 C).
Pass the steam through jacket to raise the temperature.
Drain this water.
Fill the tank with water-detergent mixture (0.1% Teepol solution).
Heat and drain this water.
Use plain hot water to rinse the tank at least twice.
Clean the exterior of the tank with warm plain water & interior with freshly
collected distilled water.

Pass the steam through the jacket to make it dry. Clean lid & place it over
tank.

Label appropriately.


Continued….
 Label should include following details:
 Name of equipment :-
 Date 7 time of Cleaning :-
 Name of operator :-
 Name & batch no of previous product :-
 Name & batch no of next product :-
 Checked by :-
Title :- Cleaning of manufacturing Ref. No :-
Vessel. Version :-
Name of Mfg. :- I D No :-
Department :- Page No :-
Effective Date :- Review Date :-
Prepared By Approved By Authorized By


SOP for Mixing of Aqueous & Oily phase

Check the closure of all the outlet valves and “cleaned” label.

Open the inlet valve & Transfer the aq. And oil phase from their
respective mixing tanks.

Start heating and agitation at predetermined rate for specified time period.

Locate mixing process intermittently through sight glass.

Stop agitation and heating after the specific time gap.

Allow the product to cool at specified temperature and homogenize it.

Transfer the finished product to filling unit.

Record the details of processing.

SOP for Packaging & Labeling
Assure the cleanliness & dryness of the container.
Open the lid.
Place the containers below the nozzle of syringe on a conveyer belt.
Adjust the volume to be filled in each container.
Switch on the filling machine.
Check the filling process intermittently.
Switch off when process is complete.
Replace the lid.
Stick the label.
Keep the containers in final container.
Record the details of packaging and labeling.

SOP for Liquid mixing
Ensure that tank is closed & has „cleaned‟ status label where “use before date” has not
lapsed.

Ensure that the bottom valve of the tank is closed.

Open the top lid of the mixing tank/storage tank provided for loading the material.

Transfer the purified water & required material as per BMR of the particular of the
particular batch.

Close the lid of the mixing tank/storage tank.

Run the stirrer for the time duration mention in the respective manufacturing record, speed
adjustment can be done.

After completion of mixing, switch off the stirrer.

Affix the status label.

SOP for Filtration (Filter Press)
Check the equipment clean and ready for use.

25 liter of syrup to be filtered is taken in a tank and 1 kg filter aid is suspended in
it. This slurry is pumped into the chamber and air is displaced from the top.

Stop outlet when syrup starts coming out.

Remove the filtrated syrup from the bottom outlet of the chamber and recirculate
until the out coming filtrate is clear.

Connect the main compound to the filter press pump and open the valve.

Filter the outcoming into storage tank, which is previously cleaned.

Label the tank suitable.


SOP for Rotary Bottle Washing Machine

Remove glass piece if present.

Fill the respective tank with fresh DM water. Ensure that stainless steel tray is properly
cleaned before loading the bottles.

Inspect the broken bottles and reject is found before sending for washing.

Choose the correct size of holder and fix on the stainless steel platform. Turn the pump
switch and adjust the pump pressure of each pump with the help of control valves.

Place the bottles in inverted position on empty nozzles which are to be washed, when
washing is completed unload the washed bottles in aluminium clean perforated tray in
inverted position.

Dry the washed bottles in oven at 120 C for 1 hour.


Conclusion

 SOPs serve as a fundamental means of communication for all levels of
the organization. Not only do they involve employees
departmentally, but they also allow management and employees to gain
a cross-functional view of the organization. This approach encourages
employees to think about how process change may affect other
functional areas.
 A good system forces Employee to think through processes and
examine how Procedure might affect
product, personnel, production, and equipment.
 It shall be noted that the Best written SOPs will fail if they are not
followed.


References

1. http://aboutgdp.blogspot.in/2010/05/standard-operating-procedures-
sops.html
2. http://www.pharmainfo.net/reviews/standard-operating-procedures-
sop-back-bone-pharmaceutical-industries
3. http://pharmatips.doyouknow.in/Articles/Pharmaceutical-
Equipment.aspx
4. http://en.wikipedia.org/wiki/Standard_operating_procedure
5. http://pharmaceuticalsops.blogspot.in/2010/09/


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