standard operating procedue ppt

STANDARD OPERATING PROCEDURE
(LIQUID, SOLID & SEMI SOLID DOSAGE FORMS
MANUFACTURING EQUIPMENTS)
Prepared By:
Abdul- Rehman Sarwar
Muhammad Shakil Mirza
PHARMCY(SEM-2)
DEPARTMENT OF
PHARMACY BZU
1

Contents
WHAT IS STANDARD OPERATING PROCEDURE?
OBJECTIVES
REASONS
WHY IT IS ESSENTIAL?
BENEFITS
TYPES AND AREAS OF SOP
SOP WRITING STYLE
POINTS TO BE KEPT IN MIND WHILE WRITING SOP
INSIDE THE SOP
STEPS OF SOP PROCESS
COMMON EQUIPMENTS USED FOR LIQUID AND SEMI
SOLID PEPARATION
GENERAL SOPS
School of Pharmacy, BZU University 2

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 .
In simple terms SOP is…
A written process
A way for the clinical site to perform a task the same way
each time it is completed. 3

Reasons for having SOPs
 To provide people with all the safety, health,
environmental and operational information.
 To ensure that processes continue uninterrupted and
 completed on a prescribed schedule and maintain quality
control of processes and products.
 To ensure that no failures occur in any processes.
 To ensure that approved procedures are followed in
compliance with company and government regulations.
 To serve as an historical record of the whole process
which is
done and have a basis of that when the process is
changed.
 Provide training and guidance for new staff.

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 (Good Laboratory Process) and 2nd Company policies
• GMP ( Good Manufacturing Practices)
Q.A.
GMP
Q.C.
Documentation

Obligations
• WHO has already made it mandatory to have the required
SOPs for any manufacturing facility for grant of GMP
certificate.
• Various legal and commercial factors also influence the
manufacturer to go in providing SOPs for his facilities.

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.
School of Pharmacy, BZUUniversity 10

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.

Areas
of SOP
Prep. Of
Reagents
To Deal
With
Complaints
Q.A.
Methodic
Safety
&
Precaution
Analytical
method
Fundamental
Instruments/
equipment &
apparatus
School of Pharmacy, BZUUniversity 13

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.
School of Pharmacy, RK University 14

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.

 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.
DO

 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.
Continued….

 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.
DO
NOT 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.

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 throughout 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 21
Continued….

Types of SOPs
• SOPs may be written for any repetitive technical activity, as
well as for any administrative or functional programmatic
procedure, that is being followed within an organization.
• The types of SOPs are:
1. Technical SOP
2. Administrative /Fundamental Programmatic SOP

 SOPs instructing the user
 how to perform a specific
analytical method to be
followed in the laboratory
 how to collect a sample in
order to preserve the sample
integrity and
representativeness
 Also cover data processing and
evaluation (including
verification and validation),
modeling, risk assessment.
 SOPs generated for
administrative tasks
 reviewing documentation such
as QA Project Plans and QMP
 Writing contracts
 Performance assessment
 Also includes how to
coordinate the activity and
record the results as well as
coordinating the team efforts.
SOPTechnicalS
Technical SOP Administrative SOP

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).

SOP
PROCESS
1. Sop
Preparation
2. SOP Review and
Approval
3. Frequency of
Revisions and
Reviews4. Implementing
SOP
5. Management of
SOP

Who will/can write
SOP?
Performs the job Equipment
manufacturers
Performs maintenance
on equipmentTechnical initiationSafety personnel
Environmental
personnel

2.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.

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.
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.

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 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.

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.
 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.

SOP General Format
• SOPs should be organized to ensure ease and efficiency in
use and to be specific to the organization which develops it.
• Where possible break the information into a series of logical
steps to avoid a long list.
SOP generally consists of
1. Title Page
2. Table of Contents
3. Text

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
• T o locate the information
• To denote changes or revisions made only to certain
sections of an SOP.

3. Text
• Well-written SOPs should first briefly describe
a. The purpose of the work or process
b. The scope of the work or process
c. Responsibilities and applicabilities
d. Summary of the method/procedure
e. Definition of any specialized/unusual terms and explanation
of abbreviations.

f. Health and safety cautions
g. QC Section: Used to check the Quality of the work that
include specific assessment criteria and appropriate QC
procedures.
f. Attach any appropriate information, e.g., an SOP may
reference other SOPs.

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
Cosmetics
Cream
Cold cream
Vanishing
cream
Tooth paste
Nail lacquers
Lipstick
Face wash
Gel & Jellies
Paste
Plaster
Suppository

Liquid
dosage form
Oral
Monophasic
Simple Solutions
Drops
Syrups
Elixirs
Biphasic
Suspension
(Solid in
Liquid)
Emulsion
(Liquid in
Liquid)
Parenteral

Solid dosage forms
Drugs are prepared in various forms for
administration.
The solid type of preparation is most
common.
The advantages of solid drug forms are
convenience of administration;
accuracy and reproducibility of a dosing;
increased of a drug stability and easy of
mass production

Solid drug forms
tablets
capsules
sugar-coated tablets
powders
granules
sachets

Тablets
A tablet is a solid dosage form
that is prepared by compressing or
molding of the drug into various
sizes and shapes.
Dissolution is the rate-limiting
step in the delivery of drug from a
tablet to the systemic circulation.

Types of tablets:
Tablets for oral administration
Tablets for vaginal
administration
Tablets for implantation
(pellets)

Tablets for oral Administration
Film coated tablets
Enteric coated tablets
Effervescent tablets
Sublingual tablets
Buccal tablets
Troches (lozenges)
Chewable tablets
Controlled release tablets - slow release
tablets (SR) and modified release tablets
(MR)

Common
Equipment
As per
GMP
Mixing &
storage
tanks/Vessels Filter press
Pilfer proof cap
sealing machine
Deionizer
Clarity tester
Triple roller
mill/Ointment
mill
Colloid
mill/Emulsifier
Planetary
mixer
Liquid/Jar/Tube
filling equipment
Jacketed Kettle
• Steam heated
• Gas heated
• Electrically
heated
School of Pharmacy, RK University 46

Pilfer Proof Cap Sealing Machine

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

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

SOP for Mixing of Aqueous & Oily phase
Record the details of processing.
Transfer the finished product to filling unit.
Allow the product to cool at specified temperature and homogenize it.
Stop agitation and heating after the specific time gap.
Locate mixing process intermittently through sight glass.
Start heating and agitation at predetermined rate for specified time period.
Open the inlet valve & Transfer the aq. And oil phase from their
respective mixing tanks.
Check the closure of all the outlet valves and “cleaned” label.

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

SOP for Liquid mixing
Affix the status label.
After completion of mixing, switch off the stirrer.
Run the stirrer for the time duration mention in the respective manufacturing record, speed
adjustment can be done.
Close the lid of the mixing tank/storage tank.
Transfer the purified water & required material as per BMR of the particular of the
particular batch.
Open the top lid of the mixing tank/storage tank provided for loading the material.
Ensure that the bottom valve of the tank is closed.
Ensure that tank is closed & has ‘cleaned’ status label where “use before date” has not
lapsed.
School of Pharmacy, BZU
University
52

SOP for Filtration (Filter Press)
Label the tank suitable.
Filter the outcoming into storage tank, which is previously cleaned.
Connect the main compound to the filter press pump and open the valve.
Remove the filtrated syrup from the bottom outlet of the chamber and recirculate
until the out coming filtrate is clear.
Stop outlet when syrup starts coming out.
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.
Check the equipment clean and ready for use.
School of Pharmacy, BZU niversity 53

SOP for Rotary Bottle Washing Machine
Dry the washed bottles in oven at 120°C for 1 hour.
Place the bottles in inverted position on empty nozzles which are to be washed, when
washing is completed unload the washed bottles in aluminum clean perforated tray in
inverted position.
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.
Inspect the broken bottles and reject is found before sending for washing.
Fill the respective tank with fresh DM water. Ensure that stainless steel tray is properly
cleaned before loading the bottles.
Remove glass piece if present.

Introduction
• Tablet coating is a procedure by which tablet
coating with sugar coat or cellulose film.
• Coating is achieved by the spraying of the
coating material to the tablet in form of droplet
at the same time passing hot air by the heated
oven.

Purpose
 Protect From Moisture And Light
 Mechanically Protect Tablet From Breakage
 Mask The Taste
 Control The Release
 Protection From Gastro Intestinal Fluid
Scope
 This Is Applicable For Proper Film And Sugar
Coating In Dry Product Manufacturing Section

Procedure
• clean the coating pan and intimate quality
control department to collect swab samples/rinse
water as per requirement
• After receiving the approval from the quality
control department put “cleaned” label to all
equipment
• Assemble the hot air blower assembly. start the
exhaust and coating pan and check it for proper
working.
• Set the rpm of the coating pan and the
temperature of the inlet air as per instruction
given in the batch manufacturing record.

Continue....
• Assemble the spray gun assembly with peristaltic
pump or dosing pump and check it for proper
working.
• Write the status on the coating pan,other
equipment and the area.
• Check all the container detailed label as per the
batch manufacturing records.
• Load the tablets from the container serially and
check the labels accordingly .
• Weigh the 100 tablets before coating and records
to the same in the batch manufacturing records.

Continue.....
• Coat the tablets as per the parameter
given in batch manufacturing records.
• During coating, frequently check the
spray gun nozzles for correct spraying,
inlet air temperature and exhaust.
• Clean the compressed air filters starting
the coatings
• Check the appearance of the tablets for
smoothness and intactness of the edges

Continue....
• Abnormally if any, observed stop the coating
procedure and inform it to shift in charge. If coating
is to be stopped in between, dry the tablet in the
pan inching at 350c to 400c for 30 minutes
• After completion of coating procedure check the
tablets for desire appearance and weight gain as
per BMR (batch manufacturing record).
• Dry the tablets as per instruction given in BMR and
it to come to room temperature and then unload it
in the containers lined with doubly poly bags

Continue....
• Clean the spray gun assembly as per respective
SCP (standard cleaning procedure).
• If the next batch of the same product is to be
taken check the inner surface of the coating pan
for cleanliness if required clean the pan and
spray guns.
• If the batch of the new product is to be taken for
coating remove all the left over materials and
records of the previous batch from the area and
put ‘to be cleaned’ label to all equipments and
area.

Continue....
• Clean the air inlet and exhaust assembly
and check the air inlet filters for absence
of leakage if any and intactness.
• After completion of cleaning of the area
and the equipment give intimation to
quality assurance department for
collection of swab/rinse water sample as
per requirement.

Disinfectants
• Chemical or mixture of chemical used to
kill microorganisms but not necessary for
spores. Disinfectants are usually applied
to intimate surfaces or objects.
• The term which means a substance with
bactericidal action. Most of the American
literature it implies disinfection combined
with cleaning process

Scope of disinfection
• This sop describe the use of disinfectants
used in the laboratory to decontaminate
surfaces and equipment and also as a
pre-decontamination treatment before
autoclaving, burning or incinerating waste
to be eliminated.
Purpose
• this document describe the use of
disinfection for routine laboratory
decontamination of surfaces and
equipment.

Disinfectant which are used....
1.Phenol
At low concentration, disturb the cytoplasmic
membrane causing leakage of bacterial cellulose
constituents. In high concentrations acts as
protoplasmic poisons E.g. :cresol, clorocresol,xylenol
2. Alcohols
denaturations of bacterial proteins in the
presence of water conc. 60-90%v/v(60% alcohols and
40% water).

3. Surface active agents
these are quaternary ammonium compounds. They
are strongly absorbed on to the negatively charged
bactericidal surfaces. They cause damage to the cell
membrane and leads to cell leakage
E.g.: soap – sodium stearate
4. Metals
In the concentration they causes protein
precipitation
e.g. : mercury, copper, silver

Procedure
At the and of the days operation, remove all
the unneeded material from the sterile area
including reject vials, stopper etc.
Use only the sterile sponges and mops for
cleaning and disinfection in the sterile area

Continue......
Prepare approximately 15 litres of sterile
disinfectants solution using sterile distilled
water
Wipe sterile area by sponges and the mops it
with the required concentration of
disinfectants solution, the areas including
walls, floors and doors.

Continue....
Spray and wipe the surface of all
equipment and glass penals using 70%
isopropanol
Wipe the plastic bucket with 70%
isopropanol
Wipe the ultraviolent lamps in sterile area
with 70% isopropanol
 once in every week wipe the ceiling of
sterile area using sterile 70% isopropanol.

 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.
Conclusion
School of Pharmacy, BZU
University
77

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/
 http://www.authorstream.com/Presentation/Rashami-1345512-
sop-final
 http://www.authorstream.com/Presentation/
References

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