standard operating procedue ppt

STANDARD OPERATING PROCEDURE(LIQUID, SOLID & SEMI SOLID DOSAGE FORMS

MANUFACTURING EQUIPMENTS)Prepared By:Abdul- Rehman SarwarMuhammad Shakil MirzaPHARMCY(SEM-2) DEPARTMENT OF PHARMACY BZU 1

2

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

School of Pharmacy, BZU University

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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.

STANDARD OPERATING PROCEDURE [SOP]

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.

FDA’s three golden rules on proper documentation

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.

POSITION OF SOP IN TOTAL DOCUMENTATION

• 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.

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ObjectivesTo 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.

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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


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.

Benefits


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.

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Areas of SOP

Prep. OfReagents

To DealWith

Complaints

Q.A.Methodic

Safety&

Precaution

Analyticalmethod

Fundamental

Instruments/ equipment &

apparatus


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SOP WRITING STYLE

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.


While Writing SOP…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.

DONOT DO

While Writing SOP…


INSIDE THE SOPCompany 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….

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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

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.

h. 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 equipmentWHAT: What is needed to perform the test. The list should be completely specific.


Introduction of Semisolid, Solid& Liquid dosage forms


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 SolutionsDropsSyrupsElixirs

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 capsulessugar-coated tablets powdersgranulessachets

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 AdministrationFilm coated tabletsEnteric coated tablets Effervescent tabletsSublingual tabletsBuccal tabletsTroches (lozenges)Chewable tabletsControlled release tablets - slow release tablets (SR) and modified release tablets (MR)

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Common Equipment

As per GMP

Mixing & storage

tanks/Vessels Filter press

Pilfer proof cap sealing machine

Deionizer

Clarity testerTriple roller mill/Ointment

mill

Colloid mill/Emulsifier

Planetarymixer

Liquid/Jar/Tube filling equipment

Jacketed Kettle• Steam heated• Gas heated• Electrically

heated


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


SOP for Packaging & Labeling

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SOP for Liquid mixing

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SOP for Filtration (Filter Press)

School of Pharmacy, BZU niversity


SOP for Rotary Bottle Washing Machine

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.

Pan coater

SOP OF DISINFECTION

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

Example of disinfectants

For sanitation..

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.

Log book sample..

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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


AIM HIGH

THANK

YOU



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_procedure5. http://pharmaceuticalsops.blogspot.in/2010/09/ http://www.authorstream.com/Presentation/Rashami-1345512-

sop-final http://www.authorstream.com/Presentation/

References

http://pharmaceuticalsops.blogspot.in/2010/09/

http://pharmaceuticalsops.blogspot.in/2010/09/

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

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

http://www.authorstream.com/Presentation/

Health & Medicine

standard operating procedue ppt