standard operating procedure pharmacy

A SEMINAR ONINTRODUCTION OF

STANDARD OPERATING PROCEDURE(LIQUID & SEMI SOLID DOSAGE FORMS

MANUFACTURING EQUIPMENTS)

Prepared By:SAGAR SOMAIYAM.PHARM(SEM-1) ROLL NO. 2DEPARTMENT OF PHARMACEUTICS

1School of Pharmacy, RK University

School of Pharmacy, RK University 2

ContentsWHAT 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 .

STANDARD OPERATING PROCEDURE [SOP]

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 and 2nd Company policies

Q.A.

GMP

Q.C.

Documentation


Objectives

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.

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.


Types of SOP

Prep. OfReagents

To DealWith

Complaints

Q.A.Methodic

Safety&

Precaution

Analyticalmethod

Fundamental

Instruments/ equipment &

apparatus


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….

19

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 statementsSchool of Pharmacy, RK University

Continued….


SOP PROCESS

1. Sop Preparation

2. SOP Review and Approval

3. Frequency of Revisions and

Reviews4. Implementing SOP

5. Management of SOP


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.

SOP Preparation


Who will/can write SOP?

Performs the job Equipment manufacturers

Performs maintenance on equipmentTechnical initiationSafety personnel

Environmental personnel


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


Introduction of Semisolid& 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


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 7 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


SOP for Liquid mixing


SOP for Filtration (Filter Press)


SOP for Rotary Bottle Washing Machine


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


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/

References

AIM HIGH

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