QA SOP Seminar

8/8/2019 QA SOP Seminar

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What is standard operating

procedure (SOP)

An authorized written procedure givinginstructions for performing operations

necessarily specific to a given process,product or material (e.g. equipmentoperation, maintenance and cleaning;validation; cleaning of premises andenvironmental control; sampling andinspection).


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Introduction to SOP: In order to ensure that the best possible

medicine be made available to the consumer

There are three critical parameters for SOP

1. Right quality

2. Right quantity

3. Right price


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Major information contain in

any SOP is :

1. Objective of the SOP

2. Procedure to be followed

3. Person responsible for doing the activity

4. Person responsible for checking and

supervision5. Frequency of the activity


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In addition to the various SOPs that are

required, the company has to make SOPs

that define,how the various SOPs are made

i.e. what kind of information, structure and

numbering system will be included in variousSOPs. Include a time frame for revision of

the SOPs and identify the person authorized

for each activity (1.including creating 2.

checking 3. verifying and implementing )


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Why do you require a standard

operating procedure (SOP)For some time now during last 10 year there has

been an overwhelming demand for ensuring

safety and efficacy of various drug product that

are available in the market.


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Other reasons:

Storage and handling of raw materials at thevendor place and consuming factory warehouse ,

cross contamination possibilities Manufacturing precaution( to ensure right quantity

and right quality)

Quality control lab procedure for testing the drug

product and finally the storage and handlingprocedures at the warehouse andstockiest/distributor/retailer.


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Benefits Of Sop:

1. To provide people with all the safety, health, environmental andoperational information necessary to perform a job properly.

2. To ensure that production operations are performed consistently tomaintain quality control of processes and products.

3. To ensure that processes continue uninterrupted and are completedon a prescribed schedule.

4. To ensure that no failures occur in manufacturing and otherprocesses that would harm anyone in the surrounding community.

5. To ensure that approved procedures are followed in compliance withcompany and government regulations.

6.To serve as a training document for teaching users about the

process for which the SOP was written.


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7.To serve as a checklist for co-workers who observe job

performance to reinforce proper performance.

8.To serve as a checklist for auditors.

9.To serve as an historical record of the how, why andwhen of steps in an existing process so there is a

factual basis for revising those steps when a process

or equipment are changed.

10.To serve as an explanation of steps in a process so

they can be reviewed in accident investigations.


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1. Company Name and PaginationCompany Name and Pagination : Thecompany name and pagination must appear onevery page

2. Title : The title should be descriptive. The title

should use directive language to declare what isbeing done to what.

3. Identification and control:Procedures must be

easily identified by giving unique number andversion number. This identification number of theSOP supports accountability of the documentthroughout the facility and over time as it change

Format of an SOP


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4. Review and Approval: All Sops shall have space for signature ofinitiator (the person who has written the SOP) Reviewer (Thepersons who has reviewed the SOP) and approver (QualityAssurance Head of the organization).

5. Purpose : : Describes as to why this procedure is required.

6. Scope: : Describes as to the areas / activities encompassed.

7. Responsibility:Names a person who remains accountable forimplementation.

8. Procedure: Describe the procedure in a step by step, chronologicalmanner. Use active verbs and direct statements (e.g. check the

cleanliness of machine and too.

9. Check : Many activities use checklists to ensure that steps arefollowed in order. Checklists are also used to document completedactions


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Precautions for preparing SOP:

Instruction and procedure should be written ina clear language.

Record are made in such a way that during

manufacturing process.

Necessary step required by defined

procedures and instruction have been taken

and that the quality and quantity of the product

is expected.Any significant expected deviation are fully

recorded and investigated.


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Procedure

Document required are to be designed,prepared reviewed and distributed with sucha care that it will be comply with relevant partof the manufacturing and operating

procedures as well as facility available.

Document will be approved, signed and datedby appropriate authorized persons and

person nominated by the management.


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1. Document must not be changed, amended or

added without authorization

2.Document should be title, code number,

supersede number, date of issue, effective date

as well as the purpose should be clearly stated.

3.Document should be laid out in orderly fashionand easy to check, critical step should be

highlighted

4.Reproduced document should be clear and

legible.

5.Document should be regularly reviewed and

kept up to date.


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6. Any alteration made to a document will be

signed and dated by all the above person who

are authorized to do.

7. One original copy each ofMaster Formula

Cards, Standard Operating Procedure and

specifications should be stored in lock, onecopy should be retained with each member

who signed that document and one copy is

required to be kept at each concerned

department.

8. All the record should posses particular code

number to identify it and should be easily

accessible with respective department.


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Company Name and Address: Page No: X of Y

Title : SOP No:

Revision No:

Review Period:

Prepared By Reviewed By Approved By

Objective :

Scope :

Responsibility:

Procedure :

Standard Operating Procedure


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What are the kinds of standard OperatingWhat are the kinds of standard Operating

Procedure ?Procedure ?

Procedure for control and assurance

Procedures for preparing protocol

SOP can be classified into following types : 1) CORPORATE SOPs

2) LOCAL SOPs

3) MIXED LOCAL AND CORPORATE SOPs 4) sponsor and CRO SOPs


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How is compliance of an SOPverified ?

Evaluation through questionnaire Internal auditing / Verification of Actual

Performance

Verification of Documents prepared incompliance

Quality compliance of intermediate /finished product and meeting yields forms

On the job evaluation by front linesupervisors

Reduction trend in rejection of product


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What are the records to bemaintained for compliance with

procedure ?

Filled formats Equipment Logs

Maintenance Logs Calibration records Test reports List all materials or equipment needed to

perform the procedure wherever found tonecessary

If any formats have to be maintained duringcarrying out the activity, the same has to beattached


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FREQUENT PROBLEMS CONCERNING

SOPs :

1) They do not cover all aspects of clinical

research. Statistics, IT etc. are examples of

functional groups that frequently

2)

QA SOP Seminar

Documents

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