Presented by: Guided by:

MR. GOMTESH MILIND DOSHIMR. GOMTESH MILIND DOSHI Dr. S.S CHITLANGE Dr. S.S CHITLANGEM.Pharm.1st year[QAT] Sem-1 Principal & Professor

Roll No. 526 Dr. D Y Patil IPSR,PIMPRI,PUNE

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CONTENT1) DESIGN, SIZE AND CONSTRUCTION OF

EQUIPMENTA) DESIGNB) SIZEC) LOCATIOND) CONSTRUCTION

2) EQUIPMENT IDENTIFICATION3) EQUIPMENT LOG4) CLEANING AND MAINTENANCE OF EQUIPMENT5)AUTOMATIC AND ELECTRONIC EQUIPMENT

(computer system)6) BIBLIOGRAPHY

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INTRODUCTIONi) EQUIPMENT: Pieces of plant, machine, instrument to do

specific activity e.g. mixer, grinder, granulator

ii) EQUIPMENT: may be single piece or set of integrated pieces to perform common activity e.g. water demineralization plant

iii) Performance of equipment: affects manufacturing or control activity

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DESIGN, SIZE, LOCATION AND CONSTRUCTION OF MATERIAL

1)DESIGN: URS: User tells his requirement based on this URS (User

Requirement Specification is made) for equipment is made what operation equipment will perform Capacity: In put (holding) and output capacity Material (API etc.) will be processed Cleaning method is Used Validation how to do validation

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2. SIZE:

Batch size / vol. of material decides size

i) Physical dimension: L x W x H of equipment, size of room, avoid difficulties in taking in to room, new wall construction

ii) Holding and output capacity, Minimum or maximum volume of material decides size

Autoclave for small scale

Autoclave for large scale

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3. LOCATION:

i) Based on equipment layout, mix up, contaminationii) Utility services required to equipmentiii) Easy material handling & movementiv) Man movement for repair and cleaning.v) Equipment discharge gas, powder fumes

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4. CONSTRUCTION:

(Material of Construction – MOC)i) Easy of cleaningii) Easy of operationaliii) Easy of maintenanceiv) Contamination: MOC does not react with material (API)

MOC does not absorb material (API)

Document required:1) Machine/equipment/layout drawing showing the location in room 2) Machine equipment manual 7

Preparation of URS Of Equipment

URS: List of all requirements of buyer regarding the equipment to be purchased.

•Use of equipment in mfg•Required capacity of equipment•Space availability for installation•Accuracy of equipment•Cleaning requirement•Power supply

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EQUIPMENT IDENTIFICATION

As per US FDA guidelines CFR 211.05:a) All compounding and storage containers, processing lines and major

equipments used during production of batch of a drug product shall be properly identified at all times to indicate their contents and when necessary the phase of processing of the batch.

The label shall be following detail: Name of product Batch No. Batch Size Processing stage Supervisor

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b) Major equipment identified by a distinctive identification number or code that shall be recorded in the Batch Production record to show the specific equipment used in manufacturing of each batch.

Documents Required: SOP for numbering of equipment List of major equipment with their distinctive

identification number or code

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EQUIPMENT LOG

1) Equipment Log or Register: Each manufacture maintains a log or register. Log mentions the name of various operation (operation, cleaning or maintenance) done on various equipments

2) Content / Details in Log: Following details are mentioned in log. Sr. No. Name of equipment (with identification number, code) Product Batch no. handled Name of activity / operation (operation, cleaning or maintain and

with date Name operator and supervisor working on equipment

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Documents Required: Equipment Log: for activities e.g. operation, cleaning

and maintenance SOP for major equipment of operation, cleaning,

maintenance

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CLEANING AND MAINTENANCE OF EQUIPMENT

1) Need cleaning, Maintenance And Sanitation: Prevents malfunction of equipment, cross contamination, and

achieve identification, purity, strength and safety of product.

2) When cleaning required: Change over from one batch to another Change over from one product to another Change over from potent to non potent Change over from non potent to potent

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3) Water washing sample: Water washing sample is analyzed to check

acceptable level of cleanliness.

4) Duration of cleaning: Equipment should be cleaned after use, checked

before use, after specific interval of time rewashing is to be done.

Documents Required: SOP for maintenance and cleaning of equipment Equipment log for operation, cleaning and

maintenance.

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Department: Month:Equipment: Make:Equipment code no.: Working capacity:Cleaning SOP no.: Maintenance SOP no:

Date Sign Remark Date Sign RemarkCleaning Maintenance

Equipment Cleaning and Maintenance Record

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Introduction / Computer Systemi) Automatic, mechanical and electronic equipments or computer

systems is used in R&D, QCL, QA and Production

ii)It is mandatory that performance of computer system is confirmed that results are consistent, accurate and repeatable

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Why is computer validation required?

1) Minimize Risk to Patient life and increase product quality and Good will

2)Business Opportunity: Validated computer system is Required to export in Australia, Europe, USA and South Africa

3) Helps in perfecting the system and make free from any errors

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BIBLIOGRAPHY

1) M.A.Potdar Pharmaceutical quality assurance ,Nirali publication.3 rd, 1-14

2) www.pharmaguideline.com WHO ,Geneva-1999

3)Quality assurance of pharmaceutical guideline material Vol-ll,

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THANK YOU

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