Good Manufacturing Practices (GMP) Guidelines

FOR EQUIPMENTS

Prepared By: Modi Nirav M.Pharm (Q.A.), Semester-1

Guided By: Vishnubhai M. Patel

A.P.M.C.COLLEGE OF PHARMACY, HIMMATNAGAR.

CONTENT:

Introduction Selection criteria Design and Construction Installation Cleaning and maintenance Documentation Automatic, mechanical and electronic

equipments.

GMP

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Equipments

GMP

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Equipments

Introduction: Equipments is important factor which can affect

the quality of drug to great extent.

Equipment used in the manufacture, processing, packing of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

The effectiveness of equipment, like the quality of a product, starts at the design stage.

GMP

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GMP

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Selection criteria:

1. Operating criteria (size, speed, effectiveness)2. Availability of spares and servicing3. Maintenance4. Easy accessibility and cleanability5. Environmental issues6. Construction materials and design.7. Availability of process controls 8. Cost9. Availability of design and maintenance manuals

from the supplier

GMP

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GMP

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• New equipment should not be used for commercial production until it has been qualified and the process in which it is to be used has been validated; this applies equally to laboratory and other test equipment.

GMP

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GMP

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Design and construction:

Equipment used in manufacturing process, handling or storage should be of suitable design and of adequate capacity to facilitate the operations for which it is intended.

Not allow to contact any in process material. do not affect the product adversely in case of leakage. Those parts of equipment which come into contact

with any material should be made of material which would not be reactive, additive or absorptive.

GMP

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GMP

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Equipments

Equipment for processing inflammable materials should be equipped with explosion proof electrical parts.

Equipment used for critical steps should have, as far as recording devices. If it is not possible, other measuring devices like pressure gauge should be fixed at easily accessible location.

GMP

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GMP

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Appropiate design :

• Easily clened on a schedule basis.

• FOR THE SAFETY OF PRODUCT

• The equipment effect should be• * Non additive• * Non adsorptive

Installation:

While installing equipment points mentioned below should be considered:

Equipment should be located in such a way that contamination of sub. By other materials is minimized.

One equipment should be located at sufficient distance from the other so do not get admixed with each other.

All open mechanical belts and pulleys should be covered with safety belts.

GMP

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GMP

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Equipments

Water and other utility service lines should be so installed as to be easily accessible during all phases of operation.

All pipes, tanks and jackets which handle steam or coolants should be properly insulated.

GMP

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GMP

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Equipments

Cleaning and maintenance:Purpose:

To remove product residue of previous product or batch and to clean and sanitize the equipment for next batch.

Equipment should be cleaned regardless of their size. Larger equipment which are fixed or too heavy to

move should be cleaned on location. Detachable parts and small equipments should be

taken to cleaning area assigned for the purpose.

GMP

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GMP

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Written cleaning procedures or SOP should be prepared for all the equipments.

These should be in the language that is understood by the workers and be available in the section.

Cleaning procedures are different for dry product and liquid tanks.

Tags with words like ‘equipment cleaned’, ‘cleaned’ or ‘ready for use’ can be used for clean equipment. Clean equipment should be covered to protect from contamination.

GMP

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GMP

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Cleaning implements:• scrubber, brush.. Washed with water Antiseptic solution(0.5% cetrimide sol.) Sterilize-70% IPA Sanitizing agent(sodium hypochlorite, IPA)Cover ends of clean tubing with polyethylene sheet

GMP

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GMP

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A format which can be used as a guide for log book is printed below:

M/s

Log book for cleaning and sanitization of

Date Time SOP no. Cleaned By Checked By

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GMP

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Maintenance program:

Systematic and routine cleaning, adjustment, or replacement of instrument and equipment parts Performed periodically, daily, weekly, monthly

Example: Cleaning optical lenses Thermostat adjustments Changing motor brushes

GMP

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GMP

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Function checks:

Monitoring of instrument to verify that your equipment is working according to the manufacturer’s specification

Performed periodically- daily, weekly, monthly Performed after major instrument repair

Example: Daily monitoring of temperatures Checking wavelength calibration Checking autoclave indicator paper

GMP

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GMP

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Weekly sterilization checks:

Weekly Sterilization Record Sterilizer Location

Date of Mfg.

& Lot #

Mfg. Date plus 2 yrs. expiration

Date

of Test

Tester’s initials

Sterilized Vial

Expected Results

(purple = neg)

Control Vial

Expected Results

(yellow = gr)

ResultOkay

The laboratory should develop a procedure for the

weekly sterilization check using a biological indicator

and keep detailed records of each check.

GMP

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GMP

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For the proper maintenance implementation of maintenance program are necessary.

• Assign responsibility– Oversight of all laboratory equipment– Individual responsibilities

• Develop written policies and procedures• Train staff• Keep records

GMP

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GMP

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Create a record for equipment inventory Name, Model #, Serial # Location in lab Date purchased Manufacturer and vendor contact information Warranty, expiration date Spare parts

For each piece of equipment: Establish routine maintenance plan Establish required function checks Develop a list of spare parts

GMP

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GMP

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Documentation:

A maintenance protocol that outlines function verification and maintenance activities

Develop a problem log record for each piece of equipment (Important for future selection)

Date problem occurred, removed from service Reason for breakdown or failure Corrective action taken Date returned to use Change in maintenance or function checks

GMP

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GMP

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Electronic, mechanical and electronic equipments:

Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function used in the manufacture, processing, packing, and holding of a drug product.

If such equipment is so used, it shall be routinely calibrated, inspected or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.

GMP

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GMP

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Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy.

The degree and frequency of input/output verification all be based on the complexity and reliability of the computer or related system.

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GMP

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A backup file of data entered into the computer or related system shall be maintained except where certain data such as calculations performed in connection with laboratory analysis, are eliminated by computerization or their automated processes.

Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.

GMP

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GMP

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Stages:

Design and specification

Operation

Installation

Ongoing operation

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These four stages have been integrated into the ‘‘life cycle approach’’ which starts with the identification of user requirements, continues through the stages of development, installation, validation, operation, and maintenance, and ends only when the use of the system is discontinued.

Revalidation should ideally only need to be considered when there have been approved changes to the system.

GMP

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GMP

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Reference: Sidney H. Willig, “Good manufacturing Practices

for Pharmaceutical”, volume-109, Marcel Dekker N.Y. Page No.65-75.

P.P.Sharma, “How to practice GMP’s”, 3rd edition, Vandana Publication. Page no.152-155.

www.cde.gov/dls/ilq/cd/../module.ppt

www.pacificbiolabs.com

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GMP

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