A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Manufacturing

INTRODUCTION TO GMP REQUIREMENTS FOR
MEDICAL DEVICES INDUSTRY

- V.P.Malhotra, R.K. Raina, Sanjay Rajput 
Abstracts of presentation made by Mr. Kalpesh Bhalja during the "SEMINAR ON QUALITY SCENARIO AND NEW CHALLENGES TO MEDICAL DEVICES INDUSTRY OF GUJARAT"

Following Good Manufacturing Practice needs thorough understanding of Product, Manufacturing Operations, Quality Assurance, Necessary Documentation etc. In a detailed presentation, Mr. Kalpesh Bajlja elaborated all the major issues relevant to the subject as abstracted below.

Mr. Kalpesh Bhalja
Head R&D, Claris Lifesciences Ltd

MEDICAL DEVICES:

  • Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purposes of: 

  • diagnosis, prevention, monitoring, treatment or alleviation of disease

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap 

  • investigation, replacement or modification of the anatomy or of a physiological process 

  • control of conception

Definitions

Device Master Record:

A compilation of records containing the design, formulation, specifications, complete manufacturing procedures quality assurance requirements and labelling of a finished device.

Outer or Transit Container:

A package, carton or other protective container which may contain one or more unit or shelf containers and which one or more unit or shelf containers and which provides additional protection for storage and distribution.

Quarantine:

The status of materials or products awaiting release by the person responsible for quality assurance.

Devices History Record:

A Compilation of records containing the complete production history of a finished device.

Manufacturing Procedure:

The manufacturing steps required to produce an intermediate of finished product.

Unit Container:

A pack counting a single item or combination of procedure-related components or products. The pack is designed to maintain the sterility and integrity of the contents up to the time of use to permit, where appropriate, aseptic removal of its contents & such that once opened it cannot be released easily & clearly that it has been opened.

Batch/Lot:

A defined quantity of raw materials, intermediate product, work in progress or finished devices. The batch is defined by the facts that all items are essentially identical and have been processed either together or in unbroken succession.

Batch Manufacturing Records:

Written and where necessary, authorised records relating to individual batches comprising quality control and production records including details of raw materials and/or components, intermediate products, labels and any production conditions.

All documents should relate to the batch number.

Clean Room:

A room with control of particulate contamination, constructed and used in such a way as to minimise the introduction, generation & retention of particles inside the room. The temperature, humidity and pressure are controlled as necessary and special attention is paid to the control of microbial contamination.

Raw Materials:

Any material or fabricated component used singly or in conjunction with other raw materials and/or components in the assembly or fabrication of parts or in the total production.

Surgical Product:

An Adhesive or non-adhesive, non-medicated surgical dressing or other similar or related article which is used during the treatment of humans.

Quality

  • Totality of characteristics of an entity that bear on its ability to satisfy stated & implied need.

  • Fitness for use or purpose

  • Customer satisfaction

  • Conformance to the requirements
Location and Surrounding

  • Pollution free, from open sewage, drains & any factory producing obnoxious odour & dust.

  • Availability of water, power, skilled & unskilled persons.

  • Local facilities like housing, transport & education.
Building
  • Sufficient space for each activity
  • appropriately constructed
  • orderly operation
  • contamination control arrangement
  • Environmental control
  • Facility for Personnel Sanitation
  • Personal Practices
Building

  • Designed on scale of operation, type of machinery etc.

  • Separate building for hazardous process.

  • Specific requirements for utilities.

  • Designed for logical flow of materials & maintenance

  • Toilet: Should be isolated & properly maintained

  • Change room: clean and isolated

  • Canteen : isolated from the manufacturing area

  • Floors: smooth & impervious

  • Walls & floor joints: curved

  • Pipes & ducts: sealed

  • Ceiling: smooth, impervious, leak proof & free from ducts, if not should be concealed

  • Shelves, cupboards & fixtures: minimum

  • Doors: hydraulic closures, air tight

  • Windows: SS of aluminium type with glass & air tight

  • Drains: trapped gullies, air breaks

  • Corridors: spacious & an isolated Q.A & AHU
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