“QUALITY-CONTROL”WITH “QUALITY PREMISES” IN PHARMACEUTICAL INDUSTRY

 

About Authors:
Sharma Monish*, Kumar Bhupender
Seth G.L Bihani S. D. College of Technical Education,
Institute of Pharmaceutical Sciences & Drug Research. Sri Ganganagar,
Rajasthan (INDIA)
*monish28sharma@gmail.com

INTRODUCTION1:  GMP emphasis on the Quality Control on environment and facilities, testing of the materials, components and Product in accordance with the standard.

As Per INDIAN GMP2  :  Following Five elements in the schedule M are  inter-related and these are:
i)       
Factory Premises(location& surrounding, building& premises)
ii)     
Warehousing area;
iii)   
Production area;
iv)   
Ancillary area;
v)     
Quality control area.

WHO Provides Guidelines for Quality Premises who fulfill the following Objectives :-
i)      Suitability of premises to carryout intended operations.
ii)     Minimizing risk of errors.
iii)    Permitting effective cleaning & maintenance.
iv)    Minimizing contamination.


REFERENCE ID: PHARMATUTOR-ART-1646

To achieve these objective, consideration has considered :
i) Location
ii) Design
iii) Construction
iv) Adoption &
v) Maintenance

Quality Premises Principle3&4 :- (As Per European Guidance on Good Manufacturing Practice & WHO Guidelines :-
Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross contamination, buildup of dust or dirt and, in general, any adverse effect on the quality of products. (building& premises shall confirm to the conditions laid down in the Factories Act ,  1948 (63 of 1948).

Elements Of Quality Premises :-

1.    Factory Premises3 :- As per European Guidance on GMP

  • Premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products.
  • Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures.
  • Lighting, temperature, humidity and ventilation should be appropriate and such that they do not adversely affect, directly or indirectly, either the medicinal products during their manufacture and storage, or the accurate functioning of equipment.
  • Premises should be designed and equipped so as to afford maximum protection against the entry of insects or other animals.
  • Steps should be taken in order to prevent the entry of unauthorised people. Production storage and quality control areas should not be used as a right of way by personnel who do not work in them.


Schedule M (II)1 to the Drugs and Cosmetic Rules stated as under5:
“The building used for factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents and flies etc.  The walls of the room in which manufacturing operations are carried out , shall be upto a height of six feet from the floor, water proof and capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust.”


Walls

Floors

Ceilings

Warehouse

Painted

Hardened concrete, sealed


Dispensary

Epoxy coved

Epoxy or in situ terrazzo coved

Epoxy coved

Solids manufacturing

Epoxy coved

Epoxy or in situ terrazzo coved

Epoxy coved

Liquids  manufacturing

Epoxy coved

Epoxy or in situ terrazzo coved

Epoxy coved

Solids packaging

Painted

Sealed concrete, terrazzo tile, or vinyl

Suspended ceiling

Liquids packaging (nonsterile)

Epoxy coved

Epoxy or in situ terrazzo coved

Epoxy coved

Laboratory

Epoxy

Terrazzo tile or epoxy sheet

Suspended ceiling

Table 1: Typical Finishes As per USFDA Guidelines

i)                 Construction materials   :- (As per USFDA Guidelines)

i.                    Walls6 :-

  • Walls in manufacturing areas, corridors, and packaging areas should be of plaster finish on high-quality concrete blocks or gypsum board. The finish should be smooth, usually with enamel or epoxy paint.
  • Prefabricated partitions may be used in packaging areas where flexibility of layout is important. Prefabricated units have also been used in other areas, including sterile suites where panel joints must be given particular attention. Where possible, walls should be flush and projections should be avoided.

ii.                  Floors6 :-    Floor covering should be selected for durability as well as cleanability and resistance to the chemicals with which it is likely to come into contact.

  • Terrazzo provides a hard-wearing finish.
  • Epoxy flooring provides a durable and readily cleanable surface.

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