The document outlines the quality assurance and quality control measures for pharmaceutical facilities, emphasizing the importance of proper location, design, construction, and maintenance. It covers essential elements such as sanitation practices for sterile areas, separation of production and quality control labs, and the need for continuous monitoring and maintenance of facilities. The goal is to ensure compliance with Good Manufacturing Practices (GMP) to facilitate drug production under hygienic conditions.

1. Mahatma Gandhi Vidyamandir’s
Pharmacy college
Panchavati ,Nashik
Pharmaceutical Quality Assurance Department
Sub :Quality Assurance and Quality Control.
Prepared By Guided by
Mr. Suryawanshi Kunal Anil Dr. K.V. Bhambar Sir
Roll NO: 45
Presentation on
Construction and plant layout, maintenance,
sanitation

2.  VISION-
To be a Centre of professional excellence by contributing honestly to the
pharmacist moulding process.
 MISSION-
Impart high quality education to graduates
Contribute to all spheres of professional activities
Uphold human values and ethics
Nature them into globally competent professional

3. Content
Location
 Design and Construction
 Sanitation and Sanitation of sterile areas
 Maintenance and Maintenance of sterile areas

4. Introduction
 Location design, Construction and layout of premises is a vital part of
GMP.
 Premises refers to the building and facilities where pharmaceutical
processing is done.
 These place must comply with cGMP requirement.
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5.  Introduction
There should be defined areas for the following activities.
• Receipt, Identification, Sampling and quarantine of incoming material.
• Sampling of intermediates
• Storage of rejected material before disposition.
• Storage of released materials.
• Production areas, Packaging and labelling, Laboratory operations.
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6.  Location
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The following factors should be considered while selecting location.
• Nature of manufacturing and testing performed.
• Magnitude of operations.
• Number of products that will be processed.
• Storage space required for raw product, in process and finished goods.
• Climatic conditions and hygenic levels

7.  Design and Construction
 The building used must be design, Constructed and maintained in the manner
that permits drug production under hygienic conditions.
 The following factors are considered.
• General requirement
• Ancillary areas
• Storage areas
• Weighing areas
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8.  Design and Construction
• Production areas
• Quality control area’s
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9.  General requirement
• Lightning
• Electricity
• Sewage
• Toilet and washing
• Utilities
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10.  Ancillary areas
 Rest and refreshment rooms are separated from other areas.
 Facilities for changing cloths and washing and tiolets are easily
accessible.
 Toilets should not be directly communicate with production areas.
 Animal house should be isolated from other areas.
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11.  Storage areas
 Storage area should be designed and adopted to ensure good storage
conditions.
 Receiving and dispatched area should be separated and protected.
 In particular, they should be cleaned and dry and maintained with
acceptable temperature limits.
 Highly active materials should be stored in safe and secure areas.
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12.  Production layout( Tablet)
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13.  Quality Control areas
 QC labs should be separate from production areas.
 Areas where biological, microbiological, test methods are employed
should be separated from each other.
 Should avoid cross contaminations and mix-ups.
 Separate air supply to laboratory areas.
 Adequate storage space for samples, reference standards, Solvents
reagents and records.
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14.  Sanitation
 All areas must be cleaned regularly and cleaning record must be maintained.
 Waste should be disposed in a safe manner.
 Restrooms, toilets, refreshment area must be located far from production areas.

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15. Sanitation of sterile areas
• Must be cleaned and sanitized often.
• Regular monitoring to detect the presence of microorganisms.
• For spaces that are inaccessible, Fumigation should be used.
• Cleaning procedures should be validated.
•
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16.  Maintenance
CFR 211 states that, “ Any building use in the manufacture, Processing, Packaging amd
holding of a drug product should be in good state of repair.
Facility maintenance includes a check on:
• Spoilage of plaster.
• Peeling of a paints
• Ceiling leakages
• Water, steam, gases pipeline leakage.
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17.  Maintenance
• Loose or broken tiles.
• Improper closing of doors, windows, electrical wiring or fitting.
• Missing tube lights.
A detailed checklist maybe prepared, during routine inspection of the
facilities and identified deficiencies should be rectified immediately and
maintained.
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18. Maintenance of sterile areas
• The sterile manufacturing areas should be maintained as per the written
SOP for cleaning and disinfection.
1. Cleanliness of air = Grade 1, Grade 2, Grade 3, Grade 4 .
2. HVAC System.
3. Temperature and RH.
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19. THANK YOU
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