This document discusses equipment, materials, and documentation requirements for pharmaceutical plants according to Good Manufacturing Practices (GMP). It defines equipment as physical entities used to carry out activities, and notes GMP guidelines for equipment location, design, cleaning, and maintenance. It also discusses two types of materials used - excipients, packaging, and active pharmaceutical ingredients. GMP guidelines for materials include quality, quantity, price, and vendor selection. Finally, it outlines various documentation requirements such as batch manufacturing records, master formulae, and standard operating procedures to ensure traceability and prevent errors.

1. EQUIPMENT, MATERIALS AND
DOCUMENTATION
Presented by- Saiphali
M.pharma IInd sem.

2. What is equipments….???
• Equipment may be de
fi
ned as a physical entity which is
used to carry out a general or speci
fi
c activity in the
plant.
• Two types of equipments are used in pharmaceutical
industry.
• A. Single piece, eg- table, compression machine, a
mixer, HPLC, weighing balance etc.
• B. Integrated system, eg- water demineralising plants,
an air handling system.

3. Management of equipments in pharmaceutical
plants as per GMP.
• Location
• Design
• Construction
• Size
• Adaptation
• Cleaning and cross contamination
• Preventive and breakdown maintenance
• Installation, calibration, quali
fi
cation, validation
• Automatic, mechanical, electronic equipment, including computers
• Weighing balance and
fi
lters.

4. GMP guidelines for equipments
• Equipments must be located, designed, adapted and maintained to suit
the operation to be carried out.
• Equipments should be installed in such a way as to minimise any risk of
error or of contamination.
• Production equipment should be designed, located and maintained to
serve its intended purpose, so that it can be easily and thoroughly cleaned
on schedule basis. It should not present any hazard to the products.
• Identi
fi
cation should be clearly labeled to indicate the equipments.
• Equipment cleaning and maintenance should be properly.
• Calibration and documentation should be maintained.

5. What is materials….???
• Pharmaceutical materials are the substances that are
used to manufacture wide range of drug formulations,
tablets, capsules, injectable etc.
• The raw material used in the pharmaceutical industry
are consisted of three major parts, they are,
• A. Excipients
• B. Packaging
• C. API

6. Objectives and functions of material..
• Maximising the use of working capital.
• Ensuring cooperation of all departments.
• Providing best services to the level of customer’s delight.
• Material planning and programming.
• Inventory control and management.
• Receiving of incoming materials.
• Storage, preservation and administration of materials.
• Improving operation ef
fi
ciency through training.

7. GMP guidelines for material
• Quality
• Quantity
• Price
• Delivery time
• Vendor selection
• Value analysis
• Value ratio (function/total cost)
• Discount
• Risk, life and bene
fi
ts
• Receiving of material
• Plant layout

8. What is documentation…..…???
• It is the key to GMP compliance and ensures
traceability of all……development, manufacturing
and testing activities.
• It is essential part of quality assurance system.
• It should be clearly written procedures prevent
errors resulting from spoken communication.

9. DOCUMENTATION ARE…….
• Records
• Labels
• Speci
fi
cations and testing procedures
• Master formulae
• Packaging instructions
• Batch manufacturing records
• Batch packaging records
• Standard operating procedures

10. BATCH MANUFACTURING
RECORD
• BMR is the necessary quality and GMP
documentation for tracing the complete cycle of
manufacturing batch or lot.
• It should include dates, timing, identity of major
equipments, critical process records, IPQC tests,
description of packaging and label, results of release
testing, deviation note, certi
fi
cate of analysis and
actual yield etc.

11. RESPONSIBILITIES
• Primary: Of
fi
cer QA/Of
fi
cer-production
• Secondary: Manager- QA/ Manager-
production

12. MASTER FORMULA RECORD
• MFR is a master document for any pharmaceutical
product which contain all information about the
manufacturing process for the product.
• MFR is prepared by the research and development
team of the company and all other documents like-
BMR, BPR. BPR are prepared using MFR by the
manufacturing unit.

13. PREPARATION OF MFR
• It should include product detail,
fl
ow chart, equipment,
manufacturing process, batch size,
product code, brand, calculation,
special instructions, packaging
process and actual yield etc.

14. RESPONSIBLE DEPARTMENTS
FOR MFR
• Primary responsibility: F&D And Production
Department
• Secondary responsibility: Quality Assurance
Department
• Head Quality Assurance shall be responsible for
implementation of SOP.

15. –Johnny Appleseed
THANK YOU