Good Manufacturing Practice (GMP) consists of regulations and guidelines ensuring the consistent quality, safety, and efficacy of pharmaceutical products. Key components include quality assurance, personnel training, facility and equipment maintenance, documentation, and stringent testing processes. Compliance with GMP is crucial for regulatory approval, consumer confidence, and minimizing the risk of contamination or defects in products.

1. GOOD MANUFACTURING PRACTICE
Ms. Ashwini Ashok Jamdhade
Assistant Prof. (M.Pharm, P’ceutics)
Sanjivani College of Pharmaceutical Education and Research,
Kopargaon

2. What is GMP?
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the
manufacture of drug substances and drug products, medical devices, in vivo and in
vitro diagnostic products, and foods.
Definition:
Good Manufacturing Practices (GMP) are a set of guidelines and regulations that
ensure pharmaceutical products are consistently produced and controlled according
to quality standards.
Importance in Pharma Industry:
•Ensures the safety, efficacy, and quality of drugs.
•Prevents contamination, mix-ups, and errors.
•Essential for regulatory compliance.
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3. OBJECTIVE
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Guarantee high quality products to the consumer.
Delivering products free of all possible
contamination

4. General Requirements
Avoid risks and possibilities of mix-up at all stages of Mfg,
labeling Pkg and testing
Air handling Units (AHUs), comfort of the personnel working
and regular monitoring of temp & humidity, Particle Count,
Disperse Oil Particles(DOP) testing etc.
Proper drainage system which prevents backflow. Avoid open
channels and if provided must be able to clean and disinfect.
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Components of GMP in Pharma Industry
• Quality Assurance:
Ensures that products meet the required standards of quality.
• Control of Raw Materials:
Ensures that raw materials and components meet the specified standards.
• Personnel Training:
Properly trained personnel to follow GMP procedures.
• Facility and Equipment Maintenance:
Clean and well-maintained equipment and facilities to avoid contamination.
• Documentation:
Accurate and thorough record-keeping for traceability and accountability.

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Components of GMP in Pharma Industry
• Facility Design and Layout:
• Separate zones for manufacturing, storage, and packaging.
• Airflow control, lighting, and temperature regulation.
• Raw Materials and Packaging Materials:
• Quality control of incoming materials.
• Proper storage conditions and handling.
• Production Process:
• Standard Operating Procedures (SOPs) for each step.
• Validation and qualification of processes.

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Personnel and Training
• Training Requirements:
• Regular training on GMP practices for all staff.
• Certification and competence evaluations.
• Roles and Responsibilities:
• Clear role definitions and accountability for everyone in
the production chain.

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Equipment and Facility Maintenance
• Equipment Calibration and Validation:
• Regular calibration of manufacturing equipment.
• Validation of automated systems.
• Facility Cleaning and Sanitation:
• Routine cleaning procedures to avoid cross-contamination.
• Pest control measures.
• Temperature and Humidity Controls:
• Monitoring and maintaining proper conditions.

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Quality Control and Assurance
• Testing and Inspection:
• Routine quality checks on raw materials, in-process goods, and
finished products.
• Microbiological and chemical testing.
• Batch Production Records:
• Maintaining detailed production logs for each batch.
• Ensuring traceability in case of issues.
• Handling Deviations:
• Identifying and managing deviations or non-conformances in the
process.

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Documentation and Record-Keeping
• Importance of Documentation:
• Ensures traceability and accountability.
• Legal requirement for regulatory audits.
• Types of Records:
• Batch production records.
• Testing and inspection reports.
• Equipment maintenance logs.

11. Records
• Document all GMP activities
• Use Good Documentation Practices (GDP)
• Records must be readily available
Good Documentation Practices
Documentation must be:
• permanent (black or blue ink)
• legible, clear, concise
• accurate
• Timely, complete
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Benefits of GMP in Pharma
• Product Quality and Safety:
Ensures high-quality drugs for consumers.
• Regulatory Approval:
Compliance with GMP is a requirement for obtaining licenses.
• Consumer Confidence:
Builds trust in the pharmaceutical brand and products.
• Reduced Risk of Recalls:
Lower risk of product contamination or defects.

13. GMP Categories
• Building and Facilities
• Sale
• Premises and Equipment
• Personnel
• Sanitation and Hygiene
• Raw Material Testing
• Manufacturing Control
• Packaging Material Testing
• Finished Product Testing
• Quality Control Department
• Records
• Samples
• Stability
• Sterile Products
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14. Building & Facilities
1. Design and construction features.
2. Lighting.
3. Ventilation, air filtration, air heating and cooling.
4. Plumbing.
5. Sewage and refuse.
6. Washing and toilet facilities.
7. Sanitation.
8. Maintenance.
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15. Quality Control Department
• Quality Control Responsibilities
• Testing of bulk components prior to use by production
• Testing of finished product prior to release for sale
• Stability program
• Review batch records, labels
• Release product, based on QC test results
• Training, auditing
• Customer complaints
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16. Sale
• No distributor … and no importer shall sell a drug unless it has
been fabricated, packaged/labeled, tested, and stored .
Premises & Equipment
• Permits effective cleaning
• Prevents contamination
• Orderly conditions
• Good state of repair
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17. Personnel
• Appropriate education, training and experience
• Sufficient number of people
• Receive GMP training
Sanitation
• Sanitation Program to prevent contamination
• Limit the sources and types of contamination
• Cleaning procedures for facilities & equipment
• Pest control
• Environmental monitoring
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18. Manufacturing Control
• Written procedures are established and followed
• Master formulae, manufacturing order and packaging order
• Critical processes are validated
• 2nd person verification of activities
• Self-Inspection Programmed
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19. Raw Material, Packaging Material and Finished Product Testing
• Each lot or batch of raw material is tested
• confirm the identity of the raw materials
• provide assurance that quality of the drug in dosage
• Samples of incoming materials are collected and tested before use
• Approved test methods and specifications are used
• Results must conform to specifications for release for use or sale
• Transportation and storage records
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20. Samples
• Retain samples of each lot of raw material and finished
product for specified period of time
Stability
• Establish the length of time in which the
product meets all specifications
• Monitor the drug for this period of time
Sterile Products
• Packaged in separate enclosed area by trained personnel
using method to ensure sterility
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THANK YOU