Good Manufacturing Practices in pharmaceuticals

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1. GMP
Good Manufacturing Practices

2. Starlin, Sudair Pharmaceutical Company, Riyadh
GOOD
MANUFACTURING
PRACTICES (GMP)
Good Manufacturing Practices
(GMP)are guidelines established by
regulatory authorities to ensure that
products are consistently produced
and controlled according to quality
standards.
These practices apply to the
manufacturing, processing,
packaging, and storage of products,
ensuring their safety, quality, and
efficacy.

3. Starlin, Sudair Pharmaceutical Company, Riyadh
CURRENT GOOD MANUFACTURING
PRACTICES (CGMP)
Current Good Manufacturing Practices (cGMP) are the most
updated version of GMP guidelines.
They reflect the latest standards and technological
advancements to ensure the highest quality in manufacturing
processes.
cGMPs are enforced by regulatory agencies such as the US Food
and Drug Administration (FDA) to ensure compliance and
protect public health.

4. Starlin, Sudair Pharmaceutical Company, Riyadh
KEY PRINCIPLES OF GMP/ cGMP
•The key principles of Good Manufacturing Practices
(GMP) and Current Good Manufacturing Practices
(cGMP) are designed to ensure that products are
consistently produced and controlled to quality
standards, ensuring their safety and efficacy.

5. Starlin, Sudair Pharmaceutical Company, Riyadh
QUALITY MANAGEMENT
A robust QMS ensures that pharmaceutical products are produced
consistently and meet the intended quality standards.
Quality Assurance (QA): Focuses on preventing mistakes or defects in
manufactured products and avoiding problems when delivering
solutions or services to customers.
Quality Control (QC): Involves testing the products to identify defects.
It is a reactive process aimed at ensuring that the end products are safe
and effective.
Quality Risk Management (QRM) : A systematic process for the
assessment, control, communication, and review of risks to the quality of
the drug product across the product lifecycle.

6. Starlin, Sudair Pharmaceutical Company, Riyadh
PERSONNEL
Training Programs:
Continuous training
programs should be in
place to keep staff
updated with the latest
regulations and
technologies.
Competency Assessment:
Regular assessments
should be conducted to
ensure personnel have the
necessary skills and
knowledge.

7. Starlin, Sudair Pharmaceutical Company, Riyadh
SANITATION AND HYGIENE
Personal Hygiene: Personnel must follow strict
hygiene practices, including wearing appropriate
clothing, washing hands, and using sanitizers.
Cleanroom Standards: Areas where pharmaceutical
products are manufactured should be clean and free of
contaminants. This includes controlling air quality,
surface cleanliness, and ensuring that materials and
equipment are sanitized.

8. Starlin, Sudair Pharmaceutical Company, Riyadh
BUILDING AND FACILITIES
Design and Construction: Facilities must be designed to
facilitate cleaning, maintenance, and minimize
contamination. Layout should prevent cross-contamination
and ensure smooth material flow.
Environmental Control: Temperature, humidity, and air
quality must be controlled to protect product quality.
Monitoring systems are essential for detecting any
deviations.

9. Starlin, Sudair Pharmaceutical Company, Riyadh
EQUIPMENT
Design and Maintenance: Equipment should be
designed for ease of cleaning, maintenance, and
operation. Regular maintenance schedules should be
followed to ensure they remain in good working
condition.
Calibration: Instruments and equipment must be
regularly calibrated to ensure accuracy.

10. Starlin, Sudair Pharmaceutical Company, Riyadh
RAW MATERIALS
Specifications and Testing: Raw materials
must meet predefined specifications and be
tested for quality and purity before use.
Storage Conditions: Proper storage conditions
must be maintained to preserve the integrity of
raw materials.

11. Starlin, Sudair Pharmaceutical Company, Riyadh
PRODUCTION AND PROCESS CONTROLS
Standardization:
Implementing strict
controls over
production processes
to ensure uniformity
and consistency.
In-Process Controls:
Monitoring critical
points during
manufacturing to
detect and correct
deviations promptly.

12. Starlin, Sudair Pharmaceutical Company, Riyadh
VALIDATION AND QUALIFICATION
Process Validation: Ensures that the manufacturing process
consistently produces products meeting quality standards.
Equipment Qualification: Involves Installation Qualification
(IQ), Operational Qualification (OQ), and Performance
Qualification (PQ) to ensure equipment works correctly.
Cleaning Validation: Ensures that cleaning procedures
effectively remove residues and contaminants

13. Starlin, Sudair Pharmaceutical Company, Riyadh
DOCUMENTATION
Standard Operating Procedures (SOPs):
Detailed, written instructions to achieve
uniformity of the performance of a specific
function.
Batch Records: Comprehensive records of
each batch produced, detailing the
production process, materials used, and any
deviations.
Logbooks: Records of equipment usage,
cleaning, and maintenance.

14. Starlin, Sudair Pharmaceutical Company, Riyadh
COMPLAINTS AND RECALLS
Complaint Handling:
Procedures must be in
place to handle product
complaints efficiently,
including investigation
and corrective actions.
Recall Procedures:
Systems should be in
place to quickly and
effectively recall
defective products from
the market.

15. Starlin, Sudair Pharmaceutical Company, Riyadh
SELF-INSPECTION AND QUALITY AUDITS
Internal Audits: Regular
internal audits to ensure
compliance with GMP
regulations and identify
areas for improvement.
External Audits: Periodic
audits by regulatory
authorities or third-party
auditors to verify
compliance and ensure
continuous improvement.

16. Starlin, Sudair Pharmaceutical Company, Riyadh
IMPLEMENTATION AND COMPLIANCE
Regulatory Agencies: The FDA, EMA, and other regulatory
bodies enforce GMP/cGMP regulations through inspections
and audits.
Inspections: Regular inspections ensure ongoing
compliance. Inspectors check for adherence to SOPs, quality
control measures, and other GMP requirements.
Continuous Improvement: Manufacturers must continually
improve their processes and systems to align with cGMP
standards.

17. Starlin, Sudair Pharmaceutical Company, Riyadh
IMPORTANCE OF GMP/ cGMP
Product Safety and
Efficacy:Ensures that
products are safe for
consumption and perform
as intended.
Regulatory Compliance:
Meets the requirements
set by regulatory
authorities, avoiding legal
and financial penalties.
Customer Trust:Builds
and maintains consumer
confidence in the quality
and reliability of products.
Risk Management:
Identifies and mitigates
risks associated with
manufacturing processes
to prevent product recalls
and safety issues.

18. Starlin, Sudair Pharmaceutical Company, Riyadh
REFERENCES TO GUIDELINES
•FDA cGMP Regulations:21 CFR Part 210 (Current Good
Manufacturing Practice in Manufacturing Processing,
packing, or Holding of Drugs) and 21 CFR Part 211 (Current
Good Manufacturing Practice for Finished Pharmaceuticals).
•WHO GMP Guidelines: World Health Organization's
guidelines on GMP for various types of products.
•ICH Q7:International Conference on Harmonisation
guideline for Good Manufacturing Practice for Active
Pharmaceutical Ingredients.

19. Starlin, Sudair Pharmaceutical Company, Riyadh
THANK YOU
Prepared By,
Starlin
Sterile Production
Sudair Pharmaceutical Company
Riyadh, Saudi Arabia
Ph. No. [phone]
Email: [email protected]