CYPRUS INTERNATIONAL UNIVERSITY 2024-

2025 FALL SEMESTER

PHAR217- Introduction to pharmaceutical

technology

Week 5: Introduction to Good Manufacturing Practice

Dr. Lara Alhajj

 What is GMP?
• Good Manufacturing Practices or GMP is a system that consists of
processes, procedures and documentation that ensures manufacturing
products, such as food, cosmetics, and pharmaceutical goods, are
consistently produced and controlled according to set quality
standards.

• Implementing GMP can help cut down on losses and waste, avoid
recall, seizure, fines and jail time
 Importance of GMP
• GMPs examine and cover every aspect of the manufacturing process
to guard against any risks that can be catastrophic for products, such as
cross-contamination, adulteration, and mislabeling.

• Some areas that can influence the safety and quality of products that
GMP guideline and regulation address are the following :
 GMP Area’s

Quality Building and

Management facilities

Sanitation and
hygiene Equipment
 GMP Area’s

Raw Materials Personnel

Validation Complaints
 GMP Area’s

Documentation and Inspections &

record-keeping quality audits
 1. Quality management

• The principle of quality management is to ensure that manufactured

products are fit for their intended use, comply with requirements and
does not place consumers at risk due to inadequate safety, quality, or
efficacy measures.

• To achieve this quality objective, quality assurance, good

manufacturing practices, quality control, and quality risk management
should be comprehensively and correctly implemented.
 Quality Assurance and Quality Control

• Quality Assurance - The system of quality assurance aims to ensure

that manufactured products are designed and developed in a way that
meets the requirements for Good Manufacturing Practice

• Quality Control - Quality control is a part of Good Manufacturing

Practice that focuses on sampling, specification, and testing. It checks
the organization, documentation, and release procedures to ensure that
products go through the required tests before being released for sale or
supply.
 2. Sanitation and hygiene

• Sanitation and hygiene are vital in every aspect of the manufacturing

process. It covers anything that can cause contamination such as
personnel, the premises, equipment, containers, and production
materials. All potential sources of contamination should be identified
and eliminated with a comprehensive sanitation and hygiene program.
 3. Building and facilities/premise

• Building and facilities/premise As a principle, the premises should

be situated in an environment that is suitable for its operations and one
that is free from risks of contamination of materials and products. The
premises should also be designed to minimize errors in operations and
should be easy to clean and maintain
 4. Equipment

• Equipment Same with the premises, equipment should be designed,

located, and maintained to function according to its intended use.
Additionally, it should be cleaned and stored according to procedures.
In the event of a defect or malfunction, it should be removed or
labeled as defective.
 5. Raw materials

• Raw materials All materials used for production should be stored

properly according to the appropriate conditions which are set by the
manufacturers. There should be a proper stock management system
implemented to ensure that all incoming materials are correct and of
high quality.
 6. Personnel

• Personnel The success of GMP compliance heavily relies on the

people implementing it. For this reason, it is vital that all personnel are
qualified and trained to do the job.
• They should be aware of the principles of GMP and receive continued
training, hygiene instructions, and other tools relevant to their needs.
Respective managers should be clear on job descriptions for each
worker to avoid misunderstandings and reduce the risk of issues like
overlapping responsibilities
 7. Validation and qualification

• Validation and qualification Qualify systems, premises, and

equipment if they are fit/ready for their intended use and validate if
processes and procedures can repeatedly produce high-quality
products. Critical steps in the manufacturing process should be
verified to ensure that product quality is consistent and maintained at a
high level.
 8. Complaints

• Complaints Handling complaints is also part of GMP, therefore all

manufacturing companies should have a well-designed GMP
complaint system. Ideal complaint handling should have a ready
solution to provide for all contingencies
 9. Documentation and record-keeping

• Good documentation and record keeping are an essential part of the

quality assurance system and are required in compliance with GMP
requirements. Accurate recordkeeping can help managers and
supervisors keep track of the historical record of manufacturing
procedures and corrective measures implemented.
5 Main Components of Good Manufacturing Practice?
5 Main Components of Good Manufacturing Practice

1. People - All employees are expected to strictly adhere to

manufacturing processes and regulations. A current GMP training
must be undertaken by all employees to fully understand their roles
and responsibilities. Assessing their performance helps boost their
productivity, efficiency, and competency.
2. Products - All products must undergo constant testing, comparison,
and quality assurance before distributing to consumers.
Manufacturers should ensure that primary materials including raw
products and other components have clear specifications at every
phase of production. The standard method must be observed for
packing, testing, and allocating sample products.
5 Main Components of Good Manufacturing Practice

3. Processes - Processes should be properly documented, clear,

consistent, and distributed to all employees. Regular evaluation should
be conducted to ensure all employees are complying with the current
processes and are meeting the required standards of the organization.
4. Procedures- A procedure is a set of guidelines for undertaking a
critical process or part of a process to achieve a consistent result. It must
be laid out to all employees and followed consistently. Any deviation
from the standard procedure should be reported immediately and
investigated
5 Main Components of Good Manufacturing Practice

5. Premises - Premises should promote cleanliness at all times to avoid

cross-contamination, accidents, or even fatalities. All equipment should
be placed or stored properly and calibrated regularly to ensure they are
fit for the purpose of producing consistent results to prevent the risk of
equipment failure.
 What is cGMP

• Current Good Manufacturing Practices (cGMP) are regulations

enforced by the FDA and other regulatory agencies to ensure that
pharmaceutical products are consistently produced and controlled to
quality standards.
 What is Quality Risk Management

• Quality risk management is a systematic process of assessing risks

that can affect the quality of the product. According to its principles,
quality risk management should ensure that:
1. The evaluation of the risk to quality is based on scientific
knowledge, experience with the process and ultimately links to the
protection of the patient and users
2. The level of effort, formality, and documentation of the quality risk
management process is commensurate with the level of risk
 What is a GMP Audit?
• A GMP audit is a third-part audit conducted to assess if an
organization is compliant with regulations and industry standards on
acceptable good manufacturing practices.

• It helps identify areas for improvement on GMP compliance and also

provides guidance on how to become compliant.
 What is GMP compliance

• GMP compliance refers to adherence to Good Manufacturing

Practice (GMP) regulations. These are standards that ensure products,
particularly pharmaceuticals, cosmetics, and food, are consistently
produced and controlled according to quality standards.

• GMP compliance is vital for safeguarding consumer health by

minimizing risks involved in production that cannot be eliminated
through testing the final product alone.