Assignment:02

Pharmaceutical Quality Management

Submitted To Sir Dr. Zia ur Rehman

Department of Pharmaceutical Sciences

Definition:
GMP, which stands for Good Manufacturing Practices, is a system that ensures that
manufactured 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, and avoid recalls, fines, and jail time. Overall, it
protects both the company and the consumer from negative food safety events.
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:
● Quality management
● Sanitation and hygiene
● Building and facilities
● Equipment
● Raw materials
● Personnel
● Validation and qualification
● Complaints
● Documentation and recordkeeping
● Inspections & quality audits
Difference between GMP and cGMP
Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP)
are, in most cases, interchangeable. GMP meaning the basic regulation promulgated by the
US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and
Cosmetic Act to ensure that manufacturers are taking proactive steps to guarantee their
products are safe and effective. cGMP, on the other hand, was implemented by the FDA to
ensure continuous improvement in the approach of manufacturers to product quality. It
implies a constant commitment to the highest available quality standards through the use of
up-to-date systems and technologies.
5 Main Components of Good Manufacturing Practice
It is paramount to the manufacturing industry to regulate GMP in the workplace to ensure
consistent quality and safety of products. The five main components of GMP, commonly
referred to as the 5P’s, help organizations comply with strict standards throughout the entire
production process.
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.
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. 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.
Principles of GMP
● Create Standard Operating Procedures (SOPs)
● Enforce / Implement SOPs and work instructions
● Document procedures and processes
● Validate the effectiveness of SOPs
● Design and use working systems
● Maintain systems, facilities, and equipment
● Develop job competence of workers
● Prevent contamination through cleanliness
● Prioritize quality and integrate into workflow
● Conduct GMP audits regularly
Importance of GMP
A poor quality medicine May contain toxic Substances that have been Unintentionally added.
A medicine that contains Little or none of the Claimed ingredient will Not have the intended
Therapeutic effect.Poor quality drugs can be a disaster for both patients and governments
from a health and a cost perspective. If companies cannot manufacture appropriate quality
products due to GMP issues (the most common reason) there is a high risk of drug shortage,
which unfortunately affects patients who cannot get their prescribed medication when they
need it. The pharmaceutical industry has a responsibility to ensure a safe and sufficient
supply of medicinal products, and this must be taken into consideration in pharma
engineering and consulting projects from the outset.Additionally, GMP can help boost
pharmaceutical export opportunities. The majority of countries worldwide only accept the
import and sale of medicines that have been manufactured to internationally recognized GMP
standards.Investing in GMP means investing in quality medicine. It saves costs, minimizes
risks, and improves the standard of drugs worldwide.