PHARMACEUTICAL QUALITY MANAGMENT

ASSIGNMENT 2 :

TOPIC: GMP (GOOD MANUFACTURING

PRACTICE) / CGMP (CURRENT GOOD
MANUFACTURING PRACTICE)

NAME: MEHAK
ENROLLMENT NO: 5-2/2021/059
4TH YEAR, 7TH SEMESTER
SUBJECT CODE: 614
COURSE INCHARGE: DR. SHAZIA
DATE: 6. MAY. 2024
DEFINITION OF QUALITY MANAGMENT:
Quality Management involves systematic processes to ensure products or services
consistently meet or exceed customer expectations. It includes planning, control, assurance,
continuous improvement, customer focus, leadership involvement, and supplier
management. Its goal is to deliver consistent quality, enhance customer satisfaction, and
drive organizational excellence.

DEFINITION OF GMP AND CGMP:

Good Manufacturing Practice (GMP) and Current Good Manufacturing Practice (cGMP) are
regulatory standards ensuring that pharmaceuticals, food, and other consumer products are
consistently produced to high quality and safety standards. GMP applies broadly, while
cGMP specifically refers to the most current practices mandated by regulatory agencies like
the FDA.

DIFFERENCE BETWEEN GMP AND CGMP:

1. GMP (Good Manufacturing Practice):
 GMP refers to the general manufacturing guidelines and standards established to
ensure that products are consistently produced and controlled according to quality
standards.
 It sets out basic principles and guidelines for manufacturing processes, facilities,
personnel, documentation, and quality control.
 GMP standards are often adopted and enforced by regulatory agencies globally to
ensure the safety, efficacy, and quality of pharmaceuticals, food, and other
consumer products.

2. cGMP (Current Good Manufacturing Practice):

 cGMP, on the other hand, specifically refers to the most current set of GMP
standards and regulations mandated by regulatory agencies such as the FDA (Food
and Drug Administration) in the United States.
 The term "current" emphasizes the importance of keeping pace with technological
advancements, scientific understanding, and industry best practices.
 cGMP ensures that manufacturers are implementing the latest standards and
practices to maintain product quality and safety.
 Non-compliance with cGMP regulations can lead to regulatory actions, including
product recalls, warning letters, fines, and legal penalties.

SIGNIFICANCE OF GMP AND CGMP:

GMP (Good Manufacturing Practice) and cGMP (Current Good Manufacturing Practice) are
of paramount importance in ensuring the quality, safety, and efficacy of pharmaceutical
products. Here's how:
 1. Quality Assurance:
GMP and cGMP establish rigorous quality assurance standards that guide every aspect of
pharmaceutical manufacturing, from raw material sourcing to final product distribution.
By adhering to these standards, manufacturers can maintain consistent quality throughout
the production process, reducing the risk of defects or contamination that could
compromise product safety and efficacy.

2. Risk Mitigation:
GMP and cGMP frameworks include measures to identify, assess, and mitigate risks
associated with pharmaceutical manufacturing, such as cross-contamination, mix-ups, or
product variability.
Implementing these practices helps minimize the likelihood of errors or deviations that
could result in substandard or unsafe products reaching consumers.

3. Compliance with Regulatory Requirements:

Regulatory agencies such as the FDA and EMA mandate adherence to GMP and cGMP
regulations to ensure that pharmaceutical products meet established quality and safety
standards.
Compliance with these regulations is a legal requirement for pharmaceutical manufacturers
to operate and market their products in domestic and international markets.

4. Product Efficacy:
GMP and cGMP standards emphasize the importance of maintaining product efficacy by
ensuring that manufacturing processes consistently produce pharmaceuticals with the
intended therapeutic effects.
By controlling critical parameters such as ingredient potency, formulation consistency, and
manufacturing processes, GMP and cGMP help optimize product performance and efficacy.

5. Public Health and Patient Safety:

GMP and cGMP regulations play a crucial role in safeguarding public health and patient
safety by preventing the distribution of substandard, adulterated, or counterfeit
pharmaceuticals.
Ensuring that pharmaceutical products are manufactured under controlled conditions and
meet quality standards reduces the risk of adverse reactions, treatment failures, and other
safety concerns.

6. Trust and Reputation:

Adherence to GMP and cGMP standards enhances the trust and reputation of
pharmaceutical manufacturers by demonstrating a commitment to quality, reliability, and
compliance.
PRINCIPLES OF QM IN CONTEXT OF GMP AND CGMP:
In the context of Good Manufacturing Practice (GMP) and Current Good Manufacturing
Practice (cGMP), the principles of Quality Management Systems (QMS) are fundamental to
ensuring that pharmaceutical products are produced consistently to high-quality standards.
Here's a discussion of these principles:

1. Documentation and Record-Keeping:

QMS principles emphasize the importance of comprehensive documentation and record-
keeping to ensure traceability, accountability, and regulatory compliance.
GMP and cGMP require the establishment of documented procedures for all aspects of
pharmaceutical manufacturing, including production, testing, and quality assurance.
QMS ensures that documents are controlled, updated as necessary, and readily accessible
to authorized personnel.

2. Process Control and Standardization:

QMS principles advocate for the standardization and control of manufacturing processes to
minimize variation and ensure consistency in product quality.
GMP and cGMP require the implementation of robust process controls, including validation
of critical processes, monitoring of process parameters, and adherence to established
procedures.
QMS facilitates the identification of process deviations, the implementation of corrective
actions, and the continuous improvement of manufacturing processes.

3. Risk Management:
QMS principles incorporate risk management practices to identify, assess, and mitigate risks
to product quality, safety, and efficacy.
GMP and cGMP emphasize the importance of risk-based approaches to decision-making,
such as risk assessments for raw materials, manufacturing processes, and supply chain
activities.

4. Training and Competency:

QMS principles underscore the importance of training and competency programs to ensure
that personnel understand their roles, responsibilities, and the requirements of GMP and
cGMP.
GMP and cGMP mandate the training of employees involved in pharmaceutical
manufacturing to ensure they possess the necessary knowledge, skills, and qualifications to
perform their tasks effectively.
QMS facilitates the development, delivery, and documentation of training programs, as well
as ongoing competency assessments to verify personnel proficiency.

5. Continuous Improvement:
QMS principles promote a culture of continuous improvement by encouraging systematic
review, analysis, and optimization of processes, procedures, and systems.
GMP and cGMP require pharmaceutical manufacturers to establish mechanisms for
monitoring and measuring performance, identifying opportunities for improvement, and
implementing corrective and preventive actions.
QMS supports the implementation of quality objectives, key performance indicators (KPIs),
and management review processes to drive ongoing improvement initiatives.

The 5 P’s of GMPs

1. Products
Constant testing, comparison, and quality assurance are crucial steps in the product lifecycle
to ensure they meet the desired standards before reaching consumers. All primary
materials, including raw products and other components, should have clearly defined
specifications at every production phase. Standard methods for packing, testing, and
allocating sample products should be adhered to, ensuring consistency and quality at all
times.

2. Processes
Clear, consistent, and well-documented processes are essential to effective GMP. These
documented processes should be made accessible to all employees, and regular evaluations
should be conducted to ensure compliance and alignment with the organization’s quality
standards.

3. Procedures
Procedures, defined as a set of guidelines for performing a critical process or a part of a
process, play a pivotal role in achieving consistent results. All employees must be familiar
with these procedures and follow them diligently. Any deviation from standard procedures
should be immediately reported, thoroughly investigated, and adequately addressed to
prevent compromise on product quality.

4. Premises
The condition and maintenance of premises directly influence product quality. Premises
should be maintained clean at all times to prevent cross-contamination, accidents, or other
undesirable outcomes. Equipment placement, proper storage, and regular calibration are
crucial to ensure their optimal functionality and reliability, thereby producing consistent
results and preventing equipment failure risks.
 5. People
A company’s personnel form the foundation of successful GMP implementation. All
employees are expected to strictly follow manufacturing processes and regulations. To
ensure this, we recommend regular GMP training for all employees to enhance their
understanding of their roles, responsibilities, and the importance of their contributions to
product quality and safety. Regular performance assessments further aid in boosting
productivity, efficiency, and competency.

10 PRINCIPLES OF GMP:

Principle 1: Defining and creating standard operating procedures (SOPs)

This principle states creating a “road map” with written procedures for business operations.
It involves preparing a set of ‘guidance documents’ that clearly defines work procedures and
instructions for consistency in performance. One should also focus on ​creating concise and
logical procedures that are easy to understand and follow.

Principle 2: Enforcing SOPs

This principle focuses on effectively following documents pertaining to work

procedures. One of the significant issues involves following the documented procedures.
Unfortunately, employees often use shortcut procedures that are different from those
documented. Therefore, this principle ​encourages sticking to the established procedures
and not deviating as they result in hazards.

Principle 3: Documenting work outcomes

This principle works to examine problems or complaints regarding a product. It mandates

documentation of work after completion, which also enables regulatory compliance. This
documentation also chronicles the exact procedures followed concerning the GMP
regulations.

Principle 4: Validating the SOP’s effectiveness

Validation is an essential step to progress ahead in the process. This principle

involves creating documentary evidence that the ​techniques, processes, and production
maintain the expected level of compliance during all the stages. Using various methods to
cross-check results is one of the ways to ensure confidence in the systems and processes.

Principle 5: Properly defining and designing equipment and construction facilities

Various hygienic protocols must be followed, depending on the type of product being
manufactured.

This fifth GMP principle emphasizes the value of incorporating productivity, quality, and
employee safety into the design and development of a company’s buildings and
equipment. For example, materials, goods, and components are separated to avoid
confusion, mix-ups, and errors.
Principle 6: Maintaining facilities and equipment

This principle reinforces the quality and consistency goals by enforcing proper equipment
and facilities maintenance. Consumers are exposed to various risks due to a lack of
equipment maintenance.

This important principle of good manufacturing practices involves maintaining a proper

schedule that prevents equipment breakdown. It also aims to reduce the risks associated
with product contamination and ensures that the facility or equipment is in its validated
state.

Principle 7: Developing job competence

Each employee is equally invested and contributes to the manufactured product quality.
Therefore, this principle states that each ​employee impacting the product quality should be
trained. Basic GMP theory and practice, as well as role-related training, should be included
in the training.

In addition, it’s also crucial to brush existing employees’ abilities with enhanced training
sessions, especially as new technologies come up. Employees, as a result, should
demonstrate job competency by delivering high-quality products in a safe and timely way.

Principle 8: Preventing contamination through cleanliness

Consumer protection should be at the forefront of every discussion in any production

facility. This principle emphasizes the need to maintain proper cleanliness to prevent
product contamination. This can be accomplished by ensuring that the workplace is cleaned
daily. In addition, all cleaning and sanitization procedures must also be followed.

Principle 9: Assuring quality control

​This principle entails incorporating quality directly into all production phases by putting
clearly defined controls in place and preserving accurate, timely records.

Each product goes through a series of product line processes before it is called the final
product. Effectively controlling each of these processes is critical to the end product’s
success. Good Manufacturing, packing, labelling, distribution, and marketing are all
examples of quality control.

Principle 10: Conducting planned audits

Finally, the only way to identify how successfully GMP is applied is to undertake periodic
audits to evaluate the efficacy of GMP compliance. Therefore, audits must be
performed regularly to ensure that nothing is overlooked.

WHAT IS CGMP:

cGMP is a set of regulations enforced by the Food and Drug Administration

(FDA). Concerned about the safety and quality of pharmaceutical products,
people pushed for regulations to ensure their proper control. These
regulations established requirements for thorough product definition,
validation, documentation, and review.

cGMPs first appeared in the Code of Federal Regulations (CFRs) — a set of

regulations for pharmaceutical products. The FDA published them in 1963.
The first World Health Organization (WHO) draft text of cGMPs
was released in 1968.

CGMP REQUIREMENTS:

 21 CFR Part 111

outlines the Current Good Manufacturing Practice (cGMP) requirements

for dietary supplements in the United States. It covers standards for
personnel, facilities, equipment, quality control, components, packaging,
labeling, records, and distribution to ensure the quality, safety, and
consistency of dietary supplements. Compliance with these regulations is
mandatory for manufacturers, packagers, labelers, and holders of dietary
supplements to ensure regulatory compliance and consumer safety.

 21 CFR Part 210

This part establishes the general cGMP requirements applicable to the

manufacturing, processing, packing, or holding of drugs (including
biologics). It outlines the responsibilities of manufacturers to ensure that
drugs are safe, effective, and meet established quality standards
throughout the manufacturing process.

 21 CFR Part 211

It covers various aspects of pharmaceutical manufacturing, including

personnel, buildings and facilities, equipment, control of components and
drug product containers, production and process controls, laboratory
controls, packaging and labelling, and holding and distribution.

 21 CFR Part 212

covers the registration of drug producers and listing of drugs in

commercial distribution for human use. It requires drug manufacturers,
repackers, relabelers, and salvagers to register their establishments with
the FDA and list their drug products. The regulation also includes
requirements for labeling, packaging, recordkeeping, and FDA inspections
to ensure compliance with regulatory standards and ensure the quality and
safety of drug products. Compliance with these requirements is mandatory
for drug establishments to operate legally and maintain consumer safety.
  21 CFR Part 225

outlines requirements for Current Good Manufacturing Practice (cGMP) in

Medicated Feeds. It establishes standards for the production, labeling,
distribution, and use of medicated animal feeds in the United States.
Compliance with these regulations is crucial for ensuring the safety,
efficacy, and quality of medicated feeds, as well as the health and welfare
of animals.

 21 CFR Part 606

sets forth regulations regarding the current Good Manufacturing Practice

(cGMP) for blood and blood components intended for transfusion or for
further manufacturing. These regulations aim to ensure the safety, purity,
and potency of blood and blood products and govern various aspects such
as donor eligibility, testing, processing, labeling, and distribution.
Compliance with these regulations is crucial for maintaining the quality
and safety of blood and blood components for medical use.

KEY GOALS AND OBJECTIVES OF CGMP:

 Enforcing quality standards.

 Increasing risk management.
 Improving record keeping.
 Training staff.
 Ensuring product consistency and reliability.
 Enhancing consumer safety and trust.
 Regulatory compliance and avoiding legal issues.

HOW TO MANTAIN CGMP COMPLAINCE:

 Stay Informed About Regulatory Requirements:

Stay updated on current cGMP regulations and guidelines issued by regulatory agencies
such as the FDA (Food and Drug Administration) or EMA (European Medicines Agency).
Regularly monitor regulatory updates and incorporate changes into your quality system.

 Conduct Regular Internal Audits:

Conduct regular internal audits to assess compliance with cGMP requirements. Identify
areas for improvement and take corrective actions to address any non-conformities or
deficiencies identified during audits.
  Provide Ongoing Training and Education:

Ensure that all personnel receive comprehensive training on cGMP principles, procedures,
and regulatory requirements. Training should be provided regularly and tailored to the
specific roles and responsibilities of each employee.

 Document Everything:

Maintain accurate and comprehensive documentation of all cGMP-related activities,

including manufacturing processes, testing results, deviations, corrective actions, and
validations. Ensure that documentation is organized, accessible, and up-to-date.

 Monitor and Control Manufacturing Processes:

Implement robust controls and monitoring systems to ensure that manufacturing processes
are conducted in accordance with cGMP requirements. Monitor critical process parameters,
conduct in-process testing, and implement measures to prevent deviations and errors.

 Perform Regular Equipment Calibration and Maintenance:

Ensure that manufacturing equipment is regularly calibrated, maintained, and validated to

ensure accuracy, reliability, and consistency. Establish procedures for equipment
maintenance, calibration, and validation, and document all related activities.

 Address Supplier and Vendor Compliance:

Assess the compliance of suppliers and vendors with cGMP requirements. Establish criteria
for supplier qualification, conduct audits, and ensure that suppliers provide materials and
services that meet cGMP standards.

 Prepare for Regulatory Inspections:

Be prepared for regulatory inspections by maintaining inspection readiness at all times.

Keep documentation organized and readily accessible, train employees on inspection
procedures, and conduct mock inspections to identify areas for improvement.

REFRENCE:
https://www.pulsepro.ai/blog/10-principles-of-good-manufacturing-practices/
https://www.etq.com/blog/current-good-manufacturing-practices/
https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodManufacturi
ngPractices/en/
https://www.ema.europa.eu/en/human-regulatory/research
development/compliance/good-manufacturing-practice-gmp