GMP: Good Manufacturing Practices

Presented By,

Eshanee MV

Business Improvement Specialist

 Agenda:

1. About Certvalue

2. Introduction to GMP

3. Applicability of GMP

4. Guidelines Version

5. Purpose of GMP

6. Components of GMP

7. Principles of GMP

8. GMP Guidelines

9. Benefits of GMP
About Certvalue

•Certvalue is a global organization specializing in ISO 9001,ISO

14001,OHSAS 18001/ ISO45001, ISO 27001, ISO 22000 and ISO
20000 , other International Standards Consulting and Certification.

•Our ISO Consulting solutions are suitable for organizations of all

size and nature irrespective of their location, no. of employees,
turnover, nature of business etc.
• We provide 100% customized ISO consulting solutions to your
ISO certification requirements.
•We posses capacity to deliver our services in India, Middle East,
UAE, Saudi Arabia, Oman, Qatar, Kuwait, Yemen, Bahrain, Jordon,
Africa, South East Asia, Malaysia, Thailand and Indonesia.
Introduction to GMP

• GMP sets guidelines that provide guidance for manufacturing,

testing and quality assurance in order to ensure that manufactured
product is safe for human consumption or use.
• These guidelines provide minimum requirements that a
manufacturer must meet to assure that their products are
consistently high in quality, from batch to batch, for their
intended use.
• GMP is typically ensured through the effective use of a Quality
Management System (QMS)
Applicability of GMP

• Food and Beverage

• Cosmetics

• Pharmaceuticals

• Dietary supplements

• Medical devices
Guideline Version

• GMP regulations are mandated by manufacturers’ respective national government

to regulate the production, verification, and validation of manufactured products
and ensure that they are effective and safe for market distribution.
• The World Health Organization (WHO) version of GMP is used by pharmaceutical
regulators and the Pharmaceutical Industry in over 100 countries worldwide,
primarily in the developing world.
• The European Union’s GMP (EU-GMP) enforces similar requirements to WHO
GMP, as does the FDA's version in the US. Similar GMPs are used in other
countries, with Australia, Canada, Japan, Saudi Arabia, Singapore, Philippines,
Vietnam and others having highly developed/sophisticated GMP requirements.
Purpose Of GMP

GMP looks at every aspect of the manufacturing process to guard against

potential risks that can prove detrimental to the products being produced.

GMP aims to prevent:

• Cross-contamination
• Mislabeling
• Adulteration

The main purpose of GMP is always to prevent harm from occurring to the
end user. Additional tenets include ensuring:
• the end product is free from contamination,
• that it is consistent in its manufacture,
• that its manufacture has been well documented,

• that personnel are well trained, and that the product has been checked
for quality more than just at the end phase
Components of GMP

It is paramount to the manufacturing industry to

regulate GMP in the workplace to ensure
consistent quality and safety of products.
Focusing on the following 5 P’s of GMP helps
comply with strict standards throughout the
entire production process.

1. People

2. Products

3. Process

4. Procedure

5. Premises
1. People

• All employees are expected to strictly adhere to manufacturing processes

and regulations.

• GMP training must be undertaken by all employees to fully understand

their roles and responsibilities.

• Training these workers in proper sanitation, recordkeeping, labeling, and

equipment handling can make all the difference from a quality assurance
perspective.

• Assessing their performance helps boost their productivity, efficiency, and

competency.
2. Product

• All products must undergo constant testing, comparison, and quality assurance before
distributing to consumers.

• All the raw materials used in the manufacturing process must be of highest quality.

• 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. Process

• All manufacturing processes must be followed—and documented—to the

strictest standard.

• Since auditors regularly inspect laboratories and other facilities for consistency
and quality, documentation is truly essential.

• Manufacturers can take this a step further by keeping a written framework of the
entire manufacturing process and distributing these materials to all team
members.

• 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. Procedure

• Processes and procedures go hand in hand. A procedure is a series of guidelines needed

to perform a process (with the goal of generating a specific result).

• During audits, manufacturing procedures are highly scrutinized. If any procedure is

using outdated technology, the manufacturer will risk facing noncompliance penalties.
Procedural consistency can help mitigate this.

• Employees should fully understand the procedures they must follow.

• Any deviation from the standard procedure should be reported immediately and
investigated.
5. Premises

• All facilities, laboratories, and equipment should be maintained to guarantee safe, sanitary,
and effective manufacturing conditions.

• This includes proper cleaning and storage, along with any other measures that can be taken
to achieve consistent results, lower the risk of equipment failure, and ensure timely repairs.

• Reducing product variations is the end goal here, as is protecting customers, and team
members from operational issues onsite.

• 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

1.Create Standard Operating Procedures (SOPs)

2.Enforce / Implement SOPs and work instructions

3.Document procedures and processes

4.Validate the effectiveness of SOPs

5.Design and Construction of facilities and Equipments

6.Maintain systems, facilities, and equipment

7.Develop job competence of workers

8.Prevent contamination through cleanliness

9.Prioritize quality and integrate into workflow

10.Conduct GMP audits regularly

Principle 1 & 2

Principle 1: Create Standard Operating Procedures (SOPs)

• SOPS and work instruction act as guidance documents which helps you to achieve the
objectives that are high quality product and customer satisfaction.

• Therefore all the SOPs and work instructions should be documented first and then
they have to be made available to all the employees for their better understanding.

Principle 2: Enforce / Implement SOPs and work instructions

• Whatever you have documented should be put into practice. Make sure you are
following everything that you have mentioned within the SOPs.

• Make sure no shortcuts are taken which might lead to deviation and cause great
damage to the quality and ultimately customer satisfaction.
Principle 3 & 4

Principle 3: Document the work flow

• Prompt and accurate documentation of work provides official information or serves as

a record helping in compliance and traceability.

• In case of error, these records can serve as the basis of investigation. E.g. Equipment
user manual, GMP Manual.

Principle 4: Validate the effectiveness of SOPs

• It is always important to ascertain whether when certain activities are undertaken on

the production floor and given a certain set of results, such results are actually accurate.

• Our work needs validation; normally by using other methods to cross-check results.
That’s the only way to ensure confidence in our systems and processes.
Principle 5

Principle 5: Design and Construction of facilities and Equipment

• Design and construction of facilities and equipment depends solely on the type of product being
manufactured. For example, For dairy products, the facilities and equipment used are completely
different from other products. However some protocols are going to remain same throughout the food
industry.

• For food and pharmaceuticals, production floors should be categorized into zones :

1. Zone 1: Low risk

2. Zone 2: Medium risk

3. Zone 3: High risk

Principle 6

Principle 6: Maintain systems, facilities, and equipment

• When it comes to facility and equipment maintenance, there is a huge gap in

organizations.

• Lack of equipment maintenance exposes consumers to several hazards. The aim of the
manufacturer should always be product safety and quality.

• It is quite common to see paint flaking in restaurant kitchens, exposing cooked food to
physical as well as chemical hazards. In some manufacturing sites, the amount of rust on
equipment can be quite scary.

Principle 7: Develop job competence of workers

• Every job should be well-defined before the recruitment process. Competent people should
be employed to manage processes in the establishment.

• It is also important to upgrade the skills of existing workers – especially when new
technologies emerge. Each organization must have a way of evaluating personnel on the
job to ensure they keep to quality standards in their respective areas of work.
Principle 8 : Prevent contamination through cleanliness

• This principle outlines the importance of ensuring a product to be protected

from contamination by practicing good hygiene.

• This can be achieved by incorporating cleanliness in the workplace on daily

basis.

• All cleaning and sanitization procedure should be diligently followed.

Reduce human contact with products and equipment.

• Food contamination can either physical, chemical or microbiological in

nature.
Principle 9: Prioritize quality and integrate into workflow

• Ensure product quality in each and every step in the product lifecycle which
is achieved by controlling components, controlling the manufacturing
process, packaging & labeling controls, holding and distribution controls.

• Make sure all the materials and components are meeting the specifications
defined.

• All materials and components should be identified, samples and tested.

• All the products should have individual batch / history records. To specialize
traceability, batch numbers should be assigned to all products
Principle 10

• Only way to determine how well GMP is being implemented is

to conduct planned and periodic audits.

• Audits must be conducted to assess whether the facility is

following GMP.

• Audits can be internally held to ensure GMP compliance by in

house audits or external audits can be conducted by external
bodies such as FDA etc.
GMP Guidelines
• Building and Facilities.
• Equipment.
• Personnel.
• Raw Materials.
• Production.
• Laboratory Controls.
• Records.
• Labelling.
• Complaints.
• Other.
Benefits of GMP

The key benefits to GMP certification:

• Prove organization’s management capabilities in product

quality, safety assurance

• Enable employees to develop good production /

operations habits

• Reduce safety risk in product quality and safety

• Timely detect production and management problems,

reduce cost

• Better understand and comply with the relevant laws and

regulations

• Enhance the international credibility and public image

Thank You