cgmp

The Importance of, Current Good Manufacturing Practice (cGMP)

Good Aseptic Practices (GAP) Good Documentation Practices (GDP) Good Laboratory Practices(GLP) (For Students & Industrial Visits)

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The Importance of cGMP, GLP, GAP & GDP

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What is GMP?

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• GMP stands for Good Manufacturing Practices.

• Good Manufacturing Practices (GMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced the quality standards appropriate fit for their intended use.

• The quality should be “built in” at every part of the process.

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Definition of GMP

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• The "c" in cGMP stands for “current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations

• The concept of cGMP is to reduce the risks of making mistakes.

• The practice of cGMP should start from your first day at work.

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What is cGMP?

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• Required new drugs to be safe before marketing

• Compliance with cGMP is ensure that you do everything to maintain high product quality.

• The concept of cGMP is to reduce the risk of making mistakes

• The cleaning of facilities and equipment an essential procedure of cGMP.

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Why cGMP?

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• SOP – Standard operating Procedures

• Always refer the SOP’s during every step of manufacturing .

• In production process each and every process described by a detailed procedure.

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Do’s and Don’ts of cGMP.

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• The protective clothing should be worn at all times to protect products from contamination

• Gloves are an essential item of Protective clothing.

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• The main aspect of cGMP in a pharmaceutical company is you do everything to maintain high product quality.

• Any illness should report before starting your work and Food, Chewing gums, Smoking are not allowed in any production area.

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• Always use correctly fitting headwear, foot covers and properly cover beard and mustached

• Jewelry/ Wrist watch should not be worn during work.

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• The greater source of contamination in healthcare industry is people, they involve in contamination like,

Sneezing Coughing• Rubbing the face or scratching the head• Nails and Cuticles

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Good Aseptic Practice

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What do you understand by a Sterile product?

• What are micro-organisms?• Micro-organisms are very tiny one-celled organisms,

viruses, fungi, and bacteria, and are found everywhere in the world. They are found in all living things, plants and animal

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Types of Microorganism

• Germs and Microorganism type of contamination causes the greatest concern in the pharmaceutical production.

• The medicinal product which are to be injected, used in eyes must be Sterile.

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Essentials of Good Aseptic Practices.• 121oc temperature is required to kill all microorganism.• Freezing/Refrigeration Does not kill microorganism. • Always perform Cleaning/decontamination before

starting your work.• Hand washing with good flow of water and high

standard of cleanliness is necessary to prevent transfer of residuals/chemicals or comply with cGMP.

• Skin Flakes are one of major source of contamination.• Are Bacteria removed from the hand by washing with soap only?

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• Clean room clothing developed to prevent contamination of people.

• All equipment taken in cleanroom must be spotlessly clean

• Sterile healthcare products are typically made in Class 100 Cleanroom

• Showering is the most effective way to wash away the dirt and debris from the body

The Manufacturing Environment

The wooden handles never be used in cleanroom because they cannot be sterilized.

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Basic Good Documentation Practices (GDP)

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Good Documentation Practices

Objectives

As required by the regulatory authorities such as MOH UAE, FDA, WHO etc. to train our staff to understand and use the Basic Good Documentation Tips & Practices such as:

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• To make sure we know exactly what we did, and when we did it.

• To be able to correct mistakes if they happen.

Good Documentation PracticesWhat is the purpose of GDP?

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• Always refer the related documentation at each stage of manufacturing.

• Take someone work with writing each step down clearly.

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Do’s and Don’ts of Good Documentation Practices

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Standards for a correctly prepared record:

1. Permanent- the information can't be changed, erased, or washed off.

2. Legible- the information can be easily read.3. Accurate- calculations and other information are correct. 4. Prompt- information is recorded in a timely way. Actions are

documented immediately after they are performed, never before.5. Clear- everyone who reads the document has the same

understanding of what it means.6. Consistent- all information, such as dates, times, abbreviations, etc.,

should be standardized.7. Complete- all required information is included.8. Direct- information is recorded immediately onto the proper form,

lab notebook or computer system9. Truthful- all information included in the document is, to the writers

knowledge and ability, what really happened

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• Information can be easily readable means that it is Legible.

• The use of correction fluid is prohibited to make any changes In any documents.• Never sign your name for someone else work.• Batch manufacturing record contains the

manufacturing history of the product.

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What is Good Laboratory Practice?

Good Laboratory PracticesGood Laboratory Practices

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• GLPs are generally accepted methods to perform an activity or operation in a lab. These practices are known or believed to be safe and having a positive influence on the quality of the result, and are usually independent of the test or measurement techniques employed.


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"Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported."


• Good laboratory practice or GLP specifically refers to a Quality System of management controls for laboratories to ensure the uniformity, consistency, reliability, quality and integrity of pharmaceutical safety and efficacy tests

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All measures taken to ensure that • Raw materials, • intermediates, • Packaging materials and • finished pharmaceutical products

conform with established specifications for identity, strength, purity and other characteristics.

Good Laboratory Practices

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• The main activity of the Laboratory is testing (eg. chemical, microbiological, physical etc.)

• This is done in accordance with approved written methods.

• The quality of analytical results is the responsibility of the Lab .

• The staff is responsible for ensuring Laboratory work is performed in accordance with Good Laboratory Practice (GLP).

Good Laboratory Practices

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Incoming samples-General points• Samples of Raw/Packaging materials or

products (intermediate, bulk or finished), arereceived by lab. for further analytical procedures.

• The samples are verified against their respective documents and a QC Number is assigned.

• Sample's details are entered in the respective sample registers as well as in computer programs.

• The samples and documents are then distributed to various designated sections for respective testing. (within maximum 1 hour)


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QUESTIONS??

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THANK YOU__________________________Presented By,Faiz Mohmmed KhanOJT-Coordinator Julphar Training Center –JTC

__________________________

Approved & Authorized ByDr. Rubina Rafiq Ejaz

Technical Training ManagerJulphar Training Center – JTC

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