good manufacturing practice presentation

Good Manufacturing Practice (GMP) Resources

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. 

GMP Resources

• What is GMP?
• GMP Regulations and Preambles
• GMP Guidelines
• GMP Resources by Country

Training Options

Classroom training.

• Applying the GMPs
• GMP Auditing for the Pharmaceutical Industry
• GMP Fundamentals for the Pharmaceutical Industry
• Q7A: Implementing Good Manufacturing Practices

Online Training

USFDA's Systems-Based GMP Inspection Approach

GMP compliance is widely-accepted as the best way to conduct business, putting product quality first. Representing the “original” GMP Institute, ISPE’s GMP courses combine a convenient format with an effective, interactive learning experience. To maximize and customize your professional development. Complete each of the individual US FDA's GMP Inspection Approach online courses for an overview of all the Systems.

• Quality Systems
• Facilities and Equipment Systems
• Materials Systems
• Production Systems
• Packaging and Labeling Systems
• Laboratory Control Systems

Online Webinars

• Industry Overview: Drug Dosage Forms  
• Regulatory Compliance: Standards Practices and Guides
• Regulatory Compliance: Government Regulations
• Risk Management and Quality Management Systems (QMS)

Pharmaceutical Engineering Articles

There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development approach. Advanced therapy medicinal products are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit, based on a...

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Books, Manuals, and Guidance Documents

• See all Guidance Documents
• See all Publications

Community of Practice

Join an ISPE community of practice to participate in discussions on specific topics with your peers. Learn more about Communities of Practice .

• Process/Product Development

GMP Regulation Handbooks

• 21 CFR Part 11: Electronic Signatures
• 21 CFR Part 111: Dietary Supplements
• 21 CFR Part 210 & 211: Pharmaceutical
• ICH Q7A: Active Pharmaceutical Ingredients
• ICH Q8R2: Pharmaceutical Development
• ICH Q9: Quality Risk Management
• ICH Q10: Quality Systems
• ICH Q11: Development and Manufacture of Drug Substances

Initiatives & Programs A to Z

• Advancing Pharmaceutical Quality
• Drug Shortages  
• Enabling Pharmaceutical Innovation
• Facility of the Year
• Good Manufacturing Practice
• ISPE Foundation
• ISPE in Europe
• Pharma 4.0™
• Product Quality Lifecycle Implementation
• Regulatory Digest Newsletter
• Women in Pharma®

Foundations of Good Manufacturing Practices

Good Manufacturing Practices (GMP) are critical to ensuring a medical product is quality assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients.

Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products.

This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP.

Developed by the Promoting the Quality of Medicines (PQM) program, which was funded by the U.S. Agency for International Development, this course is readily accessible for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities.

The self-paced course includes ten modules on GMP as it relates to:

• Medicinal products (finished dosage form)
• Active pharmaceutical ingredients (APIs)
• Quality risk management
• Deviations, root cause analysis (RCA) tools and corrective and preventive action (CAPA)
• Qualification of facilities, equipment, and utilities
• Data integrity and computer system validation
• Heating, ventilation, and air conditioning (HVAC) systems
• Water systems

The course is self-paced, with each module taking approximately 30-45 minutes to complete. Enroll here  

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• Pharmaceutical Quality Resources

Facts About the Current Good Manufacturing Practice (CGMP)

Pharmaceutical Quality  affects every American. The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Most people, however, are not aware of CGMP, or how FDA assures that drug manufacturing processes meet these basic objectives. Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMP. This paper discusses some facts that may be helpful in understanding how CGMP establishes the foundation for drug product quality.

What is CGMP?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, 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. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards.

It is important to note that CGMP regulations for drugs contain the minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.

Why is CGMP so important?

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

How does FDA determine if a company is complying with CGMP regulations?

FDA inspects pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained FDA staff. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the CGMP regulations.

If a manufacturer is not following CGMP, are drug products safe for use

If a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It does not mean that there is necessarily something wrong with the drug.

For consumers currently taking medicines from a company that was not following CGMP, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health. Consumers should seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with poor CGMP are often intended to prevent the possibility of unsafe and/or ineffective drugs. In rare cases, FDA regulatory action is intended to stop the distribution or manufacturing of violative product. The impact of CGMP violations depends on the nature of those violations and on the specific drugs involved. A drug manufactured in violation of CGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal. Thus, FDA’s advice will be specific to the circumstances, and health care professionals are best able to balance risks and benefits and make the right decision for their patients.

What can FDA do to protect the public when there are CGMP violations?

If the failure to meet CGMP results in the distribution of a drug that does not offer the benefit as labeled because, for example, it has too little active ingredient, the company may subsequently recall that product. This protects the public from further harm by removing these drugs from the market. While FDA cannot force a company to recall a drug, companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and can seize the drug.

FDA can also bring a seizure or injunction case in court to address CGMP violations even where there is no direct evidence of a defect affecting the drug’s performance. When FDA brings a seizure case, the agency asks the court for an order that allows federal officials to take possession of “adulterated” drugs. When FDA brings an injunction case, FDA asks the court to order a company to stop violating CGMP. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct CGMP violations, which may include repairing facilities and equipment, improving sanitation and cleanliness, performing additional testing to verify quality, and  improving employee training. FDA can also bring criminal cases because of CGMP violations, seeking fines and jail time.

How would a new drug company learn about CGMP and about FDA’s expectations on complying with them?

FDA publishes regulations and guidance documents for industry in the Federal Register . This is how the federal government notifies the public of what we are doing and why. FDA’s website, www.fda.gov also contains links to the CGMP regulations, guidance documents , and various resources to help drug companies comply with the law. FDA also conducts extensive public outreach through presentations at national and international meetings and conferences, to discuss and explain the CGMP requirements and the latest policy documents.

GOOD MANUFACTURING PRACTICES (GMP)

May 25, 2013

920 likes | 2.47k Views

GOOD MANUFACTURING PRACTICES (GMP). Rowan Chemical Engineering 2003. Delivering products free of all possible contamination. Guarantee high quality products to the consumer. OBJECTIVE. What are GMPs about?. P. M. G. TOOLS & MATERIALS. DRUGS & MEDICATIONS . HAIR PROTECTION. CONTRACTORS.

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Presentation Transcript

GOOD MANUFACTURING PRACTICES (GMP) Rowan Chemical Engineering 2003

Delivering products free of all possible contamination Guarantee high quality products to the consumer. OBJECTIVE

What are GMPs about? P M G

TOOLS & MATERIALS DRUGS & MEDICATIONS HAIR PROTECTION CONTRACTORS WASTE GLASS & LIGHT FIXTURES PRODUCT PROTECTION CIGARETTES PERSONAL HYGIENE FOOD INSERTS PEST CONTROL METALS PROTECTION FOOD & BEVERAGES BINS GMP CLOTHING

NOJEWELRY ALLOWED IN AREAS OF PRODUCT PRODUCTION OR STORAGE. • Rings / Necklaces / Bracelets / Earrings • Hair clips / Watches • Glasses with jewel decorations • NOOBJECTSCAN BE CARRIED IN POCKETS ABOVE THE WAIST LINE. CLOTHING

NOSHORTS/ SHORT SLEEVES SHIRTS/ SANDALS ARE ALLOWED IN AREAS OF PRODUCT PRODUCTION OR STORAGE. • THE APPROPRIATE UNIFORM OR LAB COAT SHOULD BE WORN IN AREAS OF PRODUCT PRODUCTION OR STORAGE. CLOTHING

HAIR PROTECTION

HAIR PROTECTION SHOULD BE WORN IN AREAS OF PRODUCT PRODUCTION OR STORAGE. • HAIR NETS PROVIDE ADEQUATE HAIR PROTECTION. • HAIR NETS should cover all the hair. HAIR PROTECTION

HAIR PROTECTION • SIDE BURNS that extend beyond ear lobes –line need to be covered by a BEARD NET. • MOUSTACHES that extend beyond the mouth line need to be covered by a BEARD NET.

FOOD AND BEVERAGES

FOOD & BEVERAGES • It is FORBIDDEN TO TAKE FOOD or CONSUME FOOD IN AREAS OF PRODUCT PRODUCTION OR STORAGE. This includes CHEWING GUM.

DRUGS & MEDICATIONS

DRUGS & MEDICATIONS • MEDICATIONS AND PRESCRIBES DRUGS ARE NOT ALLOWED IN AREAS OF PRODUCT PRODUCTION OR STORAGE.

BANDAGES • ALL CUTS should be covered with appropriate bandages • Clean gloves will be worn to isolate bandages from products. DRUGS & MEDICATIONS

GLASS & ILLUMINATION

GLASS & ILLUMINATION • ALL GLASS MATERIALS ARE FORBIDDEN IN AREAS OF PRODUCT PRODUCTION OR STORAGE.

GLASS & ILLUMINATION • All burnt light bulbs will NOT be discarded in waste bins in AREAS OF PRODUCT PRODUCTION OR STORAGE.

PEST CONTROL

WHAT ARE THE USUAL PESTS? PEST CONTROL • INSECTS • MICE/RATS • SPIDERS • BIRDS

HOW DO WE CONTROL PESTS? PEST CONTROL • Maintaining GOOD CONDITIONS OF SANITATION. • PEST CONTROL PROGRAM.

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Good Manufacturing Practices Campaign

Good manufacturing practices campaign presentation, free google slides theme and powerpoint template.

From pharmaceuticals to food products, having good manufacturing practices help manufacturers adhere to strict standards and regulations that minimize the risk of contamination and errors during the production process. This editable template has our seal of approval (actually, it has some icons that look like seals of approval), so its manufacturing must have been adhered to those practices! Make the most of the colorful elements and push your campaign so that it reaches as many people as possible.

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