cGMP File 3

What is cGMP?

cGMP stands for Current Good Manufacturing Practice and applies to facilities, buildings, production, equipment, process controls, laboratory controls, packaging, and labeling, and returned or salvaged drug products.

What is the goal of cGMP?

The goal of cGMP is to increase product quality by developing systems that proactively guarantee proper production design and control manufacturing processes and facilities.

What types of products must comply with cGMP?

The types of products that must comply with cGMP include pharmaceutical products, medical devices, biotechnology products, food and beverage, and dietary supplements.

What is the difference between GMP and cGMP?

GMP stands for Good Manufacturing Practice, while cGMP is the most current version of GMP.

Why is it important for pharmaceutical companies to be cGMP compliant?

Patients will be assured of the safety and efficacy of life-saving drugs like epinephrine, which is used for the treatment of anaphylactic shock, because they are cGMP compliant.

What is the difference between GMP and cGMP?

GMP is the minimum standard applicable to your industry, while cGMP ensures compliance with the most current rules and regulations applicable to your industry.

What are the three keywords that differentiate between GMP and cGMP?

Quality, cost, and current standards.

What is the purpose of following GMP or cGMP standards?

To ensure that products are safe, pure, and of the best quality.

What is the cost difference between implementing GMP and cGMP?

GMP is less costly to implement and maintain, while cGMP requires more investment in additional testing and state-of-the-art technologies.

Why is it important for the Pharmaceutical, BioTech, MedTech, and Medical Devices industries to be abreast of the latest regulations?

As GMP standards constantly improve, these industries must comply with the latest regulations, namely cGMP, to ensure the safety and quality of their products.

What is the difference between GMP and cGMP in terms of standards?

GMP is the required standard applicable to your industry, while cGMP ensures compliance with the most current rules and regulations applicable to your industry.

What is the difference between GMP and cGMP?

cGMP is more advanced and ensures compliance with the latest rules and regulations, while GMP only ensures compliance with current rules and regulations.

What is the cost difference between GMP and cGMP?

cGMP is more expensive because it requires additional testing and state-of-the-art technologies.

What do GMP and cGMP regulations ensure?

They ensure the quality and safety of products.

What is the timeline of the GMP regulations?

The 1906 pure Food and Drug Act created one of the first government regulatory agencies, followed by the 1938 Federal Food, Drug and Cosmetics (FD&C) Act, and then the Insulin Amendment and revisions to manufacturing and quality standards after tragedies involving sulfanilamide and sulfathiazoletablets.

What did the Insulin Amendment require?

It required the FDA to test and certify the purity and potency of insulin.

What was the result of the sulfanilamide tragedy?

It resulted in the requirement for manufacturers to prove the safety of products before marketing.

What was the result of the sulfathiazoletablets tragedy?

It resulted in revisions to manufacturing and quality standards by the FDA.

What was the result of the distribution of sulfathiazoletablets cross-contaminated with phenobarbital?

Nearly 300 deaths and injuries.

What were the Kefauver-Harris Drug Amendments?

A result of the Thalidomide catastrophe, which required manufacturers to prove efficacy and have stricter control over drugs.

What was the Thalidomide catastrophe?

A tragedy in which Thalidomide was used to treat morning sickness in pregnant women, resulting in 10,000 children born with serious deformities, such as phocomelia-malformations of the limbs.

When were the cGMP's final rules for drugs and devices established?

1978.

What do the cGMP's final rules for drugs and devices establish?

They establish minimum current GMPs for manufacturing, processing, packaging, or holding drug products and medical devices.

When was the first version of GMP guidelines introduced by the USFDA?

1963.

When was the WHO version of GMP prepared?

1967.

What is the worldwide enforcement of GMP?

It is the enforcement of GMP guidelines by regulatory bodies in different countries, such as the FDA in the United States, MHRA in the United Kingdom, and Therapeutical Goods Administration in Australia.

What is the United States regulatory agency responsible for ensuring the safety and efficacy of drugs?

The United States Food and Drug Administration (FDA).

What is the regulatory agency in the United Kingdom responsible for ensuring the safety and efficacy of drugs?

The Medicines and Healthcare Products Regulatory Agency (MHRA).

What is the regulatory agency in Australia responsible for ensuring the safety and efficacy of drugs?

The Therapeutic Goods Administration (TGA).

What is the regulatory agency in India responsible for ensuring the safety and efficacy of drugs?

The Ministry of Health (MoH).

What is the regulatory agency in Nepal responsible for ensuring the safety and efficacy of drugs?

The Department of Drug Administration.

Why is it important to manufacture drugs under conditions and practices required by cGMP regulations?

To assure that quality is built into the design and manufacturing process at every step and to ensure patient safety.

What are some basic requirements of cGMP?

Personnel, premises and industrial layout, sanitation and hygiene, water treatment system, validation and qualification.

What are the basic requirements of GMP?

Personnel, premises and industrial layout, sanitation and hygiene, water treatment system, validation and qualification, equipment materials, documentation (master formula records and batch manufacturing records), self-inspection and audits, warehousing area, QA, HVAC system ISO9001:2008, ISO14001:2004, 9000 series.

What are the 5 P's of GMP?

People, products, processes, procedures, premises.

What is the role of personnel in GMP?

They must comprehend rules and responsibilities.

What is the role of products in GMP?

Clear specifications must be provided at every phase of production.

What is the role of processes in GMP?

They must be properly documented, simple, and consistent.

What is the role of procedures in GMP?

Guidelines must be provided for undertaking critical processes.

What is the role of premises in GMP?

Cleanliness and calibration must be maintained at all times.

What is the importance of having qualified personnel in a manufacturing facility?

Qualified personnel must be sufficient to carry out tasks, and individual responsibilities must be clearly defined and understood by individuals concerned.

What should be provided to personnel whose duties take them into production areas or control laboratories?

The manufacturer should provide training for all personnel, including technical, maintenance, and cleaning personnel, and for other personnel whose activities could affect the quality of the product.

What are the appropriate protective garments that should be worn by personnel entering manufacturing areas?

Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out, considering diseases (communicable or noncommunicable), open lesions, skin diseases, and allergic conditions.

What is the importance of facility layout in a manufacturing facility?

Facility layout is an important aspect to be kept along to ensure suitability of the operation location design construction adaptation (new processes + future extensions) maintenance.

What are the conditions that should be considered in the facility layout of a manufacturing facility?

The conditions that exist within the buildings where the manufacture of the products will take place and the area of location are important aspects to be kept along to ensure suitability of the operation location design construction adaptation (new processes + future extensions) maintenance.

What are the requirements that a facility layout must satisfy?

Process requirements, personnel flows, material flows, equipment layout requirements, operational access requirements, and maintenance access requirements.

What is the primary purpose of the personnel flows in a facility layout?

To eliminate or minimize the potential for contamination of the cleanroom product and personnel.

What are the material flows that should be considered in a facility layout?

Raw materials, finished goods, waste, product (in-process, intermediate, and final), equipment, clean and dirty components, portable equipment, and product containers.

What is the principle that the layout and design of a facility should aim to achieve?

To minimize risks of error, permit effective maintenance, avoid cross-contamination, and build-up of dirt.

What is the preferred flow in a facility layout?

One-way flow.

What are the personnel flows that should be considered in a facility layout?

Manufacturing personnel, maintenance personnel, and quality personnel.

What should a facility layout provide if possible, particularly in changing areas?

Separate entry and exit ways.

What is the principle for the layout and design of a production area?

The principle for the layout and design of a production area should aim to minimize risks of error, permit effective maintenance, avoid cross-contamination, build-up of dirt and dust, and avoid any adverse effect on the quality of products.

What are the three flows that should be considered in the design of a production area?

The three flows that should be considered in the design of a production area are process flow, material flow, and people flow.

What are the hygiene and sanitization requirements for a production area?

Eating, drinking, and smoking are not allowed in the production area.

What are the requirements for washing and toilet facilities in a production area?

Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to the working area.

What are the eight design and construction requirements for a production area?

The eight design and construction requirements for a production area are ventilation, air filtration, air handling, and cooling, lighting, plumbing, sewage and refuse, washing and toilet facilities, sanitization, and maintenance.

What is the requirement for the condition of a building used for processing, packing, or holding a drug product?

It shall be maintained in a clean and sanitary condition.

What should a building used for processing, packing, or holding a drug product be free of?

It should be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals).

How should trash and organic waste matter be held and disposed of in a building used for processing, packing, or holding a drug product?

They should be held and disposed of in a timely and sanitary manner.

What should be done to ensure the cleanliness of a building used for processing, packing, or holding a drug product?

There should be written procedures assigning responsibility for sanitization and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the building and facilities.

Why is the maintenance of a building used for processing, packing, or holding a drug product important?

Deterioration of buildings not only presents a poor image of the facility but also can influence product quality.

What are the potential sources of insects and microbial contaminations in a building used for processing, packing, or holding a drug product?

Cracks in the ceiling, holes in the wall or floor crack.

What can water leakage cause in a building used for processing, packing, or holding a drug product?

Water leakage can cause significant damage to materials and equipment, give rise to electrical failure and fires, and result in damage to the basic structure of the building.

What can holes in the roof or near the tops of a building used for processing, packing, or holding a drug product provide?

They can provide ready access to birds, which may then be encouraged to visit within the building.

What is the purpose of holes in the roof or near the tops of buildings?

To provide ready access to birds, which may then be encouraged to visit within the building.

What are the general principles for pharmaceutical water systems?

Pharmaceutical water production, storage, and distribution systems should be designed, installed, commissioned, qualified, and maintained to ensure the reliable production of water of an appropriate quality.

Why is it necessary to validate the water production process in pharmaceutical water systems?

It is necessary to validate the water production process to ensure the water generated, stored, and distributed is not beyond the designed capacity and meets its specifications.

What should be monitored regularly in water sources and treated water in pharmaceutical water systems?

Water sources and treated water should be monitored regularly for chemical, microbiological, and, as appropriate, endotoxin contamination.

What is GMP validation?

GMP validation is an element of a quality assurance program for a pharmaceutical/biotech product or process to ensure that the processes, methods, tests, activities, and equipment they use are validated and verified to produce consistent and reliable results.

What is process validation?

It is a documented form of demonstrating that the processes, methods, tests, activities, and equipment deployed by a company are capable of repeatedly producing the desired product.

Why is process validation important?

It is important because each critical step in the manufacturing process must be verified to perform as intended under defined conditions.

Who has the authority and responsibility to inspect and evaluate process validation performed by manufacturers?

The FDA has the authority and responsibility to inspect and evaluate process validation performed by manufacturers.

What are the regulations that govern cGMP requirements for most organizations?

21 CFR Part 314: FDA approval for marketing a new drug.

What is the purpose of maintaining facilities and equipment in a pharmaceutical company?

To ensure that the conditions for manufacturing are safe and effective.

What is the importance of maintaining and calibrating equipment in a pharmaceutical company?

To ensure that the equipment is functioning properly and producing accurate results.

What are SOPs in a pharmaceutical company?

Standard Operating Procedures.

How can equipment calibration management software help manage equipment calibration schedules more efficiently?

The software automatically triggers calibration tasks before due dates, assigns activities to relevant employees, and sends email reminders about the upcoming tasks.

What is a core cGMP requirement?

Raw Materials and Products.

What is the purpose of the software that assigns activities to relevant employees and sends email reminders about upcoming tasks?

To manage tasks and ensure they are completed on time.

What is a core cGMP requirement for pharmaceutical products?

A master formula that must be followed without deviation throughout the entire manufacturing process.

Why is managing documentation using a manual system risky?

It increases the risk of human error and takes a lot of time.

How can a fully digital eQMS help ensure cGMP compliance?

By automating document control processes, reducing human error, and helping work more efficiently.

Why are trained staff required to operate every step of the manufacturing process under cGMP requirements?

To ensure compliance with regulations.

What should be done regularly to ensure compliance with cGMP requirements?

Revisit all procedures and make sure the latest science and technology are being used for products.

What are the necessary controls for complete data to meet cGMP compliance and regulatory requirements?

Not specified in the text.

What is the purpose of assigning ownership in meeting cGMP compliance and regulatory requirements?

Not specified in the text.

What are the necessary controls to ensure GMP compliance and regulatory requirements?

All data is complete with necessary controls.

What is the importance of assigning ownership to specific individuals for GMP compliance?

Assigning ownership to specific individuals ensures accountability.

Why is it important to authorize only selected individuals to make changes to records for GMP compliance?

Authorizing only selected individuals to make changes to records ensures data integrity.

What is the purpose of regular review of records for compliance, accuracy, and completeness in GMP compliance?

Regular review of records ensures that data is accurate and complete.

Why is it important to ensure that data is secure throughout its history for GMP compliance?

Ensuring that data is secure throughout its history ensures data integrity.

What is the main purpose of cGMP?

The main purpose of cGMP is to ensure that manufacturers, business organizations, and packagers of pharmaceutical products, medical devices, and certain foods must proactively guarantee that their products are effective, safe, and pure.

What are the benefits of being cGMP compliant?

The benefits of being cGMP compliant include facilities that are in good condition, equipment that is carefully maintained and calibrated, fully trained and qualified staff, procedures and protocols that are reproducible and reliable, and products that are of high-quality, safe, and efficacious.