GMP and cGMP

1967

year when WHO drafted GMP on the manufacture and quality control of medicines and pharmaceuticals upon the request of the 20th world health assembly

1968

year when the GMP draft was revised, adapted, and published as annex to the 22nd report

1971

year when GMP was reproduced in the supplement to the 2nd edition of the international pharmacopeia

producing

the quality of a formulation or a bulk drug depends on the quality of those ________ it

gmp

is the magic key that opens the door of the quality

interchangeably

GMP and cGMP are terms that can be used _____________

protection of the public health

GMP and cGMP are both guidelines that give the highest priority to the ____________________

minimum requirements

GMP and cGMP also define _________________

cGMP

the newer version of guidelines

cGMP

contains guidelines that are applicable in these present times due to new technology and concept use and applied in manufacturing

gmp

set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality

quality assurance

gmp is a part of _____________

1 multiple choice option

quality standards

gmp is a part of quality assurance, which ensures that the products are consistently manufactured and controlled to the _________________ appropriate to their intended use and as required by the marketing authorization, clinical trial authorization, or product specification

production, quality control

gmp involves both __________ and __________

quality, safety, efficacy

GMP exists to ensure the ______, _______, and ________ of products

batch

the basic tenet of GMP is that quality control cannot be tested into a __________ of the product

built into

a basic tenet of GMP is that quality cannot be tested into a batch of the product but must be ___________ each batch of a product during all stages

gmp

is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

cGMP

also the main regulatory standard for ensuring pharmaceutical quality

cGMP

requiring companies to use up-to-date technologies and systems to comply with the regulations

flexibility

cGMP's requirements established that permit ______________ to every manufacturer to decide individually how to implement the necessary best and even the best controls for their organization by using scientifically sound design, processing methods, control of manufacturing process and facilities, and testing procedures

higher product quality

the flexibility in these regulations of cGMP allows companies to use modern technologies and innovative approaches to achieve _________________ through continual improvement.

safety, identity, strength, quality, purity

cGMP is the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to _________, and has the __________ and ___________ and meets the ___________ and ___________ characteristics that it purports or is represented to possess

unexpected contamination of products, incorrect labels on containers, insufficient or too much active ingredient

3 main risks of cGMP

harmful substances

the guidelines are enacted to ensure food, drugs, cosmetics, medical devices and related products have no _____________

product recalls, harmful effects, eventual lawsuits

these regulations, enforced by the FDA, help reduce the instances of ___________, ________, and ____________ that may arise from defective products

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 every step

consistency

GMP is important to achieve __________ in product production and quality control

export opportunities

GMP helps boost pharmaceutical ___________

facilities

upon the inspection of the FDA, includes __________ that manufacture active ingredients and the finished product

fully compliant

If the manufacturer has no issues and has fully complied with all aspects or areas of CGMP regulations and standards, then the manufacturer is found to be ______________

compliance

determination through inspection of the content to which a manufacture is acting in accordance with prescribed regulations, standards and practices

non-compliance

the FDA found during the conduct of inspection of the manufacturer any slight issues, problem and deviance or not following in even aspect or areas of the CGMP regulations then FDA has the authority to issue warning letters and reports detailing areas of _______________

corrected, not be approved

subsequently, these areas highlighted with non-compliance must be __________ within a suitable timeframe, or a company's products will ____________ for sale into the market

adulterated

any drug not made within compliance is considered ____________ under the law

adulterated

means that the drug was not manufactured under conditions that comply with cGMP

policies, standard operating procedure, specifications, master formula record, batch manufacturing record, manuals, master plans/files, validation protocols, forms and formats, records

10 important documents in GMP

ao no. 43 s. 1999

philippine cGMP was a government mandate issued under _________________

secretary of health

philippine cGMP was issued under the authority of the government __________________

general provision, basic gmp guidelines, guidelines on sterile products

3 parts of the philippine cGMP

FDA

here, the QC unit is responsible for quality

WHO, EU

these define both separate and joint responsibilities for the QC unit and production management

FDA

here, education, knowledge, skills, or experience needed for specific job functions are not defined

WHO, EU

here, education, knowledge, skills, or experience needed for specific job functions is provided

FDA

here, it focuses on levels of approval

ICH

here, it focuses on stability requirements

quality assurance

it is the sum total of the organized arrangements with the objective of ensuring that products will be of the quality required for their intended use

quality assurance

All those planned or systematic actions necessary to provide adequate confidence that a product will satisfy the requirements for quality

quality assurance

QA/QC; company based

1 multiple choice option

quality control

is that part of GMP which is concerned with sampling, specifications, testing and with in the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out

quality control

Operational laboratory techniques and activities used to fulfill the requirement of Quality

quality control

QA/QC; lab-based

1 multiple choice option

quality assurance

QA/QC; prevention

1 multiple choice option

quality assurance

QA/QC; planning first to avoid the defect or error from occurring

1 multiple choice option

quality assurance

QA/QC; process-based approach

1 multiple choice option

quality assurance

QA/QC; involves processes managing quality

1 multiple choice option

quality control

QA/QC; detection

1 multiple choice option

quality control

QA/QC; finding defects and correcting them, whole making the product

1 multiple choice option

quality control

QA/QC; product-based approach

1 multiple choice option

quality control

QA/QC; involves verifying the quality of the product

1 multiple choice option