MANUF LAB - cGMP (OWN)

Good Manufacturing Practice

It is a set of guidelines whose ultimate goal is to safeguard the patient and produce good-quality medicine, medical devices, or active pharmaceutical products.

Good Manufacturing Practice

It refers to the minimum requirements governments consider necessary for the production and control of human drugs, veterinary drugs, and medicinal device products.

Pure Food and Drug Act

This 1906 law prohibited the sale of adulterated food and drugs and emphasized truthful labeling.

American Chamber of Horrors

This 1933 event highlighted dangerous and misleading products available to consumers and demonstrated the limitations of earlier regulations.

Sulfanilamide Elixir Incident

This 1935 drug-safety incident involved sulfanilamide being prepared using the toxic substance diethylene glycol.

Diethylene Glycol

The toxic substance mixed with sulfanilamide

Federal Food, Drug, and Cosmetic Act

This 1938 law strengthened federal regulation and was intended to ensure products were safe before marketing.

Thalidomide

This 1959 drug was associated with birth defects, particularly phocomelia.

Frances Kelsey

This FDA inspector did not approve thalidomide for use in the United States.

Kefauver-Harris Amendment

This 1962 amendment strengthened requirements for pharmaceutical manufacturers, including documentation, teratogenic testing, and clinical trials.

Current good Manufacturing Practices

This refers to the guidelines that are active and constantly changing rather than fixed.

August 2023

This was the latest update of the PIC/S cGMP guidelines

RA 3720

The Philippine law that states the policy of the State to ensure a safe and good-quality supply of food, drugs, and cosmetics

AO No. 220 s. 1974

This AO concerns Current Good Manufacturing Practice in manufacturing, processing, packing, or holding.

AO No. 43 s. 1999

This AO concerns Current Good Manufacturing Practice Guidelines for Drugs.

AO. No. 2012-0008

This AO adopted and implemented the PIC/S Guides for GMP for medicinal products.

Pharmaceutical Inspection Convention

Pharmaceutical Inspection Co-operation Scheme

PIC/S

PIC/S

It is an informal cooperative arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use.

1995

PIC/S was established in this year as an extension to the PIC of 1970.

Fitness for use

According to Joseph M. Juran, quality means this.

Joseph M. Juran

Who said: Quality = Fitness for use

Conformance to requirements

According to Philip B. Crosby, quality means this.

Philip B. Crosby

Who said: Quality = Conformance to requirements

Zero Defects

This concept is associated with Philip B. Crosby and became a cornerstone for Six Sigma.

Pharmaceutical Quality System

This concept was previously termed Quality Management and is interchangeable with Quality Assurance.

Quality Policy

This refers to the overall intention and direction regarding quality, formally expressed and authorized by senior management.

Quality Management

This wide-ranging concepts covers everything that influences product quality and includes arrangement to ensure medicinal products are of the right quality for their intended use.

Quality Assurance

The totality of systemic actions that bring the quality policy to life

Validation

Critical steps of manufacturing processes and significant changes to the process must undergo this.

Personnel

They are who must be appropriately qualified and trained under GMP requirements.

Facilities for GMP

These include adequate premises and space, suitable equipment and services, correct materials and labels, and suitable storage and transport.

Instructions and Procedures

These must be written in clear and unambiguous instructional language.

Records

These are made during manufacture to demonstrate that required steps were taken and that the quantity and quality of the product were as expected.

Root Cause

Significant deviations must be fully recorded and investigated to determine this.

Corrective and Preventive Action

CAPA

Traceability

This ensures the complete history of a batch can be followed through manufacturing and distribution.

GDP

This is considered when distributing products to minimize risks to quality

Quality Control

It involves sampling, specifications, testing, documentation, and release procedures.

Quality Control

This ensures that materials and products are not released until their quality has been judged satisfactory.

Product Quality Reviews

These are regular periodic or rolling reviews of all authorized medicinal products.

Quality Risk Management

It is the systematic process for assessment, control, communication, and review of risks to the quality of a medicinal product.

Job Description

1 General personnel requirements

Organization Chart

2 General personnel requirements

Training

3 General personnel requirements

Authorized Person

1 Key personnel

Head of Production

2 Key personnel

Head of Quality Control

3 Key personnel

Independent

The Heads of Production and Quality Control should be _____ of each other.

Head of Production

This key personnel ensures that production and storage procedures are followed.

Head of Quality Control

This key personnel approves or rejects materials

Location

1 Important aspects of premises that help suitability of operations

Design

2 Important aspects of premises that help suitability of operations

Construction

3 Important aspects of premises that help suitability of operations

Maintenance

4 Important aspects of premises that help suitability of operations

Quarantine

incoming materials and finished products should be placed in this status immediately after receipt or processing until released.

Personnel

Major source of contamination