Reference

EDT (2010). The Ten Worst Drug Recalls In The History Of The FDA. 24/7 Wall St.
FDA (2015). "Drug Recalls." from http://www.fda.gov/Drugs/drugsafety/DrugRecalls/default.htm.
Ng, R. (2005). Good Manufacturing Practice: Regulatory Requirements. Drugs, John Wiley & Sons, Inc.: 211-246.
Wikipedia, 2015 'Quality assurance' avalaible from https://en.wikipedia.org/wiki/Quality_assurance
Orlando.L (2015), 'PSC3212-Reg bodies websites-150731', Retrieved from http://moodle.vle.monash.edu/mod/resource/view.php?id=2629508

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GMP

(Good Manufacturing Practice)

GMP

GMP is a quality concept, and consists of a set of policies and procedures for manufacturers of drug products. These polices and procedures describe the facilities, equipment, methods and controls for producing drugs with the intended quality. (Ng. R, 2003)

Definition GMP

GMP Principle:

Quality cannot be tested into a product, but must be designed and built into each batch of the drug product throughout all aspects of its manufacturing processes. (Ng.R, 2003)

GMP ensures:

pure
consistent
safe
effective

GMP regulatory guidelines are revised, updated all the time to implement new research, data or information. Thus, manufacture must keep abreast with current Good Manufacturing Practice (cGMP).

cGMP is similar in various of contries. However, it will be little different in some specific area.

GMP Regulation for different regulatory bodies

GMP regulation

When manufacturing drug, we need to have a

Quality System!

Click Me

Always build a

Quality system

to get the product/drug right, first time, any time

Quality System

Quality System?

Quality Assurance

Quality assurance (QA), refers to planned and systematic production processes that provide confidence in a product's suitability for its intended purpose. It is a set of activities intended to ensure that products (goods and/or services) satisfy customer requirements in a systematic, reliable fashion. QA cannot absolutely guarantee the production of quality products, unfortunately, but makes this more likely in order to satisfy the customer. (Wikipedia, 2015)

Definition

Site Title

One of the Quality Assurance is

GMP

(Good Manufacturing Pratice)

Click any arrows to see their regulation reqiurements and documentes -->

Anymore Quality Guidelines need to consider?

consider

ICH Q(8)-R2 pharmaceutical development guidelines

In this Q8 guidelines, it provides guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products. The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However, the principles in this guideline are important to consider during those stages as well. The principles of quality by design (QbD) is also described.

Discovery & Approval

DRUG

Reference

Ready?

GMP

(Good Manufacturing Practice)

GMP is a quality concept, and consists of a set of policies and procedures for manufacturers of drug products. These polices and procedures describe the facilities, equipment, methods and controls for producing drugs with the intended quality. (Ng. R, 2003)

GMP Principle:

Quality cannot be tested into a product, but must be designed and built into each batch of the drug product throughout all aspects of its manufacturing processes. (Ng.R, 2003)

GMP regulatory guidelines are revised, updated all the time to implement new research, data or information. Thus, manufacture must keep abreast with current Good Manufacturing Practice (cGMP).

cGMP is similar in various of contries. However, it will be little different in some specific area.

GMP Regulation for different regulatory bodies

When manufacturing drug, we need to have a

Quality System!

Always build a

Quality system

to get the product/drug right, first time, any time

Quality System?

Quality System?

Quality System?

Quality System?

Quality System?

Quality System?

Quality Assurance

Site Title

One of the Quality Assurance is

GMP

(Good Manufacturing Pratice)

Click any arrows to see their regulation reqiurements and documentes -->

Anymore Quality Guidelines need to consider?

ICH Q(8)-R2 pharmaceutical development guidelines

Click to see ICH Q8 website

MONASH University

Pharmacy and Pharmaceutical Sciences